Congestive Heart Failure Trial Confirms Value of Microvolt T-Wave Alternans Testing.

Business Editors/Health/Medical Writers

BEDFORD, Mass.--(BUSINESS WIRE)--March 31, 2003

NIH Funded Study Demonstrates MTWA Negative Patients are at

Extremely Low Risk of Sudden Cardiac Death 

Cambridge Heart, Inc. (NASDAQ:CAMH) today announced the results of a large, multi-center Congestive Heart Failure trial which demonstrate that Microvolt T-Wave Alternans (MTWA) is strongly associated with an increased risk of dying, while patients with a negative MTWA test result have an extremely low risk of death. The results, presented by Dr. Daniel Bloomfield at the Late Breaking Clinical Trials Session of the annual American College of Cardiology meeting in Chicago, also demonstrate that patients meeting Madit II criteria (previous heart attack and poor pumping efficiency measured by an ejection fraction less than 0.30) are also at extremely low risk of sudden cardiac death (SCD) if they test negative for MTWA.

Patients with Congestive Heart Failure exhibit poor pumping of their hearts. According to the American Heart Association there are 4.8 million Americans who suffer from varying degrees of heart failure.

The study enrolled 590 Congestive Heart Failure patients with an average of two years of follow-up who had an ejection fraction less than 40%. Patients enrolled in the study had no prior arrhythmic events. Of the 542 patients included in the analysis 34% tested negative and 66% tested not negative (positive and indeterminate) for MTWA. Only one patient who tested negative for MTWA died while a total of 20 deaths were reported in the study. Further analysis showed that patients testing positive for MTWA were approximately 10 times more likely to have a cardiac arrest or to become a victim of SCD than patients who had a negative test.

Dr. Bloomfield also reported on a Madit II subgroup of patients enrolled within the study. In this subgroup of patients not one patient who tested negative for MTWA died. The original Madit II trial indicated the patients meeting the Madit II criteria obtained a mortality benefit from implantable defibrillator (ICD) therapy. Dr. Bloomfield's study suggests that Madit II patients who test MTWA negative may not benefit from an ICD, and that the remaining Madit II patients may obtain an increased mortality benefit from ICD therapy.

Commenting on the study, David A. Chazanovitz, President and CEO of Cambridge Heart, Inc. said, "The results of this very important study are gratifying. This is the largest trial ever conducted on the Congestive Heart Failure population utilizing Microvolt T-Wave Alternans. The trial evaluated both ischemic and non-ischemic patients and concluded that if a patient tests negative for MTWA the patient is at very low risk of dying even if they are in a generalized high risk category. It confirms that MTWA can be very useful in assisting physicians in their treatment of these patients by helping to determine which patients are truly in need of an ICD or additional testing." Mr. Chazanovitz also stated, "This could make ICD therapy even more effective and assist in controlling medical costs. I commend Dr Bloomfield and the rest of the investigators for their dedication and very fine work."

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 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.

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 NASDAQ/SmallCap under the symbol CAMH. Cambridge Heart can be found on the World Wide Web at www.cambridgeheart.com.

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