Current News

Date Title
06/19/2017 New Study Compares Performance of Masimo Next Generation SedLine® Patient State Index (PSi) to Original PSi During Anesthesia
06/05/2017 Masimo Announces Limited Market Release of Rad-67™ rainbow® Pulse CO-Oximeter® with Next Generation SpHb®
06/01/2017 Masimo and Mdoloris Announce Masimo Open Connect™ (MOC) Partnership for the Root® Patient Monitoring and Connectivity Hub
05/30/2017 Masimo Announces FDA 510(k) Clearance of O3™ Regional Oximetry for Pediatric Patients
05/19/2017 Masimo Announces the Full Market Release of Early Warning Score (EWS) with the Root® Patient Monitoring and Connectivity Hub
05/15/2017 Midmark, Masimo Announce Partnership to Improve Vital Signs Acquisition
05/15/2017 Multicenter Study at UC Davis, UC Los Angeles, and Mayo Clinic Evaluates the Trend Accuracy of Masimo Continuous SpHb®
05/09/2017 Masimo Introduces Rad-G™ Pulse Oximeter
04/11/2017 Two Fire Rescue Departments Honored for Excellence in Emergency Medical Services
04/10/2017 Masimo Announces Full Market Release of Root® Patient Monitor and Connectivity Hub with Kite™ Supplemental Display System
03/27/2017 Massena Memorial Hospital of New York Adopts Masimo Root® and Masimo Patient SafetyNet™
03/20/2017 Masimo Announces CE Marking of Rad-97™ Pulse CO-Oximeter® and Connectivity Hub with Noninvasive Blood Pressure
03/13/2017 New Study Evaluates the Utility of Masimo SpHb® Monitoring During Liver Transplantation
03/06/2017 Masimo Announces Availability of the RD SedLine® Adult EEG Sensor
02/27/2017 New Study Assesses the Utility of Masimo PVi® Monitoring During Colorectal Surgery
02/21/2017 Masimo Announces Recent Study Monitoring Methemoglobin Levels During Administration of Inhaled Nitric Oxide
02/15/2017 Masimo Announces CE Marking of Respiration Rate Measurement on MightySat™ Rx
02/01/2017 Masimo Announces the Addition of Early Warning Score to the Root® Patient Monitoring and Connectivity Platform
01/02/2017 Masimo Reaffirms Commitment to India with Launch of Advanced Monitoring Technologies Made for India
12/19/2016 Masimo Announces FDA 510(k) Clearance for TFA-1™ Single-Patient-Use Forehead Sensor
12/06/2016 Giving Back with Masimo
11/11/2016 Masimo Receives Gates Foundation Grant to Develop Combined Pneumonia-Screening Device for High-Burden Settings
11/07/2016 Philips and Masimo Sign Multi-Year Business Partnership Agreement in Patient Monitoring and Select Therapy Solutions
10/22/2016 Study Investigates the Impact of Masimo Continuous SpHb® and PVI® on Anesthesia-related Mortality
10/06/2016 Masimo Announces CE Marking of Rad-97™ Pulse CO-Oximeter®
10/02/2016 Masimo Honors Birthday of Mahatma Gandhi with Global Holiday
09/30/2016 Masimo Partners with Smile Train to Advance Safe Surgery
09/26/2016 Masimo Foundation Co-Founds United for Oxygen Alliance
09/15/2016 Study on Abdominal Surgical Patients Investigates Clinical Utility of Masimo PVI®
09/09/2016 New Study Finds Continuous, Noninvasive Hemoglobin Monitoring Using Masimo SpHb® May Reduce Intraoperative Red Blood Cell Transfusion
09/06/2016 Masimo MightySat™ is Available at Apple.com and Select Apple Retail Stores in the US and Canada
09/02/2016 Masimo Announces Amendment to Nellcor Royalty Agreement
08/29/2016 Masimo Announces a Special Worldwide Program for Total Hemoglobin (SpHb®) Monitoring for Areas Affected by the Zika Virus
08/29/2016 Masimo Announces Four-Year Partnership with World Federation of Societies of Anaesthesiologists (WFSA)
08/18/2016 Masimo Announces CE Marking for RAS-45 Sensor for rainbow Acoustic Monitoring® of Respiration Rate
08/15/2016 New Article Showcases an Effective Surveillance System for General Care Units Using Masimo Patient SafetyNet™
08/04/2016 Masimo Announces CE Marking for Pediatric O3™ Regional Oximetry
07/28/2016 Leading Ohio Critical Access Hospital Adopts Masimo Root® with Radius-7® , Radical-7® , and Patient SafetyNet™ to Create Hospital-Wide Wireless Monitoring and Clinician Notification System
07/21/2016 New Study Evaluates Masimo PVI® as a Predictor of Fluid Responsiveness in Patients Undergoing Liver Transplantation
07/14/2016 New Study Assesses Utility of 1st Generation Masimo Pronto® Pulse CO-Oximeter® with SpHb® Spot Check Technology in Evaluating Pediatric Trauma Patients
07/07/2016 One of the World's Leading Centers for Cardiovascular Medicine & Transplantation Adopts Masimo's SedLine® Brain Function Monitoring and O3™ Regional Oximetry
06/28/2016 Masimo Announces FDA 510(k) Clearance for Radius-7® with rainbow® Technology, Including Continuous SpHb®
06/23/2016 New SunTech Medical CT40 Vital Signs Device to Feature Masimo SET® Pulse Oximetry Technology
06/13/2016 Masimo Announces FDA 510(k) Clearance for O3™ Regional Oximetry
06/08/2016 Masimo Announces Full Market Release of Next Generation SpHb® Spot Check Pronto®
06/02/2016 One of India's Premier Maternal Care Specialists, Motherhood Hospitals, Standardizes on Masimo SET® Technology
05/26/2016 Masimo to Showcase Next Generation SedLine® Brain Function Monitor at 2016 Euroanaesthesia Congress
05/19/2016 Two Fire Departments Honored for Excellence in Emergency Medical Services
05/04/2016 Masimo Reports First Quarter 2016 Financial Results
04/21/2016 One of France's University Hospitals Adopts Masimo Radical-7®, Including SpHb®, PVI®, and SET® Pulse Oximetry
04/20/2016 Masimo to Report First Quarter 2016 Financial Results after Market Close on Wednesday, May 4
03/31/2016 New Clinical Study Reports Relationship Between Masimo's Oxygen Reserve Index (ORI™) and Arterial Partial Pressure of Oxygen During Surgery
03/17/2016 New Study Reports on Accuracy of Masimo's Blue® Sensors at Saturations Below 85% in Children with Cyanotic Congenital Heart Disease
03/02/2016 Masimo Introduces SafetyNet™ Surveillance at HIMSS16
03/01/2016 Masimo Announces Iris™ Gateway at HIMSS16
02/25/2016 Manipal Hospitals is the First in India to Adopt Masimo Patient SafetyNet™
02/17/2016 Masimo Announces FDA 510(k) Clearance for Root® with Noninvasive Blood Pressure and Temperature
02/12/2016 Masimo's rainbow® Acoustic Monitoring (RAM™) was Associated with Fewer Alarm Events During Planned Moderate Sedation in New Clinical Study
02/04/2016 In New Clinical Study Masimo's Oxygen Reserve Index Helps Clinicians Detect Impending Desaturation in Pediatric Patients
01/29/2016 Masimo to Report Fourth Quarter 2015 Financial Results after Market Close on Tuesday, February 23
01/21/2016 New Study Shows Utility of Masimo rainbow Acoustic Monitoring™
01/19/2016 Dr. Steven Barker Awarded the Society for Technology in Anesthesia's J.S. Gravenstein Award for Lifetime Achievement
01/13/2016 North Carolina's Appalachian Regional Healthcare System Selects Patient SafetyNet™ and Radius-7™
01/06/2016 Masimo to Debut Respiration Rate in MightySat™ at Consumer Electronics Show – First Fingertip Pulse Oximeter to Measure Breath Rate
12/18/2015 Masimo Pledges to Increase Investment in Research & Development in Response to Today's Moratorium on the Medical Device Tax
12/17/2015 Retired U.S. Senator Tom Harkin Joins Masimo's Board of Directors
12/01/2015 T.J. Samson is the First Hospital in Kentucky to Adopt Patient SafetyNet™
11/25/2015 Giving Back With Masimo
11/24/2015 Masimo to Present at 27th Annual Piper Jaffray Healthcare Conference
11/16/2015 India's Leading Maternity and Birthing Care Hospital Group, Cloudnine, Adopts Masimo SET® Technology to Screen Infants for CCHD
11/12/2015 In New Study EMMA™ Capnograph Has Comparable Accuracy to Sidestream Capnography Against Gold-Standard Blood Gas Analysis
11/05/2015 Masimo Reports Third Quarter 2015 Financial Results and Announces New Five Million Share Repurchase Plan
10/29/2015 Two New Clinical Studies Using Masimo Technologies Presented at the American Society of Anesthesiologists Annual Meeting
10/27/2015 Masimo Announces FDA 510(k) Clearance for MightySat™ Rx Fingertip Pulse Oximeter
10/22/2015 Masimo & Atheer to Demonstrate Prototype of Interactive Root® Iris™ Display Powered by AiR™ Smart Glasses Platform
10/22/2015 Masimo to Report Third Quarter 2015 Financial Results after Market Close on Thursday, November 5
10/14/2015 Dr. Steven Barker Awarded the 2015 IAMPOV Lifetime Achievement Award
10/08/2015 Masimo PVI® Evaluated in 18-Study Meta-Analysis For Ability to Help Clinicians Assess Fluid Responsiveness
09/28/2015 Masimo Donates $5 Million in Medical Equipment to Assist Jordan in Providing Healthcare to Over 1 Million Syrian Refugees
09/14/2015 Ranken Jordan Pediatric Bridge Hospital Upgrades their Monitors to the Radical-7® Featuring Masimo SET® Pulse Oximetry
09/08/2015 Masimo to Present at Morgan Stanley Global Healthcare Conference
08/26/2015 Masimo Partners with St. Joseph Hoag Health to Open a Wellness Center for Employees inside their Headquarters
08/25/2015 Brazil's A.C.Camargo Cancer Center Adopts Masimo SpHb for Noninvasive and Continuous Hemoglobin Monitoring
08/05/2015 Masimo Reports Second Quarter 2015 Financial Results
07/13/2015 Masimo Renews its $1,000,000 Performance Guarantee that Masimo SET® Technology will Outperform All Nellcor™ Pulse Oximeters
06/30/2015 Turkey's Leading University Hospital Adopts Masimo SpHb for Continuous Noninvasive Haemoglobin Monitoring
06/22/2015 Masimo Receives CE Mark for MightySat Rx Pulse Oximeter
06/18/2015 Masimo iSpO2 Pulse Oximeter Set to Measure Audience Reaction to
06/15/2015 Masimo Announces Root CE Marking with Blood Pressure and Temperature
06/10/2015 Masimo Root Wins the GOLD 2015 Medical Design Excellence Award
06/05/2015 New Study Presented at the 2015 Euroanaesthesia Congress Evaluated the Impact on Mortality and Morbidity with Masimo SpHb and PVI
05/20/2015 Court Upholds Award of $467 Million to Masimo for Philips' Patent Infringement
05/14/2015 Perioperative Enhanced Recovery Program that Included Masimo PVI Led to Significant Reductions in Length of Stay, Complications and Costs
05/07/2015 Joe Kiani Launches Social Media Presence
05/06/2015 Masimo Reports First Quarter 2015 Financial Results
04/29/2015 Masimo's MightySat Pulse Oximeter Monitoring Elite Athletes at Vertical Blue Freediving Competition
04/24/2015 Masimo Proudly Sponsors Award-Winning Documentary "Personal Gold" During 2015-16 Film Festival Season
04/22/2015 U.S. Chamber of Commerce Presents Masimo CEO Joe Kiani with Intellectual Property Champion Award
04/13/2015 Masimo Announces Patient SafetyNet Series 5000 with Iris Connectivity and MyView
04/09/2015 Three Fire Departments to be Honored for Excellence in Emergency Medical Services
04/02/2015 Illinois Fire Service Institute Is First to Train Firefighters on New Carbon Monoxide Safety Standard
03/31/2015 New Clinical Study Presented at the International Anesthesia Research Society's Annual Meeting Shows Benefit of Masimo's Oxygen Reserve Index, ORI
03/27/2015 Penn Highlands DuBois Installs Masimo SedLine Brain Function Monitoring
03/20/2015 Masimo to Showcase Root® Solutions for the OR and ICU at the International Anesthesia Research Society's 2015 Annual Meeting and International Science Symposium
02/26/2015 Korean Regulators Clear Masimo PVI® for Clinical Use
02/20/2015 CFSI Announces Masimo as Co-Sponsor of the Excellence In Fire Service-Based EMS Award
02/17/2015 Masimo Reports Fourth Quarter and Full Year 2014 Financial Results
02/12/2015 National Fire Protection Association Issues Updated Standard Requiring Firefighters Exposed to Fire Smoke to be Assessed for Carbon Monoxide Poisoning at Incident Scenes and During Training
01/15/2015 Inova Fair Oaks Hospital Casts Masimo Patient SafetyNet™ to Help Improve Patient Outcomes and Reduce Costs
01/06/2015 Masimo Unveils MightySat™ at Consumer Electronics Show - First Fingertip Pulse Oximeter with Masimo SET® Measure-through Motion and Low Perfusion™ Technology
12/30/2014 CES 2015 – Come for the Spectacle, Stay for the Science.
12/16/2014 Masimo Announces Global Launch of Multigas Monitoring for the Root® Patient Monitoring and Connectivity Platform
12/15/2014 Happy Holidays from Masimo!
12/04/2014 Masimo iSpO2™ Pulse Oximeter Featured in Fitness Book by Tour de France Champion Greg LeMond
12/01/2014 Masimo Announces FDA 510(k) Clearance of Radius-7™ – First rainbow® SET® Noninvasive Wearable, Wireless Monitor for Root®
11/05/2014 New Clinical Study Shows Accuracy of Masimo Noninvasive Spot-Check Hemoglobin (SpHb®) in Trauma Patients
10/29/2014 Masimo Reports Third Quarter 2014 Financial Results
10/23/2014 Arkansas Heart Hospital Upgrades to Masimo SET® Pulse Oximetry, Resulting in Significant Reduction in False Alarms and Improved Patient Care and Satisfaction
10/16/2014 Two New Clinical Studies Show Masimo Noninvasive Hemoglobin (SpHb®) Demonstrated Similar Precision as Hemoglobin from Point of Care Devices
10/15/2014 New Clinical Study Presented at the American Society of Anesthesiologists Annual Meeting Shows Benefit of Oxygen Reserve Index™, ORI™
10/14/2014 Retrospective Study of Enhanced Recovery After Surgery Program for Patients Undergoing Colorectal Surgery, which Included Fluid Therapy Tailored to Masimo's PVI®, Showed Reduced Length of Stay and Cost Savings
10/10/2014 Masimo Announces CE Mark of Eve™ Newborn Screening Application for Radical-7, an Intuitive Software Feature to Help Clinicians More Effectively Screen for Critical Congenital Heart Disease
10/07/2014 Masimo Announces CE Mark of the 11th rainbow® Parameter - ORI™, Oxygen Reserve Index™
09/29/2014 Mercy Hospital of Buffalo Expands Use of Masimo Patient SafetyNet™ After Pilot Program Shows Reduction in Mortality
09/25/2014 Masimo Announces MX-5 OEM Circuit Board, Offering Breakthrough rainbow® Pulse CO-Oximetry™ Measurements at 250mW
09/19/2014 Masimo PVI® Helped Assess Fluid Responsiveness in Clinical Study of Adult, Noncardiac Patients
09/04/2014 Yale-New Haven Hospital Upgrades to Masimo SET® Pulse Oximetry for Improved Patient Outcomes
08/28/2014 Masimo Announces CE Mark and Limited Market Release of rainbow® DCI-mini™ – First Noninvasive Total Haemoglobin (SpHb®) Spot-Check Sensor for Infants and Small Children
08/22/2014 New Clinical Study Evaluates Masimo RAM™ Technology for Tracking Changes in Respiratory Rate in Anesthetized Patients
08/12/2014 New Study of Masimo Noninvasive and Continuous Hemoglobin (SpHb®) Monitoring Evaluates Trending and Accuracy in Pediatric Patients
08/07/2014 Masimo Reports Second Quarter 2014 Financial Results
07/28/2014 Masimo Announces CE Mark and Limited Market Release of Radius-7™ – First rainbow® SET® Noninvasive Wearable, Wireless Monitor for Root®
07/09/2014 New Study Evaluates Trending Accuracy and Reliability of Masimo's Continuous and Noninvasive SpHb® Technology
06/30/2014 Masimo Announces FDA Clearance of Root ™ Patient Monitoring Platform with Capnography, IRIS™ Standalone Device Connectivity, and MOC-9™ Third-Party Measurement Expansion
06/27/2014 Masimo Announces Support for the Every Newborn Action Plan to Reduce Global Newborn Mortality
06/25/2014 Masimo Announces TFA-1™ Transflectance Adhesive Forehead Sensor
06/18/2014 New Study of Masimo Noninvasive and Continuous SpHb® Monitoring Demonstrates Accuracy and Utility in Double-Jaw Surgery
06/12/2014 New Study Shows Masimo Noninvasive SpCO® Helps Clinicians Increase Detection of Carbon Monoxide Poisoning in Emergency Department Patients
06/06/2014 Two Randomized Trials Presented at the Euroanaesthesia 2014 Congress Show Similar Fluid Administration and Risk Profile with PVI as with Invasive or Complicated Procedures
05/21/2014 Masimo Patient SafetyNet™ and SpHb® Noninvasive Hemoglobin Monitoring Enable Clinicians to Meet New Guidance from Centers for Medicare & Medicaid Services
05/15/2014 New Study Shows Masimo SET® Pulse Oximetry Helps Yale-New Haven Children's Hospital Significantly Reduce Retinopathy of Prematurity in Newborns
05/08/2014 Masimo to Present at Bank of America Merrill Lynch 2014 Health Care Conference
05/06/2014 Largest-Ever Study of Newborn Screening for Congenital Heart Disease Again Shows Masimo SET® Pulse Oximetry as Effective Tool
05/02/2014 Masimo Celebrates 25th Anniversary of its Incorporation with Major Initiatives to Improve Patient Safety
04/30/2014 Masimo Reports First Quarter 2014 Financial Results
04/17/2014 Masimo to Report First Quarter 2014 Financial Results after Market Close on Wednesday, April 30
04/07/2014 New Clinical Study Shows Masimo PVI® Helps Clinicians Optimize Fluid Administration in Patients Under Combined General and Epidural Anesthesia
04/04/2014 Masimo Expands Its Board of Directors with Appointment of Medical Device Executive Craig Reynold
03/06/2014 Flagler Hospital Upgrades to Masimo SET® Pulse Oximetry for Improved Patient Outcomes
03/03/2014 Masimo to Present at 26th Annual ROTH Conference
02/25/2014 North Oaks Medical Center Is First to Integrate Masimo Patient SafetyNet™ with EPIC Electronic Medical Record System
02/21/2014 Masimo to Present at Raymond James 35th Annual Institutional Investors Conference
02/20/2014 Masimo Unveils iSpO2® Pulse Oximeter for Android™
02/19/2014 Masimo to Present at 2014 Citi Global Healthcare Conference
02/14/2014 Masimo Reports Fourth Quarter and Full Year 2013 Financial Results
01/30/2014 Masimo to Report Fourth Quarter and Full Year 2013 Financial Results after Market Close on Thursday, February 13
01/23/2014 Masimo Announces CE Marking of O3™ Regional Oximetry
01/07/2014 Masimo Brings High Technology Medical Equipment to India
01/07/2014 Masimo to Present at 32nd Annual J.P. Morgan Healthcare Conference
12/19/2013 Children's Hospital St. Elisabeth in Neuburg/Donau Installs Masimo Patient SafetyNet™ System for Advanced Care and Oversight of General Ward Patients
12/16/2013 Happy Holidays from Masimo!
12/10/2013 Study Shows Noninvasive SpCO® Helps Clinicians Detect Occult Carbon Monoxide Poisoning
12/09/2013 Masimo and Newborn Foundation Jointly Announce Mobile Health Initiative to Reduce Global Newborn Mortality
11/22/2013 ACUTRONIC Medical Systems Integrates Masimo SET® Pulse Oximetry into fabian HFO Neonatal Critical Care Ventilators for Improved Patient Outcomes
11/18/2013 Masimo Receives 2013 Zenith Award at the American Association of Respiratory Care Congress
11/05/2013 New Published Clinical Study Shows Masimo PVI® Helps Clinicians Assess Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock
10/31/2013 Masimo Announces Japan Launch of iSpO2 Pulse Oximeter for iPhone, iPad, and iPod touch
10/18/2013 Masimo to Report Third Quarter 2013 Financial Results after Market Close on Wednesday, October 30
10/17/2013 Multiple New Clinical Studies Presented at the American Society of Anesthesiologists Annual Meeting Show Benefits of RAM & PVI
10/08/2013 Multicenter Study Shows Clinical Value of rainbow® Acoustic Monitoring (RAM™)
10/04/2013 EMMA™ Palm Size Capnograph Earns 2013 EMS World Top Innovation Award
09/13/2013 Rochester General Health System Installs Masimo Patient SafetyNet™ for Advanced Care and Oversight of Patients
09/06/2013 Saint Alphonsus Regional Medical Center Installs Masimo Patient SafetyNet™ System for Improved Oversight of Patients
08/29/2013 Firat University Hospital Installs Masimo Patient SafetyNet™ System for Improved Oversight of NICU Patients
08/22/2013 Douglasville Nursing and Rehabilitation Center Installs Masimo Patient SafetyNet™ System for Improved Patient Monitoring
08/16/2013 Pathways Nursing & Rehabilitation Center Standardizes to Masimo SET® Pulse Oximetry
08/06/2013 OU Medical Center Upgrades to Masimo SET® Pulse Oximetry for Improved Patient Outcomes
07/31/2013 Masimo Reports Second Quarter 2013 Financial Results
07/31/2013 Masimo Announces Eight of Top 10 U.S. Hospitals Now Use Masimo SET® Pulse Oximetry Technology Hospital-Wide
07/23/2013 Community Health Ventures Signs New Supplier Agreement with Masimo
07/16/2013 Masimo to Report Second Quarter 2013 Financial Results after Market Close on Wednesday, July 31
07/15/2013 Masimo Unveils EMMA™ Mainstream Capnograph for Enhanced Assessment of End-Tidal Carbon Dioxide
07/11/2013 French Society of Anaesthesia and Intensive Care Adds Masimo PVI® to Guidelines for Perioperative Hemodynamic Optimization
07/09/2013 The Joint Commission Issues National Patient Safety Goal and Requirements for Medical Device Alarm Management
06/19/2013 South Shore Hospital Standardizes to Masimo SET® Pulse Oximetry for Improved Patient Monitoring
06/11/2013 Masimo Signs Far-Reaching Pulse Oximetry Distribution Deal with Butler Schein Animal Health
06/06/2013 University Children's Hospital Basel Installs Masimo Patient SafetyNet™ System for Advanced Care and Oversight of General Ward Patients
06/03/2013 Masimo Announces Root™
05/30/2013 Masimo Renews $1,000,000 Guarantee that Masimo SET® Will Outperform All Covidien Nellcor™ Pulse Oximeters
05/23/2013 El Paso Children's Hospital Standardizes to Masimo SET® Pulse Oximetry
05/21/2013 Study Shows Noninvasive SpCO® Can Help Rapidly Detect Carbon Monoxide Poisoning in the Emergency Department
05/21/2013 Masimo CEO Joe Kiani Receives Argyros Medal for Visionary Leadership & Commitment to Patient Safety
05/16/2013 New Clinical Study Finds Masimo rainbow® Acoustic Monitoring™ Technology More Accurately, Precisely, and Reliably Detects Ventilatory Pauses in Post-Surgical Patients
05/15/2013 New Published Clinical Study Shows Masimo PVI® Helps Clinicians Assess Fluid Responsiveness in Pediatric Patients
05/13/2013 New Clinical Studies Presented at the International Anesthesia Research Society Annual Meeting Show Benefits of Masimo Noninvasive Patient Monitoring Technologies: SpHb®, RRa™, and SedLine®
05/08/2013 Uludag University Hospital Installs Masimo Noninvasive rainbow® Technology to Improve Patient Assessments and Speed Clinical Decisions
05/07/2013 FDA Clears Masimo rainbow® Acoustic Monitoring™ Sensor for Use on Pediatric Patients
05/02/2013 Masimo Reports First Quarter 2013 Financial Results
04/29/2013 Masimo iSpO2 Pulse Oximeter & EMMA Emergency Capnometer Earn JEMS Hot Products Awards
04/26/2013 Masimo Steps Up with March for Babies™ to Fight for Healthier Newborns
04/18/2013 Masimo to Report First Quarter 2013 Financial Results after Market Close on Thursday, May 2
04/05/2013 East Tennessee Children's Hospital Installs Masimo Patient SafetyNet™ System for Improved Oversight of Postoperative Patients
03/27/2013 Holland Hospital Installs Masimo Noninvasive rainbow® Technology to Help Improve Patient Assessments and Speed Clinical Decisions
03/20/2013 Hospital General Universitario Santa Lucia Is First in Spain to Install Masimo Patient SafetyNet™ System for Improved Oversight of its Neonatal Care Unit
03/07/2013 Masimo to Present at 25th Annual ROTH Conference
02/20/2013 University of Virginia Medical Center Installs Masimo Noninvasive rainbow® Technologies to Improve Patient Assessments and Speed Clinical Decisions
02/19/2013 Masimo to Present at Raymond James 34th Annual Institutional Investors Conference
02/15/2013 Masimo Continues Its Advocacy on Behalf of Newborns During Congenital Heart Defects (CHD) Awareness Week
02/14/2013 Masimo Announces Adoption of Stock Repurchase Program
02/14/2013 Masimo Reports Fourth Quarter and Full Year 2012 Financial Results; Provides 2013 Financial Guidance
01/30/2013 Libya Becomes First to Standardize Its Blood Donation Centers to Masimo Pronto-7® for Quick, Noninvasive Spot-Checking of Hemoglobin (SpHb®), SpO2, Pulse Rate, and Perfusion Index
01/30/2013 Masimo to Report Fourth Quarter and Full Year 2012 Financial Results after Market Close on Thursday, February 14
01/11/2013 Study Featuring Transfusion Impact of Masimo SpHb® Monitoring Receives 2013 Best Clinical Application of Technology Award at Society for Technology in Anesthesia Annual Meeting
01/10/2013 New Study Shows Masimo Noninvasive & Continuous Total Hemoglobin (SpHb®) Monitoring Significantly Reduces Blood Transfusions and Costs in High Blood Loss Surgery
01/03/2013 Masimo iSpO2™ Pulse Oximeter for iOS Platform (iPhone, iPad & iPod touch) for Consumers* to Debut at CES
12/27/2012 University of North Carolina Hospitals Standardizes to Masimo SET® Pulse Oximetry for Improved Patient Outcomes
12/21/2012 Happy Holidays from Masimo!
12/19/2012 Ogden Regional Medical Center Standardizes to Masimo rainbow® Pulse CO-Oximetry™
12/18/2012 Masimo to Present at 31st Annual J.P. Morgan Healthcare Conference
12/13/2012 Masimo Launches iSpO2™ – Commercially Available Pulse Oximeter for iPhone, iPad & iPod touch
12/11/2012 Voting for the first REAL Awards is now open!
11/29/2012 Saint Mary's Healthcare Standardizes on Industry-Leading Masimo SET® Pulse Oximetry
11/27/2012 IWK Health Centre Standardizes to Masimo SET® Pulse Oximetry
11/20/2012 Masimo Corporation Founder and CEO Joe Kiani Named Ernst & Young National Entrepreneur Of The Year – 2012 Life Sciences Award Winner
11/15/2012 Maricopa Integrated Health System Installs Masimo Patient SafetyNet™ System for Improved Oversight of General Floor
11/12/2012 Trinity Medical Center Adds Masimo Patient SafetyNet™ as a High Vigilance Safeguard for Post-Surgical Patients
11/06/2012 Skagit Valley Hospital Standardizes on Masimo SET® Measure-Through Motion and Low Perfusion Pulse Oximetry
11/01/2012 Masimo Reports Third Quarter 2012 Financial Results; Board Declares Special Cash Dividend of $1.00 per Share
11/01/2012 Premier Signs SedLine® Supplier Agreement with Masimo
10/31/2012 Kennedy Health System Renews System-Wide Pulse Oximetry Contract with Masimo
10/30/2012 Masimo Reschedules Release of Third Quarter 2012 Financial Results and Associated Conference Call to Thursday, November 1st Due to Hurricane Sandy
10/25/2012 Alameda County Medical Center Deploys Masimo Patient SafetyNet™
10/24/2012 New Clinical Study Finds Pronto® Has Similar Accuracy to Commonly Used Point-of-Care Invasive Hemoglobin Analyzer
10/18/2012 Multiple New Clinical Studies Presented at the American Society of Anesthesiologists Annual Meeting Show Benefits of Masimo Noninvasive Patient Monitoring Technologies: SpHb, PVI, RRa, and SEDLine
10/16/2012 Masimo to Report Third Quarter 2012 Financial Results after Market Close on October 30
10/15/2012 Masimo Initiates Limited Market Release of Universal ReSposable™ Pulse Oximetry Sensor System
10/12/2012 Masimo Unveils Fractional Arterial Oxygen Saturation, SpfO2, and rainbow SuperSensor
10/09/2012 GE Healthcare Integrates New FDA-Cleared Masimo SET® uSpO2™ Pulse Oximetry Cable into GE's ApexPro® Telemetry Systems
10/02/2012 Albany Medical Center Standardizes to Masimo rainbow SET Pulse CO-Oximetry®
10/01/2012 Hamilton Medical Center Updates with Masimo Patient Monitoring Technologies
09/25/2012 Masimo Announces $1 Million Commitment to Action with the Clinton Global Initiative to Solve Maternal Mortality & Anemia
09/24/2012 Masimo Oximeters and Neonatal Sensors Receive FDA 510(k) Clearance with Labeling for Use in Newborn Screening for Critical Congenital Heart Disease (CCHD)
09/21/2012 Joe Kiani Speaks at TEDx Conference
09/20/2012 Masimo Pronto-7® Wins GOLD "Stevie®" Award for Best New Health Product
09/19/2012 Inova Health System Re-Ups System-wide Pulse Oximetry Contract with Masimo
09/12/2012 Easton Hospital Adds Masimo Patient SafetyNet™ System and rainbow® Pulse CO-Oximetry for Noninvasive Patient Monitoring
09/10/2012 Masimo to Host Investor Day on September 20
09/04/2012 Phoenix Children's Hospital Standardizes on Masimo
08/28/2012 Princeton's University Medical Center Deploys Masimo Patient SafetyNet™
08/13/2012 Joint Commission Issues Sentinel Event Alert on Opioid-Induced Respiratory Depression
08/07/2012 Masimo's Noninvasive Pleth Variability Index as Accurate as Invasive Stroke Volume Variation for Fluid Responsiveness Assessment in Cardiac Surgery
08/01/2012 Masimo Reports Second Quarter 2012 Financial Results
08/01/2012 Masimo Enters Noninvasive Multigas Monitoring, including Capnography, with Acquisition of PHASEIN
07/26/2012 New Study Reveals Wide Variation in Blood Transfusion Practices During Surgery
07/23/2012 Masimo Signs Pulse Oximetry Distribution Deal with MWI Veterinary Supply
07/18/2012 Masimo to Report Second Quarter 2012 Financial Results after Market Close on August 1
07/17/2012 Pulse Oximetry Screening Hailed as the 'New Milestone' to Combat Critical Congenital Heart Disease - Signal Extraction Technology Leading the Way in Large, Independent Clinical Studies
07/09/2012 New Study Affirms Masimo rainbow® Pulse CO-Oximetry™ Accuracy for Noninvasive Carboxyhemoglobin and Methemoglobin Measurements
07/03/2012 U.S. Medical Materiel Enterprise Standardization Office Selects Masimo Rad-57™ Handheld Pulse CO-Oximeter as Joint Product of Choice
07/02/2012 Masimo Signs Pronto-7™ Distribution Deal with PSS World Medical
06/25/2012 New Study Shows Masimo SET® Pulse Oximetry Outperforms Competing Technologies
06/21/2012 New Study Shows Masimo rainbow® Pulse CO-Oximetry™ Speeds Evaluation & Treatment of Carbon Monoxide Poisoning
06/18/2012 Anesthesia Patient Safety Foundation Publishes Expanded Dartmouth Hitchcock Medical Center Results with Post-Surgical Monitoring Using Masimo SET® and Patient SafetyNet™
06/13/2012 Masimo Signs Pronto-7™ Distribution Deal with Henry Schein
06/11/2012 United Kingdom's National Health Service Includes Masimo Pleth Variability Index® as "High Impact Innovation" for Intra Operative Fluid Management
06/08/2012 Masimo CEO Joe Kiani Named Ernst & Young Entrepreneur of the Year
06/04/2012 Premier Healthcare Renews Supplier Agreement with Masimo
05/31/2012 Masimo 2012 Radical-7® and Pronto-7™ Shine at Nursing Expo
05/29/2012 Masimo to Present at William Blair & Company 32nd Annual Growth Stock Conference
05/17/2012 First Published Study on Masimo Acoustic Respiration Rate Demonstrates Significantly Higher Patient Tolerance and Similar Accuracy Compared to Capnometry in Post-Surgical Patients
05/08/2012 Masimo Joins Summer Jobs+ Program, Offering Paid Internships, Free Workshops
05/08/2012 Ospedale Valduce and Masimo Announce Italy's First Installation of Masimo Patient SafetyNet™
05/03/2012 Novation Inks Supplier Contract Category Agreement for Masimo SET® pulse oximetry and rainbow® SET Pulse CO-Oximetry™
05/02/2012 Masimo Reports First Quarter 2012 Financial Results
04/26/2012 Masimo to Present at Deutsche Bank Securities 37th Annual Health Care Conference
04/25/2012 Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
04/23/2012 Essential Medical Dismisses Patent Case against Masimo and Cercacor
04/19/2012 New Study Shows Masimo's Noninvasive Pleth Variability Index Provides Similar Ability to Assess Fluid Responsiveness During Surgery as More Costly and Invasive Method
04/18/2012 Masimo to Report First Quarter 2012 Financial Results after Market Close on May 2
04/12/2012 Masimo Pronto-7™ Receives China and South Korea Regulatory Clearances
04/02/2012 Fortis Healthcare Signs Agreement Giving India's Fastest-Growing Hospital Chain Access to Masimo's State-of-the-Art Noninvasive Patient Monitoring Solutions
03/26/2012 Masimo Debuts 2012 Radical-7® at World Congress of Anaesthesiologists
03/12/2012 Masimo Acquires Assets of Spire Semiconductor to Advance Innovation, Speed Development, and Reduce Costs
03/06/2012 Sana Kliniken AG Signs Agreement with Masimo, Giving One of Germany's Largest Private Hospital Networks Access to Masimo's Advanced Noninvasive Patient Monitoring Solutions
02/27/2012 Masimo to Present at 24th Annual ROTH Conference
02/23/2012 GE Healthcare Partners with Masimo to Incorporate rainbow® SET Technology with GE Patient Monitors
02/14/2012 Masimo Announces "Better Care" Program—A Hospital Risk-Share Program for Blood Transfusion Related Cost Reduction with
02/14/2012 Masimo Reports Fourth Quarter and Full Year 2011 Financial Results; Provides 2012 Financial Guidance
01/26/2012 Masimo to Report Fourth Quarter and Full Year 2011 Financial Results After Market Close on February 14, 2012
01/09/2012 Masimo Announces FDA Clearance and Full Market Release of the New Pronto-7™ for Noninvasive Total Hemoglobin Spot-Check Measurement, Along with SpO2, Pulse Rate, and Perfusion Index
12/21/2011 Happy Holidays from Masimo!
12/20/2011 Masimo to Present at 30th Annual J.P. Morgan Healthcare Conference
12/13/2011 New Clinical Study Presented at the NYPGA Meeting Shows Respiration Rate Monitoring—Considered the Fourth Primary Vital Sign—Has Been Revolutionized With Masimo rainbow Acoustic Monitoring Technology
11/17/2011 Antelope Valley Hospital Converts to Masimo rainbow SET for State-of-the-Art Noninvasive Patient Monitoring Capabilities
11/15/2011 Masimo to Present at 23rd Annual Piper Jaffray Health Care Conference
11/10/2011 Shands Jacksonville Medical Center Converts to Masimo rainbow SET for State-of-the-Art Noninvasive Patient Monitoring Capabilities
11/08/2011 Masimo Awarded the American Association of Respiratory Cares 2011 Zenith Award
11/08/2011 Masimo to Present at Lazard Capital Markets Healthcare Conference
10/25/2011 Masimo Reports Third Quarter 2011 Financial Results
10/24/2011 Guangdong Biolight Meditech Co., Ltd. Announces the Launch of Its Modular Patient Monitors with Masimo rainbow SET Pulse CO-Oximetry Technology
10/19/2011 New Clinical Studies Presented at the American Society of Anesthesiologists Annual Meeting Show Benefits of Masimo Noninvasive Technologies: SpHb, PVI, RRa, and SEDLine
10/14/2011 Masimo to Report Third Quarter 2011 Financial Results after Market Close on October 25, 2011
10/13/2011 Masimo Launches the 2011 Radical-7 with rainbow® Acoustic Monitoring and In Vivo Adjustment™
10/10/2011 Masimo Rainbow Acoustic Monitoring Technology Cleared for Market in Japan
09/30/2011 Masimo Achieves New Milestone-Ships One Millionth Oximeter
09/29/2011 Published Study Demonstrates the Absolute and Trend Accuracy of Masimo Noninvasive and Continuous Total Hemoglobin (SpHb) Monitoring inIntensive Care Unit Patients
09/23/2011 U.S. Health & Human Services Makes Critical Congenital Heart Defect Screening Using Motion-Tolerant Pulse Oximetry a Nationwide Newborn Screening Standard
09/12/2011 Centre Hospitalier de Chaumont in France Implements State-of-the-Art Remote Monitoring System to Advance Patient Safety
08/31/2011 Shriners Hospitals for Children® - Honolulu: First in Hawaii to Implement Masimo Noninvasive Hemoglobin Monitoring Technology
08/29/2011 Masimo Pronto-7™ Receives Japanese and Canadian Regulatory Clearances
08/29/2011 Masimo to Present at Morgan Stanley Global Healthcare Conference
08/24/2011 Masimo Obtains CE Mark for SEDLine, Launches EEG-Based Brain Function Monitors in European Market
08/09/2011 Masimo Announces Adoption of Stock Repurchase Program
08/09/2011 Masimo Reports Second Quarter 2011 Financial Results Q2 2011 Highlights (compared to Q2 2010):
08/08/2011 Masimo Introduces Pronto-7™ Internationally and Lifts Voluntary Recall
07/19/2011 Masimo to Report Second Quarter 2011 Financial Results after Market Close on August 9, 2011
06/27/2011 Masimo and Dartmouth-Hitchcock Medical Center, First Cross-Industry Collaborative Honored with the Institute for Technology and Healthcare Clinical Application Award
06/16/2011 New Clinical Research Presented at the European Society of Demonstrates the Accuracy and Utility of Masimo SpHb and PVI
06/15/2011 Masimo Announces Rainbow Agreement with Philips
06/09/2011 Masimo Pronto-7 Wins GOLD in the 2011 Medical Design Excellence Award Competition—the Premier Awards Program for the Medical Technology Community
06/03/2011 Masimo to Present at William Blair & Company 31st Annual Growth Stock Conference
06/02/2011 Masimo Initiates Limited Market Release of E1, Single-Patient-Use Ear Sensor for Pulse Oximetry Monitoring
05/26/2011 Masimo to Present at Goldman Sachs 32nd Annual Global Healthcare Conference
05/19/2011 Masimo Launches MS-2040, First Sub-45 mW Signal Extraction Pulse Oximetry Platform
05/16/2011 New Published Study Demonstrates the Accuracy of Masimo Noninvasive and Continuous Hemoglobin Monitoring in Patients in Surgery and Intensive Care
05/03/2011 Masimo Reports First Quarter 2011 Financial Results
04/28/2011 Masimo Launches New Reusable SpCO® Sensor with Improved Accuracy and Reliability in Low Oxygen Saturation and Elevated Methemoglobin States
04/27/2011 Masimo to Present at the 2011 Bank of America Merrill Lynch Health Care Conference
04/21/2011 New Published Study Finds Masimo Noninvasive SpCO Effective for Screening Emergency Department Patients for Carbon Monoxide Poisoning
04/19/2011 Masimo to Report First Quarter 2011 Financial Results after Market Close on May 3, 2011
04/11/2011 New Published Study Finds Masimo SET® Delivers More Reliable Measurements Significantly Faster Than Other Pulse Oximetry Technologies
03/28/2011 Newtech, Inc., a Leading Chinese EMS Patient Monitoring Company, Partners with Masimo to Incorporate rainbow® SET Noninvasive Measurement Capabilities into New Patient Monitors
03/24/2011 New Studies Show Clinical Advantages of Masimo Noninvasive Hemoglobin, PVI, and Perfusion Index in Critically-ill Patients
03/03/2011 Masimo to Present at the Roth Growth Stock Conference
02/24/2011 Royal Fornia Medical Equipment Co., Ltd. Signs Technology Licensing Agreement to Integrate Masimo rainbow SET Pulse CO-Oximetry into New Patient Monitors
02/22/2011 Masimo to Present at the Cowen and Company Health Care Conference
02/21/2011 Mater Children's Hospital in Australia Converts to Masimo rainbow SET for State-of-the-Art Noninvasive Patient Monitoring Capabilities
02/15/2011 Masimo Reports Fourth Quarter and Full Year 2010 Financial Results; Provides 2011 Guidance
02/10/2011 Mafraq Hospital Becomes First in United Arab Emirates to Deploy Masimo rainbow SET Pulse CO-Oximetry for State-of-the-Art Noninvasive Patient Monitoring
02/08/2011 Welch Allyn Establishes Strategic Partnership to Incorporate Masimo rainbow® SET Noninvasive Measurement Capabilities in Next-Generation Patient Monitors
02/01/2011 New Published Study Finds Noninvasive Masimo PVI Accurately Predicts Fluid Responsiveness in Intensive Care Patients
01/31/2011 Masimo Provides Additional Comments Regarding Amendment to Settlement Agreement with Covidien
01/31/2011 Masimo and Covidien Announce Extension of Royalty Agreement
01/28/2011 Masimo to Report Fourth Quarter and Full Year 2010 Financial Results after Market Close on February 15, 2011
01/20/2011 New Clinical Study Finds Masimo Noninvasive Hemoglobin Accurate in Patients with Critically Low Hemoglobin Levels
01/18/2011 New Johns Hopkins School of Medicine Study Shows Masimo Noninvasive Hemoglobin Monitoring is Accurate During Complex Spine Surgeries

 

New Study Compares Performance of Masimo Next Generation SedLine® Patient State Index (PSi) to Original PSi During Anesthesia

Geneva, Switzerland – June 19, 2017 – Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at Euroanaesthesia 2017 in Geneva, Switzerland. In the study, researchers at University Medical Center Groningen, Netherlands compared original and Next Generation versions of Masimo Patient State Index (PSi, a processed EEG parameter related to the effect of anesthetic agents) during Masimo SedLine® brain function monitoring of patients under propofol and sevoflurane anesthesia.1



Masimo RD SedLine® Adult EEG Sensor

SedLine brain function monitoring features four simultaneous EEG leads to enable continuous assessment of both sides of the brain, four EEG waveforms, a Density Spectral Array (DSA; an easy-to-interpret, high-resolution display of bi-hemispheric activity and EEG power), and PSi. Next Generation SedLine enhances PSi to make it less susceptible to electromyographic (EMG) interference and to improve its performance in low-power EEG cases.

