Friday December 15, 9:59 am Eastern Time
Press Release
Vasomedical Receives 510k Clearance
From FDA to Market Next
Generation EECP System
New system expected to increase company's penetration of the hospital
market
WESTBURY, N.Y.--(BUSINESS WIRE)--Dec. 15, 2000-- Vasomedical, Inc. (Nasdaq: VASO
- news) announced today that it has been granted 510(k) clearance from the Food and Drug
Administration to market it's next generation EECP® Enhanced External Counterpulsation system,
the TS-3.
The new system is mobile and adds a state-of-the-art touch screen interface, integrated components,
and a reduced footprint to the company's current offerings. The new model will be marketed along
side the company's mainstay product, the MC2.
EECP is a non-invasive treatment that utilizes pneumatic cuffs to compress the lower extremities in
time with a patient's heartbeat. The therapy reduces angina and helps stabilize a patient by
decreasing the heart's workload and improving circulation in areas of the heart deprived of adequate
blood supply. The TS-3, which was unveiled last month at the 73rd Scientific Sessions of the
American Heart Association in New Orleans, will allow for future software upgrades as well as the
integration of such features as pulse oximetry and hemodynamic monitoring which are usually
required in treating critically ill patients.
The TS-3 is expected to provide Vasomedical with easier entree into the hospital market where
space is a factor in the acquisition process. Additionally, the smaller footprint and greater mobility of
the TS-3 will allow the system to be brought to the patient, especially into the areas of the hospital
that have the first line treatment responsibility for heart attack patients, the emergency room and
coronary care unit. There is an estimated 30,000 acute care facilities worldwide. The TS-3 also will
be the exclusive system used in the company's upcoming pivotal trial on the use of EECP to treat
congestive heart failure (CHF) patients. This multi-center, randomized trial is scheduled to begin in
January 2001. CHF is a disabling condition affecting nearly 5 million Americans and is the most
frequent cause of hospitalization for those over 65 years of age.
Commenting on the recent 510(k) clearance, CJ McGroarty IV, Vasomedical's Vice President of
Sales & Service stated, ``The introduction of the TS-3 marks a significant step forward in
Vasomedical's history. Most hospitals face enormous space constraints. The reduced ''footprint``
and the mobility of the TS-3 will make it easier for hospitals to include EECP in their treatment
facilities.''
According to Mandeep R. Mehra, MD, Vice Chairman of Clinical & Academic Affairs, Department
of Cardiology, Ochsner Clinic, Ochsner Foundation Hospital in New Orleans, ``I expect the new
TS-3 will provide the same clinical outcomes I've been accustomed to getting with the MC2. The
system is more intuitive for clinicians to use. Moreover, the fact that Vasomedical's new TS-3 is
upgradeable means that the system will facilitate additional clinical uses for EECP as new indications
become scientifically validated and approved by the FDA.''
Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting
external counterpulsation systems based on the company's proprietary technology. EECP® is a
registered trademark for Vasomedical's enhanced external counterpulsation system. This system is
now in use at major medical centers, including the Mayo Clinic, the Ochsner Foundation Hospital,
Texas Heart Institute and the Miami Heart Institute, as well as medical centers affiliated with
Columbia University, Johns Hopkins, the University of Pittsburgh, UMDNJ - New Jersey Medical
School, the University of California at San Diego, the University of California at San Francisco, State
University of New York at Stony Brook and the University of Virginia. The company provides
hospitals, clinics and private practices EECP® equipment, treatment guidance and a staff training
and maintenance program designed to provide optimal patient outcomes.
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.
Contact:
Vasomedical, Inc., Westbury
D. Michael Deignan, 516/997-4600 Ext. 155
Douglas A. Goldman, 516/997-4600 Ext. 163
www.vasomedical.com
or
Investor Relations Contact:
The Equity Group, Inc., New York
Devin Sullivan, 212/836-9608
www.theequitygroup.com |
