Masimo and Mindray Announce Expanded Partnership

Mindray to Offer Masimo SET® Pulse Oximetry
in its Patient Monitoring Devices in Additional Countries Beyond the
United States

NEUCHATEL, Switzerland & SHENZHEN, China–(BUSINESS WIRE)–Masimo (NASDAQ:
MASI) and Shenzhen
Mindray Bio-Medical Electronics Co., Ltd.
(SZSE: 300760) announced
today that they have entered into a purchase and license agreement,
under which Mindray will offer Masimo SET® Measure-through
Motion and Low Perfusion™ pulse oximetry – noninvasive, continuous
measurement of oxygen saturation (SpO2), pulse rate (PR), and
perfusion index (Pi) – in its monitoring devices. Mindray devices
equipped with SET® will now be available in select countries
in Europe, the Middle East, Russia and the Commonwealth of Independent
States, and Asia-Pacific (excluding China), including Australia and
India.


With the invention of Signal Extraction Technology® (SET®),
Masimo established a new standard for pulse oximetry by introducing the
ability to measure through motion and low perfusion. In a study
comparing multiple pulse oximetry technologies, SET® was
shown to demonstrate the highest sensitivity and specificity in
identifying desaturation events and avoiding false desaturation events
during these conditions.1 SET® has also opened up
new frontiers in patient monitoring during challenging conditions:
outcome studies have shown that SET®, combined with clinical
assessment, has helped clinicians reduce retinopathy of prematurity
(ROP) in neonates,2 improve critical congenital heart disease
(CCHD) screening in newborns,3 and through continuous
monitoring of patients in post-surgical wards, reduce ICU transfers and
rapid response team activations.4-6 In all, over 100
independent and objective studies have shown that SET®
outperforms other pulse oximetry technologies.7 Masimo
continues to refine SET®, and recently announced that SpO2
accuracy specifications have now improved to 1.5% in conditions of
motion and no motion for adult, pediatric, and infant patients (> 3 kg)
with RD SET™ sensors. Now, the benefits of Masimo SET® are
also available to clinicians using Mindray’s devices in many countries
outside the United States, where Mindray has offered SET®
pulse oximetry in devices from Datascope (which began offering SET®
in 1998) since acquiring Datascope in 2008.

Mindray is a leading global provider of medical devices and solutions.
Mindray’s products and services can be found in healthcare facilities in
over 190 countries, and over 1.1 million Mindray monitors have been used
or are in use across the world, representing the world’s third-largest
patient monitoring market share. Patient monitors now available with
integrated Masimo SET® pulse oximetry include the Mindray
BeneVision N and BeneView T series for use in high-acuity environments
and the ePM, iPM, and iMEC series for use in a variety of clinical
scenarios, among other devices.

Jon Coleman, President of Worldwide Sales, Professional Services, and
Medical Affairs, Masimo, commented, “We’re excited to enter into this
agreement with Mindray, so that more patients, clinicians, and hospitals
can benefit from the unmatched performance of Masimo SET®
pulse oximetry.”

Yang Ting, General Manager of International Sales and Marketing, Patient
Monitoring and Life Support, Mindray, said, “We are very happy to expand
our cooperation with Masimo from North America to more regions, so that
our customers will have access to the outstanding SpO2
technology from Masimo. It is a proof of our constant commitment to
bringing advanced medical technologies to people in need, and making
better healthcare more accessible for all.”

@MasimoInnovates |
#Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that
develops and produces a wide array of industry-leading monitoring
technologies, including innovative measurements, sensors, patient
monitors, and automation and connectivity solutions. Our mission is to
improve patient outcomes and reduce the cost of care. Masimo SET®
Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in
1995, has been shown in over 100 independent and objective studies to
outperform other pulse oximetry technologies.7 Masimo SET®
has also been shown to help clinicians reduce severe retinopathy of
prematurity in neonates,2 improve CCHD screening in newborns,3
and, when used for continuous monitoring with Masimo Patient SafetyNet™
in post-surgical wards, reduce rapid response activations and costs.4-6
Masimo SET® is estimated to be used on more than 100
million patients in leading hospitals and other healthcare settings
around the world,8 and is the primary pulse oximetry at 9 of
the top 10 hospitals listed in the 2018-19 U.S. News and World Report
Best Hospitals Honor Roll.9 Masimo continues to refine SET®
and in 2018, announced that SpO2 accuracy on RD SET™ sensors
during conditions of motion has been significantly improved, providing
clinicians with even greater confidence that the SpO2 values
they rely on accurately reflect a patient’s physiological status. 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®), RPVi™ (rainbow®
PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the
Root® Patient Monitoring and Connectivity Platform, built
from the ground up to be as flexible and expandable as possible to
facilitate the addition of other Masimo and third-party monitoring
technologies; key Masimo additions include Next Generation SedLine®
Brain Function Monitoring, O3® Regional Oximetry, and ISA™
Capnography with NomoLine® sampling lines. Masimo’s family of
continuous and spot-check monitoring Pulse CO-Oximeters®
includes devices designed for use in a variety of clinical and
non-clinical scenarios, including tetherless, wearable technology, such
as Radius-7®, portable devices like Rad-67™, fingertip pulse
oximeters like MightySat® Rx, and devices available for use
both in the hospital and at home, such as Rad-97™. Masimo hospital
automation and connectivity solutions are centered around the Iris®
platform, and include Iris Gateway™, Patient SafetyNet, Replica™, Halo
ION™, UniView™, and Doctella™. 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/evidence/featured-studies/feature/.

ORi and RPVi have not received FDA 510(k) clearance and are not
available for sale in the United States. 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. 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;Jan
8;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 A 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.
Published clinical studies on pulse oximetry and the benefits of Masimo
SET® can be found on our website at http://www.masimo.com.
Comparative studies include independent and objective studies which are
comprised of abstracts presented at scientific meetings and
peer-reviewed journal articles.
8. Estimate: Masimo data on file.
9.
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About Mindray

Founded in 1991, Mindray is one of the leading global providers of
medical devices and solutions. Firmly committed to our mission of
“advance medical technologies to make healthcare more accessible,”
Mindray is dedicated to innovation in the fields of Patient Monitoring &
Life Support, In-Vitro Diagnostics, and Medical Imaging System. Mindray
possesses a sound global R&D, marketing and service network. Inspired by
the needs of customers, Mindray adopts advanced technologies and
transforms them into accessible innovation, bringing healthcare within
reach. While improving the quality of care, Mindray helps reduce its
cost, making it more accessible to a larger part of humanity. Today,
Mindray’s products and services can be found in healthcare facilities in
over 190 countries and regions. In China, Mindray’s products and
solutions can be found in over 110,000 medical institutions and 99% of
Class A tertiary hospitals.

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 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.

Contacts

Masimo
Evan Lamb
949-396-3376
[email protected]

Mindray
Vicky Wang
0086 755 81888775
[email protected]

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