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Masimo Announces Support for the Every Newborn Action Plan to Reduce Global Newborn Mortality

Masimo's iSpO2 Rx Mobile Pulse Oximetry Technology Ideal for Early Detection of Health Conditions in Newborns in Low-Resource Settings

IRVINE, CA -- (Marketwired) -- 06/27/14 -- Masimo (NASDAQ: MASI) today announced its unconditional commitment to the Every Newborn Action Plan (ENAP), a global initiative to end preventable deaths of newborns. Coordinated by UNICEF and the World Health Organization, with the support of a broad group of partners, ENAP identifies actions for improving survival, health and development of newborns. Globally, about 3.3 million newborns die annually within the first month of life, with neonatal infection, sepsis, pneumonia and birth defects among the major killers, according to the World Health Organization.

ENAP's mission is in lockstep with the commitments of Masimo, its longstanding partner the nonprofit Newborn Foundation, and the nonprofit Patient Safety Movement Foundation, to reducing preventable newborn deaths.

In late 2013, Masimo launched iSpO2 Rx, the first commercial, medical-grade Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximeter technology for mobile devices in conjunction with the Newborn Foundation's BORN Project - Birth Oximetry Routine for Newborns. iSpO2 Rx is ideally suited to low-resource areas. iSpO2 Rx for neonate and infant use is currently available in certain countries such as India, Cambodia, Kenya and Guatemala.*

Masimo and the Newborn Foundation spent nearly two years working with public health officials, delivery hospitals, and clinicians to create the first viable, measure-through motion and low perfusion, mobile-enabled pulse oximetry technology that can be adopted as part of routine neonatal screening for hypoxemia. In addition to Masimo's financial contributions to the BORN Project China, Masimo's engineering, design, and technical teams spent thousands of hours researching, designing and developing a mobile medical device that would serve the needs of health workers and babies in the lowest resource settings.

"We have found that this simple, noninvasive check of oxygen levels in newborns is among the most effective health measures that can be deployed to reduce newborn mortality," said Annamarie Saarinen, co-founder and CEO of the Newborn Foundation, who is scheduled to speak Monday at the ENAP Partner's Forum in Johannesburg, South Africa. "Through our partnership with Masimo, we are eager to help fulfill the goals of the ENAP initiative, saving and improving newborn lives."

Patient Safety Movement Foundation President Jim Bialick, also is scheduled to speak Monday at the ENAP Partner's Forum, and will address the need for easily accessible and highly reliable technologies to improve newborn healthcare worldwide.

The evidence for Masimo's pulse oximetry technology has never been more powerful. The largest newborn pulse oximetry study ever conducted was recently published in The Lancet.(1) Led by a clinical team in Shanghai, more than 122,000 newborns were screened using Masimo SET® Measure-through Motion and Low Perfusion technology and found the use of Masimo SET® significantly increased the rate of congenital heart disease detection. The results corroborate those found in previous major CCHD studies in the United Kingdom and Sweden, including pioneering work by Dr. Anne de-Wahl Granelli, which showed that Masimo SET® pulse oximetry was effective in detecting newborns with CCHD with very high sensitivity and specificity.(2,3) Now, the BORN Project China is providing the first large-scale newborn data on the efficacy of mobile pulse oximetry technology at county- and village-level birth facilities in Sichuan Province. China has among the highest newborn mortality as a percentage of under-5 deaths.

"Effective, affordable, and scalable pulse oximetry evaluation of newborns, along with reliable follow-up in low- and middle-income countries, will significantly reduce infection-related newborn death rates and improve outcomes for newborns afflicted with 'hidden' congenital heart defects," said Masimo founder and CEO Joe Kiani. "Masimo SET iSpO2 Rx can arm front-line health care providers in the developing countries with the most effective pulse oximeter that is accurate in challenging conditions of patient movement and low perfusion to help save the lives of newborns."

iSpO2 Rx
iSpO2 Rx utilizes the same Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry technology proven by more than 100 independent and objective studies and used on more than 100 million patients a year in leading hospitals worldwide, including eight of the top 10 on the U.S. News & World Report Best Hospitals Honor Roll (2013-2014). Masimo SET® significantly reduces false alarms (specificity), accurately detects true alarms (sensitivity), and provides measurements when other pulse oximeters fail.(4,5) Most importantly, Masimo SET® pulse oximetry has been clinically shown to improve patient outcomes and reduce cost of care by helping clinicians:

  • Decrease retinopathy of prematurity (ROP) in neonates by avoiding giving too much oxygen based on inaccurate SpO2 measurements(6,7)
  • Increase detection of critical congenital heart disease (CCHD) in newborns by accurately identifying low SpO2 measurements(2,3)
  • Reduce ventilator weaning time by titrating FiO2 faster and reduce arterial blood gas measurements in the ICU through more reliable SpO2 measurements(8)
  • Decrease rapid response activations and ICU transfers to save lives and costs in post-surgical patients on the medical-surgical floors through earlier identification of patients in distress through low SpO2 and abnormal pulse rate measurements.(5,9)

* iSpO2 Rx for neonate and infant use is currently pending CE Mark and not available in the U.S. and Canada.

(1) Zhao Q-m, Ma X-j, Ge X-l, Liu F, Yan W-l, Wu L, Ye M, Liang X-c, Zhang J, Gao Y, Jia B, Huang G-y, Neonatal Congenital Heart Disease screening group. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. The Lancet, Early Online Publication, 23 April 2014. doi:10.1016/S0140-6736(14)60198-7
(2) de-Wahl Granelli A., et al. BMJ. 2009 Jan 8;338.
(3) Ewer A, et al. Health Technol Assess. 2012;16(2):1-184.
(4) 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.
(5) 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. Available online here.
(6) Castillo A, et al. Acta Paediatr. 2011 Feb.;100(2):188-92.
(7) Bizzarro MJ, Li FY, Katz K, Shabanova V, Ehrenkranz RA, Bhandari V. Temporal quantification of oxygen saturation ranges: an effort to reduce hyperoxia in the neonatal intensive care unit. Journal of Perinatology (2014) 34, 33-38; doi:10.1038/jp.2013.122; published online 26 September 2013.
(8) Durbin, et al. Critical Care Medicine. 2002 Aug.;30(8): 1735 to 1740.
(9) Anesthesia Patient Safety Foundation. APSF Newsletter. "No Patient Shall be Harmed by Opioid-Induced Respiratory Depression." 2011; 26(2):21-40. Available online here.

About Newborn Foundation
The Newborn Foundation is an international non-profit working specifically to leverage health IT and medical technologies to improve access and outcomes while reducing disparities for newborns. The organization has been integral in the policy development, adoption and implementation of technologies for early detection, intervention and care of the youngest patients, including universal newborn heart screening as a public health initiative.

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 the new iSpO2 Rx, 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.

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.

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