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New Johns Hopkins School of Medicine Study Shows Masimo Noninvasive Hemoglobin Monitoring is Accurate During Complex Spine Surgeries
Date:1/18/2011

IRVINE, Calif., Jan. 18, 2011 /PRNewswire/ -- Masimo (Nasdaq: MASI) announced today that a new clinical study demonstrating the clinical accuracy of its noninvasive and continuous hemoglobin (SpHb®) monitoring technology breakthrough was presented last week at the Society for Technology in Anesthesia (STA) Annual Meeting.

The study, presented by the Johns Hopkins School of Medicine, evaluated the accuracy of Masimo SpHb—a noninvasive measurement of hemoglobin blood levels obtained using a Masimo Radical-7® Pulse CO-Oximeter™ with a Masimo rainbow® ReSposable Sensor.
SpHb measurements obtained from 28 patients undergoing complex spine surgeries were compared with invasive blood samples drawn simultaneously and analyzed by a central laboratory.  Results showed a mean bias of -0.3 for SpHb, a standard deviation of 1.0 g/dL and limits of agreement from -2.3 to 1.8 g/dL—demonstrating the "clinically acceptable accuracy" of SpHb when compared to a standard laboratory reference device.  Researchers concluded that "continuous noninvasive SpHb monitoring may lead to earlier intervention and improved patient safety and care in the OR setting."(1)

According to lead researcher, Lauren Berkow, MD, Associate Professor of Anesthesiology and Critical Care Medicine at the Johns Hopkins School of Medicine, "The Masimo noninvasive hemoglobin monitor correlated strongly with gold-standard laboratory hemoglobin even during significant blood loss.  The ability to continuously monitor hemoglobin during complex spine surgery may allow for earlier diagnosis and treatment of anemia related to surgical bleeding as well as prevent over-transfusion."

Traditional blood analysis has many drawbacks, including complexity, time-consuming turnaround times that can impact clinical decisions, and blood loss due to invasive blood draws that have been found to contribute substantially to the anemic conditions that commonly occur in critically ill patients—thereby increasing transfusion rates.  Published studies have shown that transfusion of just one or two units of blood significantly increases infection, pneumonia, sepsis, and mortality after surgery.(2, 3)  These studies also suggest that transfusions and their associated risks could be "largely avoided" through implementation of better blood management techniques and "more appropriate indicators" for transfusions.

The ability to noninvasively and continuously trend a patient's hemoglobin blood level during surgery allows for constant assessment of a patient's hemoglobin status, which may enable more appropriate clinical decisions—offering a breakthrough in blood management and patient safety that has the potential to improve patient outcomes, reduce patient exposure to unnecessary blood transfusions, and preserve precious blood resources.

According to Dr. Michael O'Reilly, Chief Medical Officer at Masimo, "Every surgical procedure bears certain risks—some may be preventable while others are unavoidable.  Masimo SpHb fundamentally changes the way clinicians respond to bleeding and a patient's need for a blood transfusion by reducing measurement delays through real-time tracking and trending of hemoglobin blood levels.  This study further underscores the value and impact of SpHb as a cost-effective solution to more accurately, easily, and rapidly monitor hemoglobin."

SpHb is available as part of the Masimo rainbow® SET platform—the first-and-only technology to noninvasively and continuously measure total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVI®), and acoustic respiration rate (RRa™), in addition to the 'gold-standard' Measure-Through Motion and Low Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate (PR).

About MasimoMasimo (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 www.masimo.com.

Forward-Looking StatementsThis 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 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 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.

(1) Berkow L., Rotolo S., Mirski E. "Continuous and Noninvasive Hemoglobin Monitoring During Complex Spine Surgery." Johns Hopkins School of Medicine, Baltimore, Maryland. Presented at the STA Annual Meeting January 12-15, 2011.

(2) Bernard AC et al. Intraoperative transfusion of 1U to 2U of packed red blood cells is associated with increased 30-day mortality, surgical site infection, pneumonia, and sepsis in general surgery patients. Journal of the American College of Surgeons. 2009;208:931-937.

(3) Surgenor SD et al, for the Northern New England Cardiovascular Disease Study Group. The Association of Perioperative Red Blood Cell Transfusions and Decreased Long-Term Survival After Cardiac Surgery. Anesthesia & Analgesia 2009; 108:1741-1746.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care… by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, Pulse CO-Oximetry, Pulse CO-Oximeter, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57, Rad-8, Rad-5, Pronto-7, Pronto, Patient SafetyNet, and SEDLine  are trademarks or registered trademarks of Masimo Corporation.Media Contacts: Dana BanksMasimo Corporation(949) 297-7348dbanks@masimo.com
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