American BioMed files IDE with FDA to conduct OmniCath AV fistula graft clinical trials

Business Wire, Feb 11, 1997

THE WOODLANDS, Texas--(BW HealthWire)--Feb. 11, 1997--American BioMed Inc. (NASDAQ/EBB:ABMI) Tuesday announced that it has filed an IDE with the Food and Drug Administration for its OmniCath(r) atherectomy catheter for hemodialysis AV fistula restenosis clinical trials.

Upon approval of the IDE, the approximate 50 required clinical trials, will immediately commence in six U.S. sites and will be expanded to 10 sites within 60 days of approval. There are approximately 120,000 AV fistula grafts performed annually in the United States. Market analysts have estimated the worldwide market potential for the OmniCath(r) to be over $156 million annually for this indication. To the best of the company's knowledge, there is no competitor in this market segment.

The company further announced that is has enrolled 15 patients in its prospective randomized study comparing PTA to atherectomy. To date, the trials have progressed according to the company's business plan. The company fully expects to complete the study by the end of 1997 for FDA approval.

American BioMed's President and CEO, Steven B. Rash, stated: "The company is pleased with the progress of the clinical trials to date and is optimistic that U.S. sales could begin in early 1998, representing a major milestone in our continuing efforts to commercialize our core technologies.

"Currently, there is no competing medical device in the AV fistula market. The design for this device has actually been driven by the surgeons who are in dire need of such an instrument."

American BioMed Inc. utilizes state of the art technology to develop, manufacture and market minimally evasive medical, surgical and diagnostic devices which deliver unique advantages through advanced science. Over 25 patents cover its technologies competing in an industry with combined markets estimated at over $10 billion annually.

CONTACT: Thomas E. Waite & Associates Inc.

407/324-1606