Cambridge Heart Responds to 510K Submission Questions From Food and Drug Administration.

BEDFORD, Mass.--(BW HealthWire)--Jan. 4, 1999--Cambridge Heart, Inc. (Nasdaq:CAMH) announced today that the Company recently submitted responses to questions from the Food and Drug Administration (FDA) regarding the Company's August 510(K) submission for expanded labeling claims concerning the accuracy of its T-wave alternans technology as a significant predictor of major cardiac events, such as sudden cardiac death and episodes of life-threatening arrhythmias.

In late November, the Company received 8 questions from FDA about its submission, containing routine requests for clarification, additional information, and additional analyses. These requests were expected by the Company and were received within the 90-day statutory limit (FDA protocol specifies that requests for more information should be submitted to the manufacturer within 90 days after the Agency receives a 510(K) submission).

"We are very pleased with both the timeliness and the content of the questions we received from FDA, and are quite satisfied with our responses." stated Jeffrey M. Arnold, Company Chairman, President, and Chief Executive Officer. "We expect to receive a response from FDA in approximately 90 days or less, consistent with FDA protocol. We recognize that future action by the FDA cannot be predicted with certainty."

The Company's submission included the data from its recently completed labeling and follow-up studies, the results of which were publicly announced on August 12 and 19, 1998, respectively. The labeling study is the largest study Cambridge Heart has conducted to date and examines the ability of T-wave alternans to noninvasively identify patients susceptible to life threatening rhythm disturbances as indicated by the results of invasive electrophysiology (EP) testing. The labeling study also compares T-wave alternans to signal average ECG (SAECG), an older technique, in this prediction. The follow-up study compares the results of T-wave alternans to the results of EP and SAECG in predicting episodes of life threatening arrhythmias and sudden cardiac death. The follow-up study was conducted with the same patient population included in the labeling study.

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, 1998.

For complete investor Relations information, please visit our web site: www.cambridgeheart.com