Masimo Receives FDA Clearance For Noninvasive Total Hemoglobin

Masimo, the inventor
of Pulse CO-Oximetry(TM) and Measure-Through Motion-and-Low-Perfusion pulse
oximetry, announced it has received FDA clearance for its
breakthrough noninvasive and continuous total hemoglobin monitoring
technology (SpHb(TM)). The availability of Masimo SpHb technology should
make hemoglobin measurement more convenient and broadly available to
clinicians in both hospital and outpatient settings -- helping them make
earlier and better clinical decisions, improve patient safety and decrease
costs. Noninvasive total hemoglobin will be offered as part of the
upgradable Masimo Rainbow SET technology platform.


Ronald Miller, MD, Professor and Chair of the Department of Anesthesia
and Perioperative Care at the University of California at San Francisco
(UCSF) stated, "Management of appropriate blood levels is vitally important
to sustain life. Without up-to-date hemoglobin levels, patient bleeding in
the operating room, recovery room, intensive care or trauma departments --
where blood loss is common -- can often go undetected until it poses
critical short and long-term dangers to health and recovery. The ability to
immediately and continuously measure hemoglobin levels will facilitate the
timely administration of appropriate blood products. Conversely, during
surgery, because blood is a precious and costly resource, continuously
measuring hemoglobin levels noninvasively can help clinicians avoid
unnecessary blood transfusions and decrease costs by more effectively
titrating blood and blood replacement products."



Joe E. Kiani, Chairman and CEO of Masimo, said, "Developing
breakthrough technologies that enhance patient safety and automate patient
care is a responsibility that we take seriously. With noninvasive
hemoglobin as part of the upgradable Masimo Rainbow SET platform, we are
proud to be revolutionizing the way clinicians can assess anemic status and
make more timely decisions that affect millions of patients worldwide."



The need for better hemoglobin monitoring to manage blood levels is
reinforced by recently published controlled studies that show the safety of
blood transfusions can be improved by the use of transfusion thresholds. In
a 2008 study by the Cochrane Collaboration titled Transfusion Thresholds
and Other Strategies for Guiding Allogeneic Red Blood Cell Transfusion,
reviewers examined evidence from ten trials -- reporting outcomes on a
total of 1,780 patients -- and found that "restrictive transfusion
strategies reduced red blood cell transfusions by 42%."



Additionally, while noting that not all of these results were
statistically significant and that additional studies are required to
confirm the findings, the Cochrane reviewers also reported that, "on
average, mortality was 20% lower with the restrictive compared with the
liberal transfusion triggers." Similarly, five of the ten studies examined
showed a reduction in hospital length of stay, while three showed a
reduction in ICU length of stay. (1)
















Continuous, noninvasive hemoglobin monitoring with Masimo Rainbow SET
SpHb may enable more restrictive transfusion triggers and help maintain
optimal hemoglobin levels for critically-ill patients. In addition to
facilitating better blood level management, Masimo Rainbow SET's
noninvasive hemoglobin monitoring capability should also help clinicians
better manage chronic anemia, a blood disorder affecting two billion people
worldwide that is one of today's most prevalent public health problems.
Masimo Rainbow SET SpHb should provide hospitals, emergency medical
professionals, dialysis centers, family physicians, cardiologists,
pediatricians and other care providers with a more convenient and
accessible way to manage this pervasive condition.



More than 350 million invasive hemoglobin lab tests are performed each
year in the U.S. alone, making it one of the most common laboratory tests.
Hemoglobin lab tests are costly, time-consuming and require that clinicians
use a needle to draw a patient's blood -- however, they only provide
delayed and intermittent data. Masimo's SpHb technology requires no
invasive procedures and provides continuous, real-time, pain-free results.
This should allow clinicians to perform fewer lab tests, better manage
blood transfusions and hemodialysis procedures, speed detection of internal
bleeding, and more efficiently assess chronic anemia -- all of which should
help improve patient outcomes and reduce the cost-of-care.



"No other technology can provide continuous, noninvasive hemoglobin
measurements," stated Michael O'Reilly, MD, Executive Vice President of
Medical Affairs at Masimo. "Masimo Rainbow SET SpHb has the potential to
revolutionize the management of both acute and chronic anemia, as well as
the therapeutic interventions used to treat these conditions. We believe
SpHb will provide a significant advancement in patient safety for
clinicians worldwide."




The Masimo Rainbow SET platform allows clinicians to noninvasively and
continuously measure oxygen content (SpOC(TM)), carboxyhemoglobin
(SpCO(R)), methemoglobin (SpMet(R)), PVI(TM) and total hemoglobin
(SpHb(TM)), in addition to oxyhemoglobin (SpO2), perfusion index (PI), and
pulse rate (PR). Masimo anticipates commercial availability for both SpHb
and SpOC in Q3 2008 to select customers.



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, 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 Masimo Rainbow SET, a
breakthrough noninvasive blood constituent monitoring platform that can
measure many blood constituents that previously required invasive
procedures. Rainbow SET continuously and noninvasively measures total
hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin
(SpCO(R)), methemoglobin (SpMet(R)), and PVI(TM), 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 masimo.



Forward Looking Statements



This press release may include forward-looking statements. These
forward-looking statements are based on current expectations about future
events affecting us and are subject to uncertainties and factors, all of
which are difficult to predict and many of which are beyond our control,
including: risks related to our assumption that Masimo's new noninvasive
measurements -- total hemoglobin (SpHb(TM)) and oxygen content (SpOC(TM))
-- will deliver a sufficient level of clinical improvement over alternative
hemoglobin measurement capabilities to allow for rapid adoption of the
technology and risks related to our assumptions regarding the timing or
commercial availability of SpHb and SpOC, as well as other factors
discussed in the "Risk Factors" section of our quarterly report on Form
10-Q for the quarter ended March 29, 2008, filed with the Securities and
Exchange Commission on May 1, 2008. Although we believe that the
expectations reflected in our forward-looking statements are reasonable, we
do not know whether our expectations will prove correct. You are cautioned
not to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. We do not undertake any obligation to
update, amend or clarify these forward- looking statements or the risk
factors contained in our quarterly report on Form 10-Q for the quarter
ended March 29, 2008, whether as a result of new information, future events
or otherwise, except as may be required under the federal securities laws.



(1) Hill SR, Carless PA, Henry DA, Carson JL, Herbert PC, McClelland DBL,
Henderson KM. Transfusion thresholds and other strategies for guiding
allogeneic red blood cell transfusion. Cochrane Database of
Systematic Reviews 2000, Issue 1. Art. No.: CD002042. DOI:
10.1002./14651858.CD002042.


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.


Masimo Corporation

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