News Details

Masimo receives approval from Ministry of Health, Labor and Welfare (MHLW) for the revolutionary medical device that noninvasively measures carbon monoxide levels in the blood

IRVINE, Calif., Nov. 27 /PRNewswire-FirstCall/ -- Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, today announced approval of the Masimo Rad-57 Pulse CO-Oximeter, bringing the world's first and only technology capable of noninvasively measuring carbon monoxide (CO) levels in the blood to the Japanese market -- with 9,026 hospitals and Fire and Disaster Management Agency facilities(1) and a population of more than 127 million.(2)

The Masimo Rad-57 is a fast, accurate and noninvasive way to detect elevated levels of CO in the blood, without having to draw blood and wait for costly lab results. When a clinician places the Masimo Rad-57's sensor on a patient's finger and presses a button, the device will detect the percentage of CO in the bloodstream in just seconds, allowing for prompt and possibly life-saving treatment. In addition, the Masimo Rad-57 measures SpO2 (oxygen saturation), pulse rate and perfusion index (PI) with Masimo SET technology.

Each year in Japan, it is estimated that about 2,000 people die from CO poisoning.(3) An odorless and colorless toxic gas, poisoning from CO is notoriously difficult to diagnose because its symptoms mirror those of lesser afflictions, like the flu or food poisoning. Because of this, even the most skilled clinicians miss the chance to treat carbon monoxide poisoning early. As a result, unrecognized CO-poisoned patients are often unknowingly returned to the site of the exposure where they develop more serious levels of toxicity. Just one serious exposure to CO, as well as prolonged exposure to low levels of CO, can cause death or permanent brain, heart, or organ damage.(4,5) Certain home CO detectors don't alarm when low levels of CO are present.

Prior to the Masimo Rad-57, the only method to accurately diagnose CO poisoning required inconvenient blood tests using expensive blood gas machines that are not available outside the hospital environment, where detection is often needed most. The ability to quickly and conveniently obtain accurate measurements in any environment leads to informed and timely treatment decisions, which can save lives and money.

"Having a noninvasive hand-held device that quickly measures the amount of CO in a person's blood would enable greater cost and care efficiencies at the scene of emergencies," said Yasuhiro Yamamoto M.D., Ph. D., Professor and Chairman, Department of Emergency and Critical Care Medicine, Nippon Medical School. "The ability to accurately diagnose and triage CO-poisoned victims at the scene can speed transport and proper treatment for higher priority cases, while reducing the flood of non-emergent patients at hospitals due to suspected poisonings and eliminating unnecessary lab tests."

Joe E. Kiani, Chairman and CEO of Masimo stated, "We are excited to bring the Masimo Rad-57 Pulse CO-Oximeter to the market in Japan where thousands of people die each year as a result of CO-poisoning and countless others suffer permanent brain, heart and organ damage. All too often CO-poisoning goes undiagnosed, silently robbing unsuspecting victims of precious health and life. The Masimo Rad-57 Pulse CO-Oximeter provides an easy and timely way to detect this deadly poison."

About Masimo

Masimo (Nasdaq: MASI) develops innovative monitoring technologies that significantly improve patient care -- helping solve "unsolvable" problems. In 1995, the company debuted Read-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. Masimo SET is the most accurate and reliable pulse oximetry technology, clinically proven in more than 100 independent and objective studies to provide 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 carboxyhemoglobin (SpCO) and methemoglobin (SpMet), pleth variability index (PVI), 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 relative to our estimation of the size of the Japanese market for the Rad-57 and the pace of clinical adoption of this new technology in Japan, 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.

1. Ministry of Health, Labor and Welfare (MHLW) http://www.mhlw.go.jp/toukei/saikin/hw/iryosd/05/kekka1-1.html
2. Ministry of Internal Affairs and Communications http://www.stat.go.jp/english/data/kokusei/2005/youkei/01.htm
3. Japan Labor Health and Welfare Organization http://www.research12.jp/d_archive/co/1_3.html
4. Weaver LK, et al. N Engl J Med, 2002;347(14):1057-067.
5. Henry CR, et al. JAMA. 2006;295(4):398-402.

Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpCO, SpMet, PVI and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.

SOURCE Masimo Corporation