Current News

Date Title
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
02/12/2015 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

 

Korean Regulators Clear Masimo PVI® for Clinical Use

Neuchatel, Switzerland – February 26, 2015Masimo (NASDAQ: MASI) announced today that the Republic of Korea's Ministry of Food and Drug Safety (MFDS) and the Korean Health Technology Assessment (HTA) group have cleared Masimo's noninvasive PVI® – a measure of the dynamic changes in the perfusion index that occur during one or more complete respiratory cycles – for clinical use.

Korean regulators determined that PVI is an effective, noninvasive way to predict fluid responsiveness in mechanically ventilated patients. Regulators concluded PVI has higher accuracy of diagnosis compared to static indices (central venous pressure, pulmonary capillary wedge pressure), and similar accuracy diagnosis with dynamic indices (cardiac output variability, pulse pressure variability, blood volume amplitude variability, systolic pressure variability). They stated:

"Pleth Variability index (PVI) measurement measures pleth variability non-invasively with the sensor on the skin of patients, so that there is no issue for safety.
"Therefore, PVI is safe and effective as (an) alternative non-invasive PVI measurement to predict fluid responsiveness of machine respiration patients who need fluid supply."

Clinicians commonly use fluid administration to improve haemodynamics before, during and after surgery. Assessment of fluid responsiveness – the ability of the circulation system to increase cardiac output in response to volume expansion – is essential to guide fluid therapy and optimize preload.1 Too little fluid administration can result in low perfusion in peripheral tissue, but too much fluid administration can result in patients failing to respond to any amount of volume expansion,2,3 as well as fluid overload postoperatively.4,5

This clearance by Korean regulators is similar to the decision of the French Society for Anaesthesia and Intensive Care (SFAR), which in 2013 added PVI to guidelines for optimal haemodynamic management during surgery.6 Similar to Korean authorities, SFAR recommends the use of "dynamic" parameters such as PVI that measure variations over the respiratory cycle.

"We're excited to see another major country approve for clinical use another one of our important noninvasive, physiological measurements," said Masimo founder and CEO Joe Kiani. "From PVI, to our rainbow measurements that include noninvasive haemoglobin, carbon monoxide, and our newest noninvasive parameter, Oxygen Reserve Index or ORI, that can help clinicians optimize oxygenation before and during prolonged intubation, Masimo continues to innovate ways to improve patient outcomes and reduce the cost of care by advancing and creating new noninvasive measurements."

PVI is available with any Masimo SET® or rainbow® sensor.

1 Cannesson M: Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth 24:487-497,2010.
2 Brandstrup B, TonnesenH, Beier-HolgersenR, etal: Effects of intravenous fluid restriction on postoperative complications: Comparison of two perioperative fluid regimens: A randomized assessor-blinded multicenter trial. AnnSurg 238:641-648,2003.
3 Marik PE, Cavallazzi R, Vasu T, etal: Dynamic changes in arterial wave form derived variables and fluid responsiveness in mechanically ventilated patients: A systematic review of the literature. Crit Care Med 37:2642-2647,2009.
4 Kita T, Mammoto T, Kishi Y. Fluid management and postoperative respiratory disturbances in patients with transthoracic esophagectomy for carcinoma. J Clin Anesth. 2002;14(4):252–6.
5 Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F, Danish Study Group on Perioperative Fluid T. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003;238(5):641–8. doi:10.1097/01.sla.0000094387.50865.23.
6 Vallet B., Blanloeil Y., Cholley B., Orliaguet G., Pierre S., Tavernier B. "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 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 (SpOCTM), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and 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 of the repeatability of clinical results obtained using Masimo PVI, risks related to our belief that PVI is an easy-to-use and cost-effective measure for assessing whether patients will benefit from fluid administration, risks related to our assumptions that PVI enables personalized and goal-directed fluid therapy, 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.

