Clinical Results Published On Predictive Value of T-wave Alternans in Patients at High Risk for Ventricular Arrhythmias.

BEDFORD, Mass.--(BUSINESS WIRE)--Dec. 8, 1998--Cambridge Heart, Inc. (Nasdaq:CAMH) today announced that a paper published in this month's Journal of Cardiac Electrophysiology(1) reported on the measurement of microvolt T-wave alternans as compared to both invasive electrophysiology (EP) testing and other currently used noninvasive risk assessment methods in predicting ventricular tachyarrhythmias in patients receiving an implantable/cardioverter defibrillator (ICD). Entitled "T-Wave Alternans as a Predictor of Recurrent Ventricular Tachyarrhythmias in ICD Recipients: Prospective Comparison with Conventional Risk Markers," the study, conducted by Stefan H. Hohnloser, M.D., Professor of Medicine, J.W. Goethe University, Frankfurt, Germany, compares non-invasive T-wave alternans to the standard EP study.

Professor Hohnloser studied 95 consecutive patients undergoing implantation of an ICD. Patients were assessed with EP study and T-wave alternans, as well as a battery of other noninvasive tests. The study endpoint was the firing of the ICD for documented ventricular fibrillation or tachycardia during 18-month follow-up.

The study reported that T-wave alternans (p < 0.006) and left ventricular ejection fraction (LVEF) (p < 0.04) were the only significant predictors of subsequent arrhythmia.

"The medical community has been waiting for the publication of a significantly sized study to add to the results of the earlier study of T-wave alternans published in the New England Journal of Medicine(2)," said Jeffrey M. Arnold, Cambridge Heart Chairman, President and Chief Executive Officer. "We believe that Dr. Hohnloser's study combined with the multi-center labeling study that the Company just completed and filed with FDA adds significantly to the growing body of evidence on T-wave alternans."

The Company's current labeling does not allow it to make claims regarding the predictive accuracy of T-wave alternans. Therefore, it cannot at this time present or advertise these results to the medical community. The Company has filed a 510(k) submission with FDA for expansion of its labeling claims.

Interested investors may obtain reprints of this paper by contacting Investor Relations at Cambridge Heart, 781-271-1200.

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, non-invasive 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, Inc. 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 death, the early detection of coronary artery disease and the prompt, accurate diagnosis of heart attack.

Statements made in this news 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 the Company's annual report on form 10K for the year ending December 31, 1996.

(1) Hohnloser SH, Klingenheben, T, Li Y-G, Zabel M, Peetermans J, Cohen, RJ: T-Wave Alternans as a Predictor of Recurrent Ventricular Tachyarrhythmias in ICD Recipients: Prospective Comparison with Conventional Risk Markers. Journal of Cardiac Electrophysiology, Vol 9 No 12, December 1998.

(2) Rosenbaum DS, Jackson LE, Smith JM, Garan H, Ruskin JN, Cohen RJ: Electrical Alternans and Vulnerability to Ventricular Arrhythmias. New England Journal of Medicine, 1994;330:235-241.