News
American BioMed Granted Approval for Marketing and Sale of OmniCath in the European Market
THE WOODLANDS, Texas--(BW HealthWire)--Nov. 11, 1999--
Company Receives the CE Mark to Market Its Artherectomy Device in
Europe Representing a Target Market in Excess of $500 Million
American BioMed., Inc. (OTC Bulletin Board: ABMI), a leading medical device developer and manufacturer of minimally invasive devices for the treatment of cardiovascular disease and proprietary balloon catheters for cardiovascular, urinary and other disorders, today announced that it has received CE Marking for OmniCath(R)(TM), the Company's atherectomy catheter designed to remove artherosclerotic plaque from obstructed blood vessels throughout the body, for marketing and sale. This represents the seventh product for which the Company has received the CE Mark.
Obtaining the CE Mark signifies that the Company's product has attained rigorous international standards concerning quality and efficacy.
The OmniCath(R) product launch will take place at the November, 1999 Medica Conference in Dusseldorf, Germany one of the premier venues in the world.
Steve Rash, President and Chief Executive Officer, stated, "OmniCath(R) is unique from the competition's product in design and technology. With a target market in excess of $500 million, distribution in place and the likelihood that OmniCath(R) will become an "industry-standard" in vascular surgery, this acceptance represents one of the most significant milestones in the Company's history and in its forward momentum."
Marshall Kerr, Vice President of Sales and Marketing, concluded, The Company's products have been gaining momentum in the European countries. OmniCath's(R) introduction into this market will strengthen the Company's sales potential in these countries. In addition, the acquiring of the CE Mark allows us to proceed with the registration and clinical trials in Japan. These trials will be used to validate the Omnicath technology for the US market. We will start the product introduction and physician training in the first quarter of 2000."
American BioMed, founded in 1984, utilizes state-of-the-art technology to develop, manufacture and market minimally invasive medical devices for use in interventional cardiology, endovascular surgery, minimally invasive surgery, and drug delivery therapeutics. The company has over 25 patents and 11 FDA approvals in its product portfolio. American BioMed has 60 distributors and is represented in over 40 countries
This release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be accompanied by words such as "expect," "anticipate," or "should" that convey the uncertainty of future events or outcomes. These statements are based on assumptions that the Company believes are reasonable; however many important factors could cause the Company's actual results in the future to differ materially from the forward looking statements made herein or in any other documents or oral presentations made by, or on behalf of the Company. Factors which could cause or contribute to such differences include, but are not limited to, the uncertainties associated with governmental regulation, general economic and other market conditions, the results of research and development efforts, the results of pre-clinical and clinical testing, the impact of competitive product development and other risk factors set forth in the Company's filings with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties. The Company assumes no obligation to publicly update or revise any forward-looking statements made herein or any other forward-looking statements made by the Company.
CONTACT:
DeMonte Associates
Cynthia DeMonte, 212-473-3700 (Investor Contact)
cdemonte@demonte.com
KEYWORD: TEXAS INTERNATIONAL EUROPE |
