American BioMed Inc. files IRB at UCLA to expand OmniCath clinical trials.THE WOODLANDS, Texas--(BUSINESS WIRE)--Dec. 23, 1996--American BioMed Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB:ABMI), Monday announced that it has filed an IRB IRB See: Industrial Revenue Bond at UCLA for OmniCath(r) atherectomy catheter for hemodialysis AV fistula restenosis and that IRB's will soon be filed at other sites. The company plans to file an IDE with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for this indication by the end of December 1996. Industry analysts estimate the worldwide market potential for the AV fistula application at approximately $250-million. The company further announced that it has enrolled eight patients in its ongoing prospective randomized study comparing PTA to atherectomy (ongoing peripheral clinical trials). To date, the trials are progressing well and there have been no adverse effects or complications with any of the patients. As previously announced, the company has enrolled two more sites with Dr. Kim Hodgson at Southern Illinois University Southern Illinois University, main campus at Carbondale; state supported; coeducational; est. 1869, opened 1874 as a normal school, renamed 1947. It has a center for archaeological investigation and a fisheries research laboratory. There is also a campus at Edwardsville. School of Medicine and Dr. Darwin Eaton at University of Southern California The U.S. News & World Report ranked USC 27th among all universities in the United States in its 2008 ranking of "America's Best Colleges", also designating it as one of the "most selective universities" for admitting 8,634 of the almost 34,000 who applied for freshman admission Medical Center for its peripheral clinical trials. Four additional sites are also being considered. The company's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Steven B. Rash, stated: "These additional sites will accelerate our patient enrollment in our ongoing peripheral clinical trials as well as the AV fistula clinical trials which we expect to initiate in first quarter 1997. Our goal is to enroll 50 patients by June 1997 and complete the study by the end of 1997 for FDA approval for peripheral application. The company is very pleased with the progress of the OmniCath(r) clinicals to date and we are on schedule to obtain FDA approval which represents a major milestone in our efforts to commercialize our proprietary technology. The worldwide market potential for peripheral use is approximately $150-million." American BioMed Inc. utilizes state of the art technology to develop, manufacture and market minimally invasive 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. -0- NOTE TO EDITORS: In the Internet/email address noted in this news release, there is an "at" symbol between tewinc and aol.com. This symbol may not appear properly in some systems. CONTACT: Thomas E. Waite & Associates Inc. Phone