Masimo Announces FDA Clearance of Neonatal Indication for O3® Regional Oximetry

IRVINE, Calif.–(BUSINESS WIRE)–Masimo (NASDAQ:
MASI) announced today that O3® Regional Oximetry has received
FDA clearance for use on neonatal and infant patients (<10 kg). O3 may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain. With this expansion of the O3 platform, the benefits of monitoring with O3 are now available to patients of all ages, from neonates to adults.


O3, which uses near-infrared spectroscopy (NIRS) to monitor the regional
hemoglobin oxygen saturation of blood (rSO2) on both sides of
the brain, may be particularly helpful in providing insight into
neonatal patient status because neonatal pathology is often
brain-related.1 In neonates, O3 provides reliable measurement
with a 3% ARMS* trending accuracy specification.

O3 sensors are available in three sizes, for adult (≥40 kg), pediatric
(≥5 kg and <40 kg) and now infant and neonatal (<10 kg) patients. With its smaller size and flexible design, the neonatal sensor is designed to fit easily and comfortably on the delicate foreheads of tiny patients.

O3 is available as a Masimo Open Connect® (MOC-9®)
module for the Root® Patient Monitoring and Connectivity
Platform. Root is a powerful, expandable hub that integrates an array of
technologies, devices, and systems to provide multimodal monitoring and
connectivity solutions. Root’s plug-and-play expansion capabilities
allow clinicians to simultaneously monitor with O3 and other
measurements, such as SET® Measure-through Motion and Low
Perfusion™ pulse oximetry, providing clinicians with expanded visibility
of neonatal oxygenation status. Additional modalities available on Root
include advanced rainbow® noninvasive measurements such as
total hemoglobin (SpHb®), SedLine® brain function
monitoring (available for adult patients), NomoLine®
capnography, and more – all via an easy-to-interpret, customizable
display. Using Root in combination with Masimo Patient SafetyNet™ or
Iris Gateway™, monitoring data from O3 can be automatically charted in
electronic medical records (EMRs).

Joe Kiani, Founder and CEO of Masimo, said, “From our inception, we have
been committed to improving outcomes for the youngest and most fragile
patients. Our foundational SET® pulse oximetry was designed
with neonates and infants in mind. These patients were not an
afterthought. This focus has paid off for these young patients: SET®
pulse oximetry has helped clinicians reduce the incidence of severe
retinopathy of prematurity (ROP) in neonates2 and improve
critical congenital heart disease (CCHD) screening in newborns.3
O3 Regional Oximetry, with its ability to help clinicians accurately
track cerebral oxygen saturation, will hopefully have a similar impact.
We are happy to be able to bring O3’s advanced capabilities and accuracy
to the neonatal patient population.”

@MasimoInnovates |
#Masimo

*ARMS accuracy is a statistical calculation of the difference
between device measurements and reference measurements. Approximately
two-thirds of the device measurements fell within ± ARMS of
the reference measurements in a controlled study.

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.4 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 team activations, ICU
transfers, and costs.5-7 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® and Radius™ PPG,
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. Dix et al. Monitoring Cerebral Oxygenation in Neonates: An Update. Frontiers
    in Pediatrics
    . 2017.
  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. 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.
  5. 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.
  6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia
    Patient Safety Foundation Newsletter
    . Spring-Summer 2012.
  7. 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.
  8. Estimate: Masimo data on file.
  9. 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 O3®. 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 O3, 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]

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