In the study, Dr. Kuizenga and colleagues sought to compare the original and Next Generation PSi algorithms, referred to as PSi-1 and PSi-2, respectively, as they correlated with propofol and sevoflurane drug concentrations and with the Modified Observers Assessment of Alertness and Sedation (MOAAS) scale. They also sought to assess the influence of 2 and 4 ng/mL effect-site concentrations of remifentanil on the performance of the two algorithms.

The researchers enrolled 36 healthy volunteers, stratified by age, and assigned them randomly to a sequence of four sessions of anesthesia. In one session, propofol was administered in a series of graded steps; in the second, sevoflurane was similarly administered; in the third and fourth, the two concentrations of remifentanil were also administered. During each step of each session, after a twelve-minute delay for equilibration, MOAAS was tested and a blood sample was taken to measure drug concentrations. EEG was collected using Masimo Root® with SedLine, from which time-synchronized PSi-1 and PSi-2 values were later extracted. The researchers then plotted MOAAS, drug concentration, PSi-1, and PSi-2 values over time.

The researchers found that when charted against drug concentrations, PSi-2 showed "reduced population variability and improved baseline stability" compared to PSi-1. When charted against MOAAS, PSi-2 had "lower interindividual variability" than PSi-1. They also noted that "Both PSis distinguish MOAAS 5, 4, and 3 better during propofol anesthesia compared to sevoflurane. This difference disappears when adding remifentanil."

The investigators concluded that "PSi-2 [Next Generation SedLine PSi] has enhanced signal stability and a better description of the dose-response relationship. PSi-2 has therefore improved capacity as a pharmacodynamic monitor of anesthesia compared to PSi-1."

Next Generation SedLine has not received 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates || #Masimo

Reference
1. Kuizenga M.H., Colin P.J., Vereecke H.E.M., Struys M.M.R.F. Comparison between two versions of the Patient State Index during propofol and sevoflurane anesthesia, with or without remifentanil. Proceedings from Euroanaesthesia 2017, Geneva, Switzerland. Abstract #01AP07-4.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SedLine®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SedLine, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Limited Market Release of Rad-67™ rainbow® Pulse CO-Oximeter® with Next Generation SpHb®



Masimo Rad-67™ Handheld Pulse CO-Oximeter® with rainbow® DCI®-mini Sensor

Neuchatel, Switzerland – June 5, 2017 – Masimo (NASDAQ: MASI) announced today, in conjunction with its CE marking, the limited market release of the Spot-Check Rad-67™ Handheld Pulse CO-Oximeter®. Rad-67 offers Measure-through Motion and Low Perfusion™ SET® pulse oximetry and upgradeable rainbow® noninvasive monitoring technology in a compact, portable spot-check device. With the universal reusable rainbow® DCI®-mini sensor, Rad-67 features Next Generation SpHb® (noninvasive total hemoglobin) technology.

Next Generation SpHb technology offers improved motion tolerance and a faster time to display SpHb results (in as few as 30 seconds). In addition, field performance has been enhanced in lower hemoglobin ranges. The rainbow® DCI-mini sensor allows patients of all ages, from infants to adults, to be spot-checked using a reusable sensor. Next Generation SpHb, enabled when Rad-67 and the DCI-mini sensor are used together, significantly advances the forefront of noninvasive portable hemoglobin spot-checking.

Rad-67's ability to provide portable spot-check measurements of both oxygen saturation and SpHb, in addition to other noninvasive rainbow® measurements, makes it a useful single-device solution in multiple care areas and mobile environments, such as when screening patients during blood donation drives, emergency room screening, and in physicians' offices. In addition to a rechargeable battery with six-hour run time, Rad-67 features a high-resolution, HD color display with intuitive touchscreen navigation that automatically adjusts brightness to optimize visibility in a variety of settings, including outdoors. The slim-profile sensor connector port is designed to provide tactile feedback upon proper connection. Multiple parameters are simultaneously displayed, allowing for quick patient assessment.

Rad-67 provides convenient historical data review directly on the device, with unique patient identifiers to help improve organization of records and workflow. Using Bluetooth®, Rad-67 can connect wirelessly to portable printers. Rad-67 also includes built-in wireless connectivity via Wi-Fi. When used in conjunction with Masimo Iris Gateway™ or Patient SafetyNet™*, data from Rad-67 can be sent directly to the patient's electronic medical record (EMR). Automating data transfer with EMR integration may help reduce the possibility of human error when manually transferring data.

Dr. Aryeh Shander, Chief of Anesthesiology, Critical Care Medicine at Englewood Hospital and Medical Center, noted that, "in the process of screening for anemia, having the ability to detect hemoglobin noninvasively is one of the greatest advances. Once low hemoglobin is reported, confirmation with a conventional laboratory test will further explore the possible causes."

Joe Kiani, Founder and CEO of Masimo, said, "We're proud to announce Rad-67 with Next Generation SpHb technology. Next Generation SpHb represents a significant enhancement to the noninvasive measurement we invented a decade ago – a measurement we look forward to continuing to improve."

Rad-67 has not received 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Rad-67™ Pulse CO-Oximeter®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-67 Pulse CO-Oximeter, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo and Mdoloris Announce Masimo Open Connect™ (MOC) Partnership for the Root® Patient Monitoring and Connectivity Hub

Analgesia Nociception Index (ANI®) Module for Root to be Previewed at the European Society of Anaesthesiology in Geneva, Switzerland June 3 – 5, 2017

Irvine, California and Lille, France – June 1, 2017 – Masimo (NASDAQ: MASI) and Mdoloris Medical Systems announced today a Masimo Open Connect™ (MOC) partnership for the Root® Open Architecture Patient Monitoring and Connectivity Hub, in which Mdoloris is developing and will commercialize their Analgesia Nociception Index (ANI®) technology for Root.

Masimo's unique approach to medical technology integration through MOC partnerships is expected to address some major barriers to new technology adoption in patient monitoring. Root's open architecture and built-in connectivity enable third-party companies to determine themselves whether to pursue an integrated product. They can then independently develop, obtain regulatory approvals, and commercialize their own external MOC-9 module or Masimo Open Connect Control (MOC-C™) App for Root using Masimo's MOC software development kit (SDK). Masimo's engineering team supports MOC partner development as needed and Masimo's commercial team helps increase awareness of the availability of MOC-9 modules and MOC-C Apps from MOC partners. In turn, MOC partners use their existing distribution channels to sell their MOC-9 module or MOC-C App to Masimo customers already using Root, as well as offering the MOC-9 module or MOC-C App for Root to their potential customers as an additional option to implement their technology.

Pain relief is a major concern of all developed countries while pain assessment has historically been subjective, time-consuming due to its manual nature, and intermittent. To address these limitations, Mdoloris has developed ANI technology to provide an objective, noninvasive, and continuous way to automatically monitor the pain level of patients. Use of the ANI may help clinicians improve pain assessment and through it, patient care and pain management with more objective and precise drug administration.

"We are proud to announce our first MOC partnership and expect Root's advanced patient monitoring and versatile connectivity options will be strengthened through MOC development and the addition of innovative new technologies such as ANI from Mdoloris," said Joe Kiani, Founder and CEO of Masimo. "We believe that Root with Masimo Open Connect can do for patient monitoring what the PC did for computing: speed up the patient monitoring innovation cycle, reduce the cost of patient monitoring, and prolong the useful life of the equipment hospitals invest in."

"We consider Masimo to be the most innovative company in the patient monitoring space, so it is a pleasure to announce our MOC partnership. We share Masimo's vision of improving patient outcomes and reducing the cost of care and believe Root offers a unique and compelling solution to implement our ANI technology," said Fabien Pagniez, Founder and CEO of Mdoloris Medical Systems.

The ANI MOC-9 module for Root will be available for preview in the Mdoloris exhibit booth at the European Society of Anaesthesiology in Geneva, Switzerland, June 3 to 5, 2017.

ANI has not received 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates || #Masimo

About Mdoloris Medical Systems
Mdoloris (www.mdoloris.com), a medical devices manufacturer, was created in June 2010 out of 23 years of academic research performed in Lille University hospital, France. It has an international representation in more than 58 countries and a scientific, technical and medical acknowledgement. Mdoloris has developed so far three products, all able to continuously assess the pain level of patients (The ANI technology for patients older than two years old, the NIPE technology for neonates, the PTA technology for pets). Its innovative technologies provide clinical added values for clinicians that are not able to communicate with their patients in order to personalize pain medications and avoid known side effects due to over / under dosage of such drugs.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

ORi has not received 510(k) clearance and is not available for sale in the United States.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Open Connect™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Open Connect, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Antoine Szczypa
Mdoloris
Email: Antoine.szczypa@mdoloris.com

Potential MOC Partners
Visit: http://www.masimo.com/home/signal-extraction-pulse-oximetry/masimo-set-monitors/root/moc-9-web-form/

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA 510(k) Clearance of O3™ Regional Oximetry for Pediatric Patients



Masimo O3™ Regional Oximetry Pediatric (top) and Adult (bottom) Sensors

Irvine, California – May 30, 2017 – Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for the pediatric indication for O3™ regional oximetry with the O3 pediatric sensor. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain. With the clearance of the O3 pediatric sensor, O3 regional oximetry monitoring, which was already available for adult patients in the United States, is now also available for pediatric patients weighing more than 5 kg (11 lbs) and less than 40 kg (88 lbs).

O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. Early detection and correction of imbalances in oxygen delivery to the brain are important tools in helping patients avoid postoperative morbidity and adverse outcomes.1

"O3 regional oximetry provides access to valuable data about cerebral oxygen saturation," said Joe Kiani, Founder and CEO of Masimo. "With adult and pediatric trend accuracy of 3% and absolute accuracy of 4% and 5% on adults and pediatrics respectively,2 without controlling CO2, Masimo O3 should help clinicians build a better picture of brain oxygenation – and hopefully better outcomes for all of their patients, including pediatrics as young as three-months old."2

In addition, Masimo O3 regional oximetry and SedLine® brain function monitoring are both available on a single platform, Masimo Root® – opening up a path to better understanding of the brain.

@MasimoInnovates || #Masimo

References
1. Booth, Dukatz, Ausman, and Wider. Cerebral and somatic venous oximetry in adults and infants. Surg. Neurol Int. 2010; 1: 75.
2. Masimo data on file.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo O3™ regional oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo O3 regional oximetry, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces the Full Market Release of Early Warning Score (EWS) with the Root® Patient Monitoring and Connectivity Hub

Irvine, California – May 19, 2017 – Masimo (NASDAQ: MASI) announced today the full market release of Early Warning Score (EWS) on the Root® patient monitoring and connectivity hub. EWS aggregates information from multiple vital signs and clinical observations to generate a score that represents the potential degree of patient deterioration.

Root, which works in conjunction with Radical-7® or Radius-7® Pulse CO-Oximeters® and Masimo Open Connect™ (MOC-9™) measurements, features Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, rainbow SET™ pulse CO-Oximetry, NomoLine™ capnography and gas monitoring, SedLine® brain function monitoring, O3™ regional oximetry, and SunTech® blood pressure and Welch Allyn® temperature monitoring. Masimo SET® helps clinicians monitor oxygen saturation and pulse rate during motion and low perfusion for more than 100 million patients a year1, including at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.2



Masimo Root® with Early Warning Score (EWS)

Patient data from Radical-7 or Radius-7 and data collected using Root and other connected Masimo and third-party devices can be shared with Masimo Patient SafetyNet™*, providing hospital-wide remote monitoring and clinician notification, as well as the ability to automatically transfer patient data to a hospital's Electronic Medical Record (EMR). Each time a clinician transfers data to the EMR via Root connected to Patient SafetyNet, an Early Warning Score (EWS) can now be included. Clinicians can also choose to have the standalone Root, not connected to Patient SafetyNet, perform EWS calculations, helping assist spot-check-based nursing workflows.

Early warning scores are based on multiple contributors, including vital signs such as oxygen saturation, pulse rate, respiration rate, body temperature, and systolic blood pressure – and contributors entered by clinicians, such as level of consciousness, use of supplemental oxygen, and urine output. The weighting and number of contributors differ depending upon which EWS protocol is used. Root can be customized for various predefined EWS protocols, or hospitals can configure their own set of required contributors, and their relative weights, to create an EWS unique to their care environment.

"Root, from its versatile connectivity options to its advanced patient monitoring, from rainbow® SpHb® to SET® SpO2, helps hospitals improve patient care. We hope the addition of Early Warning Score to Root will help automate a potentially valuable calculation and streamline its inclusion in EMRs," said Joe Kiani, Founder and CEO of Masimo.

EWS is a convenient aid to clinical assessment and not a substitute for clinical judgment.

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Estimate: Masimo data on file.
2. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Root®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Midmark, Masimo Announce Partnership to Improve Vital Signs Acquisition

DAYTON, Ohio, May 15, 2017 – Midmark Corporation, a leading medical solutions provider for ambulatory care, and Masimo (NASDAQ: MASI), a global leader in innovative noninvasive monitoring technologies, today announced a partnership focused on improving the accuracy and efficiency of vital signs acquisition in the clinical space.

With this partnership, Masimo SET® pulse oximetry technology is now an available option with Midmark's recently introduced Midmark IQvitals® Zone™, the industry's first monitoring device to feature Bluetooth® low energy technology for auto-connecting during the vitals acquisition process. IQvitals Zone devices equipped with Masimo SET® technology provide clinicians with accurate, real-time vitals sign information including oxygen saturation (SpO2), pulse rate (PR), and perfusion index (Pi) to facilitate timely clinical decisions.

Midmark IQvitals Zone changes the traditional workflow in vitals acquisition by establishing a direct wireless connection between vital signs measurement and the caregiver's tablet or laptop. The vital signs monitor automatically connects with the appropriate equipment when the caregiver places a tablet or laptop on the multi-use work surface or near the monitoring device and initiates vitals acquisition. When the equipment is connected, caregivers can take patient vitals, review results and seamlessly import the information to an electronic medical records (EMR) system directly from their laptop or tablet.

"Masimo has long been a leader in creating new technologies to improve patient care," said Kurt Forsthoefel, Marketing Director, Medical Products and Services, Midmark. "Midmark and Masimo are two companies ultimately focused on improving outcomes and the healthcare experience, and we're looking forward to working together to provide caregivers with innovative technologies that enhance patient-caregiver interaction and improve outcomes at the point of care."

"Like Midmark, Masimo is focused on developing solutions which can help caregivers enhance the quality and process of care," said Rick Fishel, President of Worldwide OEM Business and Strategic Development for Masimo. "We are confident that Masimo's proven portfolio of accurate and timely measurements, in combination with Midmark's innovative solutions, will help physicians and caregivers deliver quality care and enhance clinical work flow."

The Midmark IQvitals Zone device with Masimo SET pulse oximetry technology is one part of a fully connected point of care ecosystem that promotes well-coordinated patient experiences. More information about how IQvitals Zone brings the industry one step closer to a connected ecosystem can be found in the new white paper, "Zone Technology: Connecting Vitals Acquisition within the Point of Care Ecosystem" in the Midmark content and news library.  

 

The study was supported by research grants from Masimo to Loma Linda University, Mayo Clinic in Florida, and the University of California, Irvine.

@MasimoInnovates || #Masimo

About Midmark
Midmark Corporation, a privately held company founded in 1915, is a leading provider of medical, dental and veterinary equipment and technologies. Our nearly 1,700 teammates worldwide are passionate, courageous leaders focused on making a positive difference in the lives we touch by improving the experience between patients and their caregivers. Headquartered in Dayton, Ohio, Midmark maintains production and administrative offices in Versailles, Ohio, as well as seven other locations in the United States and international subsidiaries in India, Italy and the United Kingdom. To learn more about Midmark, visit midmark.com.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 17 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Contacts:
Meghann Naveau
Content & Social Media Manager
Midmark Corporation
Phone: (937) 281-7609
Email: mnaveau@midmark.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Multicenter Study at UC Davis, UC Los Angeles, and Mayo Clinic Evaluates the Trend Accuracy of Masimo Continuous SpHb®

Washington, DC – May 15, 2017 – Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the International Anesthesia Research Society (IARS) Annual Meeting in Washington, DC. In the multicenter study, researchers at three academic medical centers evaluated the trend accuracy of noninvasive, continuous hemoglobin monitoring (SpHb®).1

The prospective observational study was a collaboration among Drs. Richard Applegate and Patricia Applegate of the University of California, Davis; Dr. Maxime Cannesson of the University of California, Los Angeles; and Drs. Prith Peiris, Beth Ladlie, and Klaus Torp of the Mayo Clinic in Jacksonville, Florida.

The researchers enrolled 135 adult patients who were scheduled for surgery with planned arterial catheter placement and continuous SpHb monitoring. Each time a blood sample was obtained, the researchers recorded SpHb using a Masimo Radical-7® Pulse CO-Oximeter® with Masimo rainbow® disposable R125 sensors (Revision K; same algorithm as Revision L). They also analyzed each blood sample twice to determine clinical laboratory hemoglobin (tHb; Sysmex 550 or Coulter LH 750), arterial blood gas CO-oximeter hemoglobin (ABGHb; Radiometer ABL800, Nova Biomedical CCX or PhOX, or Siemens RAPIDLab 1265), and point-of-care hemoglobin (aHQHb; HemoCue HB 301).

To assess overall trend accuracy and trend accuracy within defined ranges, the researchers analyzed the correlation of change in tHb to changes in SpHb, ABGHb, and aHQHb. Trend bias within 10% of tHb was considered clinically equivalent. The researchers found that "The confidence intervals for the proportion of samples with trend bias within 10% of tHb overlapped for SpHb (372 of 416 trends; 89.4%; 86.1% to 92.2%), ABGHb (391 of 416 trends; 94.0%; 91.3 to 95.9%) and aHQHb (406 of 416 trends; 97.6%; 95.6 to 98.7%)."

The researchers concluded that "SpHb, ABGHb and aHQHb appear to provide similar intraoperative guidance regarding tHb increase or decrease. Continuous noninvasive SpHb changes larger than ± 0.5 g/dL could provide a reasonable indication for the clinician to obtain a confirmatory blood sample for Hb measurement, but not replace such measurement in guiding transfusion decision making. The transfusion impact of continuous hemoglobin trend monitoring should be studied."

SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings – when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when the SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

The study was supported by research grants from Masimo to Loma Linda University, Mayo Clinic in Florida, and the University of California, Irvine.

@MasimoInnovates || #Masimo

Reference
1. Applegate R, Cannesson M, Applegate P, Peiris P, Ladlie B, and Torp K. Hemoglobin Change Measurement Accuracy Obtained from 3 Devices During Surgery. Proceedings from the 2017 IARS Annual Meeting, Washington, DC. Abstract #A1786.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 17 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Introduces Rad-G™ Pulse Oximeter

Irvine, California – May 9, 2017 – Masimo (NASDAQ: MASI) today announced the introduction of Rad-G™, a combined pulse oximeter designed primarily for use in pneumonia screening and spot-checking of oxygen saturation (SpO2) in low-resource settings. The development of the device is supported in part by a grant of $4.95 million from the Bill and Melinda Gates Foundation (BMGF), announced in November 2016, as part of a partnership with Masimo to facilitate screening for pneumonia by health workers in low-resource areas.



Masimo Rad-G™ Pulse Oximeter

Rad-G is a low-cost, rugged, handheld pulse oximetry device with a rechargeable battery and LCD display. It uses Masimo Measure-through Motion and Low Perfusion™ SET® pulse oximetry technology to measure SpO2, respiration rate from the Pleth (RRp™), pulse rate (PR), and perfusion index (Pi).

Pneumonia remains the single largest treatable infectious cause of death in children worldwide, causing over 900,000 deaths each year among children under 5 years of age.1 In a study funded by the BMGF Diagnostics Modelling Consortium, the researchers concluded that in settings where supplemental oxygen is available, the addition of pulse oximetry to standard integrated management of child illness protocols could reduce pneumonia mortality rates.2 More recently, the World Health Organization (WHO) has been conducting a multi-country evaluation of enhanced community case management of pneumonia with the use of Masimo SET® pulse oximetry by community health workers.3

Enhancing patient screening is critically important to reducing the global burden of pneumonia. Moreover, enhanced screening may empower healthcare providers by supporting informed decisions related to pneumonia diagnosis and treatment, with the appropriate administration of antibiotics and oxygen therapy when needed. Masimo and BMGF hope that Masimo pulse oximetry technology, already used to monitor approximately 100 million patients around the world, can help better screen children in even the most challenging conditions.

Joe Kiani, Founder and CEO of Masimo, said, "The introduction of the Rad-G is a critical milestone in our partnership with the Bill and Melinda Gates Foundation to help improve pneumonia screening. We are grateful to have the opportunity to bring our proven SET® pulse oximetry technology to areas of the world that are in desperate need of better healthcare, and look forward to making a positive difference in the lives of many children."

Rad-G is currently not available for sale in the United States, Canada, or the E.U.

@MasimoInnovates || #Masimo

References
1. Pneumonia Fact Sheet, World Health Organization (WHO), September 2016. http://www.who.int/mediacentre/factsheefts/fs331/en/.
2. Floyd J et al. Evaluating the impact of pulse oximetry on childhood pneumonia mortality in resource-poor settings. Nature. 2015 Dec 3;528(7580):S53-9.
3. World Health Organization (WHO), 2016.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 17 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Rad-G™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-G, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Two Fire Rescue Departments Honored for Excellence in Emergency Medical Services

Fire Service-Based EMS Awards Presented at 29th Annual National Fire and Emergency Services Dinner

Washington DC and Irvine, California – April 11, 2017 – Masimo (NASDAQ: MASI) announced today that the Congressional Fire Services Institute (CFSI) has honored the Orange County (Florida) Fire Rescue Department and the Montgomery County (Maryland) Fire & Rescue Service with the Excellence in Fire Service-Based EMS Award for best practices and innovative solutions in the delivery of emergency medical services. The awards presentation took place on April 6th in Washington, DC. Masimo is proud to be a co-sponsor of this award.

Orange County (Florida) Fire Rescue Department

The Orange County Fire Rescue Department was awarded the Excellence in Fire Service-Based EMS Award in recognition of the development of two best practices. The first is the Sepsis Alert Program, which educates EMS providers to better identify potential cases of severe sepsis among patients in pre-hospital settings, as early recognition and treatment may improve patient outcomes and lessen the financial impact of prolonged hospital stays. The program is modeled after similar "alert" programs that trigger EMS responders to initiate certain procedures, such as programs designed to recognize signs of stroke and cardiac arrest. Preliminary results since establishing the Sepsis Alert Program have included reductions in time to blood culture, time to administer antibiotics, time to administer fluids, length of hospital stay, and percentage admitted to the ICU.

The other best practice, the Paramedic Preceptor Academy, was developed to increase pass rates for Orange County's new paramedics, as well as to improve training and continuing education opportunities identified through the department's quality assurance process. As a result of the improved and standardized training, in the first year of the program first-time pass rates on written and practical assessments have increased dramatically. Several other central Florida fire departments are now also participating in the Paramedic Preceptor Academy, in the hopes of seeing similar results.

Montgomery County (Maryland) Fire & Rescue Service

The Montgomery County Fire & Rescue Service was awarded the Excellence in Fire Service-Based EMS Award in recognition of the creation of an outreach initiative called Montgomery County Non-Emergency Invention and Community Care Coordination (MCNIC3). Montgomery County developed MCNIC3 to address the disparity between the volume of emergency 911 calls, which continues to grow, and EMS resources, which have stayed relatively flat. Much of the growth in 911 calls is a result of low-priority calls from frequent 911 users. MCNIC3 targets these frequent 911 users and attempts to connect them with a variety of community-based medical and social programs, in an effort to better meet their ongoing healthcare needs without taking emergency care away from those with true emergency needs. Firefighters and EMS providers are able to refer any patient they encounter to the MCNIC3 program. By partnering with local hospitals, the health department, and various community groups, MCNIC3 can arrange periodic in-person visits to ensure that the patients' healthcare needs are being met without straining county resources. To date, MCNIC3 has reduced calls for emergency service from those patients enrolled in the program by 55%. There are plans to expand the scope of the program and develop additional community partnerships.

"CFSI takes great pride in co-sponsoring the Excellence in Fire Service-Based EMS Awards with Masimo," said Dr. William F. Jenaway, Ph.D., President of CFSI. "Through this awards program, we are able to recognize innovations in the delivery of emergency medical services throughout the nation. The recipients of the 2017 award, Orange and Montgomery Counties, certainly demonstrated themselves worthy of this recognition by developing outstanding new programs that improve training, distribute resources more wisely, and ultimately improve patient outcomes. We hope other departments around the country will be inspired to introduce similar innovations."

"Firefighters and emergency services personnel are our heroes. In saving lives, they put their own on the line for us every day. It's crucial they have the training and resources they need to provide the best care for those they protect. Recognizing the possibility of and intervening to address sepsis as soon as possible, for example, can significantly improve patient outcomes," said Joe Kiani, Founder and CEO of Masimo. "Masimo is honored to co-sponsor this awards program with CFSI and to recognize Orange and Montgomery Counties for their innovative achievements."

Approximately 1,600 fire and emergency services leaders attended the 29th Annual National Fire and Emergency Services Dinner to pay tribute to the dedication and commitment of the nation's fire and emergency services providers. Hosted by CFSI, the annual dinner benefits the mission of the non-profit policy organization, which is designed to educate members of Congress about fire and life safety issues. This year's honored speakers were four co-chairs of the Congressional Fire Services Caucus: Senator Susan Collins (ME), Senator Tom Carper (DE), Congressman Steny Hoyer (MD05) and Congressman Bill Pascrell (NJ09).

The Excellence in Fire Service-Based EMS Awards Program was established in 2010 to recognize volunteer, career, and combination fire departments for excellence in and enhancements to the delivery of emergency medical services. By showcasing their best practices, the awards program provides ideas for other fire departments to consider implementing as they seek to improve their fire service-based EMS systems.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (PI). In studies with SpHb, reductions in blood transfusion** were observed,8,9 and when used with PVi, a reduction in 30-day mortality was observed.10 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

**Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
8. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
9. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Root® and Kite™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root and Kite, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

CFSI
Bill Webb, Executive Director
Phone: (202)-371-1277
Email: bwebb@cfsi.org

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Full Market Release of Root® Patient Monitor and Connectivity Hub with Kite Supplemental Display System

Irvine, California – April 10, 2017 – Masimo (NASDAQ: MASI) announced today the full market release of Root® with Kite, a supplemental display system. Kite expands visibility of patient data for clinicians by allowing data from Root to be viewed on bigger screens, in customized configurations, in operating rooms, cardiac theaters, emergency rooms, and other venues.

Kite connects to Root via a wired or wireless connection on the same IP network and displays monitoring data from the connected device on a smart TV. Data from devices connected to Root – including the Radical-7® Pulse CO-Oximeter®, the wearable, tetherless Radius-7® Pulse CO-Oximeter, and optional monitoring modules such as SedLine® Brain Function Monitoring, O3 Regional Oximetry, and ISA capnography solutions – can also be simultaneously displayed on a supplemental screen using Kite. The Kite supplementary display system can be customized to enable clinicians to view the monitoring parameters, waveforms, and other data they require for that patient and type of care or operation.



Masimo Root® Patient Monitor and Connectivity Hub with Kite Supplemental Display System

Masimo bedside monitoring devices provide clinicians with many types of data. During complex care, monitoring might involve so many different forms of real-time output, all of value to clinicians, that displaying them simultaneously on the primary device's smaller display may be inconvenient or impractical. With Kite, that data can be conveniently displayed on a large, easy-to-read monitor, relayed from the point-of-care device. For example, during endoscopy, while a patient is anesthetized, clinicians may wish to monitor with SedLine, for brain function, with rainbow Acoustic Monitoring® (RAM), for respiration, and with ISA capnography, for end-tidal carbon dioxide, in addition to pulse oximetry and blood pressure. With Kite, the multiple data outputs from each of these types of monitoring can be simultaneously displayed on a large, centrally-located screen, in the clinicians' preferred configuration.

Dr. Don Marketto, D.O., Anesthesiologist, Mountain View Regional Hospital, Las Cruces, New Mexico, noted, "Masimo software made it extremely easy to adjust the placement and size of the information on the screen to the satisfaction of both the surgeon and anesthesiologist." Joseph Bremer, a perfusionist at Mountain View Regional Hospital, added, "Kite greatly enhanced the visibility of the Masimo monitor. During bypass I could easily view cerebral blood flow allowing time to validate adequate perfusion to my patient and maintain my attention on my bypass circuit."

"Kite showcases the versatility and flexibility of Root," said Joe Kiani, Founder and CEO of Masimo. "Our goal is to minimize clinician distraction and maximize focus on the patient and relevant data."

A promotional Kite opportunity is available for new and existing Masimo Root and Radical-7 customers.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In studies with SpHb, reductions in blood transfusion** were observed,8,9 and when used with PVi, a reduction in 30-day mortality was observed.10 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

**Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
8. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
9. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Root® and Kite. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root and Kite, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Massena Memorial Hospital of New York Adopts Masimo Root® and Masimo Patient SafetyNet

Hospital-Wide Supplemental Monitoring and Remote Clinician Notification System Automates Documentation of Patient Data

Massena, New York and Irvine, California – March 27, 2017 – Masimo (NASDAQ: MASI) announced today that Massena Memorial Hospital (MMH) of Massena, New York, has adopted Masimo Root® and Patient SafetyNet*. The hospital is integrating Root with wearable rainbow SET Pulse CO-Oximeter® Radius-7® and Patient SafetyNet to implement a wireless monitoring, patient data automation, and supplemental remote clinician notification system that will be used in all medical-surgical units.

Masimo Patient SafetyNet is a supplemental remote monitoring and clinical notification system that enables information from bedside and tetherless wearable (when used with Radius-7) monitors, which use Masimo SET® and rainbow® noninvasive blood constituent monitoring technologies, to be accessible from different locations than patients, and relays alarm notifications to clinicians, wherever they may be. Masimo Measure-through Motion and Low Perfusion SET® pulse oximetry addresses the challenges of low perfusion and motion artifact that limit conventional pulse oximetry, and has been shown to significantly reduce false alarms and increase true alarm detection,1 helping allow clinicians to focus on the patients and alarms that need the most attention. In 2016, Dartmouth-Hitchcock Medical Center, which has been using Masimo SET® pulse oximetry and Patient SafetyNet as part of a comprehensive alarm management strategy in all medical-surgical units for ten years, reported achieving a 50% reduction in unplanned ICU transfers and a 60% reduction in rescue events over those ten years, despite increases in patient acuity and occupany.2

Another important feature to MMH is the ability of Root, in conjunction with Patient SafetyNet, to automate the transfer of patient vital signs, including temperature and blood pressure, to the hospital's Electronic Medical Record (EMR) system, which may help improve nursing workflows.

"The Masimo vital sign monitoring system will provide many benefits to the patients and staff of the Medical/Surgical/Pediatric unit," said Lisa Susice, MSN, RN, ICU/Med-Surg/Pediatric Nursing Director, MMH. "To be able to combine the ability to monitor our active patients in medical-surgical units reliably with the time-saving ability to transmit pulse rate, temperature, blood pressure, breathing rate, and oxygen saturation values automatically into the patients' electronic medical records allows our nurses to spend more time nursing our patients, instead of scribing and potentially being delayed in responding to patient alarms. Our staff, who have previously had to manually transcribe the information from the vital sign machine to a paper record, then eventually key it into the electronic record, will save many steps. Additionally, staff will be able to have a quick, real-time glance at each connected patient's pulse, respirations, and oxygen saturation from monitors strategically placed throughout the floor."

Ralene North, Chief Nursing Officer, MMH, added, "We are again excited to invest in technology that is focused on patient safety and will improve the working conditions of our nurses. The less time a nurse spends dealing with false alarms or entering data into the system, the more time that can be spent at the bedside attending to the personal and educational needs of the patient."

Root with Noninvasive Blood Pressure and Temperature is available with Radical-7® or Radius-7 Pulse CO-Oximeters. Radius-7 provides continuous tetherless wearable monitoring so that patients can have freedom of movement while being monitored. Monitoring parameters from Radical-7 or Radius-7 are sent to Patient SafetyNet through Root, allowing for hospital-wide remote monitoring, automated documentation of patient data in the EMR, and supplemental remote clinician notification of alerts and alarms.

"Massena Memorial Hospital has long been a valued Masimo customer, and with this additional investment, they are continuing to focus on patient safety," stated Joe Kiani, Founder and CEO of Masimo. "Continuous monitoring in the post-surgical ward has been shown to reduce preventable death.3 In addition, automating the transmission of vital signs data can help to improve workflow and reduce incomplete and erroneous medical records. We applaud Massena Memorial Hospital for leading the way in patient safety."

MMH is a full-service 50-bed acute-care community hospital located in northern New York with a medical staff of over 50 physicians in over 15 specialties. With more than 400 healthcare employees and 6 outreach clinics, MMH is the second largest employer in the town of Massena.

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Shah N et al. Performance of Three New-Generation Pulse Oximeters during Motion and Low Perfusion in Volunteers. J Clin Anesth. 2012 Aug;24(5):385-91.
2. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
3. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 including 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In studies with SpHb, reductions in blood transfusion* were observed,8,9 and when used with PVi, a reduction in 30-day mortality was observed.10 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
8. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
9. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Root® and Patient SafetyNet™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root and Patient SafetyNet, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking of Rad-97 Pulse CO-Oximeter® and Connectivity Hub with Noninvasive Blood Pressure

Neuchatel, Switzerland – March 20, 2017 – Masimo (NASDAQ: MASI) announced today the CE marking of noninvasive blood pressure (NIBP) measurements for the Rad-97 Pulse CO-Oximeter® and connectivity hub. Rad-97 offers Measure-through Motion and Low Perfusion SET® pulse oximetry and upgradeable rainbow® noninvasive blood constituent monitoring technology in a compact standalone monitor configuration which can also collect and remotely transmit data from connected devices.

Rad-97 with NIBP enables clinicians to measure arterial blood pressure for adult, pediatric, and neonatal patients, with three measurement modes: spot-check, automatic interval (which measures blood pressure routinely, at a desired interval), and stat interval (which continually measures blood pressure for a desired duration). An integrated port allows clinicians to connect a blood pressure cuff inflation hose directly to Rad-97, and is compatible with both disposable and reusable cuffs, for a variety of patient types, designed for reliability and patient comfort.



Masimo Rad-97™ Pulse CO-Oximeter® and Connectivity Hub with Noninvasive Blood Pressure

With the addition of NIBP to Rad-97, clinicians can easily and automatically chart blood pressure data directly from the same monitoring device that measures oxygen saturation, total hemoglobin, and other noninvasive parameters. In hospital settings and when used in conjunction with Masimo Iris Gateway™ or Patient SafetyNet™*, data from Rad-97 and other devices connected via the Iris™ hub can be sent directly to the patient's electronic medical record (EMR). With Patient SafetyNet, alarms and alerts from connected devices are seamlessly forwarded to clinicians.

Rad-97 includes built-in wireless connectivity, via Wi-Fi and Bluetooth®. Using Bluetooth or a wired USB connection, Rad-97 can connect to nearby devices, such as glucometers and weight scales, and can allow the data from the connected device to be transmitted remotely. Rad-97 will be available for use on home and enterprise networks to connect to remote monitoring systems, including Patient SafetyNet. Additional devices can be simultaneously attached to Rad-97 using the Iris hub.

Rad-97 features a high-resolution, 1080p HD color display with user-friendly multi-touch navigation, allowing clinicians to easily customize the device to best suit their monitoring and viewing needs. Users can also rapidly configure the device to accommodate different patient populations using customizable profiles. A rechargeable battery lasting seven hours allows Rad-97 to be used in situations where portability or extended operation without access to power are needed. An optional roll stand allows for tetherless device transport, offering additional flexibility when space is limited.

Rad-97 will also be available with an optional camera, which can be used in conjunction with Masimo Patient SafetyNet. The camera will provide a high resolution, high-frame rate video feed, as well as audio, to the Patient SafetyNet view-station. When used at home, camera-equipped Rad-97 will allow patients and clinicians to interact remotely, making it well-suited as a point-of-care device for potential telehealth applications.

Like Radical-7®, Rad-97 features Measure-through Motion and Low Perfusion pulse oximetry (SpO2), pulse rate (PR), and perfusion index (PI). Clinicians can add other monitoring solutions such as the rainbow SET measurements PVi®, total hemoglobin (SpHb®), methemoglobin (SpMet®), acoustic respiration rate (RRa®), carboxyhemoglobin (SpCO®), and oxygen content (SpOC). Additional parameters such as Oxygen Reserve Index (ORi) and respiration rate from the pleth (RRp™) are also available, making Rad-97 the smallest Masimo bedside device currently capable of monitoring the full rainbow SET platform.

"Rad-97 brings our core SET® and rainbow® technologies to a compact design, which allows broader applications in many new settings, including the home, with its hub and telepresence capabilities," said Joe Kiani, Founder and CEO of Masimo. "We're excited to extend its range of possibilities with the addition of integrated blood pressure measurement."

Rad-97 is not available in the United States.

