Cambridge Heart Announces Completion of Enrollment in Expanded Labeling Study; CEO Notes at Goldman Sachs Conference that Submission on Track.

BEDFORD, Mass.--(BW HealthWire)--June 11, 1998--Cambridge Heart, Inc. (NASDAQ:CAMH) today announced the completion of enrollment in its clinical study intended for submission to the FDA to obtain expanded labeling for its T-wave alternans technology. The study examines the ability of T-wave alternans to non-invasively identify patients susceptible to life-threatening rhythm disturbances as indicated by the results of invasive electrophysiology (EP) testing in 270 patients. It will also compare this ability to that of Signal Average ECG (SAECG), an older, non-invasive technique. A related follow-up study will compare the results of T-wave alternans to results of EP testing in predicting a major cardiac event such as sudden cardiac death and episodes of life threatening arrhythmias.

Speaking today at the Goldman Sachs Health Care Conference in Northern California, Jeffrey M. Arnold, Chairman, President, and Chief Executive Officer of Cambridge Heart stated, "We are pleased to have completed the enrollment on schedule of 270 patients for the expanded labeling trial; we are hopeful that the excellent preliminary results from the first 148 patients will be further substantiated by data from the remaining patients. We remain on schedule to submit to the FDA for the expanded label in late July and will use data from the ongoing follow-up study to support our application for the use of T-wave alternans as an important means to assess risk of life threatening rhythm disturbances."

Cambridge Heart recently announced the presentation of preliminary data on the first 148 patients enrolled in the Company's labeling study by Michael R. Gold, M.D., Ph.D., at the North American Society of Pacing and Electrophysiology (NASPE) meeting in San Diego, CA on May 7, 1998. In the preliminary data presented by Dr. Gold, the principal investigator in the study, T-wave alternans was a statistically significant predictor of the results of invasive electrophysiology (EP) study and of events (ventricular arrhythmias and death) during follow up.

Many heart attacks are caused by ventricular arrhythmia, an abnormality in the beating pattern of the heart resulting in alterations in the rate and frequency of the electrical impulses in the ventricles. Heart attacks caused by ventricular arrhythmias generally cause death within minutes, known as sudden cardiac death. In spite of the fact that patients at risk for sudden cardiac death now have several treatment options available to them, including implantable cardioverter-defibrillators and drug therapy, 300,000 sudden cardiac deaths occur in the United States each year, primarily because there is no accurate, noninvasive method to identify those at risk. T-wave alternans is an alternating pattern which, when visible in the electrocardiogram (ECG), has been associated with life-threatening heart rhythm disturbances and sudden cardiac death.

Cambridge Heart is engaged in the research, development, and commercialization of products for the noninvasive 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 death, the early detection of coronary artery disease, and the prompt and accurate diagnosis of heart attack.

Statements made in this press release that are not historical facts include forward-looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are included in Cambridge Heart's Annual Report on Form 10-K for the year ending December 31, 1997.

CONTACT: Cambridge Heart, Inc.

Robert B. Palardy, 781/271-1200

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Feinstein Kean Partners Inc.

Michelle L. Linn, 781-577-8110