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Studies Demonstrate Effectiveness of Microvolt T-Wave Alternans in Predicting Sudden Cardiac Death Regardless of Ejection Fraction

Posted on: Tuesday, 15 November 2005, 15:00 CST

Cambridge Heart, Inc. (OTCBB-CAMH) today reported on multiple presentations given at The American Hospital Association Meeting in Dallas, Texas. Three prominent presentations, collectively representing 2,358 study patients further validates Microvolt T-Wave Alternans as an independent predictor of sudden cardiac death and sustained ventricular events regardless of the patients Ejection Fraction or EF (a measure of the heart's pumping ability).

Dr. Paul Chan, presenting information from the Lindner Clinical Trials Center in Cincinnati, reported on 768 consecutively enrolled ischemic SCD-HeFT type patients with an EF of less than or equal to 35%. In evaluating the predictive ability of Microvolt T-Wave Alternans the authors concluded that this non-invasive diagnostic test is a strong and independent predictor of mortality and appropriate ICD therapy among Madit II and SCD-HeFT eligible patients with ischemic cardiomyopathy.

Also reporting on a patient population with ejection fraction levels of 40% or less, Dr Elizabeth Kaufman from Case Western Reserve University in Cleveland, Ohio shared results from a study of 549 heart failure patients. The hypothesis being evaluated was the predictive ability of "indeterminate" MTWA tests. In this study the authors concluded that in patients with left ventricular dysfunction an indeterminate MTWA test predicted death or sustained ventricular arrhythmias at least as well as a positive test and that conversely, a negative MTWA test is associated with a very low risk of death or sustained ventricular arrhythmia.

In the third presentation Dr. Takanori Ikeda from Kyorin University in Tokyo, Japan evaluated seemingly low risk patients with an ejection fraction equal to or greater than 40% who had also experienced an acute myocardial infarction or heart attack. In this prospectively enrolled study of 1,012 patients each patient was evaluated with 10 different prognostic indicators including Signal Averaged ECG (SAECG) and non sustained ventricular tachycardia on Holter Monitoring in addition to MTWA. After performing a multivariate regression analysis MTWA was found to be the most powerful predictor. The conclusion being that in heart attack victims with preserved left ventricular ejection fraction, MTWA was not only a strong predictor of sudden cardiac death but that MTWA may be useful in identifying patients in this population who need implantable defibrillators.

Commenting on the three studies, David Chazanovitz, President and CEO of Cambridge Heart, Inc said, "In the past few years EF or ejection fraction has become the basic determinate for ICD implantation. These studies show collectively that Microvolt T-Wave Alternans has considerable prognostic value in heart failure and heart attack patients whether they have ejection fraction above or below 40%."

About Cambridge Heart

Cambridge Heart is engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. Using innovative technologies, the Company is addressing such key problems in cardiac diagnosis as the identification of those at risk of sudden cardiac arrest. The Company's products incorporate its proprietary technology, Microvolt T-Wave Alternans, and are the only diagnostic tools cleared by the U.S. Food and Drug Administration to non-invasively measure microvolt levels of T-wave alternans. The Company, founded in 1990, is based in Bedford, Massachusetts and is traded on the OTCBB under the symbol CAMH. Cambridge Heart can be found on the World Wide Web at www.cambridgeheart.com

About the Cambridge Heart Microvolt T-Wave Alternans Test

The Cambridge Heart Microvolt T-Wave Alternans Test measures extremely subtle beat-to-beat fluctuations in a person's heartbeat called T-wave alternans. These tiny heartbeat variations - measured at one millionth of a volt - are detected in any clinical setting where titration of the heart rate is possible. The preparation for the test consists of placing proprietary sensors on a patient's chest. Extensive clinical research has shown that patients with symptoms of or, who are at risk of, life threatening arrhythmias who test positive for T-wave alternans are at significant risk for subsequent sudden cardiac events including sudden death, while those who test negative are at minimal risk.

Statements contained in this press release about anticipated revenue growth, and all other statements 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 customer delays in making final buying decisions, decreased demand for our 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, failure to obtain or maintain adequate levels of third-party reimbursement for use of our products and other factors identified in our most recent Annual Report on Form 10-K under "Factors Which May Affect Future Results", which is on file with the SEC. 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, even if our estimates change.

Source: Business Wire

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