 

CFSI Announces Masimo as Co-Sponsor of the Excellence In Fire Service-Based EMS Award

(WASHINGTON, D.C., and IRVINE, Calif.) – Feb. 20, 2015 –The Congressional Fire Services Institute has announced Masimo (NASDAQ: MASI) as the new co-sponsor of the Excellence in Fire Service-Based EMS Award. CFSI said Masimo will bring a new level of recognition to the awards program based on its reputation for product innovations for fire departments across the nation.

Established in 2010, the Excellence in Fire Service-Based EMS Award honors fire departments in three categories: career, volunteer and combination. The criteria place emphasis on innovations in emergency medical care.

"We are looking for departments that are forward-thinking in their approach to EMS – departments that are developing and embracing change to adapt to the growing demand for pre-hospital emergency medical care," said CFSI Executive Director Bill Webb. "We found a partner in Masimo that shares these ideals, which is why we welcome them as a new co-sponsor of the awards program."

"Masimo has always valued the heroic work of our nation's firefighting and EMS professionals," said Masimo founder and CEO Joe Kiani. "We are honored to partner with the Congressional Fire Services Institute to recognize leaders who are using the latest technologies to improve the health and safety of their fellow first responders."

The presentation of the 2015 awards is April 16 at the 27th Annual National Fire and Emergency Services Dinner in Washington, D.C. Sponsored by the Congressional Fire Services institute, the dinner is part of the National Fire and Emergency Services Symposium hosted annually by CFSI. More than 2,000 state and national fire service leaders are expected to attend this year's program. Over the two-day event, they will attend seminars featuring federal officials and national fire service leaders who will discuss a broad range of federal fire service issues. Guests will also schedule time with their members of Congress to solicit their support for federal legislation and programs benefiting the fire and emergency services.

To apply, visit Excellence in Fire Service-Based EMS Awards Program. The deadline for submission is March 16, 2015. A representative of each of the recipient departments will receive a trip to Washington, D.C., for the award presentations.

CFSI also acknowledges its thanks to the International Association of Fire Chiefs, International Association of Fire Fighters, National Fire Protection Association and the National Volunteer Fire Council for providing representatives to serve on the selection committee.

About CFSI:
Established in 1989, the Congressional Fire Services Institute (CFSI) is a nonprofit, nonpartisan policy institute that works with members of Congress in promoting fire and life safety issues. Working with other national fire service organizations, the Institute focuses its attention on issues that benefit all first responders. Members of the Congressional Fire Services Caucus, the largest caucus in Congress, look to CFSI for guidance and information to enhance their level of understanding about the challenges and needs of our nation's fire and EMS communities.www.cfsi.org

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.

Media Contacts:
Bill Webb
CFSI
Phone: (202) 371-1277
Email: bwebb@cfsi.org

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.

 

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

Irvine, California – February 12, 2015Masimo (NASDAQ: MASI), the inventor of Masimo SET® Measure-Through Motion and Low Perfusion™ pulse oximetry and rainbow® Pulse CO-Oximetry, announced today that the National Fire Protection Association (NFPA) released an updated Fire Rehabilitation Standard (NFPA 1584) requiring firefighters exposed to smoke at incident scenes and during training to be assessed for carbon monoxide (CO) poisoning.

NFPA's consensus codes and standards serve as the worldwide authoritative source on fire prevention and public safety.

The revised standard, effective now, requires that firefighters who are "exposed to fire smoke shall be assessed for carbon monoxide poisoning." The standard further states in Annex A that, "Any firefighter exposed to CO or presenting with headache, nausea, shortness of breath, or gastrointestinal symptoms... should be assessed for carbon monoxide poisoning."

The previous version (2008) of the standard did not include assessment of CO poisoning as a requirement. The new requirement reflects a growing consensus on the risks of CO, the difficulty of assessing CO through signs and symptoms alone, the availability of portable CO monitoring devices, and the benefits of assessing CO poisoning at the scene and during training.

