Vasomedical's EECP Therapy Systems Receive FDA 510K Clearance for Revised Labeling with Fewer Contraindications.

Health/Medical Writers

WESTBURY, N.Y.--(BUSINESS WIRE)--March 8, 2004

Vasomedical, Inc. (Nasdaq: VASO) announced today that it has been granted a 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for revised labeling on all of the currently available EECP(R) external counterpulsation systems, including the most recently available model TS4. Congenital heart diseases, pacemakers, bundle branch block, and significant pulmonary disease, were removed from the list of contraindications. Hemorrhage and coagulopathy are now listed under one contraindication as bleeding diathesis. Significant valvular disease, previously a contraindication, was modified to a precaution, and a new precaution was added for patients at high risk of excessive fluid in their lungs.

"This broadens the applicability of the therapy, and physicians will have greater flexibility in offering it to their patients. There has been a significant amount of clinical experience since the original 510(k) clearance was received in 1995, including several peer reviewed publications demonstrating patients with the original contraindications receiving benefit from EECP therapy, and that led to the modifications," stated Thomas Varricchione, VP of Clinical and Regulatory Affairs.

Four contraindications were also clarified and two, pregnancy and presence of a documented aortic aneurysm requiring surgical repair, have been added to the label.

About EECP - Enhanced External Counterpulsation 

Vasomedical's advanced, state-of-the-art EECP external counterpulsation system is comprised of an air compressor, a computer console, a set of cuffs and a treatment table. To receive treatment, patients lie down on the table and have their calves and lower and upper thighs wrapped in the cuffs. The system, which is synchronized to the individual patient's cardiac cycle, inflates the cuffs with air to create external pressure when the heart is resting (diastole) and deflates the cuffs just before the heart beats (systole). The system's action, which pulses counter to the heart's beating, increases blood flow to the heart muscle, decreases the heart's workload and creates a greater oxygen supply for the heart muscle while lowering the heart's need for oxygen.

Treatment is typically given in 35 one-hour-sessions over seven weeks; the benefits have been shown to persist for years. Researchers hypothesize that EECP may work by promoting the release of beneficial growth factors, improving the neurohormonal milieu within blood vessels, and by encouraging the proliferation of collateral blood vessels. Vasomedical's EECP systems are the only counterpulsation devices shown in clinical studies published in major peer-reviewed journals to provide improvements in exercise capacity, peak oxygen consumption and quality of life.

About Vasomedical

Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting EECP external counterpulsation systems based on the Company's proprietary technology. EECP is a noninvasive, outpatient therapy for the treatment of diseases of the cardiovascular system, currently indicated for use in cases of angina, cardiogenic shock, acute myocardial infarction and, most recently, congestive heart failure. The therapy serves to increase circulation in areas of the heart with less than adequate blood supply and may restore systemic vascular function. 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. EECP is a registered trademark for Vasomedical's enhanced external counterpulsation system. Additional information is available on the Company's website at www.vasomedical.com.

Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used herein, words such as "anticipated", "believes", "estimates", "expects", "feels", "plans" and "intends" and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company's management, as well as assumptions made by and information currently available to the Company's management. Among the factors that could cause actual results to differ materially are the following: the effect of the dramatic changes taking place in the healthcare environment; the impact of competitive procedures and products and their pricing; medical insurance reimbursement policies; unexpected manufacturing problems; unforeseen difficulties and delays in the conduct of clinical trials and other product development programs; the actions of regulatory authorities and third-party payers in the United States and overseas; uncertainties about the acceptance of a novel therapeutic modality by the medical community; and the risk factors reported from time to time in the Company's filings with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to update forward-looking statements as a result of future events or developments.