FDA Clears Vasomedical's EECP® External Counterpulsation Therapy for Treatment of Congestive Heart Failure
Market Clearance for Expanded Indication Could Lead to Ten-Fold Increase in Patient Population Eligible for the Non-Invasive Therapy
June 2002 (Newstream) -- Vasomedical, Inc. (Nasdaq SmallCap: VASO) announced on June 17, 2002, that its proprietary EECP® enhanced external counterpulsation system has been granted a 510(k) market clearance from the Food and Drug Administration (FDA) for a new indication for the treatment of congestive heart failure. The 510(k) clearance applies to Vasomedical's Model TS-3 EECP system that includes the Company's patent-pending congestive heart failure treatment and oxygen saturation monitoring technologies.
"With this new indication, we estimate that the percentage of eligible patients within the average medical practice who would likely benefit from EECP could grow from 2% to upwards of 15% to 20%," said D. Michael Deignan, President and Chief Executive Officer of Vasomedical. "These patient volumes would translate into a market opportunity for our cleared indications of an estimated $2 billion in sales and services over the next several years in the United States alone."
Congestive heart failure afflicts more than 5 million people in the United States alone, with more than 550,000 new patients diagnosed every year. It is the single most expensive disease state in the nation, accounting for more than $40 billion in direct and indirect medical costs.
"This development opens a vast and exciting market opportunity for us years ahead of our most optimistic projections," said Deignan. "We believe this non-invasive, cost-effective therapy will provoke a paradigm shift in the way cardiovascular diseases come to be treated. We will continue to sponsor scientific research to better demonstrate external counterpulsation's efficacy and further explain its mechanisms of action."
Results presented in 2000 of a pilot study involving 26 patients with heart failure who received EECP treatment showed significant improvement in exercise capacity, quality of life and improved oxygen utilization at six months post-treatment. The Company is currently sponsoring the PEECH(tm) trial (Prospective Evaluation of EECP in Congestive Heart Failure), a large, multi-center, randomized controlled clinical study that will evaluate improvements in exercise capacity and quality of life in heart failure patients. The Company will also sponsor an educational symposium at the Scientific Sessions of the Heart Failure Society of America in Boca Raton in September to review existing clinical data and formally launch the use of EECP for the treatment of heart failure before a scientific audience.
The Company understands from discussions with the FDA that one reason for the change in the regulatory status of EECP for the treatment of congestive heart failure was the result of the agency's reassessment of the system's safety profile. This latest decision reverses a June 2000 determination by the FDA that use of the EECP device for the treatment of congestive heart failure would require an approved Pre-Market Approval (PMA), a more rigorous and time consuming testing standard than that required for a 510(k) clearance, before marketing.
About EECP - Enhanced External Counterpulsation
External counterpulsation has been studied for more than 40 years as a non-invasive method for the treatment of ischemic heart disease. Vasomedical's advanced, state-of-the-art EECP enhanced external counterpulsation system is composed 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, and 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.
EECP is currently reimbursed by Medicare and numerous private payors for the treatment of refractory angina. The reimbursement rate for a full course of 35 one-hour treatments ranges from $5,500 to $7,000. The Company estimates that one-third of the patients treated with EECP for refractory angina also have congestive heart failure.
About Vasomedical
Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting EECP external counterpulsation systems based on the Company's proprietary technology currently indicated for use in cases of angina, cardiogenic shock, acute myocardial infarction and most recently, congestive heart failure. EECP is a noninvasive, outpatient therapy for the treatment of diseases of the cardiovascular system. 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 in this release, words such as "anticipate," "believe," "estimate," "expect" and "intend" 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 business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the regulatory and trade environment; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments.
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Produced for Vasomedical
CONTACT:
Investor Relations:
Vasomedical, Inc.
D. Michael Deignan, President & CEO
(516/997-4600 Ext. 155)
Joseph A. Giacalone, CFO |
