"Friday January 25, 12:05 pm Eastern Time
Press Release
SOURCE: Vasomedical, Inc.
Health-Related Quality of Life Continues to Improve 12 Months After a Course of Vasomedical's EECP Therapy
The Journal of Investigative Medicine publishes the results of the MUST-EECP substudy examining the effects of EECP on Health-related QOL
WESTBURY, N.Y.--(BW HealthWire)--Jan. 25, 2002-- Vasomedical, Inc. (Nasdaq: VASO - news) announced today the publication of the results of a one-year follow-up study to its MUST-EECP trial showing dramatic improvements in health- related quality of life (HQOL) for patients with angina at one year following the completion of a course of EECP therapy.
These data were published in the January 15th issue of the Journal of Investigative Medicine (JIM), the official publication of the American Federation for Medical Research. The MUST-EECP trial, which paved the way for Medicare reimbursement of EECP therapy, was Vasomedical's randomized, controlled study on the effectiveness of the therapy for patients with chronic angina.
Compared with patients in a sham-treated control group, patients receiving active EECP reported 'across the board' improvements in standard measures of HQOL both immediately after and at 12 months following the completion of treatment. Other studies based on data from the International EECP Patient Registry (IEPR) and elsewhere have shown that the clinical benefits of EECP therapy are sustained up to five years post-treatment.
One of the expert authors, Dr. San Keller, Director of the Health Care Quality and Outcomes research program at the Research Triangle Institute, commented, ``It is rare for studies of this relatively small size to be able to demonstrate such clear-cut differences. It was possible to detect very large 'Mack truck' HQOL effect sizes, which were in fact seen for some parameters. This suggests that EECP is able to bring about quite profound improvements in patients' ability to interact with family and friends, the amount of pain they have and their satisfaction with aspects of their health that were important to them.''
The large-scale improvements for the EECP-treated group noted in this follow-up study immediately after treatment were even more dramatic at 12 months post-treatment, leading the authors to reason that either EECP triggers a process of physiologic improvement that continues after the therapy is over or that EECP had enabled these patients to capitalize on an improved exercise capacity or both. Studies published over the course of the last several years suggest that EECP helps restore vascular function by increasing shear stress on endothelial cells which line blood vessels and control vascular reactivity. It has been suggested that the increased shear stress generated by EECP stimulates the release of growth factors leading to capillary sprouting and endothelial cell migration resulting in arteriogenesis (the maturation of epicardial vessels) and angiogenesis (new vessel formation) or both. Nitric oxide levels have been shown to increase while endothelin levels have diminished, resulting in increased blood flow overall.
Along with the impact on functional ability, the extent to which HQOL is affected by treatment is central to how therapeutic success is perceived by patients. Diminished HQOL is usually the reason patients seek a physician's care in the first place. The primary parameters of measurement in this study were the Physical Functioning, Bodily Pain, and Social Functioning scales of the widely used general HQOL survey instrument, the SF36. To cross-check findings, the disease-specific instrument Quality of Life Index - Cardiac Version (QLI-CVIII) was also used. On all parameters, both primary and secondary, the magnitude of improvement was much greater in the EECP-treated group. Highly significant (P<0.01) improvements occurred in 5 out of a total of 9 scales 12 months after treatment compared to baseline.
Commenting on the current study, Rohit R. Arora, MD, Professor of Medicine and Chief of Cardiology at UMDNJ/New Jersey Medical School as well as Principal Investigator for the MUST-EECP study stated, ``These data are significant because they are based on a controlled study and are consistent with the sustained quality of life improvements noted in patients enrolled in the International EECP Patient Registry.'' The IEPR is a voluntary registry of consecutive patients treated in hospitals and clinics, which was established in 1998 to document patient characteristics, safety and efficacy of EECP therapy during the treatment period as well as long-term outcomes. Dr. Arora went on to say, ``The fact that we are able to see significant quality of life improvements in a study population made up of patients with Canadian Cardiovascular Class II and III angina should signal to all clinicians just how effective EECP can be in the treating those with chronic angina or equivalent symptoms.''
Also commenting on this study, Douglas A. Goldman, Vice President of Marketing and Business Development stated, ``The improvement in HQOL noted in this controlled study should be of particular interest to commercial insurers and other third party payers since the long-term benefits here suggest that EECP can positively affect patient satisfaction and be highly cost-effective in managing patients with cardiovascular disease.''
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 and acute myocardial infarction. 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 is also actively engaged in research to determine potential benefits of EECP therapy in the management of other major vascular disease states, including congestive heart failure and diabetes. This system is now in use at major medical centers, including the Beth Israel Medical Center - New York City, Christ Hospital and Medical Center, the Cleveland Clinic, Johns Hopkins, JFK Medical Center-Atlantis, FL, Mayo Clinic, the Miami Heart Institute, the Ochsner Foundation Hospital, Scripps Center for Integrative Medicine - La Jolla, CA, the Texas Heart Institute, and University Hospital at UMDNJ/New Jersey Medical School as well as medical centers affiliated with Columbia University, State University of New York at Stony Brook, the University of Pittsburgh, the University of California at San Diego, the University of California at San Francisco, University of Florida at Gainesville, 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. 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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Contact:
Vasomedical, Inc., Westbury
D. Michael Deignan, 516/997-4600 Ext. 155
Joseph A. Giacalone, 516/997-4600 Ext. 121
or
Investor Relations, 516/997-4600 Ext. 790
investorrelations@vasomedical.com
www.vasomedical.com"
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