Cambridge Heart Submits to FDA Updated Follow-Up Data for Expansion of Labeling Claims; Data Presented At American College of Cardiology Conference.

BEDFORD, Mass.--(BUSINESS WIRE)--March 9, 1999--Cambridge Heart, Inc. (NASDAQ:CAMH) today announced that the Company has submitted updated follow-up data in support of the Company's 510(K) regulatory filing for expansion of labeling claims on the predictive accuracy of its T-wave alternans (TWA) test. TWA is an alternating pattern which, when visible in the electrocardiogram (ECG), has been associated with life threatening heart rhythm disturbances and sudden cardiac arrest. Cambridge Heart's current labeling does not allow it to make claims regarding the predictive accuracy of TWA. The 510(K) and follow up data support requested expansion of current labeling for TWA as a significant predictor of arrhythmic events that cause Sudden Cardiac Arrest (SCA), the leading cause of death in the country.

Cambridge Heart also announced that these data, based on a nationwide, multi-center study involving 337 patients, were presented today along with three other abstracts on TWA at the 48th American College of Cardiology. The data presented included a total of 27 events in the 290 patients in whom follow-up was available. These data reflect 6 months of data collection in addition to those submitted to FDA last August. These final results for TWA are better than those originally submitted. TWA predicted tachyarrhythmic events and total mortality with a relative risk of 13.9, compared to a relative risk of 11.0 in the August submission. Relative risk for EP was 4.7, compared to 3.1 in the previous submission. Relative risk is the chance of having an event if the test is positive divided by the chance of having an event if the test is negative. The greater the number, the more predictive the test.

"We believe these final results make an even more compelling case for the clinical value of TWA in comparison with other risk-stratification modalities," said Jeffrey M. Arnold, Cambridge Heart Chairman, President, and Chief Executive Officer. "We appreciate the responsiveness of FDA throughout this process and we understand that a decision will be forthcoming after prompt review of these data."

SCA is 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. SCA claims approximately 350,000 lives a year in the United States.

Although patients at risk now have several treatment options available to them, including implantable cardioverter defibrillators and drug therapy, there is no accurate, noninvasive method to identify those at risk for SCA currently cleared for use in the United States. Only a small fraction of patients believed to be at risk presently receive invasive EP testing and go on to preventative treatment.

About Cambridge Heart

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 arrest, the early detection of coronary artery disease and the prompt and accurate diagnosis of heart attack. The Company, started in 1992, is based in Bedford, Mass., and is traded on the NASDAQ/NMS under the symbol CAMH.

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 include uncertainties associated with regulatory approval processes and other factors that are included in Cambridge Heart's Annual Report on Form 10-K for the year ending December 31, 1998.