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.
SICHUAN PROVINCE, China--(BUSINESS WIRE)--Sep. 14, 2017--
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
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
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
“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.
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.
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.
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.
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 iSpO2Rx
, 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.
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Evan Lamb, 949-396-3376