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New NIH-Funded Study Shows Masimo Rainbow SET(R) May Help Clinicians Assess Oxygenation in Children With Sickle Cell Disease

Posted on: Tuesday, 19 May 2009, 15:04 CDT

Study Presented at the American Thoracic Society by Researchers at The Children's Hospital of Philadelphia Confirms Accuracy and Clinical Value of Noninvasive SpCO(R) and SpMet(R)

IRVINE, Calif., May 19 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that a new independent clinical study, funded by the National Institutes of Health (NIH) and presented at the American Thoracic Society in San Diego, CA, shows that the noninvasive measurement of carboxyhemoglobin (SpCO) and methemoglobin (SpMet) with Masimo Rainbow SET Pulse CO-Oximetry is accurate and may help clinicians better detect hypoxemia-a potentially life-threatening lack of oxygen in the blood-in children with sickle cell disease.

Sickle cell disease is an inherited blood disorder characterized by abnormally-shaped red blood cells that compromise vital blood and oxygen supply to the tissues and organs, causing life-threatening complications. The presence of carboxyhemoglobin and methemoglobin in a sickle cell patient's blood reduces oxygen supply further because these dyshemoglobins that take the place of normal oxyhemoglobin lack the ability to carry any oxygen. However, conventional two-wavelength pulse oximeters are incapable of measuring carboxyhemoglobin and methemoglobin levels and as a result cannot provide clinicians with an accurate picture of their patients' true oxygenation status in the presence of dyshemoglobins.

Masimo Rainbow SET-the first-and-only technology that noninvasively and continuously measures SpCO and SpMet, in addition to total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), PVI, oxyhemoglobin (SpO2), pulse rate, and PI--allows for faster and more accurate assessment of the patient's true oxygenation, which may help to advance the care and management of patients with sickle cell disease.

In the study presented, Dr. Caboot and colleagues at Children's Hospital of Philadelphia simultaneously compared SpCO and SpMet measurements obtained noninvasively using the Masimo Radical-7 Pulse CO-Oximeter with invasive blood draws and laboratory analysis of carboxyhemoglobin and methemoglobin in 38 asymptomatic children (2-18 years of age) with sickle cell disease. The researchers found SpCO (with a bias of 0.1% and precision of +/- 2.2%) and SpMet (with a bias of -0.19% and precision of +/- 0.39%) to be closely comparable to invasive laboratory measurements. Researchers concluded that the Masimo Radical-7 Pulse CO-Oximeter "is useful in measuring carboxyhemoglobin and methemoglobin levels in pediatric patients with sickle cell disease."

Masimo Executive Vice President of Medical Affairs, Dr. Michael O'Reilly, stated, "This research not only reinforces the clinical accuracy of SpCO and SpMet in assessing the true oxygenation of patients, but also highlights the importance of measuring these dyshemoglobins while managing and treating pediatric patients with sickle cell disease."

Caboot, J.B., Jawad, A.F., McDonough, J.M., Bowdre, C.Y., Ohene-Frempong, K., Smith-Whitley, K., Allen, J.L. "Non-Invasive Measurements of Carboxyhemoglobin and Methemoglobin in Pediatric Patients with Sickle Cell Disease." Am. J. Respir. Crit. Care Med., Apr 2009; 179: A4788. Presented at the American Thoracic Society (ATS) Annual Meeting, May 19, 2009, San Diego, California. http://www.abstracts2view.com/ats09/view.php?nu=ATS09L_2057

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 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(R) Pulse CO-Oximetry(TM), 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 (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 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 assumptions regarding the repeatability of clinical results and our belief that SpCO and SpMet will improve clinical assessments and the identification of hypoxemia in patients with sickle cell disease, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 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 Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2009, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media 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.

SOURCE Masimo

Source: PR Newswire

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