Masimo Initiates Full Market Release of First-Ever Noninvasive Continuous Hemoglobin...

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Tue Mar 24, 2009 8:01am EDT

Masimo Initiates Full Market Release of First-Ever Noninvasive Continuous
Hemoglobin Monitor

Success in Limited Market Release Hospitals Highlights Early Clinical Benefits
and Patient Impact 

IRVINE, Calif., March 24 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI), the
inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion
pulse oximetry, announced today that it has initiated the full market release
of its breakthrough noninvasive and continuous hemoglobin (SpHb(TM))
monitoring technology. As the first noninvasive and continuous hemoglobin
monitoring technology to receive FDA 510(k) clearance and be available for
widespread commercial adoption, Masimo SpHb is already transforming the way
hemoglobin testing is performed at over 40 hospitals in the U.S., Europe,
Asia, and Africa, that have participated in the technology's limited market
release initiated in September of 2008.

The availability of noninvasive, continuous, and immediate hemoglobin
measurements is expected to have wide ranging clinical impact, from surgery
and intensive care to less acute care settings, including the emergency
department, physician office, ambulatory surgery center, and long-term care
facility by facilitating prompt detection of internal bleeding and more
appropriate administration of blood transfusions.  Early benefits and impact
of Masimo SpHb were evident in feedback received from clinicians at hospitals
around the world who participated in the limited market release.  

Ronald Miller, MD, Chief of Anesthesia, Professor and Chairman of the Dept. of
Anesthesia and Perioperative Care at the University of California, San
Francisco, stated, "Masimo SpHb is an impressive new tool that helps us to
more safely guide patients in surgery through to recovery.  With it, not only
can we spot hemoglobin changes as they occur, but we can see where they are
heading.  This ability to identify an upward or downward hemoglobin trend on a
second-by-second basis as it occurs has been of tremendous value."

Randy Marcel, MD, Medical Director and Chief of Anesthesiology at The Heart
Hospital Baylor Plano in Plano, Texas, stated, "In the past, we've only
received glimpses of our patients' hemoglobin levels from lab measurements,
but now we have complete and real-time hemoglobin visibility.  We initially
purchased SpHb for use during cardiac surgeries in the OR, and brought in
additional units for the ICU, where post-operative monitoring of internal
bleeding is critical to patient recovery."

Javed Akhtar, MD, FAAP, Medical Director, Pediatric Intensive Care Unit at
Creighton University Medical Center in Omaha, Nebraska, stated, "We purchased
the SpHb monitor after seeing it in a hands-on demonstration, and I'm glad we
did!  SpHb has reduced the traumatic experience for pediatric patients,
increased the satisfaction of parents, and reduced the workload on our nursing
staff, phlebotomist and laboratory personnel."  

Madhava Karunarathna, MD, OB/GYN at Balangoda Hospital in Sri Lanka, stated,
"With SpHb, we now have accurate hemoglobin measurements available at our
fingertips, around the clock.  In cases of severe hemorrhaging during and
after childbirth, SpHb has enabled us to immediately identify and continuously
assess blood loss severity to better manage internal bleeding, prevent
overloading of fluid, and decrease maternal death." 

Adi Abdussalam Adham, MD, Chief Manager at Accidents Hospital Abu Saleem in
Tripoli, Libya reinforced Dr. Karunarathna's comments, adding that: "In the
operating room, Masimo SpHb has enabled us to more effectively monitor blood
loss and better manage transfusions in surgery, while routine screening in the
ED has helped us to more rapidly identify patients with anemia or internal
bleeding."

Bertrand Debaene, MD, Anesthesiologist at the University Hospital Center of
Poitiers in Poitiers, France believes the combination of SpHb and PVI may
prove to have significant clinical benefits, saying that "SpHb, along with
PVI, have been important improvements for both the department and our
patients.  The ability to track hemoglobin and fluid volume in real-time
allows us to be more precise in our clinical routine." 

SpHb is part of the Masimo Rainbow SET Pulse CO-Oximetry patient monitoring
platform -- the first-and-only upgradable technology platform capable of
continuously and noninvasively measuring multiple blood constituents and
helping to predict fluid responsiveness in patients previously requiring
invasive procedures.  Masimo Rainbow SET noninvasive measurements --
including: total hemoglobin  (SpHb(TM)), oxygen content (SpOC(TM)),
carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), PVI(TM), oxyhemoglobin
(SpO2), pulse rate (PR), and perfusion index (PI) -- have the potential to
facilitate faster, easier and safer health decisions.

Currently available in bedside Masimo Radical-7(R) and Rad-87(R) Pulse
CO-Oximeter patient monitors, SpHb will also be offered in handheld monitors
and select multiparameter patient monitoring brands through Masimo Rainbow SET
Pulse CO-Oximetry technology license agreements. 

Joe Kiani, Founder and CEO of Masimo said, "SpHb's success during the limited
market release phase at hospitals around the world illustrates its expected
significant impact on clinical practice and patient care.  In addition and as
we expected, our limited market release program provided us with the
opportunity to enhance the robustness in low perfusion situations and broaden
the cross section of individuals on which the technology performs.  The
ability for clinicians in hospitals, private practices, and other healthcare
settings to perform immediate and continuous noninvasive hemoglobin monitoring
creates new opportunities to save lives, optimize decision making, improve
care, and reduce costs."

SpHb has received regulatory clearance in the U.S., Canada, Europe and
Australia, and is now available for sale in most of the countries in the
world.

About Masimo
Masimo (NASDAQ: MASI) develops innovative 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(R), 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 Sp02 and pulse rate measurements even under the most challenging
clinical conditions, including patient motion and low peripheral perfusion. 
In 2005, Masimo introduced Masimo Rainbow SET(R) Pulse CO-OximetryTM, a
breakthrough noninvasive blood constituent monitoring platform that can
measure many blood constituents that previously required invasive procedures. 
Masimo Rainbow SET continuously and noninvasively measures total hemoglobin
(SpHbTM), oxygen content (SpOCTM), carboxyhemoglobin (SpCO(R)), methemoglobin
(SpMet(R)), and PVITM, in addition to oxyhemoglobin (SpO2), pulse rate (PR),
and perfusion index (PI), allowing early detection and treatment of
potentially life-threatening conditions. 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 www.masimo.com. 

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 belief that the
commercial availability of SpHb technology and products will serve to increase
adoption, market share and/or revenues for the company, risks that limited
market release clinical results may not be duplicated in the full market
launch, risks related to our assumption that SpHb technology and products will
provide faster, easier and safer means for measuring total hemoglobin and will
lead to additional device sales, and risks related to our assumptions that
Rainbow measurements will deliver a sufficient level of clinical improvement
over alternative capabilities to allow for rapid adoption of the technology,
as well as other factors discussed in the "Risk Factors" section of our Annual
Report on Form 10-K for the fiscal year ended January 3, 2009, filed with the
Securities and Exchange Commission ("SEC") on March 4, 2009, 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 forward-looking statements or the "Risk
Factors" contained in our Annual Report on Form 10-K for the fiscal year ended
January 3, 2009, whether as a result of new information, future events or
otherwise, except as may be required under the applicable securities laws.

    Contact:
    Dana Banks
    Masimo Corporation
    949-297-7348


Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing
Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications,
Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57, Rad-9,
Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or
registered trademarks of Masimo Corporation. Other trademarks used herein are
the property of their respective owners.



SOURCE  Masimo

Dana Banks of Masimo Corporation, +1-949-297-7348
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