Vasomedical Announces Positive PEECH Trial Results at American College of Cardiology
Study Finds EECP Therapy Effective and Well Tolerated in Heart Failure Patients; Conference Call with Vasomedical Scheduled for Wednesday, March 9th at 4:15 p.m. ET
WESTBURY, NY AND ORLANDO, FL-Booth #2668-American College of Cardiology-March 8, 2005 -- Vasomedical, Inc. (NASDAQ SC: VASO), a leader in the non-invasive treatment and management of cardiovascular diseases, today announced the positive results of its PEECH™ (Prospective Evaluation of EECP® in Congestive Heart Failure) trial at the American College of Cardiology (ACC) Annual Scientific Session. Arthur Feldman, MD, professor and chairman of the Department of Medicine at the Jefferson Medical College of Thomas Jefferson University (Philadelphia, PA) will present the results of the PEECH trial today at 4:00 p.m. ET during the Late Breaking Clinical Trials session.
The PEECH trial evaluated the efficacy of EECP therapy for the treatment of congestive heart failure (CHF). The results demonstrated that EECP therapy was significantly more effective in improving exercise duration than optimal pharmacologic therapy alone. After six months, exercise time increased by 25 seconds in the EECP group and decreased by 10 seconds in the control group. Additional endpoints of symptom status, assessed by New York Heart Association (NYHA) functional class, improved 31% in the EECP group compared to 16% in the control group. Overall quality of life, as reported on the Minnesota Living with Heart Failure scale, also improved significantly among patients treated with EECP therapy. Peak oxygen consumption was not significantly different between the two groups.
"The results showed that six months after treatment with EECP therapy, significantly more patients increased their exercise time compared with those receiving optimal drug therapy alone," said Dr. Feldman, principal investigator. "That improvement together with improvements seen in symptom status and quality of life support the use of EECP therapy as an adjunctive treatment for chronic stable heart failure patients."
More than five million people in the United States suffer from CHF, with more than 550,000 new cases diagnosed annually. Despite advances in medical therapy over the past decade, many CHF patients fail to improve with treatment or experience rapid recurrence of symptoms. For these patients, their only option is to adjust their lifestyle and suffer with symptoms, which include, shortness of breath, difficulty breathing, constant fatigue and confusion.
The study included 187 patients with mild to moderate heart failure (NYHA Class II/III) in 29 centers, randomized to receive EECP therapy and optimal pharmacologic therapy or optimal pharmacologic therapy alone. All patients received optimal drug therapy including a beta blocker and an ACE inhibitor or an angiotensin receptor blocker. Patients were followed for six months after completing treatment.
"The economic burden to treat heart failure is tremendous and there is a dire need for new and effective treatment options given that there are few consensus therapies beyond medical management. The results of the PEECH trial provide clinical evidence demonstrating the benefits of EECP therapy for the management of CHF," said Thomas Glover, president and chief executive officer of Vasomedical, Inc. "The positive PEECH results announced today are a critical step toward Vasomedical's goal to include EECP therapy in the standard of care in treating CHF."
The company will conduct a teleconference to discuss the PEECH trial results on Wednesday, March 9th at 4:15 p.m. ET. To participate in the live call by telephone, please dial (800) 639-0297 from the U.S., or for international callers, please dial (706) 634-7417. A telephone replay will be available until 11:59 p.m. ET on March 11th 2005 by dialing (800) 642-1687 from the U.S. or (706) 645-9291 for international callers and entering passcode 3834310.
Those interested in listening to the conference live via the Internet may do so by visiting the Company's web site at www.vasomedical.com, under the investor relations tab. To listen to the live call, please go to the web site 15 minutes prior to its start to register, download and install the necessary audio software. The call will be archived on the Company's web site for 30 days.
About EECP® Therapy
EECP® external counterpulsation therapy is typically given in 35 one-hour-sessions over seven weeks. Patients lie down on a padded table and their calves, lower thighs and upper thighs are wrapped in a cuff set. 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 and decreases the heart's workload, creating a greater oxygen supply for the heart muscle while lowering the heart's need for oxygen.
About Vasomedical, Inc.
Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting EECP® external counterpulsation systems based on the Company's proprietary technology. EECP® therapy is a non-invasive, 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 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. Additional information is available on the Company's website at www.vasomedical.com.
EECP is a registered trademark for Vasomedical's enhanced external counterpulsation systems.
Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this report, words such as "anticipated," "believes," "could," "estimates," "expects," "may," "plans," "potential" 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 or supplier problems; unforeseen difficulties and delays in 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 SEC reports. The Company undertakes no obligation to update forward-looking statements as a result of future events or developments.
SOURCE: Vasomedical, Inc. |