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In studies with SpHb, reductions in blood transfusion* were observed,6,7 and when used with PVi, a reduction in 30-day mortality was observed.8 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Rad-97®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-97, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Evaluates the Utility of Masimo SpHb® Monitoring During Liver Transplantation

Irvine, California – March 13, 2017 – Masimo (NASDAQ: MASI) announced today the publication of a recent study conducted on adult patients undergoing liver transplantation (LT), in which researchers assessed the accuracy and trending ability of noninvasive Masimo SpHb® (total hemoglobin) measurement, as compared to conventional laboratory hemoglobin (HbL) measurements. The researchers found that SpHb had "clinically acceptable accuracy of hemoglobin measurement [compared] with a standard laboratory device when used during LT" and that "[t]his technology can be useful as a trend monitor during all surgical phases of LT and can supplement HbL to optimize transfusion decisions or to detect occult bleeding."1

Monitoring a patient's hemoglobin (Hb) levels is essential during LT because, as the researchers point out, "a serious loss of blood and fluid shift causes great variations [in] the Hb level, and delayed blood transfusion may cause graft dysfunction because of hypo-perfusion and tissue hypoxia. Moreover, more importantly, over-transfusion is associated with end organ damage and graft dysfunction." Recognizing that the "benefits and clinical advantages of noninvasive, rapid, and accurate determination of Hb in the operating room are obvious," Dr. Kayhan and colleagues sought to evaluate the accuracy and trending ability of Masimo SpHb during LT by comparing its measurements to those of a standard laboratory hematology analyzer.

To this end, the investigators enrolled fifty-five adult patients undergoing orthotopic LT in the study. The patients' Hb levels were analyzed using a Beckman Coulter LH 780 Hematology Analyzer, with each patient's arterial blood being sampled six times, twice during each of the three phases of the surgery: pre-anhepatic, anhepatic, and neohepatic. SpHb values were recorded within 10 seconds of each blood sample using a Masimo Radical-7® Pulse CO-Oximeter® (software version 7.8.0.1) and Masimo rainbow® ReSposable R2-25r and R2-25a sensors. A total of 282 paired measurements were collected and analyzed. HbL values ranged from 5.4 to 17.1 g/dL (mean 10.58) and SpHb values ranged from 6.9 to 17.7 g/dL (mean 11.44).

To compare the accuracies of the two methods, the researchers used a Bland-Altman plot and calculated absolute bias (the differences between SpHb and HbL) of 0.86 (95% CI = 0.50-1.21), precision (one standard deviation of the bias) of 1.58, and limits of agreement of -2.25 to 3.96. Using Pearson's correlation analysis, the researchers found that the correlation between the two sets of values was "highly significant": Pearson's correlation coefficient r=0.73; 95% confidence interval = 0.67-0.78, R2=0.53, p less than 0.001.

The researchers concluded that "[t]he results of this study show that SpHb has clinically acceptable accuracy of Hb measurement as compared with a standard laboratory device when used during LT. This technology may provide more timely information on Hb status than intermittent blood sample analysis and thus has the potential to improve blood management during LT. The trending accuracy may not only detect occult bleeding but can also prevent over-transfusion after bleeding; at least this method has the potential to supplement detection of changes. Nevertheless, due to underestimation in the lower Hb values, clinicians should be cautious when making decisions based on SpHb alone. Instead of focusing on a single value, SpHb may be considered an early warning system and a trend monitor. Future studies should evaluate the utility of SpHb in terms of overall clinical outcomes of transfusion decision."

"In prior studies using SpHb monitoring, reductions in blood transfusion were observed,2,3,4 and when used with PVi®, another Masimo noninvasive measurement, a reduction in 30-day mortality was observed5," stated Joe Kiani, Founder and CEO of Masimo. "Dr. Kayhan's study adds to the evidence that SpHb may be a useful tool during procedures such as liver transplantation."

SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samples. SpHb monitoring is intended to supplement, not replace, laboratory measurements. Blood samples should be analyzed by laboratory instruments when possible prior to clinical decision making.

@MasimoInnovates || #Masimo

References
1. Kayhan et al. Accuracy of Noninvasive Hemoglobin Monitoring by Pulse CO-Oximeter During Liver Transplantation. Minerva Anestesiologica. 2017 Jan 20. DOI: 10.23736/S0375-9393.17.11652-4
2. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
3. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
4. Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong, 2016. Abstract #PR607.
5. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In studies with SpHb, reductions in blood transfusion* were observed,6,7 and when used with PVi, a reduction in 30-day mortality was observed.8 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Availability of the RD SedLine® Adult EEG Sensor

Irvine, California – March 6, 2017 – Masimo (NASDAQ: MASI) announced today availability of the RD SedLine® EEG sensor, for use with Masimo SedLine Brain Function Monitoring and compatible with simultaneous use of Masimo O3 Regional Oximetry. SedLine and O3 provide simultaneous monitoring on the Masimo Root® monitoring platform, helping to give clinicians more information about the brain.



Masimo RD SedLine® Adult EEG Sensor

The RD SedLine EEG sensor features a repositioned, color-coded sensor-cable connection that lies comfortably on the patient's head and soft foam pads to reduce discomfort upon application to the patient. The sensor's streamlined shape and built-in fitting guide allow simultaneous application of SedLine and O3 sensors. The sensor's performance and specifications remain the same and work with existing SedLine modules, via an updated patient cable.

SedLine brain function monitoring features four simultaneous EEG leads to enable continuous assessment of both sides of the brain, four EEG waveforms, a Density Spectral Array (DSA; an easy-to-interpret, high-resolution display of bi-hemispheric activity and EEG power), and the Patient State Index (PSI; a processed EEG parameter related to the effect of anesthetic agents). Next Generation SedLine, available outside the U.S., enhances the PSI to make it less susceptible to electromyographic (EMG) interference and to improve performance in low-power EEG cases.

Masimo RD SedLine Adult EEG and O3 Regional Oximetry Sensors

Masimo RD SedLine® Adult EEG and O3 Regional Oximetry Sensors

O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. Regional oximetry may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors, such as the type of clinical procedure being performed.

Dr. David Drover, Professor of Anesthesiology in the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford Hospital, stated, "The RD SedLine sensor allows simultaneous application with O3 Regional Oximetry to deliver more information about my patient's brain in a single specialty monitor."

"Root with SedLine and O3 presents a powerful brain monitoring solution," said Joe Kiani, Founder and CEO of Masimo. "With the addition of the RD SedLine EEG sensor, the EEG and optical sensors fit together like puzzle pieces, making it easier for clinicians to simultaneously monitor patients with both technologies, while providing a comfortable experience for the patient."

The RD SedLine EEG sensor is available in the U.S. Next Generation SedLine does not have 510(k) clearance and is not available in the U.S.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS. 2015. doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SedLine®, RD SedLine EEG sensors, and O3. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SedLine, RD SedLine EEG sensors, and O3, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Assesses the Utility of Masimo PVi® Monitoring During Colorectal Surgery

Neuchatel, Switzerland – February 27, 2017 – Masimo (NASDAQ: MASI) announced today the findings of a recent study conducted on low-risk patients undergoing colorectal surgery, in which researchers assessed the utility of noninvasive and continuous Masimo PVi® (Pleth Variability Index) monitoring to guide fluid management, as compared to esophageal Doppler, an invasive method. The researchers found no significant difference between the two technologies in mean total fluid administered and concluded that "PVi offers an entirely noninvasive alternative for goal-directed therapy in this group of patients."1

In the study, Dr. Warnakulasuriya and colleagues at York Teaching Hospital in York, United Kingdom, evaluated the performance of Masimo PVi monitoring in guiding fluid management, as compared to that of an established technology, esophageal Doppler. Forty low-risk patients undergoing elective colorectal surgery were enrolled in the study. The patients were randomly assigned to two groups, with each group having fluid therapy directed by one of the two technologies. The researchers measured the absolute volume of fluid given intraoperatively and fluid volume at 24 hours. The researchers found "no significant difference between PVi and esophageal Doppler groups in mean total fluid administered (1286 vs 1520 ml, p=.300) or mean intraoperative fluid balance (+839 v + 1145 mL, p=.150)."

The researchers concluded that "amongst fit patients undergoing major colorectal surgery there was no significant difference in the volume of fluid administered when targeted by noninvasive PVi technology compared to a stroke volume maximization technique using esophageal Doppler. There was no significant difference in postoperative outcomes between the groups. Therefore, PVi offers a noninvasive, consumable free alternative for intraoperative fluid optimization in fit patients undergoing major colorectal surgery, where intraoperative goal-directed therapy is deemed a standard of care but there is no requirement for arterial cannulation."

PVi is a measure of the dynamic changes in perfusion index (PI) that occur during the respiratory cycle. In other clinical studies, PVi has been shown to provide benefits in the monitoring of mechanically-ventilated patients under general anesthesia during surgery,2,3,4,5 in the ICU in both adults and children,6,7 and in septic patients in the early stages of shock in the emergency department.8 Another study used PVi as part of goal-directed therapy for patients in an enhanced recovery after surgery (ERAS) program who underwent colorectal surgery; the program led to significant reductions in lengths of stay, costs, surgical site infections, fluid administered, as well as improvement in patient satisfaction.9 In a study in which PVi was used in conjunction with Masimo SpHb® (noninvasive hemoglobin measurement), the technologies were shown to reduce mortality at 30 and 90 days.10

"Clinical evidence for the utility of Masimo PVi continues to amass," said Joe Kiani, Founder and CEO of Masimo. "Dr. Warnakulasuriya's study provides additional information about the benefits of PVi. We are grateful for the opportunity we have to continue to improve patient outcomes and reduce cost of care with our innovative noninvasive monitoring."

@MasimoInnovates || #Masimo

References
1. Warnakulasuriya S et al. Comparison of esophageal Doppler and plethysmographic variability index to guide intraoperative fluid therapy for low-risk patients undergoing colorectal surgery. Journal of Clinical Anesthesia. (2016)34,600-608.
2. Cannesson M et al. Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre. Br J Anaesth. 2008;101(2):200-6.
3. Zimmermann M et al. Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major Surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.
4. Fu Q et al. Stoke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness During Resection of Primary Retroperitoneal Tumors in Han Chinese. Biosci Trends. 2012 Feb;6(1):38-43.
5. Haas S et al. Prediction of Volume Responsiveness using Pleth Variability Index in Patients Undergoing Cardiac Surgery after Cardiopulmonary Bypass. J Anesth. 2012 Oct;26(5):696-701.
6. Loupec T et al. Pleth Variability Index Predicts Fluid Responsiveness in Critically Ill Patients. Crit Care Med. 2011;39(2):294-299.
7. Byon HJ et al. Prediction of Fluid Responsiveness in Mechanically Ventilated Children Undergoing Neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91.
8. Feissel M et al. Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot Study. J Crit Care. 2013 May 14:634-639.
9. Thiele et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. Journal of the American College of Surgeons (2015). doi: 10.1016/j.jamcollsurg.2014.12.042.
10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS. 2015. doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVi®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVi, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Recent Study Monitoring Methemoglobin Levels During Administration of Inhaled Nitric Oxide

Irvine, California – February 21, 2017 – Masimo (NASDAQ: MASI) announced today the findings of a recent study conducted on children admitted to a Ugandan hospital with fever and malaria, in which Masimo's noninvasive measurement SpMet® was used to monitor methemoglobin (MetHb) levels. One group of children with severe malaria was selected to receive inhaled nitric oxide (iNO) treatment as an adjunct to intravenous therapy while a placebo group received room air. Both of these groups were monitored with SpMet.1

Red blood cells containing hemoglobin can become oxidized in the precence of certain drugs and compounds, including nitric oxide, changing it to methemoglobin (MetHb), which impairs the oxygen-carrying capacity of blood. When MetHb levels rise, headache, respiratory distress, cyanosis, and finally death may occur. A 2004 study conducted at Johns Hopkins Hospital reported that 20% of the patients tested, from neonates to geriatrics, had elevated MetHB caused by the side effects of 40 drugs given to patients in hospitals, including nitric oxide. Three patients nearly died and one patient died from elevated MetHb during the study period.2

An estimated 1.2 million people die from malaria annually worldwide, with a mortality rate of 8-20% in children with severe malaria.3 In the Ugandan study, Dr. Andrea Conroy and colleagues at Jinja Regional Referral Hospital assessed an adjunctive therapy for malarial patients: the administration of inhaled nitric oxide (iNO) – but as iNO is absorbed by the body, it "induces MetHb in a dose-dependent manner." Noting that "[t]here are no reliable estimates of methemoglobinemia in low resource clinical settings," but seeking to "evalulate whether iNO could improve clinical recovery...in a cohort of children with severe malaria," the investigators chose to monitor MetHb levels during treatment with a Masimo Rad-57® Pulse CO-Oximeter® with noninvasive SpMet monitoring.

The investigators in Uganda selected 180 children admitted to the hospital with severe malaria between 2011 and 2013 to receive either iNO (n=88) or a placebo, room air (n=92), in conjunction with standard anti-malarial treatment. MetHb levels were measured on a four-hourly basis following gas initiation, using Masimo SpMet. Between gas initiation and the first check with SpMet, MetHb levels rose from an average of 1.8% to 4.1% for the iNO group but stayed the same (1.7% to 1.8%) in the placebo group. MetHb levels typically plateaued within 12-24 hours of receiving iNO. Gas was withdrawn for 31 children (placebo: 12; iNO: 19; p=0.13).

The researchers stated that "we were able to evaluate the variability in MetHb responses within subjects and the frequency of methemoglobinemia prompting study gas discontinuation. Despite the high doses of iNO administered, study gas was temporarily discontinued only five times for MetHb greater than 10% (all children in the iNO group). We were able to re-start study gas for all children that had a MHb measurement that exceeded 10% once the MetHb returned to less than 7% without having the MetHb exceed 10% again. It was not necessary to wean children off iNO, in contrast to studies administering iNO to neonates with hypoxic respiratory failure, as we did not observe any rebound effects (e.g. worsening oxygenation) following discontinuation of study gas."

The authors concluded that, "Hospitalized children with evidence of impaired oxygen delivery, metabolic acidosis, anemia, or malaria were at risk of methemoglobinemia. However, we demonstrated high-dose iNO could be safely administered to critically ill children with severe malaria with appropriate MHb monitoring."

Joe Kiani, Founder and CEO of Masimo, stated, "It's great to see that our invention of continuous methemoglobin monitoring has allowed these clinicians to study the outcomes of administering iNO treatment. We hope to continue developing monitoring technologies that help to address such public health crises."

SpMet monitoring is not intended to be used as the sole basis for making diagnosis or treatment decisions. It is intended to be used in conjunction with other clinical tools, including signs and symptoms and laboratory blood tests.

@MasimoInnovates || #Masimo

References
1. Conroy et al. Methemoglobin and nitric oxide therapy in Ugandan children hospitalized for febrile illness: results from a prospective cohort study and randomized double-blind placebo-controlled trial. BMC Pediatrics. (2016) 16:177. DOI 10.1186/s12887-016-0719-2.
2. Ash-Bernal et al. Acquired methemoglobinemia: A retrospective series of 138 cases at 2 teaching hospitals. Medicine. October 2004;83(5)265-73. DOI 10.1097/01.md.000141096.00377.3f.
3. Murray et al. Global malaria mortality between 1980 and 2010: a systematic analysis. Lancet. 2012;379(9814):413-31.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS. 2015. doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpMet®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpMet, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking of Respiration Rate Measurement on MightySat Rx

Masimo MightySat Rx is the First Fingertip Pulse Oximeter to Measure Respiration Rate

Neuchatel, Switzerland – February 15, 2017 – Masimo (NASDAQ: MASI) announced today the the CE marking of the measurement of respiration rate from the pleth (RRp) on the MightySat Rx fingertip pulse oximeter. MightySat Rx is a noninvasive device that measures and displays functional oxygen saturation (SpO2), Pulse Rate (PR) and Perfusion Index (PI) with the option to add Pleth Variability Index (PVi®) and now, RRp.

Masimo TFA-1™ Single-Patient-Use Forehead Sensor

Masimo MightySat with RRp

Respiration rate, or the number of breaths taken per minute, typically requires manually counting breaths with a timer and then converting to a per minute rate, or being fitted with chest leads or straps that can be inconvenient. With the addition of RRp to MightySat Rx, respiration rate can conveniently be measured using the same fingertip sensor that measures SpO2, PR, PI, and PVi (a measurement of the dynamic changes in PI that occur during the respiratory cycle). RRp is measured only when the respiratory movement-induced signal is present in the pulsatile waveform and may not be available during certain conditions, such as very irregular breathing and excessive movement.

MightySat Rx is indicated for use with both adult and pediatric patients during both no motion and motion conditions, who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments. It offers a Bluetooth wireless interface to the Masimo Professional Health mobile application to track, trend, and communicate measurements. MightySat Rx features the same Measure-through Motion and Low Perfusion SET® pulse oximetry available in a variety of bedside Masimo and OEM monitors. Masimo SET® addresses the challenges of low perfusion and motion artifact that limit conventional pulse oximetry by harnessing the power of adaptive filters to reduce measurement inaccuracy. Infection control issues aside, Masimo SET® performance benefits are maximized by choosing the the correct sensor type for the applicable use scenario: adhesive sensors for continuous monitoring, reusable cabled sensors for short-term monitoring and MightySat Rx fingertip oximeters for spot-checks on those who are not moving excessively and do not have very poor perfusion. Masimo SET® helps clinicians monitor oxygen saturation and pulse rate during motion and low perfusion for more than 100 million patients a year1 and is the primary pulse oximetry at top hospitals, including 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.2

"MightySat Rx is our smallest, most compact pulse oximeter, and as such is particularly versatile, offering the convenience of portability," stated Joe Kiani, Chairman and CEO of Masimo. "We are happy to be able to increase its capability with the addition of RRp, and to continue innovating in the field of mobile monitoring devices for the professional caregiver market."

RRp does not have 510(k) clearance and is not available in the U.S.

@MasimoInnovates || #Masimo

References
1. Estimate: Masimo data on file.
2. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS. 2015. doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo MightySat Rx and SET®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo MightySat Rx and SET®, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces the Addition of Early Warning Score to the Root® Patient Monitoring and Connectivity Platform

Neuchatel, Switzerland – February 1, 2017 – Masimo (NASDAQ: MASI) announced today the limited market release of Early Warning Score (EWS) on the Root® patient monitoring and connectivity platform. EWS aggregates information from multiple vital signs and clinical observations to generate a score that represents the potential degree of patient deterioration.

Root, which works in conjunction with Radical-7® or Radius-7® Pulse CO-Oximeters® and Masimo Open Connect (MOC-9) measurements, features Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, rainbow SET pulse CO-Oximetry, Nomoline capnography and gas monitoring, SedLine® brain function monitoring, O3 regional oximetry, and SunTech® blood pressure and Welch Allyn® temperature monitoring. Masimo SET® helps clinicians monitor oxygen saturation and pulse rate during motion and low perfusion for more than 100 million patients a year1 and is the primary pulse oximetry technology at top hospitals, including 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.2

Patient data from Radical-7 or Radius-7 and data collected using Root and other connected Masimo and third-party devices can be shared with Masimo Patient SafetyNet*, providing hospital-wide remote monitoring and clinician notification, as well as the ability to automatically push patient data to a hospital's Electronic Medical Record (EMR). Each time a clinician pushes data to the EMR via Root connected to Patient SafetyNet, an Early Warning Score (EWS) can now be included. Clinicians can also choose to have the standalone Root perform EWS calculations.

There are several EWS protocols, such as Pediatric Early Warning Score (PEWS), Modified Early Warning Score (MEWS), and National Early Warning Score (NEWS). These various scores require vital signs contributors – such as oxygen saturation, pulse rate, respiration rate, body temperature, and systolic blood pressure – and contributors input by clinicians, such as level of consciousness, use of supplemental oxygen, and urine output. The weighting and number of contributors differ depending upon which EWS protocol is used. Root can be customized for various predefined EWS protocols, or hospitals can configure their own set of required contributors, and their relative weights, to create an EWS unique to their care environment.

Recent peer-reviewed studies, across care areas, have suggested that the use of NEWS may have clinical benefits: Vanamali et al. notes that NEWS is a "useful simple physiological scoring system for assessment and risk management of medical emergency admissions."3 Smith et al. found that an EWS of 5 or greater after laparotomy is associated with adverse outcomes, while recommending that future studies evaluate the ability of EWS to predict and prevent such outcomes.4

Outside the U.S., as part of the Patient SafetyNet platform, Masimo also offers Halo Index. Whereas EWS provides a spot-check score using the NEWS standard, Halo Index presents a dynamic, cumulative trending assessment of global patient status as a single displayed number ranging from 0 to 100. Halo Index uses available Masimo parameters from connected monitoring devices, but is scalable to include additional information from the patient data repository. Masimo designed Halo Index to mimic the systematic approach that expert clinicians use in assessing patient physiologic deterioration, analyzing the patient's history and extracting key vital sign parameter characteristics; increases in a patient's Halo Index may indicate the need for clinicians to more closely assess the patient.

"Root, from its versatile connectivity options to its advanced patient monitoring, from rainbow® SpHb® to SET® SpO2, has long been helping hospitals improve and automate their patient care. Now, with Early Warning Score, Root can help clinicians stay ahead of the care race and transfer their patients home safely," said Joe Kiani, Founder and CEO of Masimo.

Root with Early Warning Score (EWS) and Halo Index are not available in the U.S. EWS is a convenient aid to clinical assessment and not a substitute for clinical judgement.

@MasimoInnovates || #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. Estimate: Masimo data on file.
2. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
3. Vanamali DR, et al. The Role of National Early Warning Score (News) in Medical Emergency-Patients in Indian Scenario: A Prospective Observational Study. Journal of Evolution of Medical and Dental Sciences. 2014; Vol. 3, Issue 13, March 31; Page: 3524-3528, DOI: 10.14260/jemds/2014/2315.
4. Smith, et al. Early warning score: An indicator of adverse outcomes in postoperative patients on a gynecologic oncology service. Gynecol Oncol. 2016 Oct;143(1):105-8. doi: 10.1016/j.ygyno.2016.08.153. Epub 2016 Aug 6.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS. 2015. doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Root®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Reaffirms Commitment to India with Launch of Advanced Monitoring Technologies Made for India

Leading Bangalore Hospital CEOs Convene for Masimo Roundtable

Bangalore, India – January 2, 2017 – Masimo (NASDAQ: MASI) announced today the launch and availability of the Rad-97 Pulse-CO Oximeter®* and Next Generation Sedline®* Brain Function Monitoring in India. The announcement was made in Bangalore by Joe Kiani, Founder and CEO of Masimo, at a roundtable of the CEOs of top Bangalore hospitals.

Joe Kiani, Founder and CEO, Masimo, commented, "The Indian healthcare sector recognizes the need for technologies that help their clinicians get the best results, the first time. Masimo's noninvasive patient monitoring technology innovations offer capabilities that have never been possible before. With a large population and a burgeoning demand for an improved quality of life – including the safe, high-quality healthcare to which all are entitled – India continues to be a focus market for Masimo. We will continue to invest in India and strive to make our technologies and products as accessible as possible, as evidenced by the new Rad-97 and Next Generation SedLine."

Bharat Monteiro, Masimo Country Manager for India, noted, "Masimo is committed to doing what is best for patient care in India. In the course of our engagement with leading Indian hospitals, we have witnessed an increased awareness of and commitment to patient safety requirements. Medical providers across the country are eager to adopt advanced technologies and monitoring devices, such as Rad-97 and Next Generation SedLine, which we hope will help provide access to better healthcare, at lower cost."

Dr. Ashutosh Raghuvanshi, Managing Director and Group CEO of Narayana Health Hospitals, one of the participants in the roundtable, commented, "We constantly endeavor to improve the facilities at our hospitals to ensure better patient care and treatment outcomes. With the newly launched Rad-97, we will be able to use Masimo SET® pulse oximetry in more care areas, including ward monitoring, which will help facilitate better monitoring and patient treatment. Narayana Health performs the highest number of cardiac surgeries in India, and I believe that noninvasive hemoglobin (SpHb) will add immense value to complex cardiac surgeries, helping us reduce unwarranted transfusions and the risk of infection."

Rad-97 features Measure-through Motion and Low Perfusion SET® pulse oximetry, which studies have shown helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Rad-97 also offers the same upgradeable rainbow SET technology as the Radical-7® Pulse CO-Oximeter, in a versatile, standalone monitor configuration. Using Rad-97, clinicians can monitor such rainbow® measurements as total hemoglobin (SpHb®) and PVi®. Studies with SpHb have shown reductions in unnecessary blood transfusion+,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 rainbow® can also measure methemoglobin (SpMet®), acoustic respiration rate (RRa®), carboxyhemoglobin (SpCO®), Oxygen Reserve Index* (ORi), and oxygen content (SpOC). Rad-97 also features an integrated camera* for clinician tele-presence via Patient SafetyNet™++ and a high-resolution 1080p HD color display with user-friendly multi-touch navigation, similar to Root® and Radical-7, allowing clinicians to easily customize the device to best suit their monitoring needs.

SedLine features four simultaneous EEG leads to enable continuous assessment of both sides of the brain, as well as a Density Spectral Array (DSA), an easy-to-interpret, high-resolution display of bi-hemispheric activity. Next Generation SedLine enhances Masimo's processed EEG parameter, the Patient State Index (PSI), to make it less susceptible to electromyographic (EMG) interference and to improve performance in low-power EEG cases.

@MasimoInnovates || #Masimo

*Rad-97, the camera feature, Next Generation SedLine, and ORi do not have 510(k) clearance and are not available in the U.S.
+Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
++The use of the trademark SafetyNet is under license from University HealthSystem Consortium.

References
1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS (2015). doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Rad-97™ Pulse CO-Oximeter® and Next Generation SedLine® Brain Function Monitoring. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-97 and Next Generation SedLine, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Ajith Pai / Amrutha Moorthy
Adfactors PR (Masimo in India)
Phone: +91 96633 94732
Email: ajit.pai@adfactorspr.com / amrutha.moorthy@adfactorspr.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA 510(k) Clearance for TFA-1 Single-Patient-Use Forehead Sensor

Irvine, California – December 19, 2016 – Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for the TFA-1 Single-Patient-Use Adhesive Forehead Sensor. This single-patient-use sensor allows clinicians to monitor patients using Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry from an alternative monitoring site, the forehead, rather than a finger.

Masimo TFA-1™ Single-Patient-Use Forehead Sensor

Masimo TFA-1™ Single-Patient-Use Forehead Sensor

Forehead sensors may provide oxygen saturation measurements that are less susceptible to peripheral perfusion changes, and were shown in a 2004 study to have faster detection of desaturation and resaturation, as compared to digit sensors.1 Forehead sensors can also be easily accessed during surgery and resuscitation and on patients with finger deformities or whose fingers are not accessible. As a single-patient-use sensor, TFA-1 avoids the management complexities (cleaning, storage, and inter-department transport) that accompany reusable sensors.

Masimo SET® includes measurement of oxygen saturation (SpO2), pulse rate (PR), perfusion index (PI), and PVI®, a measure of the dynamic changes in PI that occur during the respiratory cycle. Masimo SET® addresses the challenges of low perfusion and motion artifact that limit conventional pulse oximetry by harnessing the power of adaptive filters to reduce measurement inaccuracy. Masimo SET® helps clinicians monitor more than 100 million patients a year2 and is used by 8 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.3

@MasimoInnovates || #Masimo

References
1. Redford DT et al. Intraoperative Perfusion Changes at Two Pulse Oximetry Monitoring Sites: The Digit vs. the Nare. Anesth Analg. 2004;98(2S)S-94.
2. Estimate: Masimo data on file.
3. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo TFA-1 Sensors and SET® pulse oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo TFA-1 Sensors and SET® pulse oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Giving Back with Masimo

Irvine, California – December 6, 2016 – Masimo (NASDAQ: MASI) gives thanks, as always, for the many joys and successes that 2016 has brought us. It has nonetheless been a difficult year, both at home and abroad: millions of refugees, displaced from war-torn homelands, continue to suffer. In low-resource settings across the world, many of the most at-risk patients lack access to even the most basic medical care, such as oxygen. Brexit and a particularly contentious presidential election have left many people feeling more divided than united. And hospital patients around the world, even those lucky enough to have good medical care, continue to experience unnecessary harm and to die as a result of inadvertent mistakes and lapses in patient safety.

As in years past, in the spirit of giving back and of trying to make the world a better place for everyone, we humbly ask you, our loyal friends and customers, to help us to donate to some of what we believe to be the worthiest charities, representing a variety of causes. We simply ask that you send an email to charity@masimo.com, specifying your choice from the list below, and we will donate $10 in your name to that charity. We also encourage you to donate to them directly.

As part of Masimo's commitment to giving back, in 2016 we have continued to focus on providing relief to refugees through donations to Doctors Without Borders, the Syrian Community Network, and the Syrian American Medical Society. Employee donations, matched by the Kiani family, have to date raised more than $200,000. Last year, we announced a $5 million medical equipment donation to Jordan, to help provide healthcare to over 1 million Syrian refugees, and work on that project has continued throughout 2016. In addition, this year we've formed several partnerships dedicated to advancing the quality of healthcare in low-resource settings around the world: with Smile Train, to promote safe cleft-lip and palate surgery; with a variety of non-profit organizations to create United for Oxygen, an alliance dedicated to increasing access to medical oxygen and pulse oximetry; and the Gates Foundation, to develop a low-cost pulse oximeter and promote pneumonia screening.

Joe Kiani, Founder and CEO of Masimo, notes: "Tragic headlines, bespeaking much loss and woe, have dominated the news cycle for many years now. It's time for us all to take steps to transform those headlines, so that rather than the negative, we can focus on the great work so many are doing to care for those in need around the world: helping refugees find safe and dignified refuge amongst us, eliminating preventable hospital deaths, and providing access to safe surgery for the billions who still don't have it. Please join us in trying to channel the energy of despair into forces for good. And thank you for being a part of our Masimo family. We are grateful to you all and wish you all a wonderful holiday season. Here's to a happier and healthier New Year!"

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Masimo pulse oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Receives Gates Foundation Grant to Develop Combined Pneumonia-Screening Device for High-Burden Settings

Irvine, California – November 11, 2016 – Masimo (NASDAQ: MASI) announced today, in advance of World Pneumonia Day tomorrow, that it has received a grant of $4.95 million from the Bill & Melinda Gates Foundation (BMGF). The grant will support Masimo's efforts to develop a low-cost pulse oximeter for use in pneumonia screening in several low-resource areas outside the U.S. While still in development, the device will likely measure oxygen saturation (SpO2) and respiration rate (RR) - two key parameters that would provide additional information to clinicians when screening potential pneumonia cases in high-burden settings. The grant will also support studying the clinical use environment in such settings to ensure that the device is user friendly and fit for its purpose. The grant may also support the education materials to promote proper training and use of the device at all literacy levels.

Pneumonia remains the single largest treatable infectious cause of death in children worldwide, causing over 900,000 deaths each year among children under 5 years of age.1 In a study funded by the BMGF Diagnostics Modelling Consortium, the researchers concluded that in settings where supplemental oxygen is available, the addition of pulse oximetry to standard integrated management of child illness protocols could reduce pneumonia mortality rates.2 More recently, the World Health Organization (WHO) has sponsored an ongoing multi-country study to further assess how to enhance community case management of pneumonia treatment.3

Enhancing patient screening is critically important to reducing the global burden of pneumonia. Moreover, enhanced screening may empower healthcare providers by supporting informed decisions related to pneumonia diagnosis and treatment, with the appropriate administration of antibiotics and oxygen therapy when needed. Masimo and BMGF hope that Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry technology can help better screen children in even the most challenging conditions.

Rasa Izadnegahdar, Senior Program Officer on the Pneumonia Team at BMGF, commented, "We are excited to partner with Masimo for the purpose of improving screening for pneumonia to allow improved referral decisions by health workers in low-resource settings. Evaluating a child for fast breathing is the cornerstone of pneumonia assessment and combining this with a reliable and effective approach to assessing oxygen saturation can have significant impact in ensuring children with pneumonia receive appropriate care. Our landscape review of pneumonia diagnostic aid technologies has clearly demonstrated the poor performance of existing diagnostic aids, particularly respiratory rate timers. Diagnostic aids with improved sensitivity and specificity that are adapted and designed for use by health workers and caregivers can make a significant impact on pneumonia treatment. We look forward to working with Masimo to adapt their precise and accurate technology to respond to the needs of health workers, caregivers, and children in countries where pneumonia burden and deaths remain unacceptably high."

Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry is used to monitor millions of patients around the world. This project demonstrates the company's strong commitment to reducing the unnecessarily high global burden of pneumonia by bringing its proven patient screening and monitoring technology to the areas of the world that need it most.

"We are gratified to be able to partner with BMGF, which recently joined us in co-founding the United for Oxygen Alliance to increase access to oxygen and pulse oximetry in Ethiopia, in supporting our efforts to help fight pneumonia," said Joe Kiani, Founder and CEO of Masimo. "We hope to bring a much-needed screening tool to areas of the world blighted by countless needless deaths that are due to an illness considered low-risk in the developed world."

@MasimoInnovates || #Masimo

References
1. Pneumonia Fact Sheet, World Health Organization (WHO), September 2016. http://www.who.int/mediacentre/factsheefts/fs331/en/.
2. Floyd J et al. Evaluating the impact of pulse oximetry on childhood pneumonia mortality in resource-poor settings. Nature. 2015 Dec 3;528(7580):S53-9.
3. World Health Organization (WHO), 2016.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo pulse oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo pulse oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide comparable accuracy and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Philips and Masimo Sign Multi-Year Business Partnership Agreement in Patient Monitoring and Select Therapy Solutions

  • Multi-year business partnership combines Masimo's expertise in non-invasive sensor and signal processing technologies and Philips' expertise in integrated patient monitoring and therapy solutions
  • Business partnership involves technology integration and marketing and sales cooperation in North America and certain markets in Asia and Europe
  • Agreement ends all pending lawsuits between the two companies and, in addition to marketing and integration commitments, includes a cash payment of USD 300 million by Philips to Masimo

Amsterdam, the Netherlands and Irvine, California – November 7, 2016 – Royal Philips (NYSE: PHG; AEX: PHIA) and Masimo Corporation (NASDAQ: MASI) today announced a wide-ranging, multi-year business partnership involving both companies' innovations in patient monitoring and therapy solutions. The partnership includes joint marketing and sales programs in North America and certain markets in Asia and Europe for Masimo's non-invasive sensor technologies, such as its rainbow® and SET® platforms, in conjunction with Philips' patient monitoring and select therapy solutions. In addition, Philips will in the future integrate Masimo SedLine® brain function monitoring, O3 regional oximetry, and Nomoline capnography technologies in certain Philips IntelliVue® monitors.

Philips is a global leader in patient monitoring solutions with a comprehensive product portfolio ranging from multi-parameter bedside monitors to wearable patient monitors combined with mobile applications and clinical decision support tools. With a primary focus on prediction and prevention of patient deterioration, these integrated solutions aim to support clinical workflow and caregiver efficiencies, and enhance patient care. In 2015, an estimated 275 million patients were monitored using Philips' patient monitoring solutions.

Sensor and signal processing technologies are an essential component of patient monitoring solutions, and Masimo is a prolific innovator in this field. Examples of Masimo's non-invasive sensor and signal processing technology innovations include Masimo SET® pulse oximetry, Masimo rainbow® Pulse CO-Oximetry and Masimo total hemoglobin (SpHb®) monitoring technology.

"This business partnership agreement marks an important day for us and our customers as two leaders in patient monitoring collaborate to develop solutions designed to enhance clinical outcomes and patient safety," said Frans van Houten, CEO of Royal Philips. "I am very satisfied that we have reached an agreement that is beneficial for both companies and that we have ended our legal disputes. Going forward, Philips and Masimo will completely focus on jointly delivering meaningful innovations to our customers, such as the integration of Masimo rainbow® technology across our IntelliVue® patient monitoring product range."

"It's wonderful to think that Masimo and Philips will be working together for the benefit of patients and clinicians around the world," said Joe Kiani, Chairman and CEO of Masimo. "I am delighted that we were able to reach this important agreement which allows us to focus on the future to deliver the solutions that our customers have been looking for."

In conjunction with the appropriate Philips patient monitoring platform, Masimo's rainbow SET technology analyzes multiple wavelengths of light to accurately measure total hemoglobin (SpHb), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®) and Pleth Variability Index (PVI®) non-invasively and continuously. Continuous monitoring of SpHb on a Philips monitor at the point of care provides clinicians with real-time visibility to changes in hemoglobin in between invasive blood samplings.

Anticipated cash flow and income consequences for Philips
As part of the business partnership agreement, Philips and Masimo have agreed to end all pending lawsuits between the two companies, which includes that Philips is released from paying the USD 467 million (approximately EUR 428 million) jury verdict that was awarded to Masimo in October, 2014. Philips has agreed to make a USD 300 million cash payment (approximately EUR 275 million) to Masimo in the fourth quarter of 2016; and to invest in the relationship by making certain marketing and product integration commitments over the coming years. Entering into the business partnership agreement has minimal impact on income from operations (EBIT) in the fourth quarter of 2016.

Anticipated cash flow and income consequences for Masimo
As the result of anticipated legal fee savings during the fourth fiscal quarter, Masimo now expects its fiscal 2016 GAAP earnings per diluted share, exclusive of the impact of the business partnership agreement, to be $2.14, up from $2.13. Masimo expects to use some of the after-tax proceeds from the business partnership agreement to repay amounts outstanding under its revolving line of credit. The guidance set forth above is an estimate only and actual performance could differ.

@MasimoInnovates || #Masimo

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips' health technology portfolio generated 2015 sales of EUR 16.8 billion and employs approximately 70,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements - Royal Philips
This release may contain certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.

Forward-Looking Statements - Masimo
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

For further information, please contact:

Eli Kammerman
Masimo Investor Relations
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Evan Lamb
Masimo Media Contact
Phone: (949) 396-3376
Email: elamb@masimo.com

Steve Klink
Philips Groups Communications
Phone: +31 6 10888824
Email: steve.klink@philips.com

Vanessa Bruinsma-Kleijkers
Philips Investor Relations
Phone: +31 20 5977447
Email: Vanessa.Bruinsma-Kleijkers@philips.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Study Investigates the Impact of Masimo Continuous SpHb® and PVI® on Anesthesia-related Mortality

Chicago, IL – October 22, 2016 – Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the American Society of Anesthesiologists' (ASA) Annual Meeting in Chicago. In the study, researchers at Hopital Dupuytren, part of the Centre Hospitalier Universitaire of Limoges, France (CHU Limoges), investigated the clinical utility of noninvasive, continuous hemoglobin (SpHb®) and PVI® (a measure of the dynamic changes in perfusion index that occur during the respiratory cycle), two Masimo rainbow SET measurements. The researchers' goal was to determine, at the scale of a whole hospital, improvement in mortality and transfusion needs.1

In the prospective, single-center, observational study, Professor Nathalie Nathan and colleagues reviewed two sets of patients over two eleven-month periods, before (2013) and after (2014) implementation of a clinical algorithm to guide transfusion and fluid administration. Anesthesiologists, nurses, and residents were trained on the implementation of the clinical algorithm. Masimo Radical-7® Pulse CO-Oximeters® were installed in all operating rooms, recovery rooms, and intensive care units. The Radical-7s were connected to Masimo Patient SafetyNet™* for trend data collection. All surgical patients presenting to the hospital were accepted, with these exceptions: EMT, ophthalmology, odontology, radiology, neurosurgery, and patients less than 18 years of age.

The study included 18,867 patients (in the two groups), of whom 3450 underwent SpHb and PVI monitoring via Radical-7. The patients in the monitoring group received vascular filling with crystalloids or blood, according to the clinical algorithm. Demographic, anesthesia, surgical, and transfusion data were collected in electronic medical records. The researchers compared the percentage of patients in the monitored group who received transfusions within the first postoperative 48 hours to the percentage in the non-monitored group. They also compared mortality rates for each group at 30 days and 90 days following surgery.

Using the cox-proportional hazard model, the researchers found that the patients in the group monitored with SpHb and PVI had a 30% reduction in mortality at 30 days and a 25% reduction in mortality at 90 days. The proportion of patients receiving transfusions did not change significantly between the two groups (7.9% in 2013, 8.5% in 2014, p = 0.1323), nor did the number of blood units transfused within 48 hours (3.4 ± 2.7 in 2013, 3.4 ± 2.0 in 2014, p > 0.05). However, in non-cardiac surgery, patients were transfused sooner in the operative or recovery room (72.9% vs 56.1%, p = 0.0002).

The researchers concluded that "Monitoring SpHb and PVI integrated in a vascular filling algorithm allowed earlier transfusion and reduces mortality at a scale of a whole hospital with different clinical practices (and practitioners) and unselected patients."

"Access to continuous monitoring of Hb levels and fluid responsiveness has changed the way we address blood and fluid management. By lowering inadequate fluid filling at the beginning of anesthesia, we are able to avoid diluting patients inadequately and this data helps us to guide precisely the amount of fluids or blood that must be given to patients on a case by case basis," stated Professor Nathan, Head of the Department of Anesthesiology at CHU Limoges. "Patients are transfused earlier when needed and hypovolemia is precisely treated with crystalloid. These two facts may explain the decrease in mortality at one and three months that we observed in this study. We strongly believe that surgeries of intermediate severity such as hip or knee replacement procedures as well as severe surgery will benefit from this technology. Because it is easy to use, quick to administer, provides continuous data, and does not harm the patient in any way, it is more applicable to common clinical practice."

