Cambridge Heart Announces Positive Results for Labeling Study; Results Meet Study Goals.BEDFORD, Mass.--(BW HealthWire)--Aug. 12, 1998--Cambridge Heart, Inc. (Nasdaq:CAMH CAMH Centre for Addiction and Mental Health CAMH Contemporary Arts Museum Houston (Houston, TX) CAMH Comprehensive Accreditation Manual for Hospitals ) today announced that the Company has met all study goals in the labeling study for its T-wave alternans T-wave alternans Cardiology A subtle every-other-beat variation in T waves that is prognostic of Pts at high risk for life-threatening cardiac arrhythmias and sudden cardiac death. See Alternans test. technology. In the final statistical report received from its contract research organization (CRO), the study results show that the noninvasive measure of microvolt microvolt one-millionth (10-6) of a volt; abbreviated µV. alternans predicts the results of electrophysiology electrophysiology /elec·tro·phys·i·ol·o·gy/ (-fiz?e-ol´ah-je) 1. the study of the mechanisms of production of electrical phenomena, particularly in the nervous system, and their consequences in the living organism. 2. (EP) study with a statistical significance of p<0.0001 and meets all other statistical tests defined in the protocol. The Company's current labeling does not allow it to make claims regarding the predictive accuracy of T-wave alternans; the Company plans to submit the results of this study to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. within the next few weeks for expansion of these labeling claims. "Obtaining expanded labeling is a major step toward achieving our ultimate business plan goals of including T-wave alternans testing in a significant portion of the nine million stress tests conducted annually in the U.S. With this study we have passed a major milestone for our Company and are now much closer to achieving our business plan goals." stated Jeffrey M. Arnold, Chairman, President, and Chief Executive Officer of Cambridge Heart. 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 EP testing. The labeling study also compares T-wave alternans to signal average ECG ECG electrocardiogram. ECG abbr. 1. electrocardiogram 2. electrocardiograph ECG Also called an electrocardiogram, it records the electrical activity of the heart. (SAECG SAECG Signal-Averaged Electrocardiogram ), an older technique, in this prediction. The Company also conducted a follow-up study, which, in the same patients, compares the results of T-wave alternans to results of EP testing and SAECG in predicting episodes of life threatening arrhythmias and sudden cardiac death Sudden Cardiac Death Definition Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest. , the second largest cause of death in the U.S. The Company expects to receive a report on the follow-up study shortly, and plans to hold a conference call thereafter to discuss the results of both studies. "The follow up data is key to clinical adoption of our technology," added Mr. Arnold. "We are hoping for this study to confirm the results of earlier studies which compared the accuracy of T-wave alternans to EP study in predicting major cardiac events." 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 coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. , 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ending December 31, 1997.
CONTACT: Cambridge Heart
Robert B. Palardy
781/271-1200, ext. 321
or
Evanthia K. Malliris
781/271-1200, ext. 253
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Feinstein Kean Partners Inc.
Michelle L. Linn
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Jeff Mooney
617/577-8110
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