Masimo Announces First CE-marked Third-party Masimo Open Connect® Module for the Root® Patient Monitoring and Connectivity Hub

NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ:
MASI) and Mdoloris
Medical Systems
announced today the CE marking of the Mdoloris
Analgesia Nociception Index (ANI®) module for the Masimo Root®
Patient Monitoring and Connectivity Hub, the first commercially
available result of a Masimo Open Connect® (MOC) third-party
partnership, between Mdoloris and Masimo.


Masimo’s unique approach to medical technology integration through
Masimo Open Connect partnerships addresses some of the major barriers to
new technology adoption in patient monitoring. The Root platform’s open
architecture and advanced connectivity enable third-party companies to
bypass barriers and the time it takes for traditional multi-parameter
monitor integration by controlling their own Root integration projects.
Third parties can then independently develop, obtain regulatory
approvals, and commercialize their own external MOC-9® module
or MOC-C® app for Root using Masimo’s MOC software
development kit and support from Masimo’s engineering and distribution
teams.

Joe Kiani, Founder and CEO of Masimo, said, “We are proud to announce
ANI, the first commercially available third-party MOC-9 module for Root,
the first of many to come. With the ongoing expansion of its
capabilities, Root becomes a more powerful bedside platform than ever.
We believe that Root with Masimo Open Connect can do for patient
monitoring what the PC did for computing: speed up the patient
monitoring innovation cycle, reduce the cost of patient monitoring, and
prolong the useful life of the equipment hospitals invest in.”

“We are delighted to be able to announce that ANI is now cleared for
sale in the EU,” said Fabien Pagniez, Founder and CEO of Mdoloris
Medical Systems. “We consider Masimo to be the most innovative company
in the patient monitoring space and we believe Root offers a unique and
compelling solution for implementing our ANI technology.”

ANI on Masimo Root has not received 510(k) clearance and is not
available for sale in the United States.

@MasimoInnovates |
#Masimo

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 over 100 independent and objective studies to outperform other
pulse oximetry technologies.1 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,7 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.8 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/evidence/featured-studies/feature/.

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.

About Mdoloris Medical Systems

Mdoloris (www.mdoloris.com),
a medical devices manufacturer, was created in June 2010 out of 23 years
of academic research performed in Lille University hospital, France. It
has an international representation in more than 64 countries and a
scientific, technical and medical acknowledgement. Mdoloris has so far
developed three products, all able to continuously assess the pain level
of patients (the ANI technology for patients older than two years old,
the NIPE technology for neonates, and the PTA technology for pets). Its
innovative technologies provide clinical added value for clinicians who
are not able to communicate with their patients in order to personalize
pain medications and avoid known side effects due to over- and
under-dosage of such drugs. More than 1,200 devices are now used by
anesthesiologists and intensivists worldwide and more than 140,000
patients have benefited from Mdoloris’ technologies. Mdoloris’s
standalone monitor promoting its innovative adult technology has
received 510(k) clearance through the HFVI brand in the US under the
number K142969. Mdoloris recently closed a nine-million euro fundraising
round in order to keep developing new-to-the-world technologies that
always keep one target in mind: helping clinicians improve the quality
of care.

References

  1. 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.
  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. Estimate: Masimo data on file.
  8. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

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 Root®. 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 Root, 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]

Mdoloris
Pierrick Niewiadowski
[email protected]

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