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Microcap & Penny Stocks : AMERICAN BIOMED, Minimally Invasive Technology (ABMI) -- Ignore unavailable to you. Want to Upgrade?

To: Jeffrey L. Henken who wrote (894)	5/21/1998 9:36:00 AM
From: Bill Fortune III	Read Replies (1) \| Respond to of 2887

Good News: biz.yahoo.com Bill Fortune III

To: Jeffrey L. Henken who wrote (894)	5/21/1998 9:46:00 AM
From: Lhn5	Read Replies (1) \| Respond to of 2887

American BioMed Inc. Receives FDA Approval for Revised OmniCath Clinical Trial Protocol THE WOODLANDS, Texas--(BW HealthWire)--May 21, 1998--American BioMed Inc. (OTC Bulletin Board: ABMI) Thursday announced it has received Food and Drug Administration approval for a revised protocol for its Phase II OmniCath(R) Peripheral Atherectomy catheter IDE clinical trials. According to company management, the OmniCath(R) Peripheral Atherectomy clinical trials will immediately utilize the revised IDE protocols, beginning at UCLA under the direction of the company's Chief Clinical Investigator, Dr. Samuel S. Ahn, and will be expanded to ten additional sites. The clinical trials will cover 200 subjects and will take approximately 12 to 15 months to complete. Clinical trials are also expected to begin in Japan over the next 60-90 days utilizing protocols similar to U.S. requirements. Steven B. Rash, president and chief executive officer of American BioMed stated: "Upon completion of the clinical trials and final approvals from the FDA, this product will be available for sale in the U.S and Japan. This product will be addressing an estimated $100 million peripheral market and represent the first major product that we take through the FDA approval process and then to commercialization in the United States." The OmniCath(R) Peripheral Atherectomy Catheter is a cost efficient, minimally invasive approach for the removal of plaque from obstructed blood vessels which helps return normal blood flow. This product is covered by six patents and is currently marketed in Europe, South America, Central America, Asia and the Middle East. Interested investigators should contact sponsor: American BioMed, Steven Rash, President and CEO. The OmniCath(R) Peripheral Atherectomy Catheter is labeled: "Caution -- Investigational Device, Limited by Federal Law (US) to Investigational Use." American BioMed 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 1OO%-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(R), an atherectomy catheter designed to remove atherosclerotic plaque from obstructed blood vessels throughout the body; and the OrniFilter, which is used to prevent blood clots from reaching various organs of the body. The company has over 25 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. --30--JS/np* KM/np CONTACT: American BioMed Inc. Steven B. Rash, 281/367-3895 or Coffin Communications Bill Coffin, 818/789-0100 or Coffin/Mottola Communications Christi Mottola, 714/851-1109 To edit your profile, go to keyword NewsProfiles. For all of today's news, go to keyword News.