To: Knighty Tin who wrote (82703 ) 8/7/2000 11:44:57 AM From: Exacctnt Read Replies (1) | Respond to of 132070 Mike, More VASO news.biz.yahoo.com Vasomedical Receives Approval to Begin EECP-R- Efficacy Study for Congestive Heart Failure Patients WESTBURY, N.Y.--(BUSINESS WIRE)--August 7, 2000--Vasomedical, Inc. (Nasdaq SmallCap: VASO - news) announced today that it has received approval, with conditions, of its investigational device exemptions (IDE) application from the FDA to proceed with a multicenter, controlled study on the efficacy of EECP therapy in congestive heart failure (CHF) patients. The Company will agree to meet FDA conditions and could start enrolling patients as early as the fall of 2000. The study is scheduled to enroll 180 patients in 18 centers. Site selection for the trial is now in its final stages. The interim results of a feasibility study on the use of EECP in CHF patients were presented this past March at the 49th Scientific Sessions of the American College of Cardiology and were promising. These results were provided to the FDA to support approval of this large-scale pivotal study. Vasomedical has also been informed that its EECP system, when used to treat congestive heart failure patients, is classified by the FDA as a Class III Pre-Market Approval (PMA) device. Commenting on the recent news, CEO D. Michael Deignan said, ``FDA's approval of the CHF study is a momentous event in Vasomedical's history - it permits us to pursue approval of a critically important indication. Although the agency requires PMA approval prior to marketing, and such approvals take time and resources, if we achieve a CHF approved indication, our data and market position will be afforded a measure of protection by the FDA's challenging PMA requirements. A successful PMA outcome will substantially increase our base of patients beyond current levels, assuming that Medicare and third party healthcare insurers cover a CHF indication.'' Congestive heart failure is a disabling condition affecting nearly 5 million Americans and is the most frequent cause of hospitalization for those over 65 years of age. It is also the only major cardiovascular disease whose incidence is increasing. There are now 400,000 new cases of CHF reported each year. Once diagnosed, the average survival for CHF patients is approximately five years. Congestive heart failure is the single biggest drain on the Medicare system today and remains the most expensive healthcare problem in the U.S. The annual cost to treat CHF patients in the United States is estimated to be in excess of $50 billion. Currently there is no consensus on the optimal approach to the treatment of congestive heart failure beyond medical management. As a result, many CHF patients are caught up in a cycle of visits to their physician's office and hospital emergency rooms as their condition alternately improves and declines. With the potential use of EECP therapy for CHF, the Company hopes to decrease the number of emergency room visits and hospital admissions for these patients and provide a major boost to their quality of life. Some data suggest that the cost savings which might be realized from reducing the number of hospitalizations and treating CHF patients on an outpatient basis could be significant. According to Charles Fitzgerald, MD, Medical Director of the Heartcare Clinic of Arkansas in Little Rock, one of the centers slated to participate in the upcoming trial, ``Our options for managing patients with congestive heart failure at this point in time are limited. EECP therapy may well become an integral part of the CHF therapeutic portfolio in the next several years.'' Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting external counterpulsation systems based on the Company's proprietary technology currently indicated for use in cases of angina, cardiogenic shock and acute myocardial infarction. EECP® is a registered trademark for Vasomedical's enhanced external counterpulsation system. This system is now in use at major medical centers, including Beth Israel Medical Center - New York City, Christ Hospital and Medical Center, JFK Medical Center-Atlantis, FL, Kaiser Permanente of Denver, the Mayo Clinic, the Miami Heart Institute and the Ochsner Foundation Hospital, as well as medical centers affiliated with Columbia University, the University of Pittsburgh, the University of California at San Diego, the University of California at San Francisco, University of Florida at Gainesville, State University of New York at Stony Brook and the University of Virginia. The Company provides hospitals, clinics and private practices with EECP® equipment, treatment guidance and a staff training and maintenance program designed to provide optimal patient outcomes. Additional information is available on the Company's website at www.vasomedical.com.