TO ALL: MORE GOOD NEWS From Yahoo Business Wire
Wednesday January 14, 8:01 am Eastern Time
Company Press Release
American BioMed Inc. Receives ISO 9001 Certification
THE WOODLANDS, Texas--(BW HealthWire)--January 14, 1998--American
BioMed, Inc. (OTC Bulletin Board: ABMI - news), a manufacturer of
minimally invasive medical devices for the treatment of cardiovascular
disease, today announced it has received International Standards
Organization (ISO) 9001 Certification from the ISO 9001 Registrar.
Commenting on the announcement, Mr. Steven B. Rash, president and chief
executive officer, stated, ''Receipt of ISO 9001 Certification confirms
the company's ongoing commitment to high standards of manufacturing and
product quality, and customer service. We dedicated a considerable
amount of time and preparation, corporate reorganization and training of
personnel to achieve ISO standards. Certainly, certification from the
ISO 9001 Registrar represents a major corporate milestone for American
BioMed as it will allow us to generate interest in our unique line of
cardiovascular products, here in the U.S. and abroad, as well as attract
and develop original equipment manufacturing partnerships.'' The Company
has filed for the CE Mark which will be required for marketing medical
devices in all 15 countries that comprise the European Union (EU) on
June 14, 1998.
ISO is a federation of national organizations representing approximately
100 countries. ISO 9001 is a quality-assurance model that conforms to
internationally accepted guidelines on management and quality system
elements, and is used by companies that design, produce, inspect, test,
install and service items such as medical devices.
American BioMed, Inc. utilizes state-of-the-art technology to develop,
manufacture and market minimally invasive medical devices for the
treatment of cardiovascular disease. The company's products include:
100% silicone-based catheters, through its Cathlab subsidiary; the
Evert-O-Cath(TM), a toposcopic catheter for site-specific drug delivery
and fluid removal; the OmniCath, an atherectomy catheter designed to
remove athersclerotic plaque from obstructed blood vessels throughout
the body; the OmniStent(TM), which uses stent technology for angioplasty
and atherectomy procedures; and the OmniFilter, which is used to prevent
blood clots from reaching various organs of the body. The company has
over twenty five patents covering its product portfolio, and the
combined worldwide market is estimated at over $10 billion annually.
''Safe Harbor'' Statement under the Private Securities Litigation Reform
Act of 1995: The statements which are not historical facts contained in
this release are forward looking statements that involve risks and
uncertainties, including, but not limited to, the results of research
and development efforts, the results of pre-clinical and clinical
testing, the effect of regulation by the United States Food and Drug
Administration (FDA) and other agencies, the impact of competitive
products, product development, commercialization and technological
difficulties, the results of financing efforts, the effect of the
Company's accounting policies, and other risks detailed in the Company's
Securities and Exchange Commission filings.
Malek |
