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Newborn Foundation and Masimo Partnership Reaches 52,000 Babies and 1,000 Health Workers through Newborn Screening Initiative in Support of Every Woman Every Child

MASI | September 14, 2017

Newborn Foundation and Masimo Partnership Reaches 52,000 Babies and 1,000 Health Workers through Newborn Screening Initiative in Support of Every Woman Every Child

BORN Project convenes public health stakeholders to highlight key program successes at three-year mark, reinforcing global call to action to support universal newborn pulse oximetry screening as a tool to significantly reduce newborn mortality and drive treatment infrastructure in low-resource settings.

Masimo (NASDAQ: MASI) and the Newborn Foundation today announced that the BORN Project, their joint commitment to the United Nations’ Every Woman Every Child (EWEC) initiative, has now screened 52,000 newborns across 40 delivery sites in China for critical congenital heart disease (CCHD), pneumonia, and sepsis. In addition, 1,000 health workers and public health staff have now been trained in neonatal pulse oximetry screening through the BORN project, which is also marking its third anniversary.

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These progress updates will be discussed at a UN General Assembly event in New York City on Tuesday, September 19, “Harnessing the Power of Technology and Partnerships to Combat Newborn Mortality.” The announcement comes on the heels of news that the National Health and Family Planning Commission, People’s Republic of China, and the Chinese CDC have convened a formal national committee to establish country-wide implementation and screening protocols for universal newborn pulse oximetry screening.

The BORN (Birth Oximetry Routine for Newborns) Project, developed by the Newborn Foundation in partnership with Masimo, aligns with public health initiatives with the goal of reducing newborn mortality from CCHD, pneumonia, and sepsis in pilot regions. It also provides substantive data to public health officials to demonstrate the importance of investment in sustainable universal newborn screening programs and improved access to follow-up care for fragile babies.

The project has provided the first large deployment of smart device-paired pulse oximeters for use on newborns. Training and educational tools, combined with the Masimo iSpO₂ ^® Rx smartphone- and tablet-paired pulse oximeter, teach families about the benefits of screening and allow healthcare workers at every level to screen babies and interpret screening results, helping to increase the rate of timely diagnosis and referrals.

“We have more than met the goals of the project since its launch, and seeing the impact on so many lives has been humbling,” said Annamarie Saarinen, CEO of the Newborn Foundation. “The real impact has been in working in partnership with the government to bring this policy to fruition.”

The BORN Project is conducted in collaboration with the China Office for Maternal and Child Health Surveillance, the China CDC, the Mianyang Health Bureau. It has been supported by Masimo, the Masimo Foundation, and the London-based Global Innovation Fund. An interim report on the findings of its impact of screening at hospitals in rural Sichuan Province was recently presented to the National Health and Family Planning Commission of the People’s Republic of China and Chinese CDC.

Established through an initial three-year, $50,000 commitment from Masimo in 2014 and subsequent $100,000 equipment donation, the BORN Project has now launched in the Philippines, where it is in the process of screening 72,000 newborns across 28 urban and rural hospitals, spanning all three island groups. The BORN Project is also expanding into India, Peru, Mexico, Bolivia, Pakistan, and Mongolia. The Newborn Foundation leads advocacy and implementation efforts, which focus on education, training and metrics on the benefits of routine pulse oximetry screening of newborns, as well as follow up diagnosis and treatment protocols.

“We must reframe how healthcare is delivered to the youngest and most fragile patients,” said Joe Kiani, Founder and CEO of Masimo. “The work we are doing is already having a powerful impact in China and beyond. We are proud that Masimo SET^®, with its proven clinical accuracy and reliability, is able to help save the lives of many newborns.”

Every Woman Every Child

The Masimo and Newborn Foundation partnership was among the first commitment-makers as part of the UN Secretary General’s Every Woman Every Child initiative. EWEC directly contributes to the Global Strategy for Women’s, Children’s and Adolescents’ Health and the success of the Sustainable Development Goals (SDGs).

With more than 50,000 rural and underserved babies impacted through their work thus far, Masimo and the Newborn Foundation, in collaboration with EWEC, are committed to addressing obstacles and tackling the unmet Millennium Development Goals for reducing mortality for children under the age of five, through the SDG initiatives.

iSpO₂ Rx does not have 510(k) clearance and is not available for sale in the United States.

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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 2017-18 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^®), Pleth Variability Index (PVi^®), and more recently, 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 http://www.masimo.com/cpub/clinical-evidence.htm.

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

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

References

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.
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.
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.
Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
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.
Estimate: Masimo data on file.
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About Newborn Foundation

The Newborn Foundation conducts research, implements programs, and develops technology innovations that save lives and improve health outcomes for the newest, most vulnerable citizens of the world. The Foundation programmatically delivers these solutions to those who need them most and drives policies that integrate with public health initiatives to provide sustainable impact for babies and families.

About Every Woman Every Child

Launched in 2010 and led by the UN Secretary-General, the Every Woman Every Child movement aims to intensify national and international commitment and action by governments, the UN, multilaterals, private sector and civil society to keep women's, children's and adolescents' health and wellbeing at the heart of development. As a multi-stakeholder platform to operationalize the Every Woman Every Child Global Strategy for Women’s, Children’s and Adolescents’ Health, the movement mobilizes partnerships and coordinated efforts across sectors to ensure that all women, children and adolescents not only survive, but also thrive to help transform the world. Since 2015, 62 country and around 150 multi-stakeholder commitments have been pledged in support of the EWEC Global Strategy, totaling nearly US$30 billion to deliver on the promises of a sustainable future for all. More information is available at http://www.everywomaneverychild.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 iSpO₂ ^® Rx. 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 iSpO₂ Rx , 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.