Joe Kiani, Founder and CEO of Masimo, commented, "We have created technologies that have been shown to save babies' eyesight2, screen for CCHD in newborns3, and reliably monitor patients in post-surgical wards4,5,6, but this is the first time a study has shown that one of our technologies has such a big impact on mortality. Needless to say, we are excited and thank Dr. Nathan for her and her colleagues' research. We look forward to more studies like this that investigate the impact of SpHb and PVI on other patients at other hospitals, and hope to see similar results."

SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings – when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when the SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. SpHb monitoring, accompanied by laboratory diagnostic testing, may thus help clinicians make more timely and informed decisions, and has been shown to help clinicians provide more timely blood transfusions** and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.7,8

@MasimoInnovates || #Masimo

*The use of the trademark SafetyNet is under license from University HealthSystem Consortium.
**Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
4. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
5. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
8. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb® and PVI®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb and PVI, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking of Rad-97 Pulse CO-Oximeter®

Neuchatel, Switzerland – October 6, 2016 – Masimo (NASDAQ: MASI) announced today the CE marking of the Rad-97 Pulse CO-Oximeter®. Rad-97 offers the same Measure-through Motion and Low Perfusion SET® pulse oximetry and upgradeable rainbow SET technology as the Radical-7® Pulse CO-Oximeter – in a versatile standalone monitor configuration.

Masimo Rad-97 Pulse CO-Oximeter, Masimo Rad-97 with Camera, Masimo Patient SafetyNet with SafetyNet Surveillance
top: Masimo Rad-97 Pulse CO-Oximeter®
center: Masimo Rad-97 with Camera
bottom: Masimo Patient SafetyNet with SafetyNet Surveillance

Rad-97 features a high-resolution 1080p HD color display with user-friendly multi-touch navigation, similar to Root® and Radical-7, allowing clinicians to easily customize the device to best suit their monitoring needs. Users can also rapidly configure the device to accommodate different patient populations using customizable profiles. Rad-97 provides both built-in wireless connectivity, via Wi-Fi and Bluetooth®, and built-in wired options, including Ethernet, USB, and Nurse Call Interface connections. A rechargeable battery lasting seven hours allows Rad-97 to be used in situations where portability or extended operation without access to power are needed.

In select markets outside the United States, Rad-97 will be available with an optional camera, which will be used in conjunction with Masimo Patient SafetyNet™*. The camera includes a high resolution, high-frame rate video feed, as well as audio, to the Patient SafetyNet view-station. The system will be able to use the hospital's existing IT network and to provide additional viewing of images in the same care area. Through Rad-97, it will be possible to connect other devices a patient may be using, such as glucometers and scales, to Patient SafetyNet and to remotely allow for interaction between clinicians and patients or other clinicians.

Like Radical-7, Rad-97 features Measure-through Motion and Low Perfusion pulse oximetry (SpO2), pulse rate (PR), and perfusion index (PI). Clinicians can add other monitoring solutions such as the rainbow SET measurements total hemoglobin (SpHb®), methemoglobin (SpMet®), acoustic respiration rate (RRa®), carboxyhemoglobin (SpCO®), and oxygen content (SpOC). In select markets outside the United States, additional parameters such as Oxygen Reserve Index (ORi) and respiration rate from the pleth (RRp) are available, making Rad-97 the smallest Masimo bedside device currently capable of monitoring the full rainbow SET platform.

"Rad-97 brings our core SET® and rainbow® technologies to a compact new design, which will allow broader applications in many new settings, including low-resource countries and homes," said Joe Kiani, Founder and CEO of Masimo. "We've engineered Rad-97 to take advantage of the latest advances in adaptability and connectivity, packaging Masimo's industry-leading noninvasive technology in a cost-effective monitor that will make it more accessible and useful to clinicians and patients than ever."

ORi and RRp parameters and the camera feature do not have 510(k) clearance and are not available in the U.S.

@MasimoInnovates || #Masimo

*The use of the trademark SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's Rad-97 Pulse CO-Oximeter®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-97 Pulse CO-Oximeter, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Honors Birthday of Mahatma Gandhi with Global Holiday

Irvine, California – October 2, 2016 – Masimo (NASDAQ: MASI) announced today that in honor of the birthday of Mahatma Gandhi (October 2, 1869), the company will close worldwide and offer an additional paid holiday to employees on Monday, October 3rd.

Mahatma Gandhi, born Mohandas Karamchand Gandhi, is considered the preeminent leader of the Indian independence movement, famous for seeking change, conflict resolution, and agreement through nonviolent protest, often through public fasting. He is still honored today as a global symbol of peace, with his birthday a national holiday in India and celebrated worldwide as the International Day of Nonviolence.

"Masimo has chosen to honor Gandhi's birthday to remind its employees and partners worldwide of the enduring importance of those role models who have helped shape our world for the better. At Masimo, we strive each day to remain true to our promises and responsibilities," said Joe Kiani, Founder and CEO of Masimo. "For us, that includes being thoughtful citizens of the world, striving to improve patient care through our innovative products and technologies. In these difficult times, when injustice, violence, and hatred are never far from the headlines, it's especially important to remember and admire the life of one who so consistently embodied peace, forgiveness, and understanding. Gandhi got what his people wanted and gained his country's independence from British rule through peaceful civil disobedience. I hope all Masimo employees worldwide will use this extra day to take stock of their lives, their goals, and their responsibilities, and to take steps to create a more just and peaceful world."

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Partners with Smile Train to Advance Safe Surgery

Irvine, California – September 30, 2016 – Masimo (NASDAQ: MASI) announced today that it is partnering with Smile Train to help ensure the safety of patients undergoing cleft lip and/or palate surgery in low-resource settings around the world.

Patient monitoring, including the use of pulse oximetry, is a key part of ensuring safe surgical care; however, in lower-resource settings essential monitoring equipment is often unavailable, particularly in the post-operative period.1 Working together, Smile Train and Masimo are helping to remove this barrier by equipping surgical programs in 15 countries in Asia, Africa, Central America and the Middle East with pulse oximeters.

Smile Train is an international organization that leverages the "teach a man to fish" model to train and empower local medical professionals to provide safe, high-quality, comprehensive cleft treatment for children in their own communities. Through Smile Train's local partnerships in 85+ countries, the organization has provided more than 1,000,000 cleft surgeries to date.

Through this partnership, Masimo is providing over 460 Masimo SET® Measure-through Motion and Low Perfusion pulse oximeters to Smile Train's nurse training programs and partner hospitals to support improved patient monitoring and safety. Additionally, Masimo and Smile Train will work together to develop additional initiatives to ensure that post-operative pulse oximetry can be scaled across all Smile Train programs.

One of the most common birth defects in the world, a cleft lip and/or palate occurs before a child is born, when the lip and/or roof of the mouth fail to fuse together properly during fetal development. In higher-resource settings virtually all babies with clefts have reconstructive surgery as it is relatively simple, inexpensive, and immediately transformative. This is not the case in lower-resource settings, where, as highlighted by the World Federation of Societies of Anaesthesiologists' SAFE-T Campaign, an estimated 70% of the world's population do not have access to safe and affordable anesthesia and surgical care.1,2 This startling gap in surgical access means the estimated 170,000 children born with clefts in lower-resource settings do not receive surgical treatment and live with difficulties eating, breathing, speaking, and, in the longer term, are less likely to enroll in school or hold jobs due to the stigmas associated with physical defects.3

"Proper surgical monitoring, including essential pulse oximetry, is crucially important to ensuring safe surgical outcomes. Smile Train is excited to partner with Masimo to make their high-performing, Signal Extraction Technology pulse oximeters available at Smile Train partner hospitals as we work together to continue providing safe and quality cleft care to children in need all over the world," said Susannah Schaefer, CEO of Smile Train.

"One of the greatest joys is seeing a smile on the face of a child. Every child on earth deserves to have access to safe surgery, to be treated with dignity and love, and to share their beautiful smiles," said Joe Kiani, Founder and CEO of Masimo. "Partnering with Smile Train is a fundamental part of our commitment to the Sustainable Development Goals and to our belief that no matter where a person lives or where they were born, access to quality healthcare that is dignified and safe is a human right, not a privilege. We are very proud of the work that Smile Train has done to improve surgical safety and access for cleft patients in local communities around the world. We value their commitment to scaling the use of quality pulse oximetry to all programs."

Friday, October 7th is World Smile Day®, on which we are reminded to "Do one act of kindness. Help a person smile!"4 The smile is an international symbol of peace, happiness, and kindness that knows no barriers or boundaries. Masimo and Smile Train are proud to be partnering to bring smiles to the faces of children around the globe, not just on World Smile Day®, but on every day of the year. We encourage everyone to participate in World Smile Day® this year!

@MasimoInnovates || #Masimo || @Smiletrain || #WorldSmileDay

References
1. Meara JG et al. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015 Aug 8;386(9993):569-624.
2. World Federation of Anaesthesiologists (WFSA) Safe Anaesthesia For Everybody – Today "SAFE-T" Campaign, 2016.
http://www.wfsahq.org/get-involved/safe-t.
3. Smile Train Medical Advisory Board.
4. http://www.worldsmileday.com/.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

About Smile Train
Smile Train is an international children's charity with a sustainable approach to a single, solvable problem: cleft lip and palate. Millions of children in developing countries with untreated clefts live in isolation, but more importantly, have difficulty eating, breathing and speaking. Cleft repair surgery is simple, and the transformation is immediate. Our sustainable model provides training, funding, and resources to empower local doctors in 85+ developing countries to provide 100%-free cleft repair surgery and comprehensive cleft care in their own communities. To learn more, please visit smiletrain.org.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo pulse oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo pulse oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Shari Mason
Smile Train
Phone: (212) 689-9199
Email: smason@smiletrain.org

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Foundation Co-Founds United for Oxygen Alliance

Groundbreaking Public-Private Partnership to Increase Access to Oxygen and Pulse Oximetry Launched at Clinton Global Initiative

Irvine, California – September 24, 2016 – Masimo (NASDAQ: MASI) announced today that the Masimo Foundation has co-founded the United for Oxygen Alliance, as part of a Clinton Global Initiative (CGI) commitment. The first-of-its-kind public-private partnership, announced this week at the final CGI Annual Meeting, will seek to expand access to medical oxygen and pulse oximetry for women and children in Ethiopia. Other partners in the Alliance, which has fifteen members in total, include the Bill & Melinda Gates Foundation (BMGF), the United Nations, PATH, Philips, the Pneumonia Innovations Team, Save the Children, UNICEF, and USAID.

Lack of medical oxygen access contributes to the deaths of more than 120,000 young children and thousands of pregnant women, globally, each year. It is estimated that in Ethiopia alone, each year 11,000 women die in pregnancy or during childbirth, 60,000 babies die in their first month, and 30,000 children die from pneumonia.1,2 Many of these deaths could be prevented by better access to medical oxygen and reliable pulse oximetry technology.3 An oxygen access agenda is central to that of the Ethiopian government, which has made it a part of their 2015-2020 Health Sector Transformation Plan and National Newborn and Child Survival Strategy.

United for Oxygen will partner with the Ethiopian government to increase availability of pulse oximetry screenings and oxygen therapy technologies across the country. In addition, it will provide training for local staff; establish sustainable financial solutions for procuring, installing, and maintaining equipment; and promote oxygen access and technologies in the policies and guidelines of Ethiopian health authorities. After the pilot program, the Alliance hopes to roll out similar medical oxygen and pulse oximetry programs in other countries where women and children are particularly at risk.

Leith Greenslade, Co-Chair of the Pneumonia Innovations Team, commented, "United for Oxygen is the first time companies and development agencies have joined forces to support a government to increase access to pulse oximetry and oxygen therapy across an entire African nation – in this case Ethiopia. My hope is that we will demonstrate that not only can pulse oximetry and oxygen prevent many more Ethiopian children from dying of pneumonia, but that health systems that routinely provide pulse oximetry screening and oxygen will be much more effective at driving down death rates from childbirth, unsafe surgery, cardiac arrest and injury."

Masimo, as a global leader in noninvasive monitoring technologies and whose SET® Measure-through Motion and Low Perfusion pulse oximetry technology is estimated to be used on more than 100 million patients around the world, will be responsible for improving the availability of pulse oximetry in hospitals and health centers, particularly in maternity and pediatric units. Masimo's role in United for Oxygen will also include developing an efficient, effective health screening model to prevent, detect, and treat pneumonia, as well as collaborating on recommendations for sustaining the program post-deployment through training, education, and maintenance.

Rasa Izadnegahdar, Senior Program Officer on the Pneumonia Team, BMGF, noted, "Masimo is uniquely positioned to provide leadership in the introduction of innovative life-saving devices in partnership with countries as recently exemplified by the Oxygen Roadmap of the Ethiopia Federal Ministry of Health."

"This cannot be overstated: regardless of where you live or were born, you deserve access to quality healthcare – including the life-saving benefits of reliable pulse oximetry and oxygen therapy," said Joe Kiani, Founder and CEO of Masimo. "Masimo continues to champion systematically safe, dignified health care for all, and we are proud for the Masimo Foundation to be one of the founding members of United for Oxygen. We look forward to collaborating further on this important project."

@MasimoInnovates || #Masimo || @0X2020 || #United4Oxygen || #CGI2016 || #UNGA || #globalgoals

References
1. Kuti BP et al. Determinants of oxygen therapy in childhood pneumonia in a resource-constrained region. ISRN Pediatr. 2013 Jun 2;2013:435976.
2. Rudan I, et al. Epidemiology and etiology of childhood pneumonia. Bull World Health Organ. 2008 May; 86(5): 408–416.
3. Floyd, et al. Evaluating the Impact of pulse oximetry on childhood pneumonia mortality in resource-poor settings. Nature. 528, S53-S59 (3 December 2015).

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Study on Abdominal Surgical Patients Investigates Clinical Utility of Masimo PVI®

Irvine, California – September 15, 2016 – Masimo (NASDAQ: MASI) announced today the findings of a study recently presented at the World Congress of Anesthesiologists (WCA) in Hong Kong. In the study, researchers at Cairo University in Egypt investigated the clinical utility of a Masimo SET® noninvasive, continuous measurement, PVI®.

In the prospective study of 60 adult patients undergoing major abdominal surgery, Drs. Hafez and Helmy of Cairo University evaluated the performance of Masimo PVI as a non-invasive guide to fluid optimization, as compared to Transesophageal Doppler. Patients were divided into fluid responders and non-responders, based upon the change in stroke volume due to a bolus response. The baseline value of PVI was significantly higher (p < 0.05) in responders compared to non-responders. The authors also noted that a baseline PVI cutoff value of 11 had 96.67% sensitivity and 33.33% specificity for predicting greater than 10% stroke volume increase. They concluded that PVI is "an efficient predictor of fluid responsiveness...in patients undergoing elective major abdominal surgery."1

PVI is a measure of the dynamic changes in perfusion index (PI) that occur during the respiratory cycle. In clinical studies, PVI has been shown to help clinicians assess fluid responsiveness in mechanically ventilated patients under general anesthesia during surgery,2,3,4,5 in the ICU in both adults and children,6,7 and in septic patients in the early stages of shock in the emergency department.8 Another study used PVI as part of goal-directed therapy for patients in an enhanced recovery after surgery (ERAS) program who underwent colorectal surgery; the program led to significant reductions in lengths of stay, costs, surgical site infections, fluid administered, as well as improvement in patient satisfaction.9

@MasimoInnovates || #Masimo

References
1. Hafez, Helmy. Evaluation of Plethysmographic variation indices for assessing fluid responsiveness in major operations using Masimo Radical-7 Pulse CO-Oximeter. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR371.
2. Cannesson M. et al. Br J Anaesth. 2008;101(2):200-6.
3. Zimmermann M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B.M., Wiesenack C. Eur J Anaesthesiol. 2010 Jun;27(6):555-61.
4. Fu Q., Mi W.D., Zhang H. Biosci Trends. 2012 Feb;6(1):38-43.
5. Haas S., Trepte C., Hinteregger M., Fahje R., Sill B., Herich L., Reuter D.A. J Anesth. 2012 Oct;26(5):696-701.
6. Loupec T. et al. Crit Care Med. 2011;39(2):294-299.
7. Byon H et al. BJA. 2012 December; DOI 10.1093/bja/aes467.
8. Feissel M et al. J Crit Care. 2013 May 14
9. Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, Goudreau BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. Journal of the American College of Surgeons (2015). doi: 10.1016/j.jamcollsurg.2014.12.042.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVI®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVI, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Finds Continuous, Noninvasive Hemoglobin Monitoring Using Masimo SpHb® May Reduce Intraoperative Red Blood Cell Transfusion

Irvine, California – September 9, 2016 – Masimo (NASDAQ: MASI) announced today announced today that in a new study recently presented at the World Congress of Anesthesiologists (WCA) in Hong Kong, researchers concluded that continuous and noninvasive hemoglobin monitoring, using Masimo SpHb®, may reduce excessive intraoperative red blood cell (RBC) transfusion.1

In a retrospective review of 371 patients who underwent intraoperative RBC transfusions between 2012 and 2014 at Fukushima Medical University in Japan, Dr. Imaizumi and colleagues compared 94 patients who had noninvasive hemoglobin measurements to 277 patients who did not (the control group). The total transfusion volumes and transfusion volume per 1 g of blood loss were determined for each group.

Comparing the groups, researchers noted that "a significantly lower mean RBC transfusion volume per 1 g of blood loss was observed in the SpHb group compared with the [control] group (SpHb group, 0.9 ± 1.0 ml/g blood loss vs [control] group, 2.4 ± 5.9 ml/g blood loss, p < 0.01)." They also observed that there was "no significant difference...in the average RBC transfusion volume (SpHb group, 815 ± 819 ml vs. [control] group, 785 ± 773 ml, p=0.75), or the preoperative hemoglobin concentration (SpHb group, 10.4 ± 1.9 g/dL vs. [control] group, 10.2 ± 2.4 g/dL, p=0.27) between the groups." According to results from this abstract, the authors concluded that "SpHb measurements are associated with reducing excessive intraoperative RBC transfusion."

"This is the third study, published by different researchers on three continents (US2, Egypt3, and now Japan1) that has shown that in addition to other clinical tools, SpHb may be used to help clinicians make informed transfusion decisions during different types of surgery*," stated Dr. Steven Barker, Ph.D., M.D., Chief Science Officer, Masimo.

SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings – when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when the SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. SpHb with laboratory diagnostic test may thus help clinicians make more timely and informed decisions, and has been shown to help clinicians provide more timely blood transfusions* and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.2,3

Last week Masimo announced that in response to the Zika virus and its potential impact on the availability of blood products, Masimo has created a special program to dramatically reduce the cost of and increase access to Masimo's SpHb solutions, as SpHb has been shown to help clinicians reduce blood transfusions in both low and high blood loss surgery. This special program will be available wherever the blood supply is affected by the Zika virus.

@MasimoInnovates || #Masimo

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgement considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR607.
2. Ehrenfeld JM et al. J Blood Disorders Transf. 2014. 5:9.
3. Awada WN et al. J Clin Monit Comput. 2015 Feb 4.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®and the availability of Masimo's special program for SpHb solutions. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo MightySat is Available at Apple.com and Select Apple Retail Stores in the US and Canada

Apple Health App Integrates MightySat Data

Irvine, California – September 6, 2016 – Masimo (NASDAQ: MASI) announced today that MightySat, a fingertip pulse oximeter designed for general wellness and health applications including sports, fitness, and relaxation management, is now available at Apple.com and select Apple retail stores in the US and Canada.

Masimo MightySat and Personal Health App
Masimo MightySat™ and Personal Health App

Masimo pulse oximeters, the leading brand in hospitals, provide accurate measurements when other pulse oximeters fail. By using a revolutionary invention called Signal Extraction Technology® (SET®), which allows oxygen saturation and pulse rate to be measured through challenging conditions including movement and low blood flow, the same high performance Masimo SET® technology used in hospitals is now available to Apple customers with MightySat.

The MightySat provides the following noninvasive measurements:

  • Oxygen Saturation (SpO2)
  • Pulse Rate (PR)
  • Perfusion Index (PI)

Masimo SET Accuracy Compared to That of 19 Other Hospital-Grade Pulse Oximeters
Masimo SET® Accuracy Compared to That of 19 Other Hospital-Grade Pulse Oximeters

In a study of 70 healthy volunteers during conditions of movement and low blood flow, Masimo SET® was the most accurate pulse oximeter when compared to 19 other hospital-grade pulse oximeters.1 SpO2 accuracy was defined as being within 7% of the reference value and pulse rate accuracy as being within 10%. Masimo SET® SpO2 was accurate 94% of the time while on average, the 19 other hospital-grade pulse oximeters were accurate only 60% of the time, with the least accurate only displaying accurate SpO2 27% of the time. Masimo SET® pulse rate was accurate 85% of the time while on average, the 19 other hospital-grade pulse oximeters were accurate only 27% of the time, with the least accurate only displaying accurate pulse rate 5% of the time.

Leading athletes and sports teams are increasingly using MightySat. "The reliable measurements of oxygen saturation and pulse rate from Masimo pulse oximeters were an important part of my training and recovery regimen to achieve peak athletic performance," said Dotsie Bausch, 2012 Olympic medalist in cycling. "I trust MightySat to accurately track and trend my data on a daily basis and help me achieve optimal health, wellness, and fitness."

MightySat users can display and track their data on a compatible iOS® device via the free Masimo Personal Health app available in the App Store. With user permission MightySat securely stores and trends measurements displayed in the Masimo Personal Health app in Apple's Health app. With the most recent update, the Masimo Personal Health app also now features same-screen trending for all MightySat measurements.

@MasimoPersonalHealth || #MightySat

The MightySat fingertip pulse oximeter is intended for general wellness and health applications. For medical applications, Masimo offers the MightySat Rx, which is available to medical professionals.

Reference
1. Barker S.J. Anesth Analg. 2002 Oct;95(4):967-72.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo MightySat. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our expectations regarding how retail customers will react to and benefit from the Masimo MightySat; risks related to our assumptions regarding the repeatability of study results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo MightySat, contribute to positive outcomes; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Amendment to Nellcor Royalty Agreement

Irvine, California – September 2, 2016 – Masimo (NASDAQ: MASI) today announced an amendment to the existing settlement agreement initially reached between Masimo and Nellcor in January 2006. Under the terms of the amendment, Medtronic will continue to pay Masimo a royalty of 7.75% for its current pulse oximetry products sold in the United States through October 6, 2018, after which no further royalties will be due under the agreement. For more information, please see the related Form 8-K filed with the Securities and Exchange Commission on September 2, 2016.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Investor Contact:
Eli Kammerman
Masimo
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Media Contact:
Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces a Special Worldwide Program for Total Hemoglobin (SpHb®) Monitoring for Areas Affected by the Zika Virus

Irvine, California – August 29, 2016 – Masimo (NASDAQ: MASI) announced today that in response to the Zika virus and its potential impact on the availability of blood products, Masimo is creating a special program to dramatically reduce the cost of and increase access to Masimo's continuous hemoglobin monitoring (SpHb®) solutions, shown to help clinicians reduce blood transfusions in both low and high blood loss surgery. This special program will be available wherever the blood supply is affected by the Zika virus.

Masimo's special program will allow clinicians and institutions in areas affected by the Zika virus to obtain a 50% discount off the list price of noninvasive SpHb sensors, and in addition, will make a limited number of loaner SpHb monitoring devices available at no cost during this special program.

Joe Kiani, Founder and CEO of Masimo, stated, "Because of how the Zika virus is transmitted, the FDA has recently recommended that the existing blood supply be tested for the virus, in addition to adding Zika screening for new blood donations. While this additional testing is necessary, it may constrain supplies of usable blood products while also increasing the cost of blood for a period of time. Masimo wants to do its part to help clinicians and healthcare facilities mitigate these issues by dramatically reducing the price of and increasing access to our SpHb monitoring solutions, which permit continuous, real-time visibility to changes in hemoglobin levels to help clinicians facilitate more informed and timely transfusion decisions. Independent, published studies completed by different researchers on three continents (US1, Egypt2, Japan3) have shown that SpHb may help clinicians reduce blood transfusions during different types of surgery*."

"We believe the use of continuous SpHb monitoring can help reduce demand for donated blood and the risk posed by blood donated before the additional testing, which may be infected," Mr. Kiani added. "In addition, Masimo will expand its ongoing efforts to increase awareness of the transfusion reduction benefits of the multidisciplinary pillars of Patient Blood Management, including the importance of pre-operative screening and therapies to safely increase patients' hemoglobin levels before elective surgery4."

@MasimoInnovates || #Masimo

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgement considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References
1. Ehrenfeld JM et al. J Blood Disorders Transf. 2014. 5:9.
2. Awada WN et al. J Clin Monit Comput. 2015 Feb 4.
3. Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR607.
4. Meybohm P et al. Patient Blood Management is Associated With a Substantial Reduction of Red Blood Cell Utilization and Safe for Patient's Outcome. Ann Surg. 2016;264:203-211.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Four-Year Partnership with World Federation of Societies of Anaesthesiologists (WFSA)

Joint Initiative, "Safe Anaesthesia – ASAP," Is to Improve Anesthesia Care in Low Resource Countries

Irvine, California and Hong Kong, China – August 29, 2016 – Masimo (NASDAQ: MASI) announced Sunday at the World Congress of Anaesthesiologists (WCA) in Hong Kong that it has become the first Global Impact Partner of the World Federation of Societies of Anaesthesiologists (WFSA). The four-year partnership, "Safe Anaesthesia – ASAP" (Anesthesia Safety Action Plan) will initially identify one country with poor access to safe anesthesia, and will work toward implementing programs and training designed to improve anesthesia care and safe surgery outcomes.

In 2015, the Lancet Commission on Global Surgery reported that approximately 5 billion people – the majority of the world's population – do not have access to safe, affordable anesthesia and surgical care, and estimated that 16.9 million die annually as a result.1 These deaths are attributable to a lack of infrastructure, essential monitoring equipment, and drugs, as well as a shortage of adequately trained healthcare workers.1

As part of the first phase of the joint project between the WFSA and Masimo, a high burden country will be identified as the ASAP's focus. Key to the project's success will be bringing together all stakeholders, including the government, so that infrastructure gaps can be identified, needs assessed, and the ASAP implemented. Implementation will involve a combination of training courses and other educational materials, distribution of essential drugs, and installation of and training on medical equipment. Training, monitoring, and project assessment will be ongoing throughout the four years, with an emphasis on ensuring that the improvements are sustainable.

Lifebox, an NGO (not-for-profit, non-governmental organization) dedicated to improving safe surgery, will also be assisting with training support. Kristine Stave, Chief Operating Officer of Lifebox, commented, "Lifebox works with colleagues on the frontline of the global surgical safety crisis to support long term improvement in the safety and quality of anesthesia care. We know firsthand the challenges of environment, equipment, education – and we also know the extraordinary capacity for positive change that the best partnerships can bring. We're proud to be a part of this urgent and historic undertaking between the WFSA and Masimo, and to be delivering our shared goal of making anesthesia safer for millions of patients worldwide."

WFSA has been uniting anesthesiologists globally for more than 60 years. With a network of hundreds of thousands of anesthesiologists in more than 150 countries, WFSA is well positioned to deliver programs that facilitate learning, and promote the highest standard of anesthesia care globally. Masimo, whose clinically leading SET® pulse oximetry is used to monitor over 100 million patients across the world, has made a commitment to become a WFSA Global Impact Partner in 2016. Together, WFSA and Masimo created the ASAP action plan, which it is hoped will become a model for high burden countries to improve anesthesia care and safe surgery outcomes.

Dr. David Wilkinson, President of the WFSA, stated, "The WFSA is delighted to announce Masimo as our first Global Impact Partner. We work together to improve patient care and access to safe anesthesia around the world."

Dr Adrian Gelb, Chair of the WFSA's Safety and Quality Committee and Professor of Anaesthesia and Perioperative Care at the UCSF School of Medicine, added, "It is essential that we make safe and affordable anesthesia and surgical care available to every patient in every country. Investment in national anesthesia plans, together with key stakeholders, will ensure that specific country needs are met most appropriately in order to make the biggest impact."

"At Masimo, we believe that regardless of where you live or where you were born, access to quality healthcare that is dignified and safe – including safe, effective anesthesia and surgery – is a human right, not a privilege," said Joe Kiani, Founder and CEO of Masimo. "We are delighted to be the first partner with the WFSA in bringing much-needed help, with Safe Anaesthesia – ASAP, to areas of the world blighted by needless deaths."

Mr. Kiani added: "The new millennium goal is no longer to provide all of our people access to health care, but to provide all of our people access to health care that is systematically safe and dignified."

@MasimoInnovates || #Masimo || @0X2020 || @wfsaorg || #WCA2016

References
1. Meara JG, Leather AJ, Hagander L et al. Global Surgery 2030: Evidence and solutions for achieving health, welfare, and economic development. Surgery. 2015 Jul;158(1):3-6.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential success of the ASAP. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking for RAS-45 Sensor for rainbow Acoustic Monitoring® of Respiration Rate

Neuchatel, Switzerland – August 18, 2016 – Masimo (NASDAQ: MASI) announced today the CE Marking of RAS-45, a single-use adult and pediatric acoustic respiration sensor for rainbow Acoustic Monitoring® (RAM) of respiration rate (RRa®).

Masimo Root<sup>®</sup> with rainbow Acoustic Monitoring<sup>®</sup> (RAM™) of Respiration Rate (RRa<sup>®</sup>) with RAS-45 Sensor

Masimo Root® with rainbow Acoustic Monitoring® (RAM™) of Respiration Rate (RRa®) with RAS-45 Sensor

Continuous monitoring of respiration rate is especially important for post-surgical patients receiving patient-controlled analgesia for pain management. The Anesthesia Patient Safety Foundation (APSF) and The Joint Commission recommend continuous oxygenation and ventilation monitoring for all patients receiving opioid-based pain medications.1,2 RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer, such as Masimo's RAS-125c and now RAS-45, that is applied to the patient's neck. Using acoustic signal processing that leverages Masimo's breakthrough Signal Extraction Technology (SET®), the respiratory signal is separated and processed to display continuous acoustic respiration rate (RRa). RRa has been shown to be accurate, easy-to-use, and reliable, and to enhance patient compliance.3,4 RRa may facilitate earlier detection of respiratory compromise and patient distress, offering a breakthrough in patient safety for post-surgical patients and for procedures requiring conscious sedation.4

Masimo RAS-45 Sensor

Masimo RAS-45 Sensor

RAS-45 is designed to facilitate placement on and improve attachment to the neck, but with a smaller adhesive profile than the RAS-125c. It is flexible and uses a transparent adhesive. Like the RAS-125c, it operates with Masimo MX technology boards to measure RRa and display the acoustic respiration wave form. RAS-45 maintains the same performance parameters, range, and accuracy specifications as RAS-125c. Both sensors are for patients who weigh more than 10 kg.

Joe Kiani, Founder and CEO of Masimo, commented, "RAM harnesses the power of our breakthrough signal processing technology, using Masimo SET® and rainbow® technologies, and applies those achievements to a respiratory measurement derived from the sound of breathing. Studies have found that RAM RRa is more sensitive to detecting respiratory pause5 and yet easier for clinicians and patients to use."3

@MasimoInnovates || #Masimo

References
1 Stoelting, RK et al. APSF newsletter. 2011. www.apsf.org.
2 The Joint Commission Sentinel Event Alert. Issue 49, August 8, 2012. www.jointcomission.org.
3 Macknet MR et al. Anesthesiology. 2007;107:A84 (abstract).
4 Goudra BG et al. Open J Anesthesiol. 2013;3:74-79.
5 Ramsay MAE et al. Anesthesia-analgesia. 2013:117:1.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo RAM, RRa®, and RAS-45. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo RAM, RRa, and RAS-45, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Article Showcases an Effective Surveillance System for General Care Units Using Masimo Patient SafetyNet

Irvine, California – August 15, 2016 – Masimo (NASDAQ: MASI) announced today that a new article published in The Joint Commission Journal on Quality and Patient Safety reports on the results of an expansion of the use of Masimo Patient SafetyNet™* to more than 200 general floor beds at Dartmouth-Hitchcock Medical Center (D-H) in Lebanon, New Hamphire.1 Patient SafetyNet is a remote monitoring and clinician notification system that works in conjunction with a variety of bedside monitors, such as Masimo Root® with Radical-7® and Root with Radius-7®, powered by Masimo SET® pulse oximetry – the first Measure-through Motion and Low Perfusion pulse oximetry and the most accurate and reliable pulse oximeter in such conditions according to over 50 studies.2

Masimo Patient SafetyNet was first implemented in the 36-bed orthopedic unit at D-H in December 2007, as part of a surveillance strategy supporting patient safety improvement. Clinicians reported that after 11 months, rescue events had been reduced by 65% and intensive care unit transfers by 48%, and calculated annual cost savings of $1,480,000.3,4 They also announced that they had experienced zero preventable deaths or instances of irreversible seizure brain damage due to opioids since installation.4 As a result of the positive outcomes of the pilot unit implementation, D-H expanded this continuous patient monitoring approach, including the use of Patient SafetyNet, to remaining post-surgical ward units in February 2009, to medicine ward units in April 2010, and to the pediatric ward unit in February 2012. Patients in more than 200 beds are now covered by D-H's patient surveillance system. As the authors note, "The original success in terms of patient outcomes and enthusiastic endorsement by nurses prompted request from other units for the system and led to the rapid spread of the system across the institution." The improvements first seen in the pilot unit – in addition to the dramatic reductions in rescue events and unplanned transfers, approximately two alarms per patient per 12-hour nursing shift, and resolution of more than 85% of all alarm conditions within 30 seconds and more than 99% before escalation was triggered – have been "sustained over time in spite of increasing patient acuity (up 20% from 2010 to 2015) and unit occupancy (93% in 2015)."

Much of the initiative's success is due to D-H's development of a robust general care alarm management strategy, including the implementation of Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry. As the authors note, "device-level characteristics such as measurement reliability and alarm annunciation" are critical. A systematic approach to alarm management is needed because of the growing problem of "'alarm fatigue' – the growing desensitization of health care providers to alarms" as a result of the "growing number of monitoring devices, combined with suboptimal patient monitoring and alarm management strategies." False and/or nonactionable alarms may occur as much as 90% of the time, according to one study5; another, involving the Philips HP Merlin M1094 monitor, found that 77% were either not recognized or ignored6; a third, involving Nellcor pulse oximetry, found an actual risk for patients in only 3% of alarm states, and that anesthesiologists have been shown to disable alarms because of high false alarm rates.7

D-H attempted to optimize several key elements of an effective alarm management strategy: 1) static alarm settings – setting thresholds based on patient groups to reduce nuisance alarms; 2) alarm delays – introducing a delay of 15 seconds before an alarm sounds, as "Many changes in physiologic parameters are brief and self-correcting"; 3) alarm threshold adjustments – adapting to "physiologic variation among different patients" by adjusting alarms based on a three-tiered system of the static defaults, independent nurse adjustments, and provider-ordered individualized settings; and 4) alarm announcement – having the alarm sent to the nurse in charge of the patient via remote pager and allowing customization of when and how alarms are escalated to additional clinicians, by which practice alarm exposure has now been reduced by almost 90%.

Important to the success of the D-H alarm management strategy was the selection of Masimo SET® and Patient SafetyNet architecture, as part of D-H's patient surveillance system. As the authors note, a fundamental factor affecting operation of and response to clinical monitor alarms is "device-level characteristics such as measurement reliability and alarm annunciation." As the initiative's centrally-monitored parameter they notably chose oxygen saturation (SpO2), measured using Masimo SET® pulse oximetry, which has been shown to reduce false alarms by over 95% and increase true alarm detection to over 97%, even during motion and low perfusion.8 Regarding the choice of remote monitoring system, the authors note that "A previously installed multiparameter monitoring system on the pediatric unit was largely rejected by the staff because of alarm system issues, such as high false alarm rates, lack of directed notification, and ambiguous alarm indicators. The alarm rate [with Masimo Patient SafetyNet] was 75% lower than the alarm rate of the previous system immediately following implementation of [Masimo Patient SafetyNet], and 100% of nursing staff survey respondents were in favor of continuing use of [Masimo Patient SafetyNet]. The staff credited the robust alarm management strategy and leadership rounding with the improved system performance and high level of staff adoption."

"Dartmouth-Hitchcock provides a compelling example of the benefits that a robust patient monitoring and surveillance system, coupled with a carefully executed strategy, can reap," said Joe Kiani, Founder and CEO of Masimo. "It is estimated that as many as 50,000 patients die each year due to failure to rescue patients in the general ward.9 Any hospital that wants to eliminate general ward preventable deaths should read both this article and Dartmouth-Hitchcock's original study, 'Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: A before-and-after concurrence study,' published in 2010.3 Together, they provide an excellent guide to designing, implementing, and maintaining a successful hospital-wide continuous monitoring system, as well as showcasing the innovative practices that have arisen out of their focus on alarm management. Dartmouth-Hitchcock's success story, laid out in a well-executed plan and follow on analysis over nearly a ten-year period, sets a powerful precedent for other medical facilities: it's time for all hospitals to develop hospital-wide alarm management strategies and as part of that, to implement Patient SafetyNet – to help save money and save lives."

@MasimoInnovates || #Masimo

References
1. McGrath, S.P., Taenzer, A.H., Karon, N, Blike, G. "Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation." The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
2. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
3. Taenzer A.H., Pyke J.B., McGrath S.P., Blike G.T. Anesthesiology. 2010 Feb;112(2):282-7.
4. Taenzer A, Blike G, McGrath S, Pyke J, Herrick M, Renaud C, Morgan J. "Postoperative Monitoring - The Dartmouth Experience." Anesthesia Patient Safety Foundation Newsletter Spring-Summer 2012. Available online.
5. Imhoff M, Kuhls S. Alarm algorithms in critical care monitoring. Anesth Analg. 2006;102:1525-1537.
6. Gorges M, et al. Improving alarm performance in the medical intensive care unit using delays and clinical context. Anesth Analg. 2009;108:1546-1552.
7. Kestin IG, Miller BR, Lockhart CH. Auditory alarms during anesthesia monitoring. Anesthesiology. 1988;69:106-109.
8. Shah N et al. J Clin Anesth 2012 Aug;24(5):385-91.
9. HealthGrades Quality Study. Patient Safety in American Hospitals (July 2004).

*The use of the trademark SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Patient SafetyNet. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Patient SafetyNet, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Evan Lamb
Masimo
Phone: (949) 396-3376
Email: elamb@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces CE Marking for Pediatric O3 Regional Oximetry

Neuchatel, Switzerland – August 4, 2016 – Masimo (NASDAQ: MASI) announced today the CE marking for the pediatric indication for O3 regional oximetry with the O3 pediatric sensor. Regional oximetry, also referred to as tissue or cerebral oximetry, helps clinicians monitor cerebral oxygenation.

Masimo Root<sup>®</sup> with O3™ Regional Oximetry with Pediatric Sensor
Masimo Root® with O3™ Regional Oximetry with Pediatric Sensor

O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. Early detection and correction of imbalances in oxygen delivery to the brain and vital organs are important tools in helping patients avoid postoperative morbidity and adverse outcomes.1 With the release of the O3 pediatric sensor, O3 regional oximetry monitoring of rSO2 is now available to pediatric patients weighing less than 40 kg (88 lbs).

"O3 regional oximetry provides access to valuable data about cerebral oxygen saturation, and studies have shown that the risks of cerebral desaturations include neurological injury2,3, increased length of hospital stays3, increased time on mechanical ventilation4, and other adverse outcomes5," said Joe Kiani, Founder and CEO of Masimo. "With adult trend accuracy of 3% and absolute accuracy of 4% without controlling CO2, and trend accuracy of 3% in pediatric patients6, Masimo O3 should help clinicians build a better picture of brain oxygenation – and hopefully better outcomes for all of their patients, including pediatric ones."

Masimo O3 regional oximetry and SedLine® brain function monitoring are both available on a single platform, Masimo Root® – opening up a path to better understanding of the brain.

O3 regional oximetry for use with adults weighing 40 kg (88 lbs) or greater has received FDA 510(k) clearance. O3 regional oximetry for use with pediatric patients weighing less than 40 kg (88 lbs) has not received FDA 510(k) clearance; the O3 pediatric sensor is not currently for sale in the United States.

@MasimoInnovates || #Masimo

References
1. Booth, Dukatz, Ausman, and Wider. "Cerebral and somatic venous oximetry in adults and infants." Surg. Neurol Int. 2010; 1: 75.
2. Colak Z, Borojevic M, Bogovic A, Ivancan V, Biocina B, Majeric-Kogler V. Influence of intraoperative cerebral oximetry monitoring on neurocognitive function after coronary artery bypass surgery: a randomized, prospective study. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2015 Mar;47(3):447-54.
3. Slater JP, Guarino T, Stack J, et al. Cerebral Oxygen Desaturation Predicts Cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009;87:36-45.
4. Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. The heart surgery forum. 2004;7(5):E376-381.
5. Deschamps A, Lambert J, Couture P, et al. Reversal of decreases in cerebral saturation in high-risk cardiac surgery. Journal of cardiothoracic and vascular anesthesia. 2013;27(6):1260-1266.
6. Masimo data on file.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo O3 Regional Oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo O3 Regional Oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Leading Ohio Critical Access Hospital Adopts Masimo Root® with Radius-7® , Radical-7® , and Patient SafetyNet to Create Hospital-Wide Wireless Monitoring and Clinician Notification System

Geneva, Ohio and Irvine, California – July 28, 2016 – Masimo (NASDAQ: MASI) announced today that University Hospitals Geneva Medical Center (UH Geneva), a Critical Access Hospital in Geneva, Ohio, is building a hospital-wide wireless monitoring and clinician notification system using Masimo Patient SafetyNet™* in conjunction with Masimo Root® with Radius-7® and Masimo Radical-7®. UH Geneva is part of University Hospitals, based in Cleveland, Ohio.

Masimo Patient SafetyNet is a supplemental system that enables information from bedside and tetherless wearable monitors to be accessible from remote locations and relays alarm notifications to clinicians. Used with Root, Patient SafetyNet allows hospitals to automate the transfer of patient vital signs, including temperature and blood pressure, to patients' medical records, which may help improve nursing workflows. Root, available with Radical-7 or Radius-7, provides monitoring of Masimo rainbow SET parameters such as oxygen saturation (SpO2) and total hemoglobin (SpHb), and is expandable to monitor additional parameters, such as respiration rate from RAM (rainbow® acoustic monitoring). Radius-7 provides continuous tetherless wearable monitoring of FDA-cleared rainbow SET parameters so that patients can have freedom of movement while being monitored – and studies have shown that patient mobility is a key factor in more rapid patient recovery.1,2 Monitoring parameters from Radical-7 or Radius-7 are sent to Patient SafetyNet through Root, allowing for hospital-wide remote monitoring and clinician notification.

UH Geneva is part of the University Hospitals system, which employs over 26,000 physicians and employees in Northeast Ohio, and whose flagship academic medical center, UH Case Medical Center, is the primary affiliate of Case Western Reserve University School of Medicine. UH Geneva has been using Masimo SET® pulse oximetry for several years. Along with implementing such parameters as RAM acoustic respiration rate, they are now adopting Root with Radius-7, Radical-7, and Patient SafetyNet to create a hospital-wide wireless monitoring solution, which will include remote caregiver notification.

Thomas P. Knowles, MHA, RRT, RPSGT, Manager of Respiratory Therapy and the Center for Advanced Sleep Medicine at UH Geneva, a key stakeholder in implementing the system, commented, "I've always believed in Masimo's technology and felt it was important for us to expand our patient monitoring practices. Patient SafetyNet will provide tremendous benefits."

"Patient safety is extremely important to us," said Dr. Amitabh Goel, Chief Medical Officer at UH Geneva Medical Center. "The addition of Patient SafetyNet, which will work hand-in-hand with Root, Radical-7, and Radius-7, helps ensure our doctors and nurses always have the data they need, when they need it. We're also looking forward to integrating Patient SafetyNet with our EMR system, which will automate many administrative duties and free up our caregivers to focus on the enhanced patient experience we strive for."

"UH Geneva provides a compelling example of the standard of care that more and more community hospitals are adopting," said Joe Kiani, Founder and CEO of Masimo. "Powerful centralized monitoring and surveillance, such as those provided by Patient SafetyNet, fueled by industry-leading rainbow SET and innovative devices like Root with Radius-7, are key to patient monitoring, and it's important, and gratifying, that hospitals like UH Geneva recognize this. We look forward to deepening our collaboration with UH Geneva."

@MasimoInnovates || #Masimo

References
1. Needham D, Korupolu R, Zanni J, Pradhan P, Colantuoni E, Palmer J, Brower R, Fan E. "Early Physical Medicine and Rehabilitation for Patients With Acute Respiratory Failure: A Quality Improvement Project." Archives of Physical Medicine and Rehabilitation. Vol 91, Issue 4, PP 536–542, April 2010.
2. Ronnenbaum J, Weir J, Hilsabeck T. Earlier mobilization decreases length of stay in the intensive care unit. J Acute Care Phys Ther. 2012;3(2):204-210.

*The use of the trademark SafetyNet is under license from University HealthSystem Consortium.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

About University Hospitals
Founded in May 1866, University Hospitals serves the needs of patients through an integrated network of 18 hospitals, more than 40 outpatient health centers and primary care physician offices in 15 counties throughout Northeast Ohio. At the core of our $4 billion health system is University Hospitals Case Medical Center, ranked among America's best hospitals by U.S. News & World Report. The primary affiliate of Case Western Reserve University School of Medicine, UH Case Medical Center is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women's health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and genetics. Its main campus includes UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University. UH is the second largest employer in Northeast Ohio with 26,000 employees. For more information, go to www.UHhospitals.org.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Radical-7®, Root® with Radius-7®, and Patient SafetyNet. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Radical-7, Root with Radius-7, and Patient SafetyNet, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

University Hospitals
Dan Bomeli
Phone: (216) 767-8548
Email: daniel.bomeli@UHhospitals.org

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Evaluates Masimo PVI® as a Predictor of Fluid Responsiveness in Patients Undergoing Liver Transplantation

Irvine, California – July 21, 2016 – Masimo (NASDAQ: MASI) announced today that a new study of patients undergoing liver transplantation evaluated the relationship of PVI® to right ventricular end-diastolic volume (RVEDVI) and concluded that PVI provided a "reliable estimate of [cardiac] preload status and may be a useful predictor of fluid responsiveness."1 PVI measures the dynamic changes in perfusion index that occur during one or more complete respiratory cycles, using the Masimo pulse oximetry plethsymographic waveform.

Because of hemodynamic instability during orthotopic liver transplantation (OLT), estimating cardiac preload to optimize fluid management is essential. There are several methods for estimating cardiac preload. Two conventional static measurements of cardiac filling pressure are pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP). The standard invasive method is RVEDVI, obtained from thermodilution using a pulmonary artery catheter (PAC).

In the prospective study, published in Transplantation Proceedings and conducted at Chang Gung Memorial Hospital in Taiwan, Dr. H.-C. Lee and colleagues compared methods of estimating cardiac preload, with the aim of evaluating the relationship between a dynamic hemodynamic parameter, PVI (derived from pulse oximetry), and RVEDVI (using a PAC), as well as comparing PVI to the static measures CVP and PAOP. They measured the four hemodynamic parameters–CVP, PAOP, RVEDVI, and PVI–on 18 patients undergoing OLT at 10 defined time points before, during, and at the conclusion of surgery.

Analyzing the 180 measurements from each of the parameters, the Receiver Operating Characteristic (ROC) determined in this study to distinguish different thresholds of RVEDVI showed an area under the curve (AUC) of 0.702 for CVP, 0.748 for PAOP, and 0.762 for PVI.

The researchers concluded that "PVI may serve as a reliable estimate of cardiac preload status in patients undergoing OLT, explicitly, higher PVI values correlated with lower RVEDVI values," so that "an increase in ventricular preload status could be inferred from a decrease in PVI during OLT." They also noted that "RVEDVI was better correlated with PVI than with other static filling pressure[s], such as CVP or PAOP," therefore giving a "safer, faster, and better estimate of fluid responsiveness."

The researchers noted as a limitation that the quality of the signal from which PVI is calculated is "critically based on peripheral perfusion, which may be significantly affected by factors such as extreme low cardiac output, drug-induced vasoconstriction, and hypothermia." The researchers also noted that further studies are needed to investigate the application and effectiveness of additional dynamic hemodynamic parameters such as SVV and PPV during OLT.

@MasimoInnovates || #Masimo

References
1. Lee HC, Tsai YF, Tsai HI, Chung PC, Yu HP, Lee WC, Lin CC. Pulse Oximeter-Derived Pleth Variability Index is a Reliable Indicator of Cardiac Preload in Patients Undergoing Liver Transplantation. Transplant Proc. 2016 May;48(4):1055-8.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVI®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVI, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Assesses Utility of 1st Generation Masimo Pronto® Pulse CO-Oximeter® with SpHb® Spot Check Technology in Evaluating Pediatric Trauma Patients

Irvine, California – July 14, 2016 – Masimo (NASDAQ: MASI) announced today that in a new study using the 1st Generation Masimo Pronto® Pulse CO-Oximeter®, which noninvasively measures total hemoglobin (SpHb®), researchers found that noninvasive and invasive measurements correlated well and that "[g]iven the rapid availability of results and the lack of requirement of venipuncture, noninvasive hemoglobin monitoring may be a valuable adjunct in the initial evaluation and monitoring of pediatric trauma patients."1

Pronto features rainbow SET technology, allowing for the noninvasive spot checking of SpHb, oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI).

In the study, published online in the Journal of Trauma and Acute Care Surgery and conducted at the University of Tennessee Health Science Center, Le Bonheur Children's Hospital, Dr. Mark Ryan and colleagues evaluated noninvasive SpHb measurement accuracy relative to current invasive and point-of-care testing in pediatric trauma patients. They performed a prospective observational trial involving 114 patients under age 17, measuring hemoglobin levels with a point-of-care device (i-STAT) and a lab analyzer (Sysmex XN Series). Noninvasive hemoglobin measurement, using 1st Generation Pronto, was performed within 15 minutes of phlebotomy.

Of the 114 patients, SpHb was successfully measured 89% of the time. Mean lab hemoglobin was 12.6 ± 1.9 and mean SpHb was 12.3 ± 1.6 (mean point-of-care hemoglobin was 12.2 ± 2.0). Bland-Altman analysis showed the limits of agreement between lab hemoglobin and non-invasive SpHb to be -2.9 and 1.9, with a mean difference of -0.49.

The researchers concluded that they were able to demonstrate "low bias and strong correlation between hemoglobin measurements using a noninvasive monitor, a point-of-care testing device, and laboratory co-oximeter in pediatric trauma patients." They noted that noninvasive SpHb testing "may be most effective in determining when invasive testing of hemoglobin is warranted."

Key limitations to the study include: the majority of the hemoglobin values measured were within normal limits; limited data on injury severity, morbidity, and mortality to understand their effects on device accuracy and precision; data is based on a convenience sample depending on availability of certified personnel; and no assessment on the effects of pre-hospital administration of intravenous fluids.

The researchers noted that "[f]urther study is required to determine the clinical utility of the [Pronto] device during the initial assessment and its accuracy in evaluating hemoglobin levels in hemodynamically unstable patients." They stated that SpHb measurements should not be relied upon alone to determine active hemorrhage or the need for transfusion, and suggested the following reasons a noninvasive measurement could not be taken in 11% of the study's participants: severe anemia; patients who were normotensive but tachycardic; patients unreadable due to the presence of nail polish; and cold extremities or low signal IQ without hemodynamic instability or anemia.

The University of Tennessee Health Science Center received equipment from Masimo to support the data collection for this study.

@MasimoInnovates || #Masimo

References
1. Ryan, Maxwell, Manning, Jacobs, Bachier-Rodriguez, Felizm, and Williams. "Noninvasive hemoglobin measurement in pediatric trauma patients." Journal of Trauma and Acute Care Surgery. DOI: 10.1097/TA.0000000000001160. E-published ahead of print.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Pronto® Pulse CO-Oximeter with SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Pronto Pulse CO-Oximeter with SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

One of the World's Leading Centers for Cardiovascular Medicine & Transplantation Adopts Masimo's SedLine® Brain Function Monitoring and O3 Regional Oximetry

NEUCHATEL, Switzerland – July 7, 2016 – Masimo (NASDAQ: MASI) announced today that Deutsches Herzzentrum Berlin (DHZB / German Heart Center Berlin) in Berlin, Germany has adopted Masimo's SedLine® Brain Function Monitoring and O3 Regional Oximetry technologies to monitor patients in the operating room and intensive care unit.

"Our non-profit hospital performs over 32,000 treatments each year. Easy access to advanced parameters and the data they provide are very important for our patients, many of whom are undergoing especially complex and critical operations," stated Prof. Dr. Hermann Kuppe, Director of the Department of Anesthesiology at DHZB. "Masimo's technology allows us to access multiple parameters quickly and noninvasively from one monitor."

SedLine brain function monitoring provides four channels of electroencephalogram (EEG) to help clinicians better understand the effects of anesthesia on the brain. SedLine monitors the effects of anesthesia and sedation by monitoring electrical activity on both sides of the brain. O3 regional oximetry provides regional oxygen saturation (rSO2) and reference arterial oxygen saturation (SpO2) information, helping clinicians detect regional hypoxemia that pulse oximetry alone can miss.

"The innovative treatment programs at Deutsches Herzzentrum Berlin have helped it to become recognized as one of the world's leading centers for cardiovascular medicine and transplantation. They have doctors, medical students, and scientific researchers from around the world apply to visit the hospital as clinical observers every year," stated Joe Kiani, Founder and CEO of Masimo. "We are happy to see them adopt our SedLine and O3 technologies and are impressed by their focus on patient safety."

DHZB is a specialist hospital dedicated to the diagnosis and treatment of cardiovascular and thoracic diseases, the implantation of mechanical circulatory support systems, and heart and lung transplantations. A cooperative partnership with Charite-Universitatsmedizin Berlin, each year the hospital performs more than 6,700 operations, including 2,400 operations using heart-lung machines. DHZB treats more than 7,200 inpatients and 24,000 outpatients annually. The hospital has 194 beds, 71 of which are in intensive care. Since 2002, DHZB has received certification by KTQ, the national quality control board, recognizing the high standard of care DHZB provides. DHZB and its subsidiaries employ 1,300 people, including 190 doctors and almost 500 nurses.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SedLine® and O3 technologies. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SedLine® and O3 technologies, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Deutsches Herzzentrum Berlin
Christian Maier
Phone: + 49 03 04 5931211
Email: cmaier@dhzb.de

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA 510(k) Clearance for Radius-7® with rainbow® Technology, Including Continuous SpHb®

Radius-7 is the First Wearable, Tetherless, Noninvasive rainbow® Monitor

IRVINE, California – June 28, 2016 – Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for Radius-7® – the first and only wearable, tetherless, noninvasive rainbow® monitor. Radius-7, which connects to the Root® patient monitoring and connectivity platform, is now available in the U.S. with breakthrough Masimo rainbow® technology. With this clearance, Radius-7 with Root now enables noninvasive monitoring of more than 10 parameters, including, for the first time in a wearable device, total hemoglobin (SpHb®), a breakthrough measurement that noninvasively and continuously measures hemoglobin concentration.

Masimo Root® with Radius-7® with rainbow®
Masimo Root® with Radius-7® with rainbow®

SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings – when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. SpHb may thus help clinicians make more timely and informed decisions, and has been shown to help clinicians provide more timely blood transfusions* and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.1,2

Professor Christer Svensen, Professor of Anesthesiology and Intensive Care at the Karolinska Institute in Stockholm, Sweden, who has been using Radius-7 as part of a research study, commented, "We are currently performing a noninvasive continuous study monitoring respiratory rate, heart rate and saturation for all patients admitted to a surgical ward. Additionally, we are monitoring SpHb for selected postsurgical patients, which can be extremely beneficial because it can provide insight into hemoglobin trends between invasive blood samplings. Such insight may lead clinicians to confirm trends by performing blood draws sooner than they might otherwise have done, which may then suggest the need to intervene."

For the first time, it is possible to offer patients freedom of movement while providing such important monitoring, and studies have shown that patient mobility is a key factor in more rapid patient recovery.3,4 When monitoring ambulating patients, Radius-7 communicates to Root at the bedside and thereby to Masimo Patient SafetyNet to alert clinicians of critical changes in oxygen saturation, pulse rate, respiration, and hemoglobin, among other parameters. Radius-7 is lightweight, weighing only 0.34 lbs, and attaches to the arm, thus allowing untethered monitoring whether a patient is in or out of bed – which also reduces the need for nursing assistance, as there is no need to disconnect from or reconnect to a bedside monitor. Each Radius-7 comes with two "hot-swappable" rechargeable battery modules (one with the patient, one charging), each with a battery life of 12 hours, minimizing monitoring interruption.

"Never before could patients be monitored for such key parameters as continuous SpHb, which can help clinicians make more timely and informed blood management decisions, while patients are fully mobile. Previous wearable patient monitors were hampered by a limited range of measurements and false alarms due to motion," said Joe Kiani, Founder and CEO of Masimo. "Root with Radius-7 with rainbow SET, coupled with Patient SafetyNet for mobile clinician notification, is now an even more versatile and powerful monitoring system, all while promoting freedom of patient movement and quicker recovery times."

*Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgement considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

@MasimoInnovates || #Masimo

References
1. Ehrenfeld JM et al. J Blood Disorders Transf. 2014. 5:9. 2.
2. Awada WN et al. J Clin Monit Comput. 2015 Feb 4.
3. Needham D, Korupolu R, Zanni J, Pradhan P, Colantuoni E, Palmer J, Brower R, Fan E. "Early Physical Medicine and Rehabilitation for Patients With Acute Respiratory Failure: A Quality Improvement Project." Archives of Physical Medicine and Rehabilitation. Vol 91, Issue 4, PP 536–542, April 2010.
4. Ronnenbaum J, Weir J, Hilsabeck T. Earlier mobilization decreases length of stay in the intensive care unit. J Acute Care Phys Ther. 2012;3(2):204-210.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's Radius-7®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo's Radius-7®, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New SunTech Medical CT40 Vital Signs Device to Feature Masimo SET® Pulse Oximetry Technology

NEUCHATEL, Switzerland and EYNSHAM, England – June 23, 2016 – Masimo (NASDAQ: MASI) and SunTech Medical, a Halma (LSE:HLMA) company, jointly announced today the integration of Masimo SET® pulse oximetry technology into SunTech's CT40, a next generation spot-check vital signs device.

Masimo Signal Extraction Technology (SET®) Measure-through Motion and Low Perfusion pulse oximetry measures oxygen saturation (SpO2), pulse rate, and perfusion index. Masimo SET® has been shown to significantly reduce false alarms and accurately monitor for true alarms1,2 and is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world.

The SunTech CT40 is an ideal, affordable solution for clinical-grade spot-check measurements of blood pressure, temperature and pulse oximetry in hospitals and clinics. Ambulatory care, long-term care and low-acuity hospital departments can easily implement this versatile, user-friendly vital signs device that offers both advanced features and digital connectivity. The modular design allows clinicians to easily make adaptations to the device while in the field, adding thermometry, SpO2 and Wi-Fi as needed. Other advanced features include the ability to transmit measurement data directly from the device, in accordance with HL7 messaging protocols, as well as BP Averaging Mode - an increasingly important component of accurate blood pressure measurement, as evidenced by the recently published SPRINT Study from the National Institutes of Health (NIH), which specified that a mean of three office BP measurements would be used to establish target BPs for Standard Group participants.3

"Both SunTech and Masimo share industry-leading technologies within our respective areas of expertise," said Kenny Andersen, VP of Strategic Product Development at SunTech Medical. "Partnering with them on our next-generation vital signs platform is a very natural strategy. Masimo SET pulse oximetry is the benchmark for clinical performance, just as SunTech Advantage technology is for blood pressure. We look forward to a long and successful partnership."

Rick Fishel, Masimo's President of Worldwide OEM Business and Strategic Development, stated, "SunTech Medical is a recognized global leader and worldwide supplier of non-invasive blood pressure measurement technology. Combining best-in-class measurement technologies that provide superior performance, accuracy, and affordability, in flexible and cost effective monitors, supports our organizations' mutual vision to offer solutions that help clinicians improve patient outcomes and reduce the cost of healthcare delivery. We are very pleased to partner with SunTech Medical and that Masimo SET pulse oximetry is the preferred pulse oximetry offering in the highly versatile and cost-effective SunTech CT40 monitor."

The SunTech CT 40 with Masimo SET® technology has a CE Mark. It is not FDA cleared and is not available for sale in the United States.

@MasimoInnovates || #Masimo

References
1. Shah N, Ragaswamy HB, Govindugari K, Estanol L "Performance of Three New-Generation Pulse Oximeters during Motion and Low Perfusion in Volunteers". J Clin Anesth. 2012 Aug;24(5):385-91.
2. Taenzer, Andreas H.; Pyke, Joshua B.; McGrath, Susan P.; Blike, George T. "Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-and-After Concurrence Study." Anesthesiology, February 2010, Vol. 112, Issue 2.
3. The SPRINT Study Research Group. The design and rationale of a multi-center clinical trial comparing two strategies for control of systolic blood pressure: The Systolic Blood Pressure Intervention Trial (SPRINT). Clin Trials. October 2014; 11(5): 532-546.

About Masimo
SunTech Medical, a Halma company, has been the preeminent supplier of clinical-grade blood pressure monitoring products and technologies for nearly 30 years. More than 75 companies trust SunTech Medical's OEM non-invasive blood pressure solutions for their patient monitoring needs. SunTech Medical produces the leading cardiac stress test blood pressure monitor and is the world's foremost manufacturer of ambulatory blood pressure monitoring products. SunTech Medical also offers solutions for in-office blood pressure monitoring as well as a complete line of blood pressure cuffs designed for general and specific applications.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SET® pulse oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SET® pulse oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

SunTech Medical
Elliott Holloway
Phone: (919) 654-2366
Email: eholloway@suntechmed.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA 510(k) Clearance for O3 Regional Oximetry

Irvine, California - June 13, 2016 – Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for O3 regional oximetry. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors, such as the type of clinical procedure being performed.

Masimo Pronto® Pulse CO-Oximeter® with Next Generation SpHb® and rainbow® DCI®-mini Reusable Sensor
Masimo Root® with O3 Regional Oximetry and SedLine® Brain Function Monitoring

O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. In a study on 27 subjects published in Anesthesia and Analgesia in 2014, Dr. Daniel Redford of the University of Arizona compared cerebral oxygen saturation measurements obtained from O3 with saturations obtained from blood samples (SavO2) through induced hypoxia.1 O3 regional oximetry provided absolute root-mean-squared error of 4% and relative root-mean-squared error of 2.1%.1 This study did not require that end tidal carbon dioxide (EtCO2) levels be fixed in the study protocol, allowing the rSO2 measurement to be responsive to changes in tissue oxygen saturation due to changes in CO2 in the blood. Follow up studies with O3 extended the subject pool to 74 subjects and demonstrated that O3 maintained its absolute and relative accuracy.2

"O3 regional oximetry delivers again on Masimo's technical prowess and gives clinicians access to valuable, accurate data about cerebral oxygen saturation," stated Joe Kiani, Founder and CEO of Masimo. "With the addition of O3 regional oximetry to the Root platform, clinicians can simultaneously access rSO2 and other measurements including SedLine brain function monitoring, Masimo SET SpO2, PVI, and SpHb monitoring – all in one monitoring platform."

O3 regional oximetry is currently intended for use with adults weighing 40 kg (88 lbs) or greater.

@MasimoInnovates || #Masimo

References
1. Redford D, Paidy S, Kashif F. Absolute and Trend Accuracy of a New Regional Oximeter in Healthy Volunteers During Controlled Hypoxia. Anesth Analg. 2014 Dec;119(6):1315-1319.
2. Masimo FDA submission data on file.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo O3 Regional Oximetry. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo O3 Regional Oximetry, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Full Market Release of Next Generation SpHb® Spot Check Pronto®

NEUCHATEL, Switzerland – June 8, 2016 – Masimo (NASDAQ: MASI) announced today the full market release outside the U.S. of the Pronto® Pulse CO-Oximeter® with Next Generation SpHb® Spot Check technology. Next Generation Pronto features rainbow SET technology, for noninvasive spot checking of total hemoglobin (SpHb), oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI).

Masimo Pronto® Pulse CO-Oximeter® with Next Generation SpHb® and rainbow® DCI®-mini Reusable Sensor
Masimo Pronto® Pulse CO-Oximeter® with Next Generation SpHb® and rainbow® DCI®-mini Reusable Sensor

In addition to the Next Generation SpHb technology, Masimo has also released the rainbow® DCI®-mini reusable sensor to accompany the Pronto. The DCI-mini is a universal sensor usable on patients greater than 3 kg, making Pronto an even more versatile solution.

The Next Generation SpHb technology in Pronto offers motion tolerance and a 40% reduction in time to display SpHb results. Field accuracy has been improved in the range of 6 to 11 g/dL, and is comparable to certain portable invasive point of care devices.

"This is a significant enhancement to the noninvasive measurement we introduced 7 years ago," stated Joe Kiani, Founder and CEO of Masimo. "Since then, all of the clinical outcome studies we're aware of on our continuous SpHb technology have been positive,1-3 which is something that couldn't be said for standard pulse oximetry before the introduction of Masimo SET SpO2. We will continue to improve SpHb until it has the same measure-through motion and low perfusion performance as our SET SpO2 technology."

An upgrade program will be available for qualified existing Pronto customers. Pronto with Next Generation SpHb and the DCI-mini reusable sensor have not received FDA 510(k) clearance and are not currently available for sale in the United States.

@MasimoInnovates || #Masimo

References
1. Ehrenfeld JM, Henneman JP, Bulka CM, Sandberg WS. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial .2014. J Blood Disorders Transf. 5:237.
2. Awada WN, Mohmoued MF, Radwan TM, Hussien GZ, Elkady HW. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Dec;29(6):733-40.
3. Ponsonnard S, Yonnet S, Marin B, Cros J, Ben Miled S, Nathan N. "Continuous Hb and plethysmography variability index (PVI) monitoring is associated to a decreased mortality at the scale of a whole hospital." Proceedings of the European Society of Anaesthesiology's Euroanaesthesia 2015 Annual Congress, May 30-June 2, Berlin, Germany, 16AP3-2, Room A1 – Poster Abstract Presentation Session, e-Board 8.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's Pronto® Pulse CO-Oximeter®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo's Pronto Pulse CO-Oximeter, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

One of India's Premier Maternal Care Specialists, Motherhood Hospitals, Standardizes on Masimo SET® Technology

Bangalore, India and Irvine, California - June 2, 2016 - Masimo (NASDAQ: MASI) announced today that Motherhood Hospitals, a maternal care specialist with five hospitals in three cities in India, has standardized on Masimo SET® (Signal Extraction Technology®) pulse oximetry at all locations. Motherhood Hospitals will also be screening for Critical Congenital Heart Disease (CCHD) using Masimo's technology.

"We evaluated several technologies and found Masimo SET pulse oximetry to be the most reliable even in the most challenging conditions," said Dr. Mohammed Rehan Sayeed, Chairman, Motherhood Hospitals. "This entire standardization exercise was driven by the clinical staff."

Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry measures oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI), and helps clinicians monitor more than an estimated 100 million patients a year.1 In a study of newborns, researchers found CCHD was identified by physical examination alone 63% of the time, and when Masimo SET® pulse oximetry was added to the physical exam screening, researchers found that clinicians were able to identify CCHD 83% of the time - a 31% increase.2

"We are happy to see the team at Motherhood Hospitals, which conducts research into how to improve the health and well-being of neonates in India, select our SET technology," said Joe Kiani, Founder and CEO of Masimo. "We hope to work with Motherhood Hospitals to standardize universal screening for CCHD in newborns. We are seeing more and more hospitals in this region of the world realize the important role reliable pulse oximetry plays in patient care and safety."

Motherhood Hospitals, a premium birthing boutique, provides a variety of services to expecting women and newborns in India, specializing in obstetrics, gynecology, neonatology, pediatrics, fetal medicine, fertility, and cosmetology. At their combined locations in Bangalore, Chennai, and Hyderabad, they perform over 6,000 deliveries annually.

@MasimoInnovates || #Masimo

References
1. Masimo data on file.
2. de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganäs L, Eriksson M, Segerdahl N, Agren A, Ekman-Joelsson BM, Sunnegardh J, Verdicchio M, Ostman-Smith I. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009 Jan 8;338:a3037.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SET®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SET®, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo to Showcase Next Generation SedLine® Brain Function Monitor at 2016 Euroanaesthesia Congress

SedLine, Which Helps Clinicians Improve Anesthetic Management, Receives CE Mark

Neuchatel, Switzerland – May 26, 2016 – Masimo (NASDAQ: MASI) announced today the CE mark and scheduled full market release of Next Generation SedLine® Brain Function Monitoring technology at the European Society of Anaesthesiology's (ESA) 2016 Euroanaesthesia Congress in London, England.

Masimo Root® with Next Generation SedLine®
Masimo Root® with Next Generation SedLine®

Next Generation SedLine enhances how Masimo's processed EEG parameter, the Patient State Index (PSI), responds in challenging situations, addressing many of the concerns raised with quantitative EEG while bolstering brain function monitoring's support of anesthetic management.

Next Generation PSI uses Masimo's breakthrough Parallel Engines and Adaptive Signal Processing technology and provides the following enhancements:

  • Less susceptibility to electromyography (EMG) interference by extracting a clearer EEG signal even in the presence of EMG
  • Improved PSI performance in low power EEG cases

These improvements build upon the existing benefits of SedLine technology:

  • Four simultaneous EEG leads to enable continuous assessment of both sides of the brain
  • Density Spectral Array (DSA) offers easy-to-interpret, high-resolution display of bi-hemispheric activity
  • Multiple screen views expand information while enabling customization in the OR and ICU
  • Electrocautery resistance

"We are delighted to unveil Next Generation SedLine," said Joe Kiani, Founder and CEO of Masimo. "Next Generation PSI takes advantage of Masimo's signal processing prowess and promises to do for brain function monitoring what SET did for pulse oximetry."

Next Generation SedLine has not received FDA 510(k) clearance and is not currently available for sale in the United States.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SedLine®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SedLine®, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Two Fire Departments Honored for Excellence in Emergency Medical Services

Fire-Service Based EMS Awards Presented at 28th Annual National Fire and Emergency Services Dinner

Washington, DC and Irvine, CA – May 19, 2016 – The Congressional Fire Services Institute (CFSI) and Masimo (NASDAQ: MASI) honored two fire departments for best practices and innovative solutions in the delivery of emergency medical services with the Excellence in Fire Service-Based EMS Award. The award presentation took place on May 5th in Washington, DC. Masimo is proud to be a co-sponsor of this award.

  • The Olathe Fire Department in Olathe, Kansas, established the Mobile Integrated Health (MIH) team to provide better treatment in the field for patients. With the support of local government, community partners, and the Olathe Medical Center, the MIH team reduced the number of patient transports to emergency rooms, monitored the progress of these patients, and scheduled follow-up visits for evaluation and continued treatment.
  • Kittitas Valley Fire and Rescue (KVFR) in Kittitas, Washington, implemented new programs that are reducing demand for emergency services while providing better care and treatment for its citizens. KVFR has launched a community paramedicine program to provide alternative medical care options to alleviate pressure on the 911 system and improve patient outcomes. They conduct educational programs for students, law enforcement, and other community members that address the dangers of alcohol and drug abuse. In addition, KVFR has developed a new fee structure and an educational program to address a rising call volume for non-injury lift assistance requests at assisted living facilities.

"CFSI takes great pride in co-sponsoring the Excellence in Fire Service-Based EMS Awards with Masimo," said Dr. William F. Jenaway, Ph.D., President of CFSI.  "Through this awards program, we are able to recognize innovations in the delivery of emergency medical services throughout the nation.  The recipients of the 2016 award – Kittitas Valley (WA) Fire and Rescue Department and the Olathe (KS) Fire Department – certainly demonstrated themselves worthy of this recognition by developing new programs to enhance their delivery of emergency medical services. Congratulations to both departments."

"Firefighters and emergency services personnel are our heroes. They put their lives on the line for us every day and we want to make sure they have the technology and community support they need to keep them safe and help them better care for the citizens they protect," said Joe Kiani, Founder and CEO of Masimo. "Masimo is honored to co-sponsor this awards program with CFSI and to recognize these two departments for their innovative achievements."

Approximately 1,600 fire and emergency services leaders attended the 28th Annual National Fire and Emergency Services Dinner to pay tribute to the dedication and commitment of the nation's fire and emergency services providers. Hosted by CFSI, the annual dinner benefits the mission of the nonprofit policy organization, which is designed to educate members of Congress about fire and life safety issues. This year's guest speaker was the Honorable Tom Vilsack, U.S. Secretary of Agriculture.

The Excellence in Fire Service-Based EMS Awards Program was established in 2010 to recognize volunteer, career, and combination fire departments for excellence in and enhancements to the delivery of emergency medical services. By showcasing their best practices, the awards program provides ideas for other fire departments to consider implementing as they seek to improve their fire service-based EMS systems.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:
Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

CFSI
Bill Webb, Executive Director
Phone: (202) 371-1277
Email: bwebb@cfsi.org

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Reports First Quarter 2016 Financial Results

Q1 2016 Highlights (compared to Q1 2015):

  • Total revenue, including royalties, rose 10.8% to $171.2 million
  • Product revenue rose 10.8% to $163.3 million
  • Masimo rainbow® revenue rose 39.2% to $16.9 million
  • SET® and rainbow® SET® units shipments were 46,300
  • GAAP net income of $27.6 million, or $0.53 per diluted share versus $20.5 million, or $0.38 per diluted share in the year-ago period

Irvine, California, May 4, 2016 – Masimo (NASDAQ: MASI) today announced its financial results for the first quarter ended April 2, 2016.

First quarter 2016 product revenues rose 10.8% to $163.3 million, compared to $147.4 million for the first quarter of fiscal year 2015, and total revenue, including royalties, rose 10.8% to $171.2 million, up from $154.5 million for the first quarter of fiscal year 2015.

The company's worldwide direct product revenue in the first quarter of 2016 rose by 12.7% compared to the same period in 2015 and represented 86.3% of product revenue. OEM sales, which accounted for 13.7% of product revenue, rose by 0.2% to $22.3 million in the first quarter of 2016 compared to the same period in 2015. Revenue from sales of Masimo rainbow® products rose by 39.2% to $16.9 million in the first quarter of 2016, compared to the same period in 2015.

GAAP net income for the first quarter of 2016 was $27.6 million, or $0.53 per diluted share, compared to GAAP net income of $20.5 million, or $0.38 per diluted share, in the first quarter of 2015. During the first quarter of 2016, the company shipped 46,300 SET® pulse oximeters and rainbow® pulse CO-Oximeters, excluding handheld units. Masimo estimates its worldwide installed base as of April 2, 2016 to be 1,438,000 units, up 7.3% from 1,340,000 units as of April 4, 2015.

Joe Kiani, Chairman and Chief Executive Officer of Masimo, said, "We are happy to report results for the first quarter exceeded our expectations. Our strong revenue growth is the result of increasing demand for both our SET® Pulse Oximetry and rainbow SET Pulse CO-Oximetry technologies, as well as increasing demand from our new products. Given the strong Q1 results and our continued optimism about the rest of the year, we are happy to be in a position to raise our full year 2016 financial guidance."

During the first quarter of 2016, the company generated $18.8 million in cash from operations and as of April 2, 2016, total cash and cash investments were $139.9 million compared to $132.3 million as of January 2, 2016. Also, during the first quarter of 2016, the company repurchased approximately 1.1 million shares of stock for $42.9 million.

2016 Financial Guidance
Masimo today is updating its 2016 financial guidance. Masimo now expects fiscal 2016 total revenues to be approximately $677 million, up from $670 million. Total fiscal 2016 product revenues are now expected to be approximately $647 million, up from $640 million, while royalty revenue expectations have not changed from the previous estimate of approximately $30 million. Masimo now also expects its fiscal 2016 GAAP earnings per diluted share to be $1.83, up from $1.69. Masimo will provide additional financial information during the conference call today. Each of the components of Masimo's guidance set forth above is an estimate only and actual performance could differ.

Conference Call
Masimo will hold a conference call today at 1:30 p.m. PT (4:30 p.m. ET) to discuss the results. A live webcast of the call will be available online from the investor relations page of the company's website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 95558540. After the live webcast, the call will be available on Masimo's website through May 18, 2016. In addition, a telephonic replay of the call will be available through June 3, 2016. The replay dial-in numbers are (855) 859-2056 for domestic callers and +1 (404) 537-3406 for international callers. Please use reservation code 95558540.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.


Forward-Looking Statements
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements including, in particular, the statements about our expectations for full fiscal year 2016 total, product and royalty revenues and GAAP earnings per diluted share; demand for our products; anticipated revenue and earnings growth; our financial condition, results of operations and business generally; expectations regarding our ability to design and deliver innovative new noninvasive technologies and reduce the cost of care; and demand for our technologies. These forward-looking statements are based on management's current expectations and beliefs and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control and could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to, those related to: our dependence on Masimo SET® and Masimo rainbow® SET® products and technologies for substantially all of our revenue; any failure in protecting our intellectual property exposure to competitors' assertions of intellectual property claims; the highly competitive nature of the markets in which we sell our products and technologies; any failure to continue developing innovative products and technologies; the lack of acceptance of any of our current or future products and technologies; obtaining regulatory approval of our current and future products and technologies; the risk that the implementation of our international realignment will not continue to produce anticipated operational and financial benefits, including a continued lower effective tax rate; the loss of our customers; the failure to retain and recruit senior management; product liability claims exposure; a failure to obtain expected returns from the amount of intangible assets we have recorded; the maintenance of our brand; the amount and type of equity awards that we may grant to employees and service providers in the future; our ongoing litigation and related matters; and other factors discussed in the "Risk Factors" section of our most recent periodic reports filed with the Securities and Exchange Commission ("SEC"), including our most recent Form 10-K and Form 10-Q, all of which you may obtain for free on the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Investor Contact:

Eli Kammerman
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Media Contact:

Irene Paigah
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation

 

One of France's University Hospitals Adopts Masimo Radical-7®, Including SpHb®, PVI®, and SET® Pulse Oximetry

Neuchatel, Switzerland – April 21, 2016 – Masimo (NASDAQ: MASI) announced today that Centre Hospitalier Universitaire (CHU) de Limoges, in Limoges, France has installed Masimo's Radical-7®, including noninvasive, continuous hemoglobin (SpHb®), Pleth Variability Index (PVI®), and SET® pulse oximetry technology, to monitor surgical patients and critical patients in the post-anesthesia care unit and intensive care unit.

"For three years, we tested SpHb and PVI on every surgical patient in our facility and then compared this data to the previous period without this technology," said Professor Nathalie Nathan, Head of the Department of Anesthesiology at CHU Limoges. "In this retrospective review of before and after periods across the entire hospital, in different clinical settings and with many different practitioners, we found that there was a notable reduction in mortality in surgeries lasting longer than 2 hours and patients in the 60+ age range."

SpHb is a breakthrough measurement that noninvasively and continuously measures total hemoglobin in the blood, and offers real-time visibility into changes – or lack of changes – in hemoglobin between invasive blood samples. PVI is a measure of dynamic changes in Perfusion Index (PI) that occur during one or more complete respiratory cycles, and may show changes that reflect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions. PVI is noninvasive, easily obtained and has no incremental procedural cost.

"According to the World Health Organization, France ranks number one in the world in patient safety. For over 40 years, CHU Limoges has been recognized as a leading hospital in France for patient care, training, research and innovation," stated Joe Kiani, Founder and CEO of Masimo. "We are impressed with the format of this three-year evaluation and happy to see Limoges incorporate SpHb and PVI in the care of their patients."

CHU Limoges is a university hospital that includes four locations and one nursing home. Dupuytren (866 beds) hosts an emergency department, Jean Rebeyrol (459 beds) handles rehabilitation patients, Cluzeau (59 beds) specializes in respiratory diseases, diabetes, endocrinology and metabolic diseases, and Mother & Child (197 beds) specializes in pediatric and gynecological emergencies.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2", pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's SpHb®, PVI®, and SET® technologies. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo's SpHb®, PVI®, and SET® technologies, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo to Report First Quarter 2016 Financial Results after Market Close on Wednesday, May 4

Conference call and webcast to begin at 1:30 p.m. PT (4:30 p.m. ET)

IRVINE, Calif., April 20, 2016 – Masimo (NASDAQ: MASI) announced today that it will release financial results for the first quarter ended April 2, 2016, after the market closes on Wednesday, May 4, 2016. The conference call to review the results will begin at 1:30 p.m. PT (4:30 p.m. ET) and will be hosted by Joe Kiani, Chairman and Chief Executive Officer, and Mark P. de Raad, Executive Vice President and Chief Financial Officer.

