New Study Shows Masimo Noninvasive SpCO(R) Helps Clinicians

IRVINE, CA--(Marketwired - Jun 11, 2014) - Masimo ( NASDAQ : MASI ) today announced that a new study published in the International Journal of Clinical Practice demonstrated that Masimo's noninvasive SpCO ^® helped clinicians improve detection of carbon monoxide (CO) poisoning in patients presenting to a large emergency department. ¹  In the study, the reported prevalence of CO poisoning was nearly twice as high as reported in a previous study in the Journal of Emergency Medicine . ²

CO poisoning is the leading cause of death from accidental poisoning, according to the Centers for Disease Control and Prevention . Lack of timely diagnosis can delay treatment or, worse, patients discharged with an incorrect diagnosis can be re-exposed to CO. CO poisoning accounts for an estimated 50,000 ED visits in the U.S. annually. ³ Headaches are the most common symptom of CO poisoning -- others include dizziness, nausea/vomiting, confusion, fatigue, chest pain, shortness of breath, and loss of consciousness. CO poisoning often is misdiagnosed and attributed to other illnesses such as the flu. Failure to diagnose CO poisoning can have disastrous consequences for patients and potentially other family members of affected households. ⁴

In the 12-month study conducted July 2008 through June 2009 in the emergency department at Vienna General Hospital, in Vienna, Austria, Dr. Wolfgang Schreiber and colleagues prospectively assessed the prevalence of occult, or unsuspected, CO poisoning in 32,396 patients presenting to the ED. During the study period, noninvasive carboxyhemoglobin (SpCO) values using the Masimo Radical-7 ^® Pulse CO-Oximeter were included as part of the standard vital-signs assessment. SpCO values exceeding 6% for non-smokers and 12% for smokers were validated by venous blood gas analysis with a laboratory CO-Oximeter (Radiometer ABL700).

The average noninvasive SpCO was 3.0% higher with smokers than non-smokers (4.0% vs. 2.0%, p < 0.01). Among all patients, invasive COHb was measured in 2,377 individuals, similarly with smokers higher than non-smokers (2.9% vs. 0.7%, p < 0.01). A total of 32 (1%) of the 32,396 patients presenting to the emergency department were diagnosed with CO poisoning -- higher than the previously reported rates from both retrospective ^2,5-7 , and prospective studies ^8,9 . Of the 32 patients, 22 cases or 69% were occult and only identified due to SpCO assessment, which caused an invasive COHb test to be occur and the CO poisoning diagnosis to be made.

"Our data on 32,396 prospectively screened ED patients, who received measurement of vital signs on triage, based on clearly stated definitions, and validated by blood gas analysis, suggest a prevalence of CO poisoning nearly twice as high as previous highest estimates," researchers stated. "This underlines the importance of this intoxication and appeals physicians for more alertness on the topic, especially as patients were unaware of CO poisoning in 22 out of 32 patients."

The researchers added: "The main consequence of testing for occult CO poisoning in an ED can be the prevention of potentially deadly re-exposure for patients, exposure for their adjacencies, as well as prevention of long term exposure that may lead to coronary artery disease, delayed neuropsychiatric syndrome, premature death," and "Screening of all patients using noninvasive technique might facilitate diagnosis, but an in-depth exposure history remains crucial."

SpCO is part of the Masimo rainbow ^® SET platform, which enables the assessment of multiple blood constituents and physiologic parameters that previously could only be measured invasively or with complicated procedures, in addition to providing Masimo SET ^® Measure-through Motion and Low Perfusion™ pulse oximetry including SpO ₂ , pulse rate, perfusion index, and PVI ^® . Multiple noninvasive and continuous measurements -- including SpHb ^® , RRa ^® SpCO, and SpMet ^® -- offer an advancement in patient safety by helping clinicians better assess patients.

"SpCO has been shown to be effective for screening large populations for CO poisoning, even when it is not suspected based on clinical presentation," said Dr. Steve Barker, M.D., Ph.D., Chairman of the Scientific Advisory Board of Masimo. "This large, prospective study further demonstrates early assessment with SpCO can help clinicians identify patients with unsuspected CO poisoning who are at serious risk for injury or death." 

1 Roth D, Schreiber W, Herkner H, Havel C. "Prevalence of carbon monoxide poisoning in patients presenting to a large emergency department." Int J Clin Pract , March 2014; doi: 10.1111/ijcp.12432 2 Hampson NB. "Emergency department visits for carbon monoxide poisoning in the Pacific Northwest." J Emerg Med 1998; 16: 695-8. 3 Hampson N., Weaver L. "Carbon Monoxide Poisoning: A New Incidence for an Old Disease." Undersea Hyperb Med 2007;34:163-168. Available online here  4 Hampson N., Piantadosi C., Thom S., Weaver L. "Practice Recommendations in the Diagnosis, Management, and Prevention of Carbon Monoxide Poisoning," American Journal of Respiratory and Critical Care Medicine , Vol. 186, No. 11 (2012), pp. 1095-1101. Available online here 5 Patrick M, Fiesseler F, Shih R, Riggs R, Hung O. Monthly variations in the diagnosis of carbon monoxide exposures in the emergency department. Undersea Hyperb Med 2009; 36: 161-7 6 Handa PK, Tai DY. Carbon monoxide poisoning: a five year review at Tan Tock Seng Hospital, Singapore. Ann Acad Med Singapore 2005; 34:611-4. 7 Keles A, Demircan A, Kurtoglu G. Carbon monoxide poisoning: how many patients do we miss? Eur J Emerg Med 2008; 15: 154-7. 8 Suner S, Partridge R, Sucov A et al. Non-invasive pulse CO-oximetry screening in the emergency department identifies occult carbon monoxide toxicity. J Emerg Med 2008; 34: 441-50 9 Chee KJ, Nilson D, Partridge R et al. Finding needles in a haystack: a case series of carbon monoxide poisoning detected using new technology in the emergency department. Clin Toxicol (Phila) 2008;46: 461-9.

About Masimo Masimo ( 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 have shown that Masimo SET® outperforms other pulse oximetry technologies, 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 could only be measured invasively, 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). 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, risks related to our belief that Masimo SpCO will provide an accurate and effective noninvasive method of screening for CO poisoning, 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 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.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation