Study Supports Use of MTWA Test as Predictor of Sudden Cardiac DeathNovember 18, 2009 9:12 AM ET
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Cambridge Heart, Inc. (OTCBB-CAMH), today announced that results of the PREVENT-SCD trial, presented at the American Heart Association Scientific Sessions in Orlando, Florida, reinforce the value of the Microvolt T-wave Alternans (MTWA) test in identifying patients at risk of sudden cardiac death (SCD). PREVENT-SCD (PRospective EValuation of VENtricular Tachyarrhythmic Events and Sudden Cardiac Death in Patients with Left Ventricular Dysfunction), a prospective multi-center study of patients with cardiomyopathy and ejection fraction of 40% or lower, enrolled a total of 453 patients from 38 institutions in Japan. Two hundred eighty (280) patients underwent non-invasive MTWA testing using the analytic spectral method and were followed for up to three years. At a median follow-up time of 36 months, patients with an abnormal MTWA test were 4.4 times more likely to experience a life-threatening arrhythmia or SCD than those with a normal test. The 3-year negative predictive value was reported to be 97.0%, indicating that patients with a normal or negative MTWA test are at low risk for experiencing sudden death. "MTWA has a very high negative predictive value for lethal arrhythmias in this population,” said Dr. Satoshi Shizuta, Kyoto University Hospital, Kyoto, Japan, lead author of the study. In PREVENT-SCD, 29% of patients eligible for the test had a negative MTWA result. He noted that these patients are at very low risk for SCD in the next three years. "The PREVENT-SCD trial further confirms the results of several previously published studies of MTWA in patients with left ventricular dysfunction," said Dr. Ali Haghighi-Mood, President and Chief Executive Officer of Cambridge Heart, Inc. "The value of MTWA as an accurate predictor of sudden cardiac arrest in this population has become very well established." About Cambridge Heart, Inc. Cambridge Heart develops and commercializes non-invasive diagnostic tests for cardiac disease, with a focus on identifying those at risk for sudden cardiac arrest (SCA). The Company’s products incorporate proprietary Microvolt T-Wave Alternans™ measurement technologies, including the patented Analytic Spectral Method® and ultrasensitive disposable electrode sensors. The Company’s MTWA test, originally based on research conducted at the Massachusetts Institute of Technology, is reimbursed by Medicare under its National Coverage Policy.
Cambridge Heart, founded in 1990, is based in Tewksbury, MA. It is
traded on the Over-The-Counter Bulletin Board (OTCBB) under the symbol
CAMH.OB. Statements contained in this press release that are not purely historical are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995.In some cases, we use words such as “believes”, “expects”, “anticipates”, “plans”, “estimates”, “could”, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements.Actual results may differ materially from those indicated by these forward-looking statements.Factors that may cause or contribute to such differences include failure to achieve broad market acceptance of the Company’s MTWA technology, failure of our sales and marketing organization to market our products effectively, inability to hire and retain qualified clinical applications specialists in the Company's target markets, failure to obtain or maintain adequate levels of first-party reimbursement for use of the Company's MTWA test, customer delays in making final buying decisions, decreased demand for the Company's products, failure to obtain funding necessary to develop or enhance our technology, adverse results in future clinical studies of our technology, failure to obtain or maintain patent protection for our technology and other factors identified in our most recent Annual Report on Form 10-K under “Risk Factors”, which is on file with the SEC and available at www.EDGAR.com.In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date.While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so except as may be legally necessary, even if our estimates should change.
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