A live webcast of the conference call will be available online from the investor relations page of the company's corporate website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 95558540. After the live webcast, the call will be available on Masimo's website through May 18, 2016. In addition, a telephonic replay of the call will be available through June 3, 2016. The replay dial-in numbers are (855) 859-2056 for domestic callers and +1 (404) 537-3406 for international callers. Please use reservation code 95558540.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Investor Contact:

Eli Kammerman
Masimo
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Media Contact:

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Clinical Study Reports Relationship Between Masimo's Oxygen Reserve Index (ORI) and Arterial Partial Pressure of Oxygen During Surgery

Neuchatel, Switzerland – March 31, 2016 – Masimo (NASDAQ: MASI) announced today that a new retrospective study reports the relationship between Masimo's Oxygen Reserve Index (ORI) and arterial partial pressure of oxygen (PaO2) during surgery. The study suggests that ORI may provide an advanced indication of impending desaturation in adults undergoing surgery based on trends in the relationship between ORI and PaO2.1


Masimo Root® with ORI

ORI, Masimo's 11th rainbow® parameter2, which is available outside of the United States, is a relative index of the PaO2 operating in the range of 100 to 200 mm Hg. ORI can provide a calculated oxygen reserve index that may add to information from pulse oximetry when oxygen saturation (SpO2) is >98%. ORI is intended to supplement, not replace, SpO2 monitoring and PaO2 measurements.

In the study, published in the journal Anesthesia & Analgesia and conducted at Loma Linda University, Dr. Applegate and colleagues studied 106 patients in which arterial catheterization and intraoperative arterial blood gas analysis were planned during surgery. Multiwavelength Pulse CO-oximetry data from multiple sensors on each patient were continuously collected (Masimo Radical-7® with Root®). A retrospective analysis was then conducted to evaluate the ORI to PaO2 relationship.

Regression analysis showed a positive ORI to PaO2 relationship for PaO2 values up to 240 mm Hg (r2 = 0.536), but not for PaO2 over 240 mm Hg (r2 = 0.0016). Measured PaO2 was ≥100 mm Hg for all ORI values over 0.24, and when ORI was higher than 0.55, the measured PaO2 was ≥150 mm Hg in 96.6% of samples.

The investigators concluded, "This study suggests that intraoperative ORI can distinguish PaO2 between 100 and 150 mm Hg when SpO2 is >98%. Decreases in ORI to near 0.24 may provide advance indication of falling PaO2 when SpO2 is still >98% and above the PaO2 level at which SaO2 [arterial oxygen saturation] declines rapidly. Usefulness of ORI >0.24 to distinguish PaO2 ≥100 mm Hg and ORI >0.55 to distinguish PaO2 ≥150 mm Hg should be tested prospectively in a range of clinical settings." Additionally, the investigators noted that "the clinical utility of interventions based on continuous ORI monitoring should also be studied prospectively," and that other clinical or feasibility limitations may not have been identified. The authors also noted that the study was limited by a small number of subjects and samples with PaO2 values <100 mm Hg, and that the study results did not apply to intensive care settings.

The Loma Linda University School of Medicine, Department of Anesthesiology received a grant from Masimo to support the data collection for this study.

Radical-7 with Root has a CE Mark with the ORI parameter. ORI has not received FDA 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates || #Masimo

References
1. Applegate RL 2nd, Dorotta IL, Wells B, Juma D, Applegate PM. The Relationship Between Oxygen Reserve Index and Arterial Partial Pressure of Oxygen During Surgery. Anesth Analg. 2016 Mar 22. [Epub ahead of print] PubMed PMID: 27007078.
2. The 11 rainbow® parameters include: 1) oxygen saturation (SpO2); 2) Pulse rate; 3) Perfusion index (PI); 4) Pleth Variability Index (PVI®); 5) Respiration Rate from the pleth (RRp®); 6) Total hemoglobin (SpHb®); 7) Oxygen Content (SpOC); 8) Carboxyhemoglobin (SpCO®); 9) Methemoglobin (SpMet®); 10) Fractional oxygen saturation (SpfO2®); 11) Oxygen Reserve Index (ORI).

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's Oxygen Reserve Index (ORI). These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo's Oxygen Reserve Index (ORI), contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Reports on Accuracy of Masimo's Blue® Sensors at Saturations Below 85% in Children with Cyanotic Congenital Heart Disease

Irvine, California – March 17, 2016 – Masimo (NASDAQ: MASI) announced today that a new study reported on the accuracy of Masimo's Blue® sensors as compared to Nellcor and Masimo Standard sensors for cyanotic children with blood oxygen saturation less than 85%.1 Masimo's Blue sensor was designed specifically for cyanotic infants and children with congenital heart disease.

The study was performed at the Lucile Packard Children's Hospital at Stanford University with the aim of determining, in children with cyanotic congenital heart disease, which of three different pulse oximeter sensors is the most accurate at lower blood oxygen saturation levels, when compared to the "gold standard" of arterial blood gas analysis with CO-oximetry. The three sensors were Masimo SET® with LNCS® sensor (Masimo Standard), Masimo SET® with Blue sensor (Masimo Blue), and Nellcor N-600 with MAX-I sensor (Nellcor).

In the study, published in the journal Pediatric Critical Care Medicine, Dr. Harris and colleagues collected data from 50 infants and children weighing 3–20 kg with baseline saturations under 90% (measured by pulse oximetry at the time of clinical assessment) undergoing surgical or catheterization procedures. Following standard care monitoring, which included placement of the Masimo Standard sensor, the Masimo Blue and Nellcor MAX-I sensors were placed on a thumb or great toe, or alternatively on a finger. Up to four arterial blood samples were taken from each subject.

Compared to the CO-oximeter saturations (SaO2) over all measurements, the mean error ± standard deviation of the saturation values from pulse oximetry (SpO2) for the Masimo Blue, Nellcor, and Masimo Standard sensors were 1.7% ± 3.3%, 1.7% ± 5.4%, and 2.4% ± 4.9%, respectively.

The investigators concluded that "the Masimo Blue sensor has improved accuracy at saturations 75–85% versus the Nellcor and Masimo Standard sensors," although the authors noted inaccuracies with all three sensors in this saturation range. The authors suggested there is a continued need for device manufacturers to calibrate and develop algorithms for pulse oximeters to have improved overall accuracy at saturations less than 85%. The authors further stated "clinical decisions at saturations below 85% should not be made by pulse oximetry alone; instead, co-oximetry and/or an arterial blood gas is warranted."

Study limitations included small sample size, difficulty collecting steady-state samples from the operating room and catheterization lab, and placement of the Masimo Standard sensor in nonstandard locations.

The institution where this study was performed received a grant from Masimo to partially support the data collection for this study.

@MasimoInnovates || #Masimo

References
1. Harris BU, Char DS, Feinstein JA, Verma A, Shiboski SC, Ramamoorthy C. Accuracy of Pulse Oximeters Intended for Hypoxemic Pediatric Patients. Pediatr Crit Care Med. 2016 Feb 24. [Epub ahead of print] PubMed PMID: 26914626.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at www.masimo.com/cpub/clinical-evidence.htm.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's Blue® sensor. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo's Blue® sensor, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Introduces SafetyNet™ Surveillance at HIMSS16

Patient Video Surveillance System Provides High-Definition Real-Time Imaging at the Bedside

Irvine, California – March 2, 2016 – Masimo (NASDAQ: MASI) today announced the debut of SafetyNet Surveillance at the HIMSS (Healthcare Information and Management Systems Society) 2016 Annual Conference and Exhibition in Las Vegas.

Masimo Root® with SafetyNet™ Surveillance
Masimo Root® with SafetyNet™ Surveillance

SafetyNet Surveillance is a video surveillance system that provides real-time video images of a patient's room, including the patient with connected monitoring devices, to a central station. Masimo SafetyNet Surveillance is a software option for Masimo's Patient SafetyNet system, adding existing communication technology to central monitoring.

The camera delivers a high-resolution, high-frame rate video feed to the Patient SafetyNet view-station. An external mechanical lens cap lets patients or their visitors disable the camera at any time. Two-way audio is available to allow the caregiver to listen and communicate with the patient. The system utilizes the existing hospital IT network and can provide viewing of images in the same care area.

"Video surveillance that is not cost prohibitive adds an exciting new dimension to hospital healthcare systems," said Joe Kiani, Founder and CEO of Masimo. "SafetyNet Surveillance combines innovations we take for granted in our everyday lives—real-time video and two-way audio communication—with top-tier noninvasive medical technology to deliver a holistic system cost effectively. We hope this enhancement to Patient SafetyNet will improve the quality and safety of patient care and help reduce costs."

For more information on Masimo and its products, go to http://www.masimo.com.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's SafetyNet Surveillance system. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including SafetyNet Surveillance, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Iris Gateway at HIMSS16

Integrated Medical Device Data Management Solution Designed to Fill the Gaps in Electronic Medical Records

Irvine, California – March 1, 2016 – Masimo (NASDAQ: MASI) today announced the debut of Iris™ Gateway, a server-based software solution for integrating medical device data, at the HIMSS (Healthcare Information and Management Systems Society) 2016 Annual Conference and Exhibition in Las Vegas.

Data generated from medical devices remain captive within each device, and may not be captured in the patients' electronic medical records (EMR). Iris Gateway can provide a timely and cost-effective solution by connecting to existing medical devices and performing the required translations to move the data from the devices into EMRs. Iris Gateway can be deployed on a remote server farm or as a server appliance in the hospital.

The Iris ports on the Root® patient monitor allow other medical devices (such as infusion pumps, ventilators, patient monitors, and "smart" beds) to connect to Iris Gateway via Root. Data from these connected devices can be associated with the patient and entered into the patient's EMR, via Iris Gateway. Root with noninvasive blood pressure and temperature measurements, deployed at the bedside or on a roll stand, can chart these parameters at the point of care while also copying the data into an EMR.

"Iris Gateway is an important part of Masimo's goal of bridging medical device data silos," said Joe Kiani, Founder and CEO of Masimo. "It can be used to connect isolated devices to hospital EMR systems in high-acuity settings like the OR and the ICU or in low-acuity settings like medical-surgical units. When data from different medical devices is more readily available in the patient's electronic medical record, they may provide a clearer and more complete picture of the patient. At Masimo, we are dedicated to providing clinicians with vital information when they need it most."

Iris_Gateway_big

For more information on Masimo and its products, go to http://www.masimo.com.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's Iris™ Gateway. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Iris Gateway, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Manipal Hospitals is the First in India to Adopt Masimo Patient SafetyNet™

Irvine, California & Bengaluru, India – February 25, 2016 Masimo (NASDAQ: MASI) announced today that Manipal Hospitals is the first hospital in India to install Masimo Patient SafetyNet, a remote monitoring and clinician notification system.

"With Patient SafetyNet, we are now able to monitor a certain set of patients 24x7," said Gopal Devanahalli, Chief Operating Officer of Manipal Hospitals. "One of the key features of this system is its proprietary Signal Extraction Technology (SET®) that helps significantly reduce false alarms."

"This is the technological advancement that we were awaiting," said Dr. Nagendra Swamy SC, MD, Senior President, Manipal Health Enterprises, and Group Medical Director & Chairman, Quality Council, Manipal Health Enterprises. "The technology will notify the hospital team when there are signs of deterioration and allow our patients to be monitored even though the nurse is not physically in the room with them."

Masimo Patient SafetyNet works in conjunction with Masimo bedside monitors which provide continuous and noninvasive monitoring of oxygen saturation (SpO2), pulse rate, respiration rate, and other parameters. When changes occur in the measured values, which may indicate deterioration in the patient's condition, in addition to bedside alarms, Masimo Patient SafetyNet automatically sends wireless alerts directly to clinicians. Continuous patient surveillance with Masimo Patient SafetyNet has been shown to reduce the need for rescue events and intensive care unit transfers in hospitals and, as a result, can reduce costs related to these events.1,2

"Manipal Hospitals treats close to 2 million patients annually and needed a monitoring system that they could trust would work in challenging patient populations," said Joe Kiani, Founder and CEO of Masimo. "We are excited to see this shift internationally with more and more hospitals worldwide recognizing the importance of integrating remote monitoring systems as a part of their patient safety initiatives."

For more information on Patient SafetyNet, go to http://www.masimo.com.

@MasimoInnovates || #Masimo

References
1. Taenzer A.H., Pyke J.B., McGrath S.P., Blike G.T. Anesthesiology. 2010 Feb;112(2):282-7.
2. Taenzer A, Blike G, McGrath S, Pyke J, Herrick M, Renaud C, Morgan J. "Postoperative Monitoring - The Dartmouth Experience." Anesthesia Patient Safety Foundation Newsletter Spring-Summer 2012. Available online.

About Manipal Hospitals
As a pioneer in healthcare, Manipal Hospitals is among the largest hospital networks in India, serving over 2 million patients annually. Its focus is to develop an affordable tertiary care multispecialty healthcare framework through its entire multispecialty delivery spectrum and further extend it to homecare. With its flagship quaternary care facility located in Bengaluru, India, 8 tertiary care, 7 secondary care and 2 primary care clinics spread across India and abroad, today Manipal Hospitals successfully operates and manages 5,200+ beds. Manipal Hospitals provides comprehensive curative and preventive care for a multitude of patients from across the globe. Manipal Hospitals is the first in India to be awarded accreditation by the AAHRPP for ethical standards in clinical research activities. It is also NABL, NABH and ISO certified. Manipal Hospitals is also the most respected hospital company in India and the most patient recommended hospital in India by consumer survey.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Patient SafetyNet™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results or studies; risks related to our belief that Masimo's unique noninvasive measurement technologies and monitoring system solutions, including Masimo Patient SafetyNet, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation, including the dental setting; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Anjana Chandran
Manipal Hospitals
Phone: +91-988-627-8400
Email: anjana.chandran@manipalhospitals.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA 510(k) Clearance for Root® with Noninvasive Blood Pressure and Temperature

Irvine, California – February 17, 2016 – Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for noninvasive blood pressure and temperature measurements for the Root® patient monitoring and connectivity platform.

Root with noninvasive blood pressure from SunTech Medical enables clinicians to measure arterial blood pressure for adult, pediatric, and neonatal patients, with three distinct measurement modes: spot-check, automatic interval, and stat interval. The temperature module from Welch Allyn is indicated to measure the temperature of adult and pediatric patients.

With the addition of noninvasive blood pressure and temperature to the Root platform, clinicians can easily and automatically chart vital signs data directly from Root. Enhancing the solution with Masimo Patient SafetyNet allows data to be sent directly to the patient's electronic medical record (EMR) while alarms and alerts are seamlessly forwarded to the patient's clinician.

Root with noninvasive blood pressure and temperature provides a monitoring solution for step-down, medical, and surgical environments. Clinicians on a unit equipped with this technology are expected to be able to continuously monitor their patients and automatically document vital signs while improving workflow, allowing them to spend more time with their patients.

Masimo Root® with noninvasive blood pressure and temperature

Root offers a high visibility display with intuitive, touchscreen navigation for easy and adaptable use in any hospital environment:

> Integrates measurements from Masimo Radical-7® handheld for SET® Measure-through Motion and Low Perfusion pulse oximetry, continuous hemoglobin (SpHb®), PVI®, and other noninvasive rainbow® parameters, or the Radius-7 patient-worn monitor for continuous pulse oximetry and respiration rate monitoring of mobile patients.

> Flexible measurement expansion through Masimo Open Connect (MOC-9), including:

> ISA CO2 capnography for sidestream monitoring featuring Nomoline™ technology, allowing for the cost-effective use of consumables.

> Additional MOC-9 modules available include measurements such as SedLine® brain function monitoring.

> Automatic display of parameters, waveforms, and viewing configuration based on the clinician's presence through MyView™ technology enabled with Patient SafetyNet version 5000 or higher.

> Optional USB barcode scanner for easy patient association.

> Available roll stand for ease of transport throughout the hospital.

> Built-in wireless radio allows data to be transmitted continuously during rounds.

"We are excited to bring this addition to the U.S. market," said Joe Kiani, Founder and CEO of Masimo. "We designed Root to do for patient monitoring what PCs did for computing. By creating a platform which allows third-party measurement expansion, with an intuitive user interface and network connectivity, we hope to speed up innovation while reducing the cost of monitoring, as well as potentially improving patient care and patient safety."

For more information on Root with noninvasive blood pressure and temperature, go to www.masimo.com.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's Root® with noninvasive blood pressure and temperature. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Root® with noninvasive blood pressure and temperature, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo's rainbow® Acoustic Monitoring (RAM) was Associated with Fewer Alarm Events During Planned Moderate Sedation in New Clinical Study

For Breath Rates Less Than or Equal to 4 Breaths Per Minute, RAM Showed 78% True Positives and 22% False Positives, While Capnography Showed 30% True Positives and 70% False Positives

Irvine, California – February 12, 2016 – Masimo (NASDAQ: MASI) announced today that Masimo's rainbow® Acoustic Monitoring (RAM) was associated with fewer alarm events during planned moderate sedation in a new clinical study.1

This two-part pilot study used RAM and SedLine® brain function monitoring as the additional monitoring parameters during planned moderate sedation to (1) determine the incidences of alarm events (desaturation, respiratory depression and deeper than intended sedation), and (2) determine whether monitoring with these parameters is associated with fewer alarm events.

RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer that is applied to the patient's neck.

In the two-part study, published in the journal Anesthesia & Analgesia by Dr. Richard Applegate II and colleagues from the Loma Linda University School of Medicine, data were collected from adult patients undergoing gastroenterology or interventional radiology procedures under moderate sedation. The patients were monitored per standard protocols (electrocardiography, blood pressure, pulse oximetry, and capnography) along with the additional parameters RAM and SedLine. RAM and SedLine were not visible to the care teams in part one of the study (standard) but were visible to the care teams in part two of the study (advanced). Alarm events were defined as desaturation (SpO2 <=92%), acoustic respiration rate <=8 breaths per minute, and PSI <=50.

Data were analyzed from 90 patients (44 standard and 46 advanced). There were 55% fewer alarm events in advanced patients compared with standard patients (median 2.5 vs. 5.5, p=0.038). Fewer advanced patients had >=1 respiratory depression event (17 vs 26; p=0.035) or >=1 desaturation event (15 vs 25; p=0.02).

The investigators also compared respiratory rate events between capnography (using the Covidien Capnostream™ 20p) and RAM in the standard group and conducted a retrospective analysis to determine the true positive rates for capnography and RAM. The true positive rates were 30% and 78% respectively; the false positive rates were 70% and 22% respectively.

There were no significant differences between groups in the number of deeper than intended sedation events using SedLine.

The authors concluded that "the use of advanced monitoring during planned moderate sedation was associated with fewer alarm events, patients experiencing desaturation, and patients experiencing respiratory depression alarm events. ... The findings The findings of this pilot study suggest that further study into the safety and outcome impacts of advanced monitoring during procedure-related sedation is warranted."

For more information on RAM and SedLine, go to www.masimo.com.

@MasimoInnovates || #Masimo

References
1 Applegate RL II, Lenart J, Malkin M, Meineke MN, Qoshlli S, Neumann M, Jacobson JP, Kruger A, Ching J, Hassanian M, Um M. Advanced Monitoring Is Associated with Fewer Alarm Events During Planned Moderate Procedure-Related Sedation: A 2-Part Pilot Trial. Anesth Analg. 2016 Feb 1. [Epub ahead of print].

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's rainbow® Acoustic Monitoring (RAM) and SedLine® brain function monitoring technologies. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Root® with SedLine® and RAM, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

In New Clinical Study Masimo's Oxygen Reserve Index Helps Clinicians Detect Impending Desaturation in Pediatric Patients

Neuchatel, Switzerland – February 4, 2016 – Masimo (NASDAQ: MASI) announced today that in a new clinical study, Masimo's Oxygen Reserve Index (ORI), the first noninvasive and continuous parameter to provide insight into patients' oxygen reserve when they are receiving supplemental oxygen, helped clinicians in the early identification of impending desaturation in pediatric patients during induction of anesthesia.1

Oxygen saturation (SpO2) using pulse oximetry provides noninvasive, continuous visibility to arterial blood oxygenation in hypoxia (lower than normal oxygenation) and normoxia (normal oxygenation). For procedures such as induction of anesthesia and intubation, clinicians will usually build an "oxygen reserve" in the patient by providing supplemental oxygen or "pre-oxygenation," creating a transitional state of hyperoxia (higher than normal oxygenation). The extent of hyperoxia can be determined by the measured partial pressure of oxygen in the blood (PaO2 ), which requires invasive arterial blood sampling and laboratory analysis. When patients have low oxygen reserve prior to intubation of the trachea, they are susceptible to sudden hypoxia, depending upon the time taken to perform the intubation.

ORI, Masimo's 11th rainbow® parameter2, is a relative index of the partial pressure of oxygen in arterial blood (PaO2) within the range of 100 to 200 mmHg that can provide insight into significant changes in oxygen reserve. ORI is intended to supplement, not replace, SpO2 monitoring and PaO2 measurements.

In a prospective study published in Anesthesiology and conducted at Children's Medical Center in Dallas, Texas, Dr. Peter Szmuk and colleagues evaluated whether ORI could provide a clinically important warning of impending desaturation in pediatric patients with induced apnea after pre-oxygenation. The investigators enrolled 33 patients in this study. Eight of these resumed spontaneous ventilation during the study period, leaving 25 apneic patients to evaluate, with an average age of 7.6 years. Data were recorded continuously by the Masimo Radical-7® Pulse CO-Oximeter®, connected to the patient through an R1 25L rainbow® sensor. ORI was retrospectively calculated and was not visible to investigators.

After pre-oxygenation with supplemental oxygen, anesthesia induction, and endotracheal intubation, the anesthesia circuit was disconnected and SpO2 was allowed to decrease to 90% before ventilation recommenced. During the period of apnea, the ORI progressively decreased from a mean of 0.73 ±0.2 at the beginning of apnea to 0.37 ± 0.1. The SpO2 remained at 100% during this initial period. After decreases in ORI that would trigger the ORI alarm if monitored in real time, there was a median elapsed time of 31.5 seconds before the SpO2 decreased to 98%. After reinstitution of ventilation, SpO2 values declined further to 88%, before recovering to 98%, 34 seconds later. The researchers concluded that "In this pilot study, we found that during prolonged apnea in healthy anesthetized children, the ORI detected impending desaturation in median of 31.5 seconds (IQR, 19 to 34.3 seconds) before noticeable changes in SpO2 occurred. Knowing even roughly how much time remains before the rapid desaturation phase begins seems likely to guide proper decisions."

Radical-7® with Root® has a CE Mark with the ORI parameter. ORI is not FDA cleared and is not available for sale in the United States.

For more information on ORI go to http://www.masimo.co.uk/ori/.

@MasimoInnovates || #Masimo

References
1 Szmuk P, Steiner JW, Olomu, PN, Ploski, RP, Sessler, DI, Ezri, T. Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A Pilot Study. Anesthesiology 2016; 124:00-00. doi:10.1097/ALN.0000000000001009.

2 11 parameters include: 1) oxygen saturation (SpO2); 2) Pulse rate; 3) Perfusion index (PI); 4) Pleth Variability Index (PVI®); 5) Respiration Rate from the pleth (RRp®); 6) Total hemoglobin (SpHb®); 7) Oxygen Content (SpOC); 8) Carboxyhemoglobin (SpCO®); 9) Methemoglobin (SpMet®); 10) Fractional oxygen saturation (SpfO2®); 11) Oxygen Reserve Index (ORI).

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo's Oxygen Reserve Index (ORI). These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including ORI, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo to Report Fourth Quarter 2015 Financial Results after Market Close on Tuesday, February 23

Conference call and webcast to begin at 1:30 p.m. PT (4:30 p.m. ET)

IRVINE, Calif., January 29, 2016 – Masimo (NASDAQ: MASI) announced today that it will release financial results for the fourth quarter ended January 2, 2016, after the market closes on Tuesday, February 23, 2016. The conference call to review the results will begin at 1:30 p.m. PT (4:30 p.m. ET) and will be hosted by Joe Kiani, Chairman and Chief Executive Officer, and Mark P. de Raad, Executive Vice President and Chief Financial Officer.

A live webcast of the conference call will be available online from the investor relations page of the company's corporate website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 40429223. After the live webcast, the call will be available on Masimo's website through March 22, 2016. In addition, a telephonic replay of the call will be available through March 8, 2016. The replay dial-in numbers are (855) 859-2056 for domestic callers and +1 (404) 537-3406 for international callers. Please use reservation code 40429223.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Investor Contact:

Eli Kammerman
Masimo
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Media Contact:

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Shows Utility of Masimo rainbow Acoustic Monitoring

IRVINE, California – January 21, 2016 – Masimo (NASDAQ: MASI) announced today that in a new study that compared acoustic respiration rate (RRa®) from Masimo's rainbow® Acoustic Monitoring (RAM) to respiration rate from conventional capnography, researchers concluded that RAM was useful for monitoring dental patients under intravenous anesthesia.1

rainbow Acoustic Monitoring (RAM) from Masimo.

The Anesthesia Patient Safety Foundation (APSF) and The Joint Commission recommend continuous oxygenation and ventilation monitoring in all patients receiving opioid-based pain medications.2 RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer that is easily and comfortably applied to the patient's neck.

The study, published in the Journal of Clinical Monitoring and Computing by Dr. Kentaro Ouchi and colleagues from Japan, compared the respiration rate measurements from RAM and capnography (Psychorich IS nasal cannula and BP-608 Omron Colin monitor) in non-intubated patients with dental anxiety undergoing dental treatment. A total of 1953 data points of respiratory rate were taken from the start to the end of anesthesia. Over the entire observation period, the results showed a significantly higher detection of respiratory rate by RAM (1884 points, 96.5%) than by capnography When comparing respiration rate from RAM and capnography during the induction, intraoperative, and emergence periods, the 95% limits of agreement (LOA) were -7.4 to 6.7, -5.4 to 7.0, -3.9 to 5.3, respectively. The researchers commented that this study was only a comparison between two devices, since neither method could be considered a "corrective control," or gold-standard reference.

The authors concluded, "In comparison between capnography using a nasal cannula for continuous monitoring for the respiratory rate, the acoustic method is useful during intravenous general anesthesia in unintubated spontaneously breathing patients undergoing dental procedures." The authors note that the acoustic method might not accurately detect respiratory rate in cases in which a dental air turbine is used.

For more information on the RAM Acoustic Respiratory Rate Monitoring System, go to www.masimo.com.

@MasimoInnovates || #Masimo

References
1 Ouchi (et al.), Acoustic Method Respiratory Rate Monitoring is Useful in Patients Under Intravenous Anesthesia. J Clin Monit Comput 2016; published online.
2 Stoelting, RK et al. APSF newsletter. 2011. www.apsf.org.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results or studies; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo's rainbow® Acoustic Monitoring (RAM) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation, including the dental setting; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Dr. Steven Barker Awarded the Society for Technology in Anesthesia's J.S. Gravenstein Award for Lifetime Achievement

IRVINE, California – January 19, 2016 – Masimo (NASDAQ: MASI) announced today that a member of its Board of Directors, Chairman of its Scientific Advisory Board, and its Chief Science Officer, Steven Barker, Ph.D., M.D., was honored with the 2016 J.S. Gravenstein Award recognizing lifetime achievement at this month's Society for Technology in Anesthesia (STA) Annual Meeting in Palm Beach, Florida.

"We selected Dr. Barker as the recipient of the Gravenstein Award because of his years of innovation, instruction and service," said Dr. Joseph Orr, President of the STA. "Dr. Barker is a rare combination of training in the physical sciences (Ph.D. in aerospace engineering) and in medicine. Over the years, he has been able to apply his training, research and talent to study and improve medical monitoring devices. Through his collaboration with Masimo, Dr. Barker's work has improved technology available for clinical anesthesia practice."

The STA was founded in 1988 and is an international organization of physicians, engineers, students and others with an interest in anesthesia-related technologies. The organization also publishes the journal Anesthesia & Analgesia. Each year, the STA bestows the J.S. Gravenstein Award for lifetime achievement in the area of technology in anesthesia. The J.S. Gravenstein Award is named for J.S. "Nik" Gravenstein (1925-2009), a founding member and former president of the STA. For over thirty years, Dr. Gravenstein was a driving force in advancing anesthesia technology, patient simulation and anesthesia patient safety.

"This is a great honor and we are very proud of Steve," said Joe Kiani, Founder and CEO of Masimo. "He has always been at the forefront of technology development and research in every area of anesthesia, but what sets Steve apart is his commitment to the truth and integrity. His work has contributed to improving quality of care and patient safety around the world."

Steven J. Barker, Ph.D., M.D., received his Ph.D. in Aeronautical Engineering from the California Institute of Technology in 1972, and his M.D. from the University of Miami in 1981. He has reached the rank of tenured professor in both engineering (University of California at Los Angeles) and anesthesiology (University of California at Irvine, University of Arizona). He chaired the Department of Anesthesiology at UC Irvine from 1990 to 1995, and then at the University of Arizona from 1995 to 2013. He has published over 150 scholarly works, including 15 textbook chapters. Dr. Barker has served as president of the national organization of anesthesiology department chairs (AAPD) and of the Society for Technology in Anesthesia (STA), senior oral examiner for the American Board of Anesthesiology, and Section Editor for Technology for the journal Anesthesia & Analgesia. During his 18-year tenure as anesthesiology chair at the University of Arizona, Dr. Barker was active in a number of governance roles outside of his department. He also served seven years as the American Society of Anesthesiologists (ASA) Director for Academic Anesthesiology, representing all university anesthesiology departments for ASA. Since 2005, Dr. Barker has been a member of Masimo's Board of Directors and Chairman of Masimo's Scientific Advisory Board. In 2015, Dr. Barker also took on the role of Chief Science Officer of Masimo.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor and the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Media Contacts:

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

 

North Carolina's Appalachian Regional Healthcare System Selects Patient SafetyNet™ and Radius-7™

Irvine, California and Boone, North Carolina – January 13, 2016 - Masimo (NASDAQ: MASI) and Appalachian Regional Healthcare System announced that Watauga Medical Center in Boone is the first hospital in North Carolina to install Masimo Patient SafetyNet, a remote monitoring and clinician notification system, and Radius-7, a patient-worn monitor that is designed to allow for patient mobility along with continuous monitoring.

"We are always looking for cutting-edge technologies focused on patient safety," said Richard Sparks, President & CEO, Appalachian Regional Healthcare System. "We wanted a system that provides continuous monitoring that wasn't restricted to the patient's room. The Radius-7 combined with Patient SafetyNet allows us the ability to keep a close eye on our patients 24/7."

Continuous patient surveillance with Patient SafetyNet has been shown to reduce the need for rescue events and intensive care unit transfers in hospitals and, as a result, can reduce costs related to these events.1,2 When changes occur in the measured values, which may indicate deterioration in the patient's condition, in addition to bedside alerts, the alert also shows in the Telemetry room and nurse's stations. This allows the telemetry technician to contact the unit where the alarm is happening immediately. Masimo Patient SafetyNet works in conjunction with Masimo beside monitors and the Radius-7 wearable monitor to provide wireless, continuous and non-invasive monitoring of oxygenation, pulse rate and respiration, among other parameters.

Appalachian Regional Healthcare System's Charles A. Cannon, Jr. Memorial Hospital also recently implemented continuous monitoring. At this location, the monitors are connected to the patient call system. When an alert goes off, it sounds through the call lights and then sends a message to the nurse's station call monitor.

"Watauga Medical Center in Boone and Cannon Memorial Hospital in Linville understand the importance of patient safety," said Joe Kiani, Founder and CEO of Masimo. "We are excited to see more and more hospitals implement continuous monitoring of their patients in post-surgical wards, as part of their patient safety protocols."

@MasimoInnovates || #Masimo

1 Taenzer A.H., Pyke J.B., McGrath S.P., Blike G.T. Anesthesiology. 2010 Feb;112(2):282-7.
2 Taenzer A, Blike G, McGrath S, Pyke J, Herrick M, Renaud C, Morgan J. "Postoperative Monitoring - The Dartmouth Experience." Anesthesia Patient Safety Foundation Newsletter Spring-Summer 2012. Available online.

About Appalachian Regional Healthcare System
Appalachian Regional Healthcare System (ARHS), the healthcare leader in the High Country, is comprised of two hospitals - Charles A. Cannon, Jr. Memorial Hospital in Linville and Watauga Medical Center in Boone - a physician practice management group - Appalachian Regional Medical Associates (ARMA) - the Blowing Rock Rehabilitation & Davant Extended Care Center in Blowing Rock - and Appalachian Regional Healthcare Foundation. Appalachian Regional Healthcare System stays committed to promoting health in the High Country, enhancing quality of life and simply "making life better." This charge makes Appalachian Regional Healthcare System the premier healthcare system in this region. For more information, visit www.apprhs.org.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Gillian Baker
Watauga Medical Center
Phone: (828) 268-8958
Email: gbaker@apprhs.org

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo to Debut Respiration Rate in MightySat™ at Consumer Electronics Show – First Fingertip Pulse Oximeter to Measure Breath Rate

Visit CES booth 73710 for Live Audience Cycling Competition

Irvine, California – January 6, 2016 – Masimo (NASDAQ: MASI) announced today that it has added a new parameter, respiration rate from the pleth (RRp), to its MightySat fingertip pulse oximeter. MightySat is intended for general wellness and health applications including sports, fitness, and relaxation management.

Respiration rate, or the number of breaths per minute, is infrequently measured outside of healthcare settings because it typically requires manual counting of breaths with a timer and then multiplying to convert to a per minute rate or chest leads or straps that are not convenient to use. Fingertip pulse oximeters are being increasingly used for general wellness and health applications. Now consumers will be able to quickly and easily measure respiration rate, in addition to arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (PI), and Plethysmograph Variability Index (PVI®).

Masimo pulse oximeters are #1 in U.S. hospitals1 because they provide accurate measurements when other pulse oximeters fail, by using a revolutionary invention called Signal Extraction Technology (SET®). MightySat features hospital-grade SET pulse oximetry and also provides parameters not available on other fingertip pulse oximeters, such as RRp and PVI. In addition, MightySat offers a Bluetooth wireless interface to the Masimo Personal Health and Apple Health App to track, trend, and communicate measurements. MightySat is increasingly being used by elite athletes and teams to assess and improve performance.

"The addition of respiration rate to the MightySat is a game changer because we can now quantify breathing - a fundamental indicator of health, wellness, and sports performance," stated Olympic Silver Medalist Dotsie Bausch.

"Sometimes matches are won by a few points, and I need every breath to count," said Coco Vandeweghe, Professional Tennis Player on the WTA Tour. "MightySat makes breath tracking easier."

"We believe the MightySat will help transform the wearables market by providing fitness enthusiasts with the same valuable personal data that to date has only been available to elite athletes," said Joe Kiani, Chairman and CEO of Masimo.

"Helping athletes to improve their overall performance ecosystem is what I do," stated Tim DiFrancesco, PT, DPT, ATC, CSCS, Head Strength and Conditioning Coach for the Los Angeles Lakers. "That requires gaining insight into the well-being of the person as well as the physiology within the person. Many objective monitoring tools fail to provide accurate and valuable information in a swift and noninvasive manner, but MightySat succeeds. After incorporating MightySat into my athlete monitoring toolbox, I see an impressive list of potential value through quantifying and measuring markers that give a more granular look at athlete readiness, fatigue/overtraining, fuel source utilization, and cardiovascular conditioning."

This year at the Sands Expo in Las Vegas, attendees can visit Masimo at CES booth 73710 and observe MightySat measurements before and after a live audience cycling competition. Cycling participants will be aided by two experts, Stig Severinsen and Dotsie Bausch. Stig is a four-time World Champion freediver and holds multiple Guinness World Records, including history's longest breath-hold, of 22 minutes. Dotsie is a seven-time USA Cycling National Champion, two-time Pan-American Champion, and silver medalist in team pursuit cycling at the 2012 London Olympics. Both Stig and Dotsie will also be available in the booth to answer questions about how they have incorporated MightySat into their health and fitness routines.

MightySat is available for purchase on Amazon U.S. and Amazon U.K. MightySat with Respiration Rate will be available for purchase by the end of February 2016.

@MasimoInnovates || #Masimo

1 iData Research. U.S. Market for Patient Monitoring Equipment. 2014.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the MightySat fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, those related to the expected adoption of MightySat. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

 Masimo Pledges to Increase Investment in Research & Development
in Response to Today's Moratorium on the Medical Device Tax

Irvine, California – December 18, 2015 – Masimo (NASDAQ: MASI), the global innovator of noninvasive patient monitoring technologies, announced today that it will increase investment in research and development and other areas in response to the moratorium on the Medical Device Tax.

For years, the United States has led the world in life-saving medical innovations. Unfortunately, the Medical Device Tax of 2013 became an impediment to innovation that springs from start-ups. In addition, many established companies curtailed their investments in research and development and reduced their workforces to pay the new tax.

"We applaud the bipartisan efforts of Congress and the administration to suspend the medical device tax for two years," said Joe Kiani, Chairman and CEO of Masimo. "This two-year moratorium will allow us to begin to increase our investment in research and development and other areas."

@MasimoInnovates | #Masimo

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through-Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at
www.masimo.com.

Media Contact:

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Retired U.S. Senator Tom Harkin Joins Masimo's Board of Directors

Irvine, California – December 17, 2015 – Masimo (NASDAQ: MASI), a global innovator of noninvasive patient monitoring technologies, announced today that retired Senator Tom Harkin, former five-term U.S. Senator and former Chairman of the Senate Health, Education, Labor and Pension (HELP) Committee, has been elected to Masimo's Board of Directors.

Senator Harkin retired from the U.S. Senate in January 2015. Senator Harkin was chairman of the Senate HELP Committee for eight years. In that role, he worked to ensure the health of our economy, guarantee access to quality education, and provide affordable, quality health care for all Americans. Senator Harkin crafted the prevention and wellness title of the country's new health reform bill, the Patient Protection and Affordable Care Act. Senator Harkin's signature legislation achievement was leading the effort and sponsorship of the Americans with Disabilities Act (ADA) signed into law in 1990 by President George H.W. Bush. He later created the Clinical Trials Network to measure the effectiveness of rehabilitation therapies for those living with paralysis, and drafted the Christopher and Dana Reeve Act, passed in 2009. Prior to his retirement, Senator Harkin worked closely with President Obama to lift restrictions on embryonic stem cell research.

"For years, Tom has worked tirelessly to ensure that everyone has access to affordable, quality health care and those who are in need are not forgotten. We are honored to welcome Tom to the Board," said Joe Kiani, Chairman and CEO of Masimo. "We believe his integrity, extensive experience and insight into our complex health system, along with his dedication and passion to help those in need will be extremely valuable to Masimo."

"I've been very impressed with Masimo's innovations and contributions to healthcare," said Harkin. "I got to know Joe through his advocacy work to improve competition in healthcare, align misaligned incentives that impede patient care and the Patient Safety Movement. He has been steadfast in his commitment to improve our healthcare system through innovation and advocacy. I look forward to working with him and the rest of the board to help Masimo with its mission to improve patient care and reduce cost of care."

Senator Harkin was first elected to the U.S. House of Representatives in 1974, and 10 years later, he was elected to US Senate. Senator Harkin was born in Cumming, Iowa, where he still resides with his wife Ruth. They have two daughters and three grandchildren.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through-Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Media Contact:

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

T.J. Samson is the First Hospital in Kentucky to Adopt Patient SafetyNet™

Irvine, California and Glasgow, Kentucky – December 1, 2015 – Masimo and T.J. Samson Community Hospital announced that the hospital is the first in Kentucky to install Masimo Patient SafetyNet, a remote monitoring and clinician notification system.

"Patient safety is my top priority," said Bud Wethington, Chief Executive Officer of T.J. Samson Community Hospital. "We did a lot of research in finding the system that was right for us. After trying several other systems and visiting another hospital that was utilizing Patient SafetyNet, we found it to be a perfect fit for our hospital. The installation was easier than anticipated and we were up and running in a very short amount of time."

Masimo Patient SafetyNet works in conjunction with Masimo beside monitors which provide continuous and non-invasive monitoring of oxygenation, pulse rate and respiration, and other parameters. When changes occur in the measured values, which may indicate deterioration in the patient's condition, in addition to bedside alerts, Patient SafetyNet automatically sends wireless alerts directly to clinicians. Continuous patient surveillance with Patient SafetyNet has been shown to reduce the need for rescue events and intensive care unit transfers in hospitals and, as a result, can reduce costs related to these events.1,2

"We are so impressed when we see a community hospital equip their team with the latest in technology to better monitor their patients and improve patient safety practices," said Joe Kiani, Founder and CEO of Masimo. "There are much larger hospitals throughout the country that have yet to install wireless notification systems for supplemental monitoring."

@MasimoInnovates || #Masimo

1 Taenzer A.H., Pyke J.B., McGrath S.P., Blike G.T. Anesthesiology. 2010 Feb;112(2):282-7.
2 Taenzer A, Blike G, McGrath S, Pyke J, Herrick M, Renaud C, Morgan J. "Postoperative Monitoring - The Dartmouth Experience." Anesthesia Patient Safety Foundation Newsletter Spring-Summer 2012. Available
online.

