Masimo to debut this latest Rainbow SET(R) parameter at the upcoming World
Congress of Anesthesiologists Meeting
IRVINE, Calif., Feb. 25 /PRNewswire-FirstCall/ -- Masimo, the inventor of
Pulse CO-Oximetry(TM) and Measure-Through Motion and Low Perfusion pulse
oximetry, announced that it will debut its breakthrough technology for
noninvasive and continuous total hemoglobin (SpHb(TM)) and oxygen content
(SpOC(TM)) monitoring at the World Congress of Anesthesiology (WCA) in Cape
Town, South Africa, on March 3, 2008.
The advent of noninvasive total hemoglobin within the Masimo Rainbow SET
platform will make hemoglobin testing more convenient and broadly available to
medical personnel in both the acute and outpatient settings-the measurement is
instantaneous and pain-free. Over 350 million hemoglobin tests are done in
the US alone each year. Prior to Masimo Rainbow SET, invasive and
time-consuming lab tests were the only methods available to determine total
hemoglobin levels which provided delayed and intermittent data.
Masimo expects to make SpHb and SpOC shipments to select customers for
clinical use in the second half of 2008, pending regulatory clearances. There
is a 510(k) pending for SpHb and SpOC in the US.
Martin Allard, M.B.Ch.B, FRC, Professor and Director of Research,
Department of Anesthesiology, Loma Linda University, stated, "From its
application as a noninvasive tool for universal hemoglobin screening at
routine health check-ups to the management of blood loss and blood replacement
in patients experiencing acute blood loss, or those undergoing surgery
-- these new measurements could prove to be indispensable in a wide variety of
healthcare settings."
"Noninvasive, continuous total hemoglobin and oxygen content monitoring
should allow for more timely interventions both inside and outside of the
operating room and should enable emergency medical professionals, dialysis
centers, family physicians, cardiologists and other care providers to better
care for their patients," said Joe E. Kiani, Founder & CEO of Masimo.
For the first time, the Masimo Rainbow SET technology platform will
provide clinicians with access to real-time trending and tracking of a
patient's total hemoglobin status enabling them to quickly identify conditions
of anemia, or blood loss. When patients undergo blood transfusions,
clinicians will be able to use Masimo Rainbow SET SpHb to titrate blood and
maintain hemoglobin levels within acceptable ranges. Additionally, continuous
monitoring of hemoglobin levels may provide clinicians with an early warning
of possible internal hemorrhaging in the emergency department, trauma and
post-op settings. Because blood and hemoglobin restoration must be carefully
titrated to targeted levels to avoid potentially serious morbidities, Masimo
Rainbow SET SpHb provides instant feedback that the proper levels are
achieved, advancing patient safety and accelerating recovery. On July 30,
2007, The Centers for Medicare and Medicaid Services released their final
National Coverage Determination (NCD) restricting coverage for the treatment
of anemia, specifically Erythropoiesis Stimulating Agents (ESA) therapy, to
when the hemoglobin level is less than 10g/dL. This ruling makes hemoglobin
testing a prerequisite to coverage and possibly administration of ESA therapy
in certain patients.
"I believe the availability of Masimo Rainbow SET SpHb will revolutionize
the management of anemia across clinical settings and scenarios and could
provide a solution for those looking to satisfy The Centers for Medicare and
Medicaid Services' new rules for hemoglobin testing," stated Michael O'Reilly,
MD, EVP of Medical Affairs at Masimo.
A simple upgrade to most Masimo Radical pulse oximeters is all that will
be necessary to transform an existing monitor to Masimo Rainbow SET
performance -- enabling integration of noninvasive total hemoglobin monitoring
into any clinical setting.
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, and with it 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 trustworthy SpO2 and pulse rate measurements even under the most
difficult 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(TM)), methemoglobin (SpMet(TM)),
and pleth variability index (PVI(TM)), in addition to oxyhemoglobin (SpO2),
perfusion index (PI) and pulse rate, 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 http://www.masimo.com.
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 testing
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, and will be timely cleared, if ever, by appropriate regulatory bodies,
as well as other factors discussed in the "Risk Factors" section of our
quarterly report on Form 10-Q for the quarter ended September 29, 2007, filed
with the Securities and Exchange Commission on November 1, 2007. 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 September
29, 2007, whether as a result of new information, future events or otherwise,
except as may be required under the federal securities laws.
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, and Pulse CO-Oximeters are trademarks
or registered trademarks of Masimo Corporation.
SOURCE Masimo Corporation
CONTACT: Dana Banks of Masimo Corporation, +1-949-297-7348
Web site: http://www.masimo.com