New Study Reports on Accuracy of Masimo’s Blue® Sensors at Saturations below 85% in Children with Cyanotic Congenital Heart Disease

IRVINE, Calif.–(BUSINESS WIRE)–Masimo
(NASDAQ: MASI) announced today that a new study reported on the accuracy
of Masimo’s Blue® sensors as compared to Nellcor and Masimo Standard
sensors for cyanotic children with blood oxygen saturation less than 85%.¹
Masimo’s Blue sensor was designed specifically for cyanotic infants and
children with congenital heart disease.

The study was performed at the Lucile Packard Children’s Hospital at
Stanford University with the aim of determining, in children with
cyanotic congenital heart disease, which of three different pulse
oximeter sensors is the most accurate at lower blood oxygen saturation
levels, when compared to the “gold standard” of arterial blood gas
analysis with CO-oximetry. The three sensors were Masimo SET^®
with LNCS^® sensor (Masimo Standard), Masimo SET® with Blue
sensor (Masimo Blue), and Nellcor™ N-600 with MAX-I sensor (Nellcor).

In the study, published in the journal Pediatric Critical Care
Medicine, Dr. Harris and colleagues collected data from 50 infants
and children weighing 3–20 kg with baseline saturations under 90%
(measured by pulse oximetry at the time of clinical assessment)
undergoing surgical or catheterization procedures. Following standard
care monitoring, which included placement of the Masimo Standard sensor,
the Masimo Blue and Nellcor MAX-I sensors were placed on a thumb or
great toe, or alternatively on a finger. Up to four arterial blood
samples were taken from each subject.

Compared to the CO-oximeter saturations (SaO₂) over all
measurements, the mean error ± standard deviation of the saturation
values from pulse oximetry (SpO₂) for the Masimo Blue,
Nellcor, and Masimo Standard sensors were 1.7% ± 3.3%, 1.7% ± 5.4%, and
2.4% ± 4.9%, respectively.

The investigators concluded that “the Masimo Blue sensor has improved
accuracy at saturations 75–85% versus the Nellcor and Masimo Standard
sensors,” although the authors noted inaccuracies with all three sensors
in this saturation range. The authors suggested there is a continued
need for device manufacturers to calibrate and develop algorithms for
pulse oximeters to have improved overall accuracy at saturations less
than 85%. The authors further stated “clinical decisions at saturations
below 85% should not be made by pulse oximetry alone; instead,
co-oximetry and/or an arterial blood gas is warranted.”

Study limitations included small sample size, difficulty collecting
steady-state samples from the operating room and catheterization lab,
and placement of the Masimo Standard sensor in nonstandard locations.

The institution where this study was performed received a grant from
Masimo to partially support the data collection for this study.

@MasimoInnovates
| #Masimo

1. Harris BU, Char DS, Feinstein JA, Verma A, Shiboski SC, Ramamoorthy
C. Accuracy of Pulse Oximeters Intended for Hypoxemic Pediatric
Patients. Pediatr Crit Care Med. 2016 Feb 24. [Epub ahead of print]
PubMed PMID: 26914626.

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 by taking noninvasive monitoring to new sites
and applications. 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. The benefits of Masimo SET® have
been proven in more than 100 independent and objective studies and it is
estimated to be used on more than 100 million patients in leading
hospitals and other healthcare settings around the world. 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®), and more recently, Pleth Variability Index
(PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate,
and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive
open architecture patient monitoring and connectivity platform designed
to speed the pace of innovation and reduce the cost of care. Masimo is
also taking an active leadership role in mHealth with products such as
the Radius-7™ wearable patient monitor and the MightySat™ fingertip
pulse oximeter. Additional information about Masimo and its products may
be found at www.masimo.com.
All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

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’s Blue® sensor. 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’s Blue® sensor, contribute to positive clinical
outcomes and patient safety; risks related to our belief that Masimo
noninvasive medical breakthroughs provide cost-effective solutions with
comparable accuracy and unique advantages, including: immediate and
continuous results that enable earlier treatment without causing
invasive trauma in all patients and in every clinical situation; 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
Irene Paigah, 858-859-7001
irenep@masimo.com