Masimo's rainbow® SET technology provides noninvasive carboxyhemoglobin saturation (SpCO®), a measure of CO in the blood, from a single multi-wavelength finger sensor that also provides two other vital signs measurements required by the NFPA 1584 standard, oxygen saturation (SpO2) and pulse rate.

With the support of the Congressional Fire Services Institute and other organizations, Masimo will expand its efforts to help departments and agencies nationwide implement the new standard.

Gary Ludwig, fire chief of the Champaign (Ill.) Fire Department and well-known author, speaker, and consultant said, "There is nothing more important in our profession than firefighter safety. The new 1584 standard builds on the older standard and more comprehensively addresses medical monitoring and carbon monoxide poisoning of the firefighter. I am excited to see this updated standard and that Masimo is at the forefront of making sure firefighters go home at the end of their shifts."

"Emergency service rehabilitation has been found to be a critical component of firefighter physical and mental well-being," said Dr. William F. Jenaway, president of the Congressional Fire Services Institute and 40-plus year member of the Pennsylvania Fire Service. "The use of rehabilitation including medical monitoring and assessment of carbon monoxide poisoning is no longer 'a nice thing to do,' it is a critical component of firefighter safety and health."

Joe Kiani, founder and CEO of Masimo, stated: "We applaud NFPA for making assessment of carbon monoxide poisoning a requirement. We are proud that our rainbow Pulse CO-Oximetry technology can play a role in helping meet this standard by allowing the noninvasive monitoring of SpO2, pulse rate, and SpCO, and in increasing safety for our heroic public servants."

SpCO is not intended as a standalone diagnostic test. Laboratory testing should be performed prior to diagnosis.

About NFPA
A worldwide leader in providing fire, electrical, building, and life safety to the public since 1896, NFPA's mission is to reduce the global burden of fire and other hazards on the quality of life by providing and advocating consensus codes and standards, research, training, and education. NFPA's 300 codes and standards influence every building, process, service, design, and installation in the U.S. and many other countries. With a membership of more than 81,000 and more than 80 national trade and professional organizations, NFPA is the authority on fire, electrical, and building safety. Copies of the National Fire Protection Association (NFPA) Section 1584, Standard on the Rehabilitation Process for Members During Emergency Operations and Training Exercises, are now available through the NFPA.

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. @masimoinnovates

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 SpCO will provide an accurate and effective noninvasive method of screening for CO poisoning, risks related to our assumptions of the repeatability of clinical results obtained, and risks related to our assumptions that Masimo SET® pulse oximetry technology improves patient 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.

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, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57,Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine are trademarks or registered trademarks of Masimo. The use of the trademarks Patient SafetyNet and PSN is under license from University HealthSystem Consortium.

 

Inova Fair Oaks Hospital Casts Masimo Patient SafetyNet™ to Help Improve Patient Outcomes and Reduce Costs

FAIRFAX, Va., &IRVINE, Calif. – January 15, 2015Masimo (NASDAQ: MASI) and Inova Fair Oaks Hospital – listed among the 2014 Truven Health Analytics Top 100 Hospitals® for delivering the best care in its community – announced that the hospital has installed Masimo Patient SafetyNet™, a remote monitoring and clinician notification system shown to keep patients safer while reducing cost of care.1

Inova Fair Oaks Hospital embraces the patient-safety guidelines of leading health organizations, including the Anesthesia Patient Safety Foundation, the Joint Commission, and the Institute for Safe Medication Practices (ISMP), which recommend continuous oxygenation and ventilation monitoring in patients receiving opioid-based pain medications.2-4 Opioid analgesics are associated with adverse effects and cause respiratory depression in 0.50%, or 25 of every 5,000 post-surgical patients.5-9

Patient SafetyNet has been clinically shown to reduce preventable and costly rescue events, transfers to intensive care units, and deaths related to opioid-induced respiratory depression.1,10 Patient SafetyNet combines the performance of Masimo SET® pulse oximetry – the enabler of reliable oxygenation and pulse rate monitoring on medical/surgical floors – with ventilation monitoring and wireless clinician notification that can help ensure patients' safety by noninvasively and continuously measuring and tracking their underlying physiological conditions and changes that signal declining health status in real-time. When changes occur in the measured values, which may indicate deterioration in the patient's condition, the system automatically sends wireless alerts directly to clinicians – prompting a potentially lifesaving response to the patient's bedside.