About T.J. Samson Community Hospital
Since 1929, T.J. Samson Community hospital has offered a variety of health services to the region, including acute care; preventive testing and treatment; community outreach activities; and partnerships with local heath care providers, civic organizations, and public schools. The hospital has undergone several expansions, including its most recent addition—a new wing to house an ultramodern labor and delivery floor, emergency department, cardiology laboratory, and intensive care unit. In May 1997, the hospital was designated as the site for one of Kentucky's congressionally mandated Family Practice Residency Programs and is now home to the University of Louisville Glasgow/Barren County Family Medicine Residency. Today, T.J. Samson Community Hospital is a 196-bed, acute-care facility, including sixteen skilled-care beds. And the T.J. Health Pavilion, providing outpatient services and physicians' offices. For more information, please visit
www.tjsamson.org.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through-Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). The indications for EMMA include the following: 1) The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. 2) The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. Additional information about Masimo and its products may be found at
www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at
www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Bart Logsdon
T.J.Samson
Phone: (270) 651-4618
Email: blogsdon@tjsamson.org

Irene Paigah
Masimo
Phone: (858) 616-8689
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Giving Back With Masimo

Irvine, California - November 25, 2015 - Masimo (NASDAQ: MASI) is grateful, as always, to have had a wonderful year – but we nonetheless feel deep sorrow at all of the suffering around us, from unnecessary patient harm to the many refugees displaced from war-stricken homelands, who face so many difficulties as they seek even the most basic human needs.

It is in this spirit that this year, rather than wait for the December holidays, we have decided to bring forward our traditional request to you, our loyal customers and friends, to help us donate to some of the worthiest charities and organizations: the need simply feels greater and more urgent this year. We have purposefully chosen a new list of recipients, centered on refugee assistance and patient safety. We simply ask that you respond with an email to charity@masimo.com, specifying your choice from the list below, and we will donate $10 in your name. We also encourage you to donate to them directly.

AidRefugees - https://www.whitehouse.gov/campaign/aidrefugees

Medecins Sans Frontieres (MSF) International (Doctors without Borders) - http://www.doctorswithoutborders.org/our-work/humanitarian-issues/refugees-and-idps

Patient Safety Movement Foundation - http://www.patientsafetymovement.org/

RED CROSS - https://www.icrc.org/en/where-we-work/middle-east/syria

SAMS - Syrian American Medical Society - https://www.sams-usa.net/foundation/

SOS Children's Villages- http://www.sos-childrensvillages.org/

UN Refugee Agency - http://www.unhcr.org/emergency/5051e8cd6-560953162.html

UNICEF - http://www.unicef.org/emergencies/syria/

As a part of our commitment to giving back and to aiding refugees and providing quality health care for all, earlier this year Masimo announced a $5 million medical equipment donation to assist Jordan in providing healthcare to over 1 million Syrian refugees. A progress report video highlighting the Masimo relief effort was featured at the Clinton Global Initiative Annual Meeting in September in New York City, and can be viewed at the following link: https://youtu.be/8oQJqHoWTTg.

Thank you for being a part of our Masimo family. We are grateful to you all and wish you all a beautiful holiday season. Here's to a happier and healthier New Year!

@MasimoInnovates | #Masimo

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through-Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Media Contact:

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo to Present at 27th Annual Piper Jaffray Healthcare Conference

Irvine, California, November 24, 2015 Masimo (NASDAQ: MASI) today announced that its management is scheduled to present at the 27th Annual Piper Jaffray Healthcare Conference at the New York Palace on Wednesday, December 2, 2015 at 2:00 p.m. Eastern Time. A live audiocast of the presentation will be available on the Masimo website at www.masimo.com. A replay of the audiocast will be available following the live presentation.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion™ pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®) in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Investor Contact:

Eli Kammerman
Masimo
Phone: (858) 859-7001
Email: ekammerman@masimo.com

Media Contact:

Irene Paigah
Masimo
Phone: (858) 858-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

India's Leading Maternity and Birthing Care Hospital Group, Cloudnine, Adopts Masimo SET® Technology to Screen Infants for CCHD

Bangalore, India & Irvine, California – November 16, 2015 – Masimo (NASDAQ: MASI) announced today that Cloudnine Hospital Group – a leader in providing premier quality healthcare to women and children in India – has upgraded system-wide to Masimo SET® pulse oximetry.

Congenital heart disease (CHD) is the most common birth defect and it is estimated that nearly one out of every 100 babies is born with CHD. It has been reported that around 78,000 infants die because of congenital heart disease in India every year.1 Critical congenital heart disease (CCHD), defined as CHD causing death or requiring invasive intervention in the neonatal period, occurs in one to two newborns per 1,000 live births.2

"We evaluated several monitors before selecting Masimo's superior SET® technology for all 16 Cloudnine Hospitals," said Dr. Kishore Kumar, Chairman and Senior Neonatologist, Cloudnine Hospitals. "Masimo SET® will enhance our existing protocols to provide superior screening and ensure that every baby born here now has the opportunity to live a healthy life. Our hope is that universal CCHD screening become mandatory for every child born in India."

"Early detection is key in this fragile patient population," said Joe Kiani, Founder and CEO of Masimo. "It's exciting to see the adoption of CCHD screening in India. Cloudnine's hospitals have the best in class morbidity and mortality outcomes in the country – 0% maternal mortality and a 99.83% survival rate for babies. When we developed SET®, we didn't realize how many wonderful new applications our Measure-Through Motion and Low Perfusion™ technology would make possible – so it's especially gratifying that we can help clinicians around the world save the lives of so many babies."

In a study of newborns, researchers have found CCHD was detected 63% of the time by standard screening and 83% of the time when screening with Masimo SET® was added.3 Over 100 million patients are monitored with Masimo SET® pulse oximeters around the world and in more than 100 comparative studies Masimo SET® outperformed other technologies.4,5 Researchers have found that Masimo SET® in combination with changes in clinical practice led to an increase of 31% in the detection of newborns with CCHD when used as a part of the CCHD screening protocol.3

Cloudnine hospitals are also the first in the country to make a formal patient safety commitment to the World Patient Safety Movement Foundation. This non-profit organization is dedicated to eradicating preventable patient deaths in hospitals around the world. With this step, Cloudnine joins an elite group of over 1,200 hospitals worldwide that have made public commitments to implementing Actionable Patient Safety Solutions in their respective organizations.

For more information on Masimo products, go to www.masimo.com.

For more information on the World Patient Safety Movement Foundation, go to www.patientsafetymovement.org.

@MasimoInnovates | #Masimo

  1. Report available at http://indianexpress.com/article/lifestyle/health/78000-infants-die-of-congenital-heart-disease-in-india-every-year-say-doctors/.
  2. Zhao QM, Ma XJ, Ge XL, Liu F, Yan WL, Wu L, Ye M, Liang XC, Zhang J, Gao Y, Jia B, Huang GY; Neonatal Congenital Heart Disease screening group. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54.
  3. de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganäs L, Eriksson M, Segerdahl N, Agren A, Ekman-Joelsson BM, Sunnegardh J, Verdicchio M, Ostman-Smith I. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009 Jan 8;338:a3037.
  4. Data on file.
  5. All studies available at http://www.masimo.com/cpub/clinical-evidence.htm.

About Cloudnine
Set up in 2007 by the renowned neonatologist Dr. R. Kishore Kumar, in partnership with investing partners Matrix Partners and Sequoia Capital, Cloudnine is India's premier destination for comprehensive maternal, gynecological, neonatal, and pediatric care. The organization's vision is to effectively bridge the gap between Indian and international standards through a combination of clinical excellence, comprehensive care and an atmosphere of well-being, to ensure world-class standards in woman and child healthcare.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through-Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

 

Media Contact:

Irene Paigah
Masimo
Phone: (858) 616-8689
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

In New Study EMMA Capnograph Has Comparable Accuracy to Sidestream Capnography Against Gold-Standard Blood Gas Analysis

IRVINE, California – November 12, 2015 – Masimo (NASDAQ: MASI) announced today that in a new study that compared the end tidal carbon dioxide values (EtCO2) from both the Masimo EMMA capnograph and a conventional sidestream capnography device to the gold-standard carbon dioxide measurement, arterial blood gas (PaCO2), EMMA produced "reliable" values and had similar accuracy as sidestream capnography.1

EMMA capnograph from Masimo.

Carbon dioxide levels in the blood reflect the degree of gas exchange occurring in the lungs and provide a critical indicator of cardio-respiratory function that aids in the assessment of the adequacy of ventilation. PaCO2 is considered the gold standard to measure carbon dioxide levels but requires invasive blood sampling and laboratory analysis that can provide intermittent and delayed measurements. EtCO2 monitoring with capnography provides a noninvasive and continuous estimate of PaCO2 and has become a standard of care in the operating room and other critical care areas.2 Since 2010, the American Heart Association (AHA) has recommended the use of EtCO2 during cardiopulmonary resuscitation (CPR) for "confirmation and monitoring of endotracheal tube placement."3 Conventional capnography monitors require warm-up time to calibrate and measure EtCO2 from a sampling line connected to the breathing circuit. In contrast to bulkier and slower-to-calibrate sidestream capnography monitors, the EMMA is a compact and lightweight mainstream capnograph that clips directly onto the breathing circuit with no sampling line and minimal warm-up time.

The study, published in the Journal of Clinical Monitoring and Computing by Dr. Kyung Woo Kim and colleagues from Seoul Park Hospital, College of Medicine, Seoul, Korea, compared 100 EtCO2 values from both the EMMA and sidestream capnography (Datex Ohmeda S5 Anesthesia Monitor) in 35 patients undergoing general anesthesia to PaCO2 values measured from blood gas analysis (GEM Premier 3000) of simultaneously collected arterial blood samples. Compared to PaCO2, EMMA had a bias of 6.0 mm Hg with a percent error of 18% and sidestream capnography had a bias of 3.8 mm Hg with a percent error of 20%.

The authors concluded "EMMA capnometers are viable and lighter weight alternatives to legacy capnometers, as they produce capnographs and reliable EtCO2 values rapidly despite their small size and light weight." The authors also noted that "the data used in this study were only collected in situations of stable and normal respiration under general anesthesia," and "that the limitations affecting the prediction of the PaCO2 values are in accordance with the condition of the patient."

For more information on the EMMA capnograph, go to www.masimo.com.

@MasimoInnovates | #Masimo

  1. Kim (et al.), Comparison of end-tidal CO2 measured by transportable capnometer (EMMA capnograph) and arterial pCO2 in general anesthesia. J Clin Monit Comput 2015; published online.
  2. ASA Standards for Basic Anesthetic Monitoring. 2011.
  3. Field (et al.), Part 1: executive summary: 2010 American Heart Associated ion guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation 2010; 122: S640-56.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through-Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). The indications for EMMA include the following: 1) The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. 2) The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact:

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Reports Third Quarter 2015 Financial Results and Announces New Five Million Share Repurchase Plan

Q3 2015 Highlights (compared to Q3 2014):

  • Total revenue, including royalties, rose 5.9% to $152.6 million
  • Product revenue rose 5.4% to $144.6 million
  • Masimo rainbow® revenue rose 29.7% to $17.1 million
  • SET® and rainbow® SET® units shipments were 45,800
  • GAAP net income of $19.3 million, or $0.36 per diluted share versus $14.9 million or $0.27 per diluted share in the year-ago period
  • Non-GAAP net income of $21.3 million, or $0.40 per diluted share versus $15.2 million or $0.28 per diluted share in the year-ago period

Irvine, California, November 5, 2015 – Masimo (NASDAQ: MASI) today announced its financial results for the third quarter ended October 3, 2015.

Third quarter 2015 product revenues rose 5.4% to $144.6 million, compared to $137.1 million for the third quarter of fiscal year 2014, and total revenue, including royalties, rose 5.9% to $152.6 million, up from $144.1 million for the third quarter of fiscal year 2014. The unfavorable effect of foreign currency movements reduced third quarter product revenues by approximately $4.8 million.

The company's worldwide direct product revenue in the third quarter of 2015 rose by 3.5% compared to the same period in 2014 and represented 84.7% of product revenue. OEM sales, which accounted for 16.9% of product revenue, rose by 16.0% to $24.4 million in the third quarter of 2015 compared to the same period in 2014. Revenue from sales of Masimo rainbow® products rose by 29.7% to $17.1 million in the third quarter of 2015, compared to the same period in 2014.

GAAP net income for the third quarter of 2015 was $19.3 million, or $0.36 per diluted share, compared to GAAP net income of $14.9 million, or $0.27 per diluted share, in the third quarter of 2014. Non-GAAP net income for the third quarter was $21.3 million, or $0.40 per diluted share, versus non-GAAP net income of $15.2 million or $0.28 per diluted share in the year-ago period. During the third quarter of 2015, the company shipped 45,800 SET® pulse oximetry and rainbow® Pulse CO-Oximetry units, excluding handheld units. Masimo estimates its worldwide installed base as of October 3, 2015 to be 1,390,000 units, up 7.8% from 1,289,000 units as of September 27, 2014.

Joe Kiani, Chairman and Chief Executive Officer of Masimo, said, "Our third quarter results reflect the continued demand for our SET® Pulse Oximetry technology and our emerging rainbow® SET® Pulse CO-Oximetry technology. We are happy to be able to report record quarterly driver shipments and rainbow revenues, and another quarter of strong year-over-year earnings growth. Our underlying technology strength, along with our continued focus on value engineering and expense management, continue to make us confident about the financial leverage in our business model."

During the nine month period ended October 3, 2015, the company generated $53.5 million in cash from operations and as of October 3, 2015, total cash and cash investments were $103.6 million compared to $134.5 million as of January 3, 2015. Also, during the nine month period ended October 3, 2015, the company repurchased approximately 3.5 million shares of stock for $130.2 million, including approximately 1.2 million shares in the quarter ended October 3, 2015 for $48.5 million. These repurchases complete the original 9.0 million share stock repurchase plan authorized by the Board in 2013. Today, Masimo is also announcing the Board's authorization of a new 5.0 million share stock repurchase plan.

2015 Financial Guidance
Masimo today is updating its 2015 financial guidance. Masimo now expects fiscal 2015 total revenues to be approximately $627 million, up from $621 million. Total fiscal 2015 product revenues are now expected to be approximately $597 million, up from $592 million, while royalty revenues are now expected to be $30 million, up from $29 million. Masimo now also expects its fiscal 2015 GAAP earnings per diluted share to be $1.49, up from $1.43 and expects non-GAAP earnings per diluted share to be approximately $1.67, up from $1.61. Masimo will provide additional financial information during the conference call today. Each of the components of Masimo's guidance set forth above is an estimate only and actual performance could differ.

Conference Call
Masimo will hold a conference call today at 1:30 p.m. PT (4:30 p.m. ET) to discuss the results. A live webcast of the call will be available online from the investor relations page of the company's website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 64862474. After the live webcast, the call will be available on Masimo's website through December 4, 2015. In addition, a telephonic replay of the call will be available through November 19, 2015. The replay dial-in numbers are (800) 585-8367 for domestic callers and +1 (855) 859-2056 for international callers. Please use reservation code 64862474.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through-Motion and Low-Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.


Forward-Looking Statements
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements including, in particular, the statements about our expectations for full fiscal year 2015 total and product revenues and GAAP and non-GAAP earnings per diluted share; demand for our products; anticipated revenue and earnings growth; our financial condition, results of operations and business generally; expectations regarding our ability to design and deliver innovative new noninvasive technologies and reduce the cost of care; and demand for our technologies. These forward-looking statements are based on management's current expectations and beliefs and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control and could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to, those related to: our dependence on Masimo SET® and Masimo rainbow® SET® products and technologies for substantially all of our revenue; any failure in protecting our intellectual property exposure to competitors' assertions of intellectual property claims; the highly competitive nature of the markets in which we sell our products and technologies; any failure to continue developing innovative products and technologies; the lack of acceptance of any of our current or future products and technologies; obtaining regulatory approval of our current and future products and technologies; the risk that the implementation of our international realignment will not continue to produce anticipated operational and financial benefits, including a continued lower effective tax rate; the loss of our customers; the failure to retain and recruit senior management; product liability claims exposure; a failure to obtain expected returns from the amount of intangible assets we have recorded; the maintenance of our brand; the amount and type of equity awards that we may grant to employees and service providers in the future; our ongoing litigation and related matters; and other factors discussed in the "Risk Factors" section of our most recent periodic reports filed with the Securities and Exchange Commission ("SEC"), including our most recent Form 10-K and Form 10-Q, all of which you may obtain for free on the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Investor Contact:

Eli Kammerman
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Media Contact:

Irene Paigah
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation

Non-GAAP Financial Measures
The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP). The non-GAAP financial measures presented exclude the items summarized in the above table that are more fully described below. Management believes that adjustments for these items assist investors in making comparisons of period-to-period operating results and that these items are not indicative of the company's on-going core operating performance. These non-GAAP financial measures have certain limitations in that they do not reflect all of the costs associated with the operations of the company's business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. The non-GAAP financial measures presented by the company may be different from the non-GAAP financial measures used by other companies.

The company has presented the following non-GAAP measures on a basis consistent with its historical presentation, to assist investors in understanding the company's core net operating results on an on-going basis: (i) non-GAAP net income attributable to Masimo Corporation stockholders, (ii) non-GAAP product revenue, (iii) non-GAAP gross profit, (iv) non-GAAP operating expenses, (v) non-GAAP non-operating income (expense), (vi) non-GAAP noncontrolling interest, and (vii) non-GAAP net income per diluted share attributable to Masimo Corporation stockholders. These non-GAAP financial measures may also assist investors in making comparisons of the company's core operating results with those of other companies. Management believes non-GAAP product revenue, non-GAAP gross profit, non-GAAP net income attributable to Masimo Corporation stockholders and non-GAAP net income per diluted share attributable to Masimo Corporation stockholders are important measures in the evaluation of the Company's performance and uses these measures to better understand and evaluate our business.

The non-GAAP financial measures reflect adjustments for the following items, as well as the related income tax effects thereof:

Constant currency F/X adjustments. Some of our sales agreements with foreign customers provide for payment in currencies other than the U.S. Dollar. Similarly, certain of our product costs and operating expenses, and the related balance sheet payables and accruals, are denominated in foreign currencies other than the U.S. Dollar. These foreign currency revenues, costs and expenses, receivables, payables and accruals, when converted into U.S. Dollars, can vary significantly from period to period depending on the average and quarter-end exchange rates during a respective period. We believe that comparing these foreign currency denominated revenues, costs and expenses, receivables, payables and accruals by holding the exchange rates constant with the prior year period is useful to management and investors in evaluating the performance of our ongoing operations on a period-to-period basis. We anticipate that fluctuations in foreign exchange rates and these related constant currency and other foreign exchange adjustments will continue to occur in future periods.

Amortization of acquisition-related intangibles. Amortization of intangibles generally represents costs incurred by an acquired company or other third party to build value prior to our acquisition of the intangible assets. As such, it is effectively part of the transaction costs of the acquisition rather than ongoing costs of operating our core business. As a result, we believe that exclusion of these costs in presenting non-GAAP financial measures provides management and investors a more effective means of evaluating its historical performance and projected costs and the potential for realizing cost efficiencies within our core business. Amortization of intangibles will recur in future periods.

Litigation awards, damages and defense costs. In connection with litigation proceedings arising in the course of our business, we have previously recorded expenses as a defendant in such proceedings in the form of damages and directly-related legal fees, as well as reversals of such damages and directly-related legal fee expenses upon a court vacating a prior award against us. In addition, we have also previously recorded recoveries of damages and directly-related legal fees as a plaintiff in litigation proceedings. We believe that exclusion of these expenses, expense reversals and recoveries is useful to management and investors in evaluating the performance of our ongoing operations on a period-to-period basis. In this regard, we note that these expenses, expense reversals and recoveries are generally unrelated to our core business and/or infrequent in nature.

Lease termination exit costs. The effects of lease termination exits costs are excluded resulting from the purchase of the New Hampshire manufacturing facility that Masimo previous leased.

Reconciliations between the GAAP and non-GAAP amounts for each financial statement line item are as follows:

 

Two New Clinical Studies Using Masimo Technologies Presented at the American Society of Anesthesiologists Annual Meeting

Irvine, California – October 29, 2015 – Masimo (NASDAQ: MASI) announced today that two new studies using Masimo technologies were presented at the American Society of Anesthesiologists (ASA) annual meeting in San Diego, California, October 24-28. The conference is the largest gathering of anesthesiologists in the world.

Study Evaluating the EMMA Portable Capnometer in Children Under General Anesthesia

Carbon dioxide levels in the blood reflect the degree of gas exchange occurring in the lungs and provide a critical indictor of cardio-respiratory function that aids in the assessment of the adequacy of ventilation. In a study of 13 children (average age 18 months) undergoing surgery, Dr. Yuko Nawa and colleagues from the Hokkaido Medical Center for Child Health and Rehabilitation in Sapporo, Japan, compared the end tidal carbon dioxide values (EtCO2) from the Masimo EMMA portable capnometer and traditional sidestream capnography (GE Patient Monitor).1 Compared to sidestream capnography, the EMMA had 95% limits of agreement of -1.3 to 2.5 mm Hg, leading the investigators to conclude that the EMMA has "good correlation with sidestream type capnometer in children" and "may be useful for general anesthesia in out-of-operating room or in case of cardiopulmonary resuscitation, bedside respiratory care and patient transportation."

Study Evaluating Pleth Variability Index in Spontaneously Breathing Adults During Regional Anesthesia

Dexmedetomidine is an intravenous drug used to sedate patients during surgery which can also cause hypertension or hypotension that may increase patient risk. In a study of 42 spontaneously breathing patients under regional anesthesia,2 Dr. Makoto Sato and colleagues from Asahikawa Medical University in Hoikkado, Japan evaluated the association of baseline pleth variability index (PVI) from Masimo SET® pulse oximetry and dexmedetomidine-induced changes in blood pressure. A baseline PVI≤15 had a 94% sensitivity, 85% specificity, and area under the curve (AUC) of 0.93 (p=0.00002) for resulting hypertension. A baseline PVI≥16 had an 83% sensitivity, 64% specificity, and area under the curve (AUC) of 0.79 (p=0.0008) for resulting hypotension. The investigators concluded, "PVI can predict dexmedetomidine-induced changes in blood pressure in spontaneously breathing patients."

For more information on the Masimo technology, go to www.masimo.com.

@MasimoInnovates | #Masimo

  1. Nawa Y, Chaki T, Tamashiro K, Sato M, Mizuno E, Yamakage M. Accuracy of Portable Capnometer in Children. Proceedings of the American Society of Anesthesiologists, Oct. 27, 2015, San Diego, A4049, Room Upper 10.
  2. Sato M, Kunisawa T, Kurosawa A, Sasakawa T, Iwasaki H. Pulse oximeter-derived pleth variability index can predict dexmedetomidine-induced changes in blood pressure in spontaneously breathing patients. Proceedings of the American Society of Anesthesiologists, Oct. 26, 2015, San Diego, A3153, Hall B2, Area B.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). For the U.S. market, PVI is a measure of dynamic changes in the perfusion index (PI) that occur during the respiratory cycle. The PVI calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a percent (0-100%). PVI may show changes that reflect physiologic factors such as vascular tone, circulating blood volume and intrathoracic pressure excursions. The utility of PVI is unknown at this time and requires further clinical studies. Technical factors that may affect PVI include probe malposition and patient motion. The indications for EMMA include the following: 1) The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. 2) The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact:

Irene Paigah
Masimo
Phone: (858) 616-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces FDA 510(k) Clearance for MightySat Rx Fingertip Pulse Oximeter

Demonstrations held at the ASA Anesthesiology 2015 Conference in Masimo Booth 3437 - San Diego Convention Center on October 24-28, 2015

Irvine, California – October 27, 2015 – Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for MightySat Rx, a fingertip pulse oximeter that incorporates Masimo SET® Measure-through Motion and Low Perfusion technology.

MightySat Rx features the same Masimo SET® technology that is used in leading hospitals worldwide and is present in all Masimo bedside devices and in many leading multi-parameter monitors. The MightySat noninvasively measures arterial oxygen saturation (SpO2) and pulse rate (PR), in addition to perfusion index (PI) and optional pleth variability index (PVI®). Masimo SET® technology enables accurate SpO2 and pulse rate measurements during motion and low perfusion.

"We use Masimo SET® throughout our hospital, and now MightySat Rx allows me to use Masimo SET® technology in a fingertip pulse oximeter - without compromising on performance," said Jon Carlson, RT, RRT-NPS, Director of Respiratory Care Services at Mercy Hospital of Buffalo, New York. "Its portability, durability, and convenient, small size are key. By pairing the device with my iPhone, I can easily view my patients' SpO2 and pulse rate trends."

MightySat Rx is designed to comfortably grip a patient's finger using a flexible, conforming silicon pad. An OLED display presents information clearly and a touchpad allows for customization. MightySat Rx is designed to be both rugged and lightweight.

"We are excited to provide clinicians the same accuracy provided by our other monitors in a fingertip pulse oximeter, said Joe Kiani, Founder and CEO of Masimo. "The MightySat Rx is an impressive device in a very compact form factor that provides clinicians easy access to patient data."

MightySat Rx is available in three versions: MightySat Rx, MightySat Rx with Bluetooth LE, and MightySat Rx with Bluetooth LE & PVI. The versions with Bluetooth allow iOS and Android mobile devices to display, trend, and communicate the measurements made on MightySat, using the free, downloadable Masimo Professional Health app.

For more information on MightySat Rx, go to www.masimo.com/pulseOximeter/mightysatRx.htm.

@MasimoInnovates || #Masimo || #MightySat

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact:

Irene Paigah
Masimo
Phone: (858) 616-8689
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo & Atheer to Demonstrate Prototype of Interactive Root® Iris Display Powered by AiR Smart Glasses Platform

Demonstrations held at the ASA Anesthesiology 2015 Conference in Masimo Booth 3437 - San Diego Convention Center on October 24-28, 2015

IRVINE, California – October 22, 2015 – Masimo (NASDAQ: MASI) and Atheer announced today that they will unveil a prototype of the Root Iris display App using the Atheer AiR (Augmented interactive Reality) platform and AiR Glasses at the American Society of Anesthesiologists (ASA) annual conference. Demonstrations will be held at Masimo's Booth 3437 at the San Diego Convention Center on October 24-28, 2015. The demonstrations will allow conference attendees to experience a prototype display and touch-free interactions powered by the Atheer AiR Glasses that, if cleared by the FDA, would provide clinicians with a novel display and interaction experience. Attendees will be invited to provide feedback on features, usability and requirements.

"This is the future of information display and interaction," said Joe Kiani, Founder and CEO of Masimo. "What was once seen only in the movies is now on the way to becoming a reality. When combined with our Root Iris technology, AiR Glasses may in the future empower anesthesiologists to visualize data from multiple information sources and interact with the data using motion gestures while continuing to care for the patient."

"We are delighted to partner with Masimo – one of the most innovative medical technology companies in the world. Our AiR smart glasses platform is known for its rich display as well as unique touch-free interaction using gestures, voice and head motion. Now both our companies are leveraging our strengths to develop a novel platform for the medical community," said Alberto Torres, CEO of Atheer.

Special demonstrations and interviews will be scheduled by appointment for the media. To schedule a media demonstration and interview time, please call (858) 859-7001. To obtain a media pass for the Anesthesiology 2015 conference, please email pr@asahq.org or call (847) 268-9106.

@MasimoInnovates || #Masimo || @Atheerlabs || #AiRGlasses

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through-Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

About Atheer
Atheer is the pioneer of AiR (Augmented interactive Reality) computing that is designed to enhance deskless professional productivity. The award-winning Atheer AiR platform combines the power of immersive augmented reality with intelligent gesture, voice and head-motion interaction, all on a mobile, smart glasses platform. Wearing our see-through AiR Glasses, you can view rich information critical to your workflow, interact with the information naturally and collaborate with your remote peers like never before – all while on the move, without the need to hold any device. Leveraging the Atheer AiR platform, developers and companies around the world are creating next generation enterprise productivity applications and workflows to empower the 21st century workforce. For more information, please visit www.atheerlabs.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact:

Irene Paigah
Masimo
Phone: (858) 858-7001
Email: irenep@masimo.com

Media Contact:

Kristen Maynard
Atheer
Phone: (415) 350-4147
Email: kristen.maynard@sparkpr.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo to Report Third Quarter 2015 Financial Results after Market Close on Thursday, November 5

Conference call and webcast to begin at 1:30 p.m. PT (4:30 p.m. ET)

IRVINE, Calif., October 21, 2015 -- Masimo (NASDAQ: MASI) announced today that it will release financial results for the third quarter ended October 3, 2015, after the market closes on Thursday, November 5, 2015. The conference call to review the results will begin at 1:30 p.m. PT (4:30 p.m. ET) and will be hosted by Joe Kiani, Chairman and Chief Executive Officer, and Mark P. de Raad, Executive Vice President and Chief Financial Officer.

A live webcast of the conference call will be available online from the investor relations page of the company's corporate website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 64862474. After the live webcast, the call will be available on Masimo's website through December 4, 2015. In addition, a telephonic replay of the call will be available through November 19, 2015. The replay dial-in numbers are (800) 585-8367 for domestic callers and +1 (855) 859-2056 for international callers. Please use reservation code 64862474.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion™ pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®, in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Investor Contact:

Eli Kammerman
Masimo
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Media Contact:

Irene Paigah
Masimo
Phone: (858) 858-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Dr. Steven Barker Awarded the 2015 IAMPOV Lifetime Achievement Award

IRVINE, California – October 14, 2015 - Masimo (NASDAQ: MASI) announced today that a member of its Board of Directors, Chairman of its Scientific Advisory Board, and its Chief Science Officer, Dr. Steven Barker, Ph.D., M.D., was honored with the Harvey W. Weiley Lifetime Achievement Award at this month's Innovations and Applications of Monitoring Perfusion, Oxygenation, and Ventilation (IAMPOV) Symposium, in Tokyo, Japan.

"We are pleased to recognize Dr. Steven Barker as the winner of the 2015 IAMPOV Lifetime Achievement Award," said Dr. Katsuyuki Miyasaka, IAMPOV Symposium Chair. "Dr. Barker was selected based on his lifelong work in championing the development of vitally important monitoring technologies and associated testing."

The IAMPOV Symposium brings together clinicians, device developers, and researchers for an interchange of expertise and ideas to promote the development of better healthcare monitoring technologies and to improve their application in the areas of perfusion, oxygenation, and ventilation.

"We congratulate Dr. Steven Barker for this Lifetime Achievement award," said Joe Kiani, Founder and CEO of Masimo. "Steve has been on the cutting edge of research in the areas of oxygen transport, oxygen saturation monitoring, dyshemoglobins, brain function monitoring, and many other patient monitoring modalitites. His steadfast commitment to science and advancements in the area of patient care is second to none. Steve's work has helped shed light on the problems and advancements in the area of oxygen transport."

Steven J. Barker, PhD, MD, received his PhD in Aeronautical Engineering from the California Institute of Technology in 1972, and his MD from the University of Miami in 1981. He has reached the rank of tenured professor in both engineering (University of California at Los Angeles) and anesthesiology (University of California at Irvine, University of Arizona). He chaired the Department of Anesthesiology at UC Irvine from 1990 to 1995, and then at the University of Arizona from 1995 to 2013. He has published over 150 scholarly works, including 15 textbook chapters. Dr. Barker has served as president of the national organization of anesthesiology department chairs (AAPD) and of the Society for Technology in Anesthesia (STA), senior oral examiner for the American Board of Anesthesiology, and Section Editor for Technology for the journal Anesthesia and Analgesia. During his 18-year tenure as anesthesiology chair at the University of Arizona, Dr. Barker was active in a number of governance roles outside of his department. He also served seven years as the American Society of Anesthesiologists (ASA) Director for Academic Anesthesiology, representing all university anesthesiology departments for ASA. Since 2005, Dr. Barker has been a member of Masimo's Board of Directors and Chairman of Masimo's Scientific Advisory Board. In 2015, Dr. Barker also took on the role of Chief Science Officer of Masimo.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through-Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Media Contact:

Irene Paigah
Masimo
Phone: (858) 858-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo PVI® Evaluated in 18-Study Meta-Analysis For Ability to Help Clinicians Assess Fluid Responsiveness

NEUCHATEL, Switzerland – October 8, 2015 – Masimo (NASDAQ: MASI) announced today that an 18-study meta-analysis of 665 subjects reported that Masimo's Pleth Variability Index (PVI®), available with Masimo's SET® and rainbow® SET® monitoring platforms, may help clinicians assess fluid responsiveness in mechanically ventilated patients in normal sinus rhythm in the operating room and intensive care unit.1

Clinicians commonly use intravenous fluid administration in the operating room and intensive care unit to attempt to improve blood flow, or cardiac output.2 Administering either too little fluid or too much fluid can increase patient risk.2 However, traditional "static" monitoring parameters such as central venous pressure (CVP) are considered unreliable to assess fluid responsiveness.2 Therefore, experts recommend the use of "dynamic" parameters that measure physiologic variation over the respiratory cycle.3 Multiple dynamic parameters have been shown to help clinicians assess fluid responsiveness, but most dynamic parameters require invasive, complex, and/or costly methods. PVI is a measure of the dynamic changes in the Perfusion Index (PI) that occur during one or more complete respiratory cycles, and may show changes that reflect physiologic factors such as vascular tone, circulating blood volume, and intrathoracic pressure excursions. In contrast to other dynamic parameters, PVI is noninvasive, easily obtained with any Masimo SET® or rainbow® sensor, and has no incremental procedural cost.

The meta-analysis, published in the Journal of Clinical Monitoring and Computing by Dr. Chu and colleagues from The First Hospital of China Medical University, Shenyang, China, combined the findings from 18 independent studies evaluating the ability of PVI to help clinicians assess fluid responsiveness. The authors reported that the pooled area under the curve (AUC) for PVI to correctly determine fluid responsiveness was 0.88 (95% confidence interval 0.84 to 0.91). The pooled sensitivity of PVI, or its ability to determine whether cardiac output would increase upon fluid administration, was 0.73 (95% confidence interval 0.68 to 0.78). The pooled specificity of PVI, or its ability to determine whether cardiac output would not increase upon fluid administration, was 0.82 (95% confidence interval 0.77 to 0.86). The authors noted that the sensitivity of PVI was greater in the operating room than in the intensive care unit (0.84 vs. 0.56, p=0.00004). The authors also noted that "the applicability of PVI may be limited by potential interference from several factors such as spontaneous breathing activity, arrhythmia, and low peripheral perfusion." Technical factors that may affect PVI include probe malposition and patient motion.

For more information on PVI, go to www.masimo.com.

@MasimoInnovates || #Masimo

  1. Chu (et al.). Accuracy of pleth variability index to predict fluid responsiveness in mechanically ventilated patients: a systematic review and meta-analysis: J Clin Monit Comput. 2015, 8:5.
  2. Navarro (et al.). Perioperative fluid therapy: a statement from the international Fluid Optimization Group. Perioperative Medicine. 2015, 4:3.
  3. Vallet B (et al). Strategy for perioperative vascular filling - Guidelines for perioperative haemodynamic optimization. Experts' Formalized Recommendations, French Society of Anaesthesia and Intensive Care (SFAR), Validation by the administrative council of SFAR on 19 October 2012.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through-Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com. For the U.S. market, PVI is a measure of dynamic changes in the perfusion index (PI) that occur during the respiratory cycle. The PVI calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a percent (0-100%). PVI may show changes that reflect physiologic factors such as vascular tone, circulating blood volume and intrathoracic pressure excursions. The utility of PVI is unknown at this time and requires further clinical studies. Technical factors that may affect PVI include probe malposition and patient motion.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact:

Irene Paigah
Masimo
Phone: (858) 858-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Donates $5 Million in Medical Equipment to Assist Jordan in Providing Healthcare to Over 1 Million Syrian Refugees

Relief Effort Progress Highlighted at the Clinton Global Initiative Annual Meeting in New York,
September 26-29, 2015

IRVINE, California – September 27, 2015 – Masimo (NASDAQ: MASI) announced progress today at the 2015 Clinton Global Initiative Annual Meeting towards its commitment to donate $5 million in Signal Extraction Technology® Pulse Oximeters and Pulse CO-Oximeters® and other medical equipment to Jordanian hospitals to help improve patient care for Syrian and Iraqi refugees, as well as Jordanian citizens. A progress report video highlighting the Masimo relief effort was featured at the Plenary Session called Investing in Prevention and Resilient Health Systems. The first shipment of equipment is already in use at Al-Bashir hospital in Amman. The rest of the equipment will arrive at the Ministry of Health Office in Jordan shortly. Masimo also committed to provide ongoing training and technical support to the clinicians in Jordan.

The wars in Syria and Iraq are one of the largest ongoing humanitarian crises in the world, with over an estimated million people seeking refuge now living within Jordan's borders, more than 600,000 of whom are registered with the United Nations High Commissioner for Refugees (UNHCR). Managing healthcare is a critical requirement of stability during crises and, while new hospitals are being built near refugee camps, the vast majority of refugees reside in existing communities, heightening the demand for health services throughout Jordan. The significant burden of providing healthcare services both for routine and emergency needs is worsening daily.

"The people of Jordan have opened their hearts and country to help their neighbors in need," said Joe Kiani, Founder and CEO of Masimo. "The situation in Syria keeps getting worse. The people of Jordan are our heroes – taking in the Palestinian refugees, the Iraqi refugees, then the Egyptian refugees, and now the large influx of Syrian refugees. We knew our plan for aid needed to be long-term. We not only donated the much needed oximeters, other medical equipment, and supplies but we also committed to train and provide continued technical support for the Jordanian clinicians that assist in the front line care of the people of Jordan. The need is great and it is too overwhelming for just a few countries to shoulder. As global citizens, we all need to get involved and help the people of Syria and those trying to save them."

Masimo's commitment to Jordan is one of several ongoing CGI commitments, and was made at a roundtable meeting convened by CGI in 2014, at which President Clinton and his Majesty King Abdullah Il ibn Al Hussein of Jordan met with Masimo's Joe Kiani, among others, to discuss the humanitarian crisis.

The measurements provided by pulse oximeters are often referred to as the "fifth vital sign." In a report published by the Jordanian government, they are identified as one of the most needed pieces of hospital equipment. Pulse oximeters allow a health worker to monitor a person's oxygen levels. Confirming oxygen levels in the blood is critical as it helps identify those in need of care, those who are deteriorating, and those who are not. Pulse oximeters are widely used from health clinics to emergency departments, from surgery and the intensive care unit to the general floor. Over 100 million patients are monitored with Masimo SET® pulse oximeters around the world and in more than 100 comparative studies Masimo SET® outperformed other technologies. Researchers have found that Masimo SET® in combination with changes in clinical practice led to a reduction in retinopathy of prematurity (ROP) in preterm babies in the neonatal intensive care unit (NICU)1 and an increase of 31% in the detection of newborns with critical congenital heart disease (CCHD) when used as a part of the CCHD screening protocol.2 Researchers found improved outcomes3 following the installation of continuous patient monitoring with Masimo SET® on post-surgical patients, including that zero patients suffered brain damage or died over a five-year period.4 A recent study with a Masimo Pulse CO-Oximeter® (SpHb and PVI) also showed that 30-day mortality after surgeries dropped by 25%.5

  1. Castillo A, Deulofeut R, Critz A, Sola A. Prevention of retinopathy of prematurity in preterm infants through changes in clinical practice and SpO2 technology. Acta Paediatr. 2011 Feb;100(2):188-92.
  2. de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganäs L, Eriksson M, Segerdahl N, Agren A, Ekman-Joelsson BM, Sunnegardh J, Verdicchio M, Ostman-Smith I. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009 Jan 8;338:a3037.
  3. Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010 Feb;112(2):282-7.
  4. Taenzer et al. The Dartmouth Experience. APSF Newsletter. Spring-Summer 2012. Volume 27, No. 1, 1-28.
  5. Ponsonnard S, Yonnet S, Marin B, Cros J, Ben Miled S, Nathan N. "Continuous Hb and plethysmography variability index (PVI) monitoring is associated to a decreased mortality at the scale of a whole hospital." Proceedings of the European Society of Anaesthesiology's Euroanaesthesia 2015 Annual Congress, May 30-June 2, Berlin, Germany, 16AP3-2, Room A1 – Poster Abstract Presentation Session, e-Board 8.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through-Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

About the Clinton Global Initiative
Established in 2005 by President Bill Clinton, the Clinton Global Initiative (CGI), an initiative of the Clinton Foundation, convenes global leaders to create and implement solutions to the world's most pressing challenges. CGI Annual Meetings have brought together 190 sitting and former heads of state, more than 20 Nobel Prize laureates, and hundreds of leading CEOs, heads of foundations and NGOs, major philanthropists, and members of the media. To date, members of the CGI community have made more than 3,200 Commitments to Action, which have improved the lives of over 430 million people in more than 180 countries. In addition to the Annual Meeting, CGI convenes CGI America, a meeting focused on collaborative solutions to economic recovery in the United States; and CGI University (CGI U), which brings together undergraduate and graduate students to address pressing challenges in their community or around the world. This year, CGI also convened CGI Middle East & Africa, which brought together leaders across sectors to take action on pressing social, economic, and environmental challenges.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contributes to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable

Media Contact:

Irene Paigah
Masimo
Phone: (858) 858-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

RankenJordan

 

Ranken Jordan Pediatric Bridge Hospital Upgrades their Monitors to the Radical-7® Featuring Masimo SET® Pulse Oximetry

MARYLAND HEIGHTS, Missouri, and IRVINE, California – September 14, 2015 - Masimo (NASDAQ: MASI) today announced that Ranken Jordan Pediatric Bridge Hospital has upgraded their monitors to the Radical-7 featuring Masimo SET® pulse oximetry.

