Masimo Announces Halo ION™

IRVINE, Calif.–(BUSINESS WIRE)–Masimo (NASDAQ:
MASI) announced today that after a decade of developing and testing its
comprehensive, scalable, and customizable continuous early warning
score, with the aid of leading expert clinicians around the world, it is
releasing Halo ION™. Halo ION allows clinicians to aggregate trend data
from as few as three physiological parameters (oxygen saturation, pulse
rate, and perfusion index), and as many as are available, including data
from EMRs, into a single continuous early warning score. Each patient’s
Halo ION score is displayed on the Masimo Patient SafetyNet™
Supplemental Remote Monitoring and Clinician Notification System as a
number ranging from zero to 100, helping to streamline clinicians’
patient assessment workflow.

What is difficult for people is easy for Halo ION: in calculating
scores, Halo ION not only takes advantage of immediately available
patient data, but more importantly, keeps track of historical
physiological data and data from other records. Halo ION thus helps to
automate the process by which clinicians assess patient status over
time, providing a cumulative, trended score for each patient, easily
visible on the Patient SafetyNet View Stations or Replica™ mobile
application, configured according to their clinical protocols, that can
help facilitate their determination of a patient’s overall status.
Trends in Halo ION scores, which are calculated according to how the
hospital has chosen to configure Halo ION, help clinicians evaluate
whether patients are improving or deteriorating according to their own
criteria. Clinicians may then use this information to, for example,
intervene with certain patients, to transfer or discharge certain
patients, and to schedule nursing assignment loads accordingly.

Halo ION works by continuously extracting key characteristics from
clinician-selected parameters that are continuously monitored on the Root^®
Patient Monitoring and Connectivity Hub and anything connected to Root –
such as oxygen saturation (SpO₂ using Masimo SET^®
pulse oximetry), noninvasive hemoglobin (SpHb^®), blood
pressure, temperature, and pulse rate – to create an overall score.
Hospitals and clinicians determine which parameters to include in the
overall score, how each is configured, how each is weighted, and how
combinations of changes across multiple parameters affect scoring –
providing the flexibility and customizability to ensure that Halo ION
reflects each institution’s assessment policy.

Unlike other Early Warning Score assessment tools, which take spot-check
snapshots of patient vital signs, Halo ION provides cumulative,
continuous visibility into patient status over time, taking into account
not only historical trend data for each parameter but also more complex
characteristics, such as a parameter’s degree of stability and
variability. Halo ION creates individualized, patient-specific baseline
scores for each parameter – not global, one-size-fits-all thresholds –
and tracks how each patient deviates from their baselines, adjusting the
overall Halo ION score differently for different patients. For example,
the Halo ION score might be different for two patients whose oxygen
saturation drops to 89% if one patient normally has 100% SpO₂
and the other 94%; those different deltas would be reflected in
different amounts of change in their Halo ION scores.

Joe Kiani, Founder and CEO of Masimo, commented, “Precision medicine is
no longer only about the right drug for the right patient based on their
genetics, but also about individualized assessment of their state of
health. Halo ION represents many years of research into how best to take
the complex, almost overwhelming stream of high quality physiological
data available to clinicians and present it in a way that is intuitive,
efficient, and provides individualized insight into a patient’s overall
status. With its unique ability to create patient-specific baselines and
to take into account many subtle changes over time, Halo ION helps
automate and simplify the process of patient assessment, helping
clinicians stay focused on providing the best care for their patients.”

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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.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 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 patients’ 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 http://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. 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 Halo ION™. 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 Halo ION, 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
elamb@masimo.com