New Clinical Study Finds Pronto® Has Similar Accuracy to Commonly Used Point-of-Care Invasive Hemoglobin Analyzer

    New Clinical Study Finds Pronto® Has Similar Accuracy to Commonly Used
                  Point-of-Care Invasive Hemoglobin Analyzer

PR Newswire

IRVINE, Calif., Oct. 24, 2012

IRVINE, Calif., Oct. 24, 2012 /PRNewswire/ --Masimo (NASDAQ: MASI) announced
today that a new study published in Postgraduate Medicine demonstrates
noninvasive total hemoglobin (SpHb^®) measurements from the Pronto have an
accuracy similar to those of the most commonly used invasive point-of-care
(POC) hematology analyzer (HemoCue^® 201+, Quest Diagnostics) in outpatient

Total hemoglobin (Hb) is one of the most frequently ordered laboratory tests
in hospitals, urgent care centers, physician offices, and public health
clinics.^2 Anemia, defined as low hemoglobin concentration, is among the most
common blood disorders in the United States, afflicting an estimated 3.4
million Americans, according to the National Center for Health Statistics.
Many people are at risk for anemia because of poor diet, intestinal disorders,
chronic diseases, infections, and other conditions. The signs and symptoms of
anemia can be easily overlooked, and many people do not realize they have
anemia until it is identified by a blood test.

Yet conventional invasive POC testing is time-consuming and exposes the
patient and clinician to potential contamination and exposure to blood-borne
pathogens. Errors occurring during the pre-analytical phase – from the time
the test is ordered by the physician until the sample is ready for analysis –
can account for up to 93% of the errors currently encountered during the total
diagnostic process.^3 A review of multiple studies in 2002 showed similarly
high levels of errors.

The study that appears in Postgraduate Medicine, by Marina Raikhel, M.D., of
the Torrance Clinical Research Institute in Lomita, Calif., measured
hemoglobin of 152 subjects (69% women) presenting at an outpatient research
clinic with common conditions such as diabetes, asthma, high cholesterol and
high blood pressure.

Compared to laboratory analysis of blood, the bias ± standard deviation were
−0.5 ± 1.0 g/dL for SpHb and 0.3 ± 1.0 g/dL for HemoCue 201+.Noninvasive
SpHb testing had bias and standard deviation similar to those of HemoCue 201+,
according to the study.

Device             Pronto             HemoCue
Sample Type        Noninvasive        Invasive
Methodology        Spectrophotometric Photometric
Bias               -0.5 g/dL          0.3 g/dL
SD                 1.0 g/dL           1.0 g/dL
Limit of agreement -2.5 to 1.5 g/dL   - 1.7 to 2.3 g/dL

"Because SpHb measurement is noninvasive, it has the potential to confer the
additional benefits of patient comfort, decreased complexity, and increased
safety for health care providers who are not exposed to risks of needle-stick
injury and blood-spill contaminations," the study concluded.

"As this study shows, the accuracy of the Pronto provides clinicians a
powerful, yet painless, tool to test total hemoglobin without many of the
risks associated with conventional, invasive testing," said Dr. Michael
O'Reilly, Chief Medical Officer at Masimo. "The simplicity, safety and
accuracy of the Pronto can help hospitals, clinics and physician offices
improve processes and patient outcomes."

1 Raikhel M. "Accuracy of Noninvasive and Invasive Point-of-Care Total Blood
Hemoglobin Measurement in an Outpatient Setting" Postgraduate Medicine, Volume
124, Issue 4, July 2012, ISSN – 0032-5481, e-ISSN – 1941-9260.
2 Steindel SJ, Rauch WJ, Simon MK, Handsfield J. National Inventory of
Clinical Laboratory Testing Services (NICLTS). Development and test
distribution for 1996. Arch Pathol Lab Med. 2000;124:1201-1208.
3 Preanalytical variability: the dark side of the moon in laboratory testing.
G Lippi, GC Guidi, C Mattiuzzi, and M Plebani. Clin Chem Lab Med, Jan 2006;
44(4): 358-65.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive
monitoring technologies that significantly improve patient care—helping solve
"unsolvable" problems. In 1995, the company debuted Measure-Through Motion and
Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated
false alarms and increased pulse oximetry's ability to detect life-threatening
events. More than 100 independent and objective studies demonstrate Masimo SET
provides the most reliable SpO2 and pulse rate measurements even under the
most challenging clinical conditions, including patient motion and low
peripheral perfusion. In 2005, Masimo introduced rainbow® SET Pulse
CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of
blood constituents that previously required invasive procedures, including
total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®),
methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to
SpO2, pulse rate, and perfusion index (PI). In 2008, Masimo introduced Patient
SafetyNet™, a remote monitoring and wireless clinician notification system
designed to help hospitals avoid preventable deaths and injuries associated
with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic
Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic
respiration rate (RRa™). Masimo's rainbow SET technology platform offers a
breakthrough in patient safety by helping clinicians detect life-threatening
conditions and helping guide treatment options. In 2010, Masimo acquired
SEDLine®, a pioneer in the development of innovative brain function monitoring
technology and devices. Masimo SET and Masimo rainbow SET technologies can be
also found in over 100 multiparameter patient monitors from over 50 medical
device manufacturers around the world. Founded in 1989, Masimo has the mission
of "Improving Patient Outcomes and Reducing Cost of Care... by Taking
Noninvasive Monitoring to New Sites and Applications®." Additional information
about Masimo and its products may be found at

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 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, 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 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
forward-looking 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

Media Contacts:
Mike Drummond
Masimo Corporation
(949) 297-7434

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and
Reducing Cost of Care… by Taking Noninvasive Monitoring to New Sites and
Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic
Monitoring, RRa, Radical-7, Rad-87, Rad-57,Rad-8, Rad-5,Pulse CO-Oximetry,
Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine are trademarks or
registered trademarks of Masimo Corporation. The use of the trademarks Patient
SafetyNet and PSN are under license from University HealthSystem Consortium.

SOURCE Masimo Corporation

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