"For children with complex medical conditions such as brain injuries, congenital defects or complications due to premature birth, our hospital specializes in bridging the gap between traditional hospital treatments and going home," said Laureen K. Tanner, RN, MSN, FACHE, President and Chief Executive Officer of Ranken Jordan Pediatric Bridge Hospital. "Breakthrough medical technology like this helps our team make the impossible possible on a daily basis."

The Radical-7 features Masimo SET® Measure-through-Motion and Low Perfusion™ pulse oximetry, shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms.1,2 The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and used on more than 100 million patients in leading hospitals.3,4 Researchers have found that Masimo SET®, in combination with changes in clinical practice, led to a reduction in severe retinopathy of prematurity (ROP) in pre-term infants.5 In a study of newborns, researchers have found critical congenital heart disease (CCHD) was detected 63% of the time by standard screening and 83% of the time when screening with Masimo SET® was added.6 The Radical-7 allows hospitals the ability to upgrade their monitor with other breakthrough measurements that are only available with Masimo rainbow® technology.

"The amazing team at Ranken Jordan Pediatric Bridge Hospital has been taking care of children with complex needs for over 70 years. They are the only pediatric sub-acute facility in Missouri and one of the largest in the Midwest," stated Joe Kiani, Founder and CEO of Masimo. "Performance in challenging situations is key and we are happy that their clinical team now has access to our flagship monitor. It is our privilege to help facilities like Ranken Jordan help kids and families safely transition from the acute care hospital to home."

@MasimoInnovates || #Masimo

1 Barker SJ. Anesth Analg. 2002 Oct;95(4):967-72
2 Shah N et al. J. Clin Anesth. 2012 Aug; 24(5):385-91
3 All studies available at http://www.masimo.com/cpub/clinical-evidence.htm
4 Data on file
5 Castillo A et al. Acta Paediatr. 2011 Feb;100(2):188-92
6 de-Wahl Granelli AD et al. BMJ. 2009;338

RankenJordan

About Ranken Jordan Pediatric Bridge Hospital
Ranken Jordan offers care through 62,000 square-foot, a 34-bed inpatient program and several outpatient programs, including outpatient therapy, intensive day treatment, a physiatry clinic and a comprehensive orthopedic rehabilitation clinic. The current hospital building houses ultramodern equipment and is specifically designed to entire patients to get out of their rooms and engage in daily life-centered activities. Ranken Jordan's Community Program provides free recreational and educational programs for all kids and their families. For more information, contact us or call (314) 872-6400. www.rankenjordan.org

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In the U.S., Masimo rainbow® SET pulse CO-OximeterTM instruments and sensors are indicated to provide noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate (PR), carboxyhemoglobin saturation (SpCO®), methemoglobin saturation (SpMet®), total hemoglobin concentration (g/dl SpHb), and/or respiration rate (RRa®). The devices are not intended to replace laboratory measurements of hemoglobin and have not been cleared by FDA to detect bleeding or reduce the amount or frequency of red blood cell (RBC) transfusions. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

 

 

Tyler Mathews
RankenJordan
Phone: (314) 872-6503
Email: tyler.mathews@rankenjordan.org

Media Contact:

Irene Paigah
Masimo
Phone: (858) 858-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo to Present at Morgan Stanley Global Healthcare Conference

Irvine, California, September 8, 2015 Masimo (NASDAQ: MASI) today announced that its management is scheduled to present at the Morgan Stanley Global Healthcare Conference at the Grand Hyatt New York on Friday, September 18, 2015, at 11:05 a.m. Eastern Time. A live audiocast of the presentation will be available on the Masimo website at www.masimo.com. A replay of the audiocast will be available following the live presentation.

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®) in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Investor Contact:

Eli Kammerman
Masimo
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Media Contact:

Irene Paigah
Masimo
Phone: (858) 858-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation

 

Masimo Partners with St. Joseph Hoag Health to Open a Wellness Center for Employees inside their Headquarters

New Wellness Center is the latest edition of St. Joseph Hoag Health's pioneering integrated medical care and lifestyle management for worksite wellness

(August 26, 2015, IRVINE, CALIF.) – Expanding on St. Joseph Hoag Health's successful efforts to bring health and wellness services directly into the workplaces, Masimo (NASDAQ: MASI) has teamed with the integrated health care system to bring a new wellness center to its worldwide headquarters at 52 Discovery in Irvine, California. The new Masimo Wellness Center will offer wellness services beginning August 25, 2015 and medical services will begin in September 2015. The center is staffed daily by a full-time wellness coach and registered nurse.

The center will serve 550 employees located in Irvine. The walk-in facility offers integrated wellness and medical services ranging from health coaching, education, and screenings to onsite lab draws and flu shots. The center uniquely features telehealth that allows for primary episodic care for common illnesses and conditions, all delivered virtually through St. Joseph Hoag Health's telemedicine network. St. Joseph Hoag Health manages the center and provides clinical and operations expertise.

"We are excited about this new addition to our wellness program," stated Joe Kiani, Founder and CEO of Masimo. "Our team consists of talented individuals who are passionate about saving lives. They go above and beyond each and every day. This new wellness center is designed to help our team stay healthy. When we looked at offering medical services onsite, we immediately thought of St. Joseph Hoag Health."

"Access and convenience are cited as top reasons why employees don't seek health care – it just doesn't fit readily into busy daily routines," said Richard Afable, MD, MPH, president & CEO of St Joseph Hoag Health. "St. Joseph Hoag Health is committed to partnering with companies to improve workforce health through the effective management of overall costs."

"Our collaboration with Masimo is another exciting step forward in our commitment to help people live healthier lives by being more available to them where they work and live," said Annette Walker, Executive Vice President of Strategic Services for St. Joseph Hoag Health. "The wellness center concept is about connecting with people within the ordinary patterns of their lives. Doing so provides powerful opportunities for us to make it easier for individuals – and businesses and our communities – to better maintain health and overall well-being."

St. Joseph Hoag Health operates four other wellness centers in Orange County, all of which have been launched within the past year. This includes the DRIVE Wellness Center for Western Digital, which opened in July 2015 at the company's international headquarters in Irvine. The other wellness centers (called Wellness Corners) are also in Irvine at the Jamboree Center business complex, The Village Irvine Spectrum apartments and the Park Place corporate office of St. Joseph Health (the parent organization of St. Joseph Hoag Health).

About St. Joseph Hoag Health
St. Joseph Hoag Health is a historic alliance for Orange County, laying the foundation for sweeping changes in the delivery and accessibility of high quality health care. Combined, St. Joseph Hoag Health has earned some of the highest honors for medical care, including Magnet designation for many of its hospitals (the highest honor bestowed to hospitals for nursing excellence). Drawing upon the strengths of renowned health care organizations, St. Joseph Hoag Health focuses on meeting the big challenges of health care today, including expanding access, improving wellness and preventive services, ensuring quality and developing more efficient methods in the delivery of care. The network includes flagship hospitals (Hoag Newport Beach, Hoag Irvine, Hoag Orthopedic Institute, Mission Hospital Mission Viejo, Mission Hospital Laguna Beach, St. Joseph Hospital Orange and St. Jude Medical Center), eight medical groups and physician networks and numerous outpatient and urgent care facilities in Orange County. The network is also affiliated with CHOC Children's and CHOC Children's at Mission Hospital.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com. @MasimoInnovates

Media Contact:

Susan Solomon
St. Joseph Hoag Health
Phone: 716-616-4567
Email: susan.solomon@stjoe.org

Media Contact:

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

 

 

Brazil's A.C.Camargo Cancer Center Adopts Masimo SpHb for Noninvasive and Continuous Hemoglobin Monitoring

NEUCHATEL, Switzerland – August 25, 2015 – Masimo (NASDAQ: MASI) announced today that A.C.Camargo Cancer Center in Sao Paulo, Brazil has installed Masimo's noninvasive and continuous hemoglobin (SpHb®) technology to monitor surgical patients.

Clinicians use invasive blood sampling and laboratory analysis of hemoglobin to determine hemoglobin levels and help estimate blood loss to determine need for red blood cell transfusions. However, lab-based hemoglobin is only available intermittently and results are often delayed. SpHb offers real-time visibility to changes – or lack of changes – in hemoglobin between invasive blood sampling.

"The data associating transfusion with higher mortality rates was clear, so we knew we had to implement strategies to reduce transfusions," said Dr. Eduardo Henrique Joaquim Giroud, anesthesiologist and Director of the Department of Anesthesiology at A.C.Camargo Cancer Center. "This technology enables us to noninvasively and continuously monitor hemoglobin, a strong indicator of blood loss. It provides continuous trend data which, in combination with invasive blood sampling data, helps us determine who actually needs to be transfused and the right amount of blood needed, not more, and not less."

SpHb monitoring may provide additional insight between invasive blood sampling when:

  • The SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing
  • The SpHb trend is rising and the clinician may otherwise think hemoglobin is not increasing fast enough
  • The SpHb trend is dropping and the clinician may otherwise think hemoglobin is stable

"For over 60 years, the A.C.Camargo Cancer Center has been serving as an international reference center for prevention, multidisciplinary treatment, teaching and research of cancer," stated Joe Kiani, Founder and CEO of Masimo. "We are happy to see them adopt SpHb technology through Masimo's Root® patient monitoring and connectivity platform for the betterment of their patients."

@MasimoInnovates || #Masimo

About A.C.Camargo Cancer Center
A.C.Camargo is a private non-profit institution maintained by Antonio Prudente Foundation and is currently one of the largest integrated cancer centers worldwide. With guided activities on four pillars: prevention, treatment, education and cancer research, they serve private patients and the Unified Health System (SUS). In 2014 alone, it had 3.5 million hospital visits with 62% dedicated to patients of the Unified Health System (SUS). It currently has about 40 medical specialties and more than 4000 professionals engaged with the task of 'combating cancer patient to patient' In 2014 alone, A.C.Camargo published over 160 articles.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In the U.S., Masimo rainbow® SET pulse cooximeter instruments and sensors are indicated to provide noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate (PR), carboxyhaemoglobin saturation (SpCO®), methaemoglobin saturation (SpMet®), total hemoglobin concentration (g/dl SpHb), and/or respiration rate (RRa®). The devices are not intended to replace laboratory measurements of hemoglobin and have not been cleared by FDA to detect bleeding or reduce the amount or frequency of red blood cell (RBC) transfusions. Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total haemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact:

Irene Paigah
Masimo
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

 

Masimo Reports Second Quarter 2015 Financial Results

Q2 2015 Highlights (compared to Q2 2014):

  • Total revenue, including royalties, rose 10.5% to $155.7 million
  • Product revenue rose 10.6% to $147.6 million
  • Masimo rainbow® revenue rose 16.3% to $13.5 million
  • SET® and rainbow® SET® units shipments were a record 44,300
  • GAAP net income of $19.4 million, or $0.36 per diluted share versus $13.8 million or $0.24 per diluted share in the year-ago period
  • Non-GAAP net income of $23.1 million, or $0.43 per diluted share versus $14.1 million or $0.25 per diluted share in the year-ago period

Irvine, California – August 4, 2015 – Masimo (NASDAQ: MASI)today announced its financial results for the second quarter ended July 4, 2015.

Second quarter 2015 product revenues rose 10.6% to $147.6 million, compared to $133.5 million for the second quarter of fiscal year 2014, and total revenue, including royalties, rose 10.5% to $155.7 million, up from $140.9 million for the second quarter of fiscal year 2014. The unfavorable effect of foreign currency movements reduced second quarter product revenues by approximately $5.5 million.

The company's worldwide direct product revenue in the second quarter of 2015 rose by 10.4% compared to the same period in 2014 and represented 84.7% of product revenue. OEM sales, which accounted for 15.3% of product revenue, rose by 11.5% to $22.5 million in the second quarter of 2015 compared to the same period in 2014. Revenue from sales of Masimo rainbow® products rose by 16.3% to $13.5 million in the second quarter of 2015, compared to the same period in 2014.

GAAP net income for the second quarter of 2015 was $19.4 million, or $0.36 per diluted share, compared to GAAP net income of $13.8 million, or $0.24 per diluted share, in the second quarter of 2014. Non-GAAP net income for the second quarter was $23.1 million, or $0.43 per diluted share, versus non-GAAP net income of $14.1 million or $0.25 per diluted share in the year-ago period. During the second quarter of 2015, the company shipped a record 44,300 SET® pulse oximetry and rainbow® Pulse CO-Oximetry™ units, excluding handheld units. Masimo estimates its worldwide installed base as of July 4, 2015 to be 1,362,000 units, up 8.1% from 1,260,000 units as of June 28, 2014.

Joe Kiani, Chairman and Chief Executive Officer of Masimo, said, "Our second quarter results reflect the continued demand for our SET® Pulse Oximetry technology and our emerging rainbow® SET® Pulse CO-Oximetry technology. The years of building a solid foundation of technologies and products that save and improve lives, along with a build out of our infrastructure to best serve our customers, should allow us to continue to deliver positive returns for our shareholders."

During the six month period ended July 4, 2015, the company generated $28.3 million in cash from operations and at July 4, 2015, total cash and cash investments were $119.4 million compared to $134.5 million as of January 3, 2015. Also, during the six month period July 4, 2015, the company repurchased approximately 2.4 million shares of stock for $81.6 million, including 2.1 million shares in the quarter ended July 4, 2015 for $73.4 million.

2015 Financial Guidance

Masimo today is updating its 2015 financial guidance. Masimo now expects fiscal 2015 total revenues to be approximately $621 million, up from $608 million. Total fiscal 2015 product revenues are now expected to be approximately $592 million, up from $580 million and total fiscal 2015 royalty revenues are now projected to be approximately $29 million, up from $28 million. Masimo now also expects its fiscal 2015 GAAP earnings per diluted share to be $1.43, up from $1.33 and expects non-GAAP earnings per diluted share to be approximately $1.61. Masimo will provide additional financial information during the conference call today. Each of the components of Masimo's guidance set forth above is an estimate only and actual performance could differ.

Conference Call
Masimo will hold a conference call today at 1:30 p.m. PT (4:30 p.m. ET) to discuss the results. A live webcast of the call will be available online from the investor relations page of the company's website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 84990153. After the live webcast, the call will be available on Masimo's website through September 1, 2015. In addition, a telephonic replay of the call will be available through August 18, 2015. The replay dial-in numbers are (800) 585-8367 for domestic callers and +1 (855) 859-2056 for international callers. Please use reservation code 84990153.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.


Forward-Looking Statements
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements including, in particular, the statements about our expectations for full fiscal year 2015 total and product revenues and GAAP and non-GAAP earnings per diluted share; demand for our products; anticipated revenue and earnings growth; our financial condition, results of operations and business generally; expectations regarding our ability to design and deliver innovative new noninvasive technologies and reduce the cost of care; and demand for our technologies. These forward-looking statements are based on management's current expectations and beliefs and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control and could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to, those related to: our dependence on Masimo SET® and Masimo rainbow® SET® products and technologies for substantially all of our revenue; any failure in protecting our intellectual property exposure to competitors' assertions of intellectual property claims; the highly competitive nature of the markets in which we sell our products and technologies; any failure to continue developing innovative products and technologies; the lack of acceptance of any of our current or future products and technologies; obtaining regulatory approval of our current and future products and technologies; the risk that the implementation of our international realignment will not continue to produce anticipated operational and financial benefits, including a continued lower effective tax rate; the loss of our customers; the failure to retain and recruit senior management; product liability claims exposure; a failure to obtain expected returns from the amount of intangible assets we have recorded; the maintenance of our brand; the amount and type of equity awards that we may grant to employees and service providers in the future; our ongoing litigation and related matters; and other factors discussed in the "Risk Factors" section of our most recent periodic reports filed with the Securities and Exchange Commission ("SEC"), including our most recent Form 10-K and Form 10-Q, all of which you may obtain for free on the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Investor Contact:

Eli Kammerman
Phone: (949) 297-7077
Email: ekammerman@masimo.com

Media Contact:

Irene Paigah
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation

Non-GAAP Financial Measures
The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP). The non-GAAP financial measures presented exclude the items summarized in the above table that are more fully described below. Management believes that adjustments for these items assist investors in making comparisons of period-to-period operating results and that these items are not indicative of the company's on-going core operating performance. These non-GAAP financial measures have certain limitations in that they do not reflect all of the costs associated with the operations of the company's business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. The non-GAAP financial measures presented by the company may be different from the non-GAAP financial measures used by other companies.

The company has presented the following non-GAAP measures on a basis consistent with its historical presentation, to assist investors in understanding the company's core net operating results on an on-going basis: (i) non-GAAP product revenue, (ii) non-GAAP gross profit, (iii) non-GAAP operating expenses, (iv) non-GAAP non-operating income (expense); (vi) non-GAAP net income attributable to Masimo Corporation stockholders, and (vii) non-GAAP net income per diluted share attributable to Masimo Corporation stockholders. These non-GAAP financial measures may also assist investors in making comparisons of the company's core operating results with those of other companies. Management believes non-GAAP product revenue, non-GAAP gross profit, non-GAAP net income attributable to Masimo Corporation stockholders and non-GAAP net income per diluted share attributable to Masimo Corporation stockholders are important measures in the evaluation of the Company's performance and uses these measures to better understand and evaluate our business.

The non-GAAP financial measures reflect adjustments for the following items, as well as the related income tax effects thereof:

Constant currency F/X adjustments. Some of our sales agreements with foreign customers provide for payment in currencies other than the U.S. Dollar. Similarly, certain of our product costs and operating expenses, and the related balance sheet payables and accruals, are denominated in foreign currencies other than the U.S. Dollar. These foreign currency revenues, costs and expenses, receivables, payables and accruals, when converted into U.S. Dollars, can vary significantly from period to period depending on the average and quarter-end exchange rates during a respective period. We believe that comparing these foreign currency denominated revenues, costs and expenses, receivables, payables and accruals by holding the exchange rates constant with the prior year period is useful to management and investors in evaluating the performance of our ongoing operations on a period-to-period basis. We anticipate that fluctuations in foreign exchange rates and these related constant currency and other foreign exchange adjustments will continue to occur in future periods.

Amortization of acquisition-related intangibles. Amortization of intangibles generally represents costs incurred by an acquired company or other third party to build value prior to our acquisition of the intangible assets. As such, it is effectively part of the transaction costs of the acquisition rather than ongoing costs of operating our core business. As a result, we believe that exclusion of these costs in presenting non-GAAP financial measures provides management and investors a more effective means of evaluating its historical performance and projected costs and the potential for realizing cost efficiencies within our core business. Amortization of intangibles will recur in future periods.

Litigation awards, damages and defense costs. In connection with litigation proceedings arising in the course of our business, we have previously recorded expenses as a defendant in such proceedings in the form of damages and directly-related legal fees, as well as reversals of such damages and directly-related legal fee expenses upon a court vacating a prior award against us. In addition, we have also previously recorded recoveries of damages and directly-related legal fees as a plaintiff in litigation proceedings. We believe that exclusion of these expenses, expense reversals and recoveries is useful to management and investors in evaluating the performance of our ongoing operations on a period-to-period basis. In this regard, we note that these expenses, expense reversals and recoveries are generally unrelated to our core business and/or infrequent in nature. Lease termination exit costs. The effects of lease termination exits costs are excluded resulting from the purchase of the New Hampshire manufacturing facility that Masimo previous leased.

Lease termination exit costs. The effects of lease termination exits costs are excluded resulting from the purchase of the New Hampshire manufacturing facility that Masimo previous leased.

Reconciliations between the GAAP and non-GAAP amounts for each financial statement line item are as follows:

 

Masimo Renews its $1,000,000 Performance Guarantee that Masimo SET® Technology will Outperform All Nellcor™ Pulse Oximeters

Addresses the Inaccurate and Misleading Claims that Covidien Continues to Make Regarding Nellcor Pulse Oximetry Performance

Irvine, California – July 13, 2015 – Masimo (NASDAQ: MASI) the inventor of measure-through motion and low perfusion pulse oximetry, today renewed its $1,000,000 (USD) performance guarantee that Masimo SET® Pulse Oximetry will outperform all Nellcor (part of Covidien and now Medtronic) pulse oximeters. Under the guarantee, if Masimo SET is proven not to be superior to all Nellcor pulse oximeters, including the three that Covidien announced have received FDA 510(k) clearance with motion claims, Masimo will pay up to $1,000,000 to help a hospital acquire that pulse oximetry.

"As a medical technology company, we believe it is our obligation to be truthful and open in our advertising because ultimately patient care is at issue. We continue to be perplexed by the misleading marketing tactics of our competitor," stated Joe Kiani, Founder and CEO of Masimo. "We are concerned that customers may be misled and we hope our guarantee will cause them to question what they are being told and evaluate the performance of the technologies for themselves."

In addition to renewing the $1 million guarantee, Masimo has updated its website to respond to each of the inaccurate and misleading claims in detail: http://www.masimo.com/nellcorfiction/

Masimo makes four promises to every hospital that to date, Covidien has not been willing to make:

  1. We will demonstrate the superior pulse oximetry performance of Masimo SET® over Nellcor in a side-by-side comparison.

  2. We will provide independent and objective scientific evidence of Masimo SET® superiority over Nellcor, as well as the evidence demonstrating Masimo SET® helps clinicians improve clinical and financial outcomes.

  3. We strongly encourage scientific side-by-side evaluations of Masimo SET® and Nellcor pulse oximetry in challenging conditions with automated data collection.

  4. We are so confident that an objective comparison will reveal the clinical superiority of Masimo SET®, we continue to offer a $1,000,000 performance guarantee.

Please note: This offer is available only to hospitals whose goal is to upgrade their pulse oximetry hospital-wide to the new standard. Important details, conditions, and qualifications for the challenge are available at http://www.masimo.com/1millionrules.htm.

@MasimoInnovates || #Masimo

  1. Eipe N et al. Indian Journal of Anesthesia. 2006; 50(1): 35-38.
  2. Ram GG et al. Chin J Traumatol. 2014;17(4):225-8.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to help clinicians detect life-threatening events. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow® Acoustic Monitoring™, the first-ever commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications®." Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors related to MightySat, including our belief in the breakthrough ability of Masimo SET® pulse oximetry to measure-through motion and low perfusion; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Irene Paigah
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Turkey's Leading University Hospital Adopts Masimo SpHb for Continuous Noninvasive Haemoglobin Monitoring

NEUCHATEL, Switzerland – June 30, 2015 – Masimo (NASDAQ: MASI) announced today that Turgut Ozal Medical Centre Liver Hospital in Malatya, Turkey has installed Masimo's noninvasive, continuous haemoglobin (SpHb®) technology to monitor surgical patients.

SpHb is a breakthrough measurement that noninvasively and continuously measures total haemoglobin in the blood, and offers real-time visibility to changes – or lack of changes – in haemoglobin between invasive blood sampling. Laboratory haemoglobin values are only available intermittently and are often delayed. Clinicians can estimate blood loss, but this can both overstate and understate actual blood loss.1,2

"In many cases with severe bleeding during liver transplantation, we had to do the blood transfusion on the patient without having the opportunity to send a sample or the time required to obtain the results," said Professor Dr. Hüseyin Ilksen Toprak, anaesthesiologist at Turgut Ozal Medical Centre. "Sometimes, the amount of blood transfused exceeded that required by the patient. However, today, thanks to routine SpHb monitoring, I am able to immediately visualise both the level of bleeding and the therapeutic effect."

SpHb monitoring may provide additional insight between invasive blood sampling when:

  • The SpHb trend is stable and the clinician may otherwise think haemoglobin is dropping

  • The SpHb trend is rising and the clinician may otherwise think haemoglobin is not rising fast enough

  • The SpHb trend is dropping and the clinician may otherwise think haemoglobin is stable

"In the area of liver transplantation, Turgut Ozal Medical Centre is recognised as one of the top five hospitals in the world," stated Joe Kiani, Founder and CEO of Masimo. "Their hospital was designed to be one of the most modern in the country. They had already been using our SET® Measure-Through Motion and Low Perfusion pulse oximetry. We are happy to see them adopt SpHb technology through Masimo's Root® patient monitoring and connectivity platform."

The Turgut Ozal Medical Centre is in the campus of the Inonu University. The hospital has 16 floors, 1024 beds, 31 services, 12 intensive care units and 26 operating rooms. In addition to liver transplants, the medical centre also handles kidney transplants, bone marrow transplants and burn injuries.

In the U.S., Masimo rainbow® SET pulse co-oximeter instruments and sensors are indicated to provide noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate (PR), carboxyhaemoglobin saturation (SpCO®), methaemoglobin saturation (SpMet®), total Haemoglobin concentration (g/dl SpHb), and/or respiration rate (RRa®). SpHb monitoring is intended to supplement, not replace, laboratory measurements. Blood samples should be analysed by laboratory instruments when possible prior to clinical decision making.

@MasimoInnovates || #Masimo

  1. Eipe N et al. Indian Journal of Anesthesia. 2006; 50(1): 35-38.
  2. Ram GG et al. Chin J Traumatol. 2014;17(4):225-8.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total haemoglobin (SpHb®), oxygen content (SpOC), carboxyhaemoglobin (SpCO®), methaemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total haemoglobin (SpHb®) contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Irene Paigah
Phone: (858) 859-7001
Email: irenep@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Receives CE Mark for MightySat Rx Pulse Oximeter

World's First Wireless Fingertip Pulse Oximeter with Masimo SET Technology Enables Clinicians to Track and Trend Measurements through Smart Mobile Devices

NEUCHATEL, Switzerland – June 22, 2015 – Masimo (NASDAQ: MASI) today announced the CE Mark and full market release of MightySat™ Rx fingertip pulse oximeter for clinical use in CE countries, offering the same Masimo SET® Measure-Through Motion and Low Perfusion™ pulse oximetry technology used in the world's leading hospitals.

Bluetooth®-enabled versions of MightySat Rx allow clinicians to track and trend up to 12 hours of patient measurements on smart mobile devices, and to share that data via standard CSV files as well as transfer to Apple's Health app.

MightySat™ Rx fingertip pulse oximeter provides oxygen saturation (SpO2), pulse rate (PR), Perfusion Index (PI), and Pleth Variability Index (PVI®).

MightySat Rx enables accurate noninvasive spot-checking of oxygen saturation (SpO2) and pulse rate (PR) for adult and paediatric patients even during motion and low perfusion. MightySat Rx measures and displays Perfusion Index (PI), which reflects the strength of the pulsatile signal. MightySat can also measure and display Pleth Variability Index (PVI®), a measure of the dynamic changes in the perfusion index that occur during one or more complete respiratory cycle/s.

"Many clinicians around the world rely on pulse oximetry as the fifth vital sign," stated Joe Kiani, Founder & CEO of Masimo. "The MightySat Rx represents a significant milestone. To deliver Masimo SET performance in this low-power form factor took some engineering, given the precision of our technology and SET's computationally intensive algorithm. We actually dropped the power consumption by nearly two orders of magnitude. But the development effort was worth it, as we expect this technology will empower clinicians and they will no longer have to compromise performance for mobility."

MightySat Rx is available in three versions for patients who weigh more than 30 kg (66 lbs):

  • MightySat Rx – Measures and displays SpO2, PR, and PI

  • MightySat Rx, Bluetooth – Adds Bluetooth LE radio for transfer of parameter data to Apple iOS® and select Android™ mobile devices

  • MightySat Rx, Bluetooth and PVI

Standard features include:

  • Measure-Through Motion and Low Perfusion performance

  • Signal I.Q.® to assess measurement confidence

  • Rugged, lightweight design for operation in challenging environments

  • Long battery life–up to 15 hours with two standard AAA alkaline batteries

  • Comfortable design with silicon finger pad to mold to patients' fingers

Bluetooth is a registered trademark owned by Bluetooth SIG, Inc.
Apple is a registered trademarks of Apple Inc. registered in the U.S. and other countries.
IOS is a trademark or registered trademark of Cisco in the U.S. and other countries and is used under license.
Android is a trademark of Google Inc. MightySat Rx is currently unavailable in the U.S.

@MasimoInnovates || #Masimo

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to help clinicians detect life-threatening events. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow® Acoustic Monitoring™, the first-ever commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care ... by Taking Noninvasive Monitoring to New Sites and Applications®." Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors related to MightySat, including our belief in the breakthrough ability of Masimo SET® pulse oximetry to measure-through motion and low perfusion; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Mike Drummond
Masimo
Phone: (949) 297-7434
Email: mdrummond@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo iSpO2 Pulse Oximeter Set to Measure Audience Reaction to "Personal Gold" Documentary Celebrating U.S. Olympic Silver Medalists

Quantified Self Conference + Expo in San Francisco Offers Ideal Setting for
Social Experiment

IRVINE, California – June 18, 2015Masimo (NASDAQ: MASI), maker of breakthrough Measure-through Motion and Low Perfusion pulse oximetry, announced today that for the first time moviegoers attending a screening of the award-winning documentary "Personal Gold: An Underdog Story" will use Masimo's iSpO2® pulse oximeter to help review the film.

MightySat fingertip pulse oximeter provides oxygen saturation (SpO2), pulse rate (PR), perfusion index (PI), and Pleth Variability Index (PVI®).

Select attendees of the "Personal Gold" screening at the QS15 Quantified Self Conference + Expo this weekend will receive an iSpO2 to track their blood oxygenation and pulse rate during the film. The Personal Gold team will overlay, graph and post the measurements on a timeline showing physiological reactions to the movie.

The film features the consumer version of Masimo's iSpO2 pulse oximeter. Masimo has since introduced the MightySat fingertip pulse oximeter with optional Bluetooth capability, enabling consumers to track and trend oxygenation and pulse rate measurements on their iOS or select Android mobile devices.

Heralded as "Miracle on Ice-meets-Moneyball" by Wall Street Journal reporter Reed Albergotti, "Personal Gold" gives a behind-the-scenes experience of four underdog women cyclists who become America's hope for a medal at the 2012 London Olympics after the men's team was banned during the Lance Armstrong drug scandal. The underfunded women relied on pulse oximetry and other technologies as part of an innovative "Data not Doping" training regimen to win the first U.S. Women's Track Cycling medal in more than 20 years.

"We believe this is the first time a pulse oximeter has been used to help 'review' a movie," said Joe Kiani, Founder and CEO of Masimo. "Masimo is dedicated to taking noninvasive monitoring to new sites and applications. The Quantified Self Expo offers an ideal setting to noninvasively measure physiological changes of viewers as they watch this inspiring film."

"'Personal Gold' is more than a must-see Olympic story – it's a film that expertly explores the intersection of sports, science and ingenuity," said Gary Wolf, contributing editor at Wired and host of this weekend's screening. "Without access to the tools of self-measurement, such as the noninvasive pulse oximetry device we'll be using at the screening this weekend, these heroic athletes would not have had a chance to make history. For these women, Quantified Self techniques meant the difference between standing on the side lines and standing atop a podium."

What: Personal Gold: An Underdog Story - Exclusive Event @ Quantified Self Expo
Hosted by Gary Wolf, contributing editor at Wired

Where: 2015 Quantified Self Expo in the newly renovated 400-seat Cowell Theater, Fort Mason Center, San Francisco, CA 94123

When: Saturday, June 20, 2015. 2:30 pm doors open; 3 pm sharp screening begins; 4:30 pm Q&A with Olympic medalist and filmmakers

#mypersonalgold
@masimoinnovates
@quantifiedself

About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors related to MightySat, including our belief in the breakthrough ability of Masimo SET® pulse oximetry to measure-through motion and low perfusion; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Mike Drummond
Masimo
Phone: (949) 297-7434
Email: mdrummond@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Announces Root CE Marking with Blood Pressure and Temperature

NEUCHATEL, Switzerland – June 15, 2015 – Masimo (NASDAQ: MASI) today announced the CE Mark and pre-market release of Root® connectivity and patient monitoring platform with noninvasive blood pressure and temperature capabilities.

Root with noninvasive blood pressure from SunTech Medical enables clinicians to measure arterial blood pressure for adult, pediatric, and neonatal patients, with three distinct measurement modes: spot-check, automatic interval, and stat interval.

The temperature module from Welch Allyn is indicated to measure temperature of adult, pediatric and neonatal patients.

"Root and Patient SafetyNet powered with Masimo SET has changed for the better our patient care and patient safety," said Caroline Stade, Chief Nursing Officer at University Children's Hospital Basel (UKBB) in Basel, Switzerland. "With remote alarm notification from Patient SafetyNet, we've been able to give proper care to patients in need without the false alarms that made proper care previously untenable. With the addition of blood pressure monitoring, we can provide patients in sub-acute care an integrated solution that will provide more efficient and effective care for our patients. We all, the physicians and nurses, are very happy with this new system and would never ever disclaim or work without the Root monitor."

Root offers a high visibility display with intuitive, touchscreen navigation for easy and adaptable use in any hospital environment:

  • Integrates measurements from Masimo Radical-7® handheld for SET® Measure-through Motion and Low Perfusion pulse oximetry, continuous haemoglobin (SpHb®), PVI®, ORI, and other noninvasive rainbow® parameters, or the Radius-7 patient-worn monitor for continuous monitoring of mobile patients
  • Flexible measurement expansion through Masimo Open Connect (MOC-9), including:
    • ISA CO2 capnography for sidestream monitoring featuring Nomoline technology for extended monitoring and cost-effective consumables
    • O3 regional oximetry for the simultaneous measurement of regional oxygen saturation (rSO2) and arterial oxygen saturation (SpO2) to help clinicians detect regional hypoxemia that pulse oximetry alone can miss, and
    • SedLine® brain function monitoring, which provides four channels of EEG to help clinicians better understand the effects of anaesthesia on the brain. SedLine measures the effects of anaesthesia and sedation by monitoring both sides of the brain's electrical activity.
  • Automatic display of parameters, waveforms, and viewing configuration based on the clinician's presence through MyView technology enabled with Patient SafetyNet version 5000 or higher
  • Enables clinicians to easily and automatically document vital signs data, measured from any connected device or manually entered, directly from Root to the patient's Electronic Medical Record (EMR). Alarms and alerts for all devices are seamlessly forwarded to the patient's clinician and all device data are effortlessly documented in the patient's EMR.

Root with noninvasive blood pressure and temperature is currently not available in the U.S.

@MasimoInnovates | #Masimo

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total haemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions that Masimo's Root Vital Signs Monitoring is adaptable to any hospital environment; risks related to our assumptions regarding the repeatability of clinical results; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Mike Drummond
Masimo
Phone: (949) 297-7434
Email: mdrummond@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

Masimo Root Wins the GOLD 2015 Medical Design Excellence Award

IRVINE, California – June 10, 2015 – Masimo (NASDAQ: MASI) announced that its Root® patient monitoring and connectivity platform has received the GOLD 2015 Medical Design Excellence Award—the highest award given in the general hospital devices and therapeutic products category. The 2015 Medical Design Excellence Award winners were honored today at a presentation ceremony in New York City's Jacob K. Javits Convention Center, in conjunction with the Medical Design & Manufacturing (MD&M) East Conference and Exposition (www.MDMEast.com).

Root comes with a dock for the Radical-7® handheld monitor or Radius-7® wearable monitor, an intuitive display, and multiple networking/connectivity options. Root integrates multiple streams of data on an easy-to-read, touch-screen.

Root innovations include:

  • MOC-9™ – Flexible measurement expansion through Masimo Open Connect™ (MOC-9™) with MOC-9 modules from Masimo or third-party measurement by other companies to expand the platform's measurements and capabilities. New MOC-9 modules in the U.S. will require new 510(k) clearances
  • ISA™ Capnography – CO2 sidestream module featuring fast warm-up time and the innovative and cost-effective Nomoline™ sampling line
  • SedLine® brain function monitoring module, which provides four channels of EEG to help clinicians better understand the effects of anesthesia on the brain
  • Iris™ connectivity gateway designed to provide integration for standalone devices such as IV pumps, ventilators, hospital beds, and other patient monitors. Iris enables Root to intake data from all devices connected to the patient, acting as an in-room patient monitor and connectivity hub. Alarms and alerts for all devices are seamlessly forwarded to the patient's clinician and all device data are effortlessly documented in the patient's electronic medical record
  • Wireless functionality – Capable of transmitting information through Bluetooth and WiFi.

Root can accommodate Radical-7 or Raidus-7, the first and only wearable, wireless monitor with Masimo's breakthrough rainbow® SET® technology, to measure blood oxygenation, pulse rate, and rainbow® acoustic monitoring (RAM™) through acoustic respiration rate (RRa®). Radius-7 offers patients continuous monitoring while providing freedom of movement, allowing hospitals to optimize capacity by getting patients out of bed faster. Studies have shown that patient mobility is a key factor in more rapid patient recovery.1

The Medical Design Excellence Awards competition (www.MDEAwards.com) is organized and presented by UBM Canon and is the only awards program that exclusively recognizes contributions and advances in the design of medical products. Entries are evaluated on the basis of their design and engineering features, including innovative use of materials, user-related functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to the patient, and the ability of the product development team to overcome design and engineering challenges so that the product meets its clinical objectives. A comprehensive review of the entries was performed by an impartial, multidisciplinary panel of third-party jurors with expertise in biomedical engineering, human factors, industrial design, medicine, and diagnostics.

"We are honored to have Root receive the GOLD MDEA-winning product," said Joe Kiani, Founder and CEO of Masimo. "We hope Root will eliminate barriers to entry for innovative products and barriers to interoperability and help automate patient care with its open and scalable architecture."

@MasimoInnovates || #Masimo

1 Needham D, Korupolu R, Zanni J, Pradhan P, Colantuoni E, Palmer J, Brower R, Fan E. "Early Physical Medicine and Rehabilitation for Patients With Acute Respiratory Failure: A Quality Improvement Project." Archives of Physical Medicine and Rehabilitation Vol 91, Issue 4, PP 536–542, April 2010

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 indepensdent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contacts:

Mike Drummond
Masimo
Phone: (949) 297-7434
Email: mdrummond@masimo.com

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo.

 

New Study Presented at the 2015 Euroanaesthesia Congress Evaluated the Impact on Mortality and Morbidity with Masimo SpHb and PVI

NEUCHATEL, Switzerland, June 5, 2015 Masimo (NASDAQ: MASI) announced today a new clinical study presented at the European Society of Anaesthesiology's Euroanaesthesia 2015 Annual Congress in Berlin, Germany. The study evaluated Masimo's parameters of noninvasive, continuous haemoglobin, SpHb®, and fluid responsiveness, PVI®, with patients in hospital settings.*

Dr. Sebastien Ponsonnard and researchers at CHU Limoges, Department of Anaesthesiology & Intensive Care, in Limoges, France, evaluated the impact on mortality and morbidity in patients who underwent general anaesthesia at the hospital after the introduction of Masimo SpHb continuous haemoglobin measurement and response to fluid loading by PVI.1

Operating rooms and ICUs were equipped with Masimo Radical-7 Pulse CO-Oximeter® monitors. Over a six-month period (Feb. 6-Aug. 7, 2014), patients receiving general anaesthesia were monitored noninvasively.

At one month, mortality decreased in 2014 (vs. 84/5123 = 1.64% vs. 121/5478 = 2.2%, P = 0.024). In-hospital mortality was not different between the two years. Death in cardiothoracic surgery was slightly lower (P = 0.07).

Researchers concluded: "These results suggest that by using a non-invasive monitor, measuring SpHb and fluid loading responsiveness is possible on a large scale. The observed reduction of mortality agrees with multi-centric randomized studies using more invasive monitoring systems2 and support the large use of such a device."

@ESA_HQ
@MasimoInnovates

* For CE Marking:

  • The Radical-7 is intended for the continuous and noninvasive monitoring of SpO2, SpCO, SpMet and SpHb.
  • The Radical-7 with PVI has been clinically evaluated for fluid responsiveness measurements.

For the US market:

  • The Radical-7 is indicated for the continuous and noninvasive monitoring of SpO2, SpCO, SpMet and SpHb.
  • The Radical-7 with PVI is a measure of dynamic changes in the perfusion index (PI) that occur during the r