Cambridge Heart to Launch ''MASTER'' Study Identifying Patients in Greatest Need of Implantable Cardiac Defibrillators.Business Editors/Health/Medical Writers BEDFORD, Mass.--(BUSINESS WIRE)--Dec. 10, 2002 Unique Non-Invasive Technology Will Stratify Risk of Sudden Cardiac Arrest among 1,800 Post-Heart-Attack Patients at 50 Leading Medical Centers Worldwide Cambridge Heart, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CAMH), developer of the only FDA-cleared non-invasive test for assessing an individual's risk of 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. (SCD ScD [L.] Scien´tiae Doc´tor (Doctor of Science). SCD 1 Sickle cell disease, see there 2 Subacute combined degeneration, see there 3 Sudden cardiac death, see there ), will launch, early next year, a new clinical study to identify heart-attack patients who will benefit most from implantable cardioverter defibrillators (ICDs). The Company's innovative technology, Microvolt microvolt one-millionth (10-6) of a volt; abbreviated µV. T-Wave Alternans (MTWA), detects extremely subtle electronic fluctuations in a person's heartbeat that are not visible on electrocardiograms. These tiny fluctuations are strong predictors of Sudden Cardiac Death, which results from an electrical, rather than vascular, malfunction of the heart. More than 400,000 Americans die each year from SCD. The risk of SCD increases very significantly in patients who have already suffered a damaging heart attack. The MASTER Study (Microvolt T-Wave AlternanS Testing for Risk Stratification of Post MI Patients) will target post-myocardial infarction (MI) patients whose hearts have been damaged by previous heart attacks. About one in every ten heart-attack patients who are left with poor heart pumping function will die of heart-rhythm abnormalities within two years, according to the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S. . Results of the recent MADIT MADIT Cardiology A clinical trial–Multicenter Automatic Defibrillator Implantation Trial that evaluated the effects of implanted defibrillators–IDs in Pts with CAD at high risk of ventricular arrhythmia II clinical trial, published in the New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. , showed that implantable defibrillators improve survival in this group by 31 percent. If members of this high-risk group can be stratified more precisely through a non-invasive test conducted in a clinic or doctor's office, ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. implantations can be more cost-effective and reduce mortality rates still further for this population. The Study, to be conducted in conjunction with a leading medical technology company, will take place at up to 50 leading medical centers around the world. 600 patients meeting MADIT II criteria (post heart attack and 30% or less ejection fraction) will be enrolled in the Study. Another 1,200 patients, with slightly better pumping function (ejection fraction 30% to 40%) will be evaluated in a related registry. Results of the study are expected to be available in late 2005. "Many of the physicians we speak to are looking for a non-invasive way to assess the MADIT II population so they can make the best possible decisions about life-saving ICD therapy," said David Chazanovitz, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Cambridge Heart, Inc. "The MASTER Study will help us evaluate this specific population and more precisely identify those at greatest risk of sudden cardiac arrest." About Cambridge Heart's Microvolt T-Wave Alternans Test The only FDA-cleared, non-invasive test for assessing an individual's risk of Sudden Cardiac Death, Cambridge Heart's MTWA Test has received a CPT CPT See: Carriage Paid To code (93025) for billing and reimbursement purposes. The MTWA Test is currently in use at many leading hospitals and physician practices across the country. It can be performed as a stand alone test or in conjunction with a variety tests which elevate the heart rate. In numerous clinical studies published in the medical literature, Microvolt T-Wave Alternans has demonstrated that its predictive ability is approximately equal to the invasive electrophysiology (EP) study in predicting which individuals will experience a cardiac event and more powerful that the EP study in predicting which patients are not at risk of a cardiac event. About Cambridge Heart, Inc. Cambridge Heart is engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. Using innovative technologies developed at the Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, (MIT) and Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. , the Company is addressing such key problems in cardiac diagnosis as the identification of those at risk of sudden cardiac arrest. Founded in 1990, the Company is based in Bedford, Mass. and is traded on the NASDAQ under the symbol CAMH. For more information, please visit www.cambridgeheart.com This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Any statements contained in this press release that relate to prospective events or developments are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will" and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: failure to achieve broad market acceptance of our products, adverse results in future clinical studies of our technology, failure to obtain or maintain patent protection for our technology, failure to obtain or maintain adequate levels of third-party reimbursement for use of our products and other factors discussed in our most recent quarterly report filed with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company specifically disclaims any obligation to update these forward-looking statements. |
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