"Masimo Patient SafetyNet provides an additional layer of patient protection by offering our staff an extra set of 'eyes' on the patient at all times even when a clinician isn't in the room," said G. Michael Lynch, M.D., Inova Fair Oaks Hospital Chief Medical Officer. "Masimo SET pulse oximetry also has the additional benefit of reducing false alarms, even during challenging conditions of patient movement or low perfusion, giving our staff greater confidence that our patients are receiving the best care possible."

1 Taenzer A.H., Pyke J.B., McGrath S.P., Blike G.T. Anesthesiology. 2010 Feb;112(2):282-7
2 Stoelting RK et al. APSF. 2011.
3 Joint Commission Sentinel Event Alert. Issue 49. August 8, 2012.
4 https://www.ismp.org/newsletters/acutecare/articles/20090312.asp
5 Vila H Jr, Smith RA, Augustyniak MJ: The efficacy and safety of pain management before and after implementation of hospital-wide pain management standards: Is patient safety compromised by treatment based solely on numerical pain ratings? Anesthesia and Analgesia, 2005;101:474-80.
6 Office of Applied Studies, Substance Abuse and Mental Health Services Administration. Substance abuse treatment admissions involving abuse of pain relievers: 1998 and 2008, http://oas.samhsa.gov/2k10/230/230PainRelvr2k10.cfm (accessed October 28, 2011).
7 McPherson ML: Strategies for the management of opioid-induced adverse effects. Advanced Studies in Pharmacy, 2008;5(2):52-57.
8 Jarzyna D, et al: American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Management Nursing, 2011;12(3): 118-145
9 Pasero C, M McCaffery: Pain assessment and pharmacologic management. Chapter 12 – Key Concepts in Analgesic Therapy, and Chapter 19 – Management of opioid-induced adverse effects. St. Louis, Mosby Elseveir, 2011
10 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 Inova
Inova is a not-for-profit health care system located in the Washington, D.C. metropolitan area, serving over two million people with over 1,700 licensed beds based in Northern Virginia. Inova consists of five hospitals including the area's only Level 1 Trauma Center and Level 4 Neonatal Intensive Care unit. Inova encompasses many health services including the nationally and internationally recognized Inova Heart and Vascular Institute (IHVI), Inova Translational Medicine Institute (ITMI) on genomics, Inova Neuroscience Institute and Inova Children's Hospital. Inova's mission is to improve the health of the diverse community it serves through excellence in patient care, education and research. More information and statistics about Inova is at www.inova.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 help clinicians 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 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™). Masimo SET® and Masimo rainbow® technologies also can be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. 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, including, but not limited to: risks related to our assumptions that all patients at Inova Fair Oaks Hospital will be cared for using the most technologically and clinically-advanced noninvasive patient monitoring solutions available; risks related to our belief that Masimo Patient SafetyNet can help keep patients safer by noninvasively, continuously measuring and tracking their underlying physiological condition to help hospitals avoid preventable patient deaths and injuries associated with failure to rescue events; risks related to our belief that Masimo SET virtually eliminates false alarms and increases a clinician's ability to detect life-threatening events; 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 forward-looking 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:
Amy Richards
Inova Fair Oaks Hospital
Phone: (703) 391-3390
Email: Amy.Richards@inova.org

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 Unveils MightySat™ at Consumer Electronics Show - First Fingertip Pulse Oximeter with Masimo SET® Measure-through Motion and Low Perfusion™ Technology

Visit Booth 73711 at CES in Las Vegas to Witness Death-Defying and Olympic-Level Demonstrations Showing How MightySat Delivers Accurate Measurements When Other Pulse Oximeters Fail

Irvine, California — January 5, 2015 — Masimo (NASDAQ:MASI) today announced the MightySat fingertip pulse oximeter for personal use. MightySat provides accurate oxygen saturation and pulse rate measurements when other pulse oximeters can fail1 and is ideal for those who want reliable measurements even under extreme conditions.


