To: James Marks who wrote (90 ) 9/10/1998 8:53:00 AM From: Jeffrey L. Henken Respond to of 939
American Biomed, Inc., Receives CE Mark for Silicone Balloon Catheters Company Simultaneously Renews ISO 9001 Quality System Certification THE WOODLANDS, Texas, Sept. 10 /PRNewswire/ -- American BioMed, Inc. (OTC Bulletin Board: ABMI - news), today announced that it has received the CE Mark of Conformity from the European Union for the company's line of silicone balloon catheters. The CE Mark certification allows the company to market medical devices within the 15 countries that comprise the European Economic Community (EEC). Under the European Union Medical Devices Directive, all devices sold onto the market since June 14 (ie. not already in the distribution chain) must bear the CE Mark. Marshall Kerr, Vice President of Sales and Marketing of American BioMed stated, ''Now with this certification, many of our distributors who have been restricted in their promotional efforts without the CE Mark, can aggressively promote our products without this limitation.'' ''Additionally, the awarding of the CE Mark allows the company to continue to establish its world class distribution network. This is extremely important, because it not only provides distribution for our current product offerings, but acts as a platform for the new products we plan to launch next year, which have an even greater market potential,'' said Kerr. Steven B. Rash, President and CEO of American BioMed said, ''Receipt of the CE Mark represents a major milestone for the company. We believe this certification will lead to an increase in both our market share and revenue growth.'' In addition to the CE Mark of Conformity, the company simultaneously renewed its ISO 9001 Quality System Certification, and was certified to EN46001 standards. EN46001 is an enhanced version of ISO 9001 written exclusively for 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 catheters, through its Cathlab subsidiary; the Evert-O-Cath(TM), a toposcopic catheter for site-specific drug delivery and fluid removal, the OmniCath(R), an atherectomy catheter designed to remove atherosclerotic plaque from obstructed blood vessels throughout the body; and the OrnniFilter, which is used to prevent blood clots from reaching various organs of the body. The Company has over twenty-five patents and 11 FDA approvals covering its product portfolio, and addresses an annual worldwide market estimated to be in excess of $10 billion. ''Safe Harbor'' statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in the 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 preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive 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. biz.yahoo.com InvestRight Regards, Jeff