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

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    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
    pierrick.n[email protected]