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New Study Investigates the Utility of Home Monitoring Using Masimo SET® Pulse Oximetry to Screen Children with Down Syndrome for Risk of Obstructive Sleep Apnea Prior to Diagnostic Multichannel Sleep Studies

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Masimo (NASDAQ: MASI) announced today the findings of a recently published study in
which researchers investigated whether home pulse oximetry monitoring
might be a useful initial screening method of determining which children
with Down syndrome (DS) – who are at high risk of obstructive sleep
apnea (OSA) – be recommended to undergo multichannel sleep studies to
diagnose the condition. The home monitoring was conducted using Masimo
SET® Measure-through Motion and Low Perfusion™ pulse oximetry.1

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Masimo Radical-7® Pulse CO-Oximeter® (Photo: Business Wire)

Masimo Radical-7® Pulse CO-Oximeter® (Photo: Business Wire)

Noting that OSA "can only be reliably diagnosed using multichannel sleep
studies, which are expensive, demanding for families and only available
in specialist centres," Dr. Hill and colleagues at the University of
Southampton and Southampton Children's Hospital sought to determine
whether home pulse oximetry monitoring could identify children at high
risk of OSA, and in particular which parameters could most sensitively
detect this risk, as an initial screening step. To that end, they
studied 161 children with DS, aged 0.5 to 6 years, of whom 25 were
separately diagnosed with OSA. The patients were monitored overnight
using Masimo Radical-7® Pulse CO-Oximeters®, with
pulse oximetry sensors placed on the great toe. Recorded measurements
included: total artifact-free time analyzed, mean oxygen saturation (SpO2),
minimum SpO2, 3% oxyhemoglobin desaturation index (ODI),
delta 12s index (the absolute difference between successive 12 second
interval recordings, a measure of baseline SpO2 variability)
and the number of minutes per hour that SpO2 was below 90%.

Receiver operating curves (ROC) and area under the curve (AUC)
statistics were calculated to determine which measurements, alone and in
combination, best predicted OSA status. During data analysis,
researchers were blinded to which children had separately received a
diagnosis of OSA. The researchers found that "the greatest AUC was
achieved by the delta 12s index. At a threshold of >0.555, this
identified 23/25 (sensitivity 92%) OSA cases and 89/136 true negatives
(specificity 65%). The same sensitivity was achieved for 3% ODI with
marginally lower specificity of 63% (86/136 true negatives)." The
combined model (delta 12s index, 3% ODI, mean and minimum SpO2)
detected all true positives (100% sensitivity) but with lower
specificity (53%). This result would lead 60% of the sample population
(12 true positives and 18 false negatives) to confirmatory multichannel
studies.

The researchers concluded that "universal screening for OSA in children
with DS using simple pulse oximetry parameters could halve the number of
children requiring specialist multichannel studies. Pulse oximetry is
widely available, well tolerated, readily acquired in the home and its
adoption could reduce the burden on health services and families alike."

The researchers noted that "our findings specifically apply to
parameters generated by Masimo oximeters and cannot be generalised to
other devices. Masimo technology extracts motion artefact, this is
important in children with DS who are restless sleepers." They also
noted that "the use of a retrospective clinical dataset, with anonymous
data shared for this analysis, limits our information on the wider
sampling frame, demographic and clinical characteristics of these
children."

Masimo pulse oximetry is not cleared in the United States to screen
children with Down syndrome for risk of obstructive sleep apnea.

@MasimoInnovates |
#Masimo

Reference

  1. Hill C, Elphick H, Farquhar M, Gringras P, Pickering R, Kingshott R,
    Martin J, Reynolds J, Joyce A, Gavlak J, and Evans H. Home oximetry to
    screen for obstructive sleep apnoea in Down syndrome. Arch Dis
    Child.
    doi:10.1136/archdischild-2017-314409.

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 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 17 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/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.

References

  1. 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.
  2. 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.
  3. 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.
  4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia
    Patient Safety Foundation Newsletter
    . Spring-Summer 2012.
  5. 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.
  6. Estimate: Masimo data on file.
  7. 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 SET® and Radical-7®. 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® and
Radical-7, 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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