MightySat™ fingertip pulse oximeter provides oxygen saturation(SpO2), pulse rate (PR), perfusion index (PI), and pleth variability index (PVI®).

Oxygen saturation (the percentage of arterial blood that is bound with oxygen) and pulse rate (the number of times the heart beats per minute) provide an indication of lung and heart efficiency and increasingly are being measured with fingertip pulse oximeters for personal use. However, until now no fingertip pulse oximeter has been available with Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry – the same technology used on more than 100 million patients a year in leading hospitals worldwide. Now, instead of guessing whether their pulse oximeter is providing accurate measurements, people can rely on MightySat with Masimo SET® technology – shown in more than 100 independent and objective studies to outperform all other pulse oximetry technologies with dramatically fewer false measurements during motion and low perfusion (or low blood flow) to the finger.1

MightySat is available in three versions – each of which provides oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI) measurements in a compact, battery-powered design with a large color screen that can be rotated for real-time display of the pleth waveform as well as measurements. Optional Bluetooth wireless functionality enables measurement display via a free, downloadable app on iOS and Android mobile devices as well as the ability to trend and communicate measurements. And for those who want to use their pulse oximeter to evaluate another physiologic dimension, MightySat is the only fingertip pulse oximeter available with the optional Pleth Variability Index (PVI®), a measure of the dynamic changes in the PI that occur during one or more complete respiratory cycles.2

Other standard features include:

  • 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
  • Two-year limited warranty

Elite athletes are among those who trust Masimo SET® pulse oximetry to help them achieve peak performance. Stig Severinsen, Ph.D. in medicine, a four-time World Champion freediver and owner of multiple Guinness World Records, including history's longest breath-hold of 22 minutes, will demonstrate MightySat while holding his breath in a coffin-sized water tank during the CES trade show in Las Vegas, Jan. 6-9, Booth 73711, Tech West, Sands Expo.

Also at the Masimo booth will be Dotsie Bausch, a seven-time USA Cycling National Champion, two-time Pan-American Champion, and silver medalist in team pursuit cycling at the 2012 London Olympics, who will perform her Olympic-level training, demonstrating Masimo SET® technology measurements.

"Training for extreme records under extreme conditions is always a huge challenge," said Severinsen, who was the subject of a recent National Geographic television special, when he used Masimo technology prior to freediving inside an iceberg. "In such situations it is of great value to be able to perform noninvasive and accurate measurements of my heart rate and oxygen saturation levels with a state-of-the-art device.

"I would recommend Masimo's MightySat to anyone interested in health and fitness – understanding what goes on inside your body is paramount to improving performance," he added.

Also at CES, win autographed books, consumer medtech devices and other prizes by entering Masimo's social media picture contest:

  • Post to your social networks a picture of you from Booth 73711 Tech West, Sands Expo, with Stig Severinsen and/or Dotsie Bausch
  • Use both hashtags #CES2015 and #Masimo

Winners will be announced throughout the day.

MightySat is available for purchase on Amazon U.S. and Amazon U.K. Please visit www.masimopersonalhealth.com for purchasing information.

In the U.S., MightySat is intended for sports and aviation use; not intended for medical use. Android is a trademark of Google Inc.

1 Shah N, Ragaswamy HB, Govindugari K, Estanol L "Performance of Three New-Generation Pulse Oximeters during Motion and Low Perfusion in Volunteers".JClinAnesth. 2012 Aug;24(5):385-91. All clinical studies are available at www.masimo.com
2 The utility of PVI is unknown at this time and requires further clinical studies. Technical factors that may affect PVI include probe position and patient motion.

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 Actof 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
Mobile: (949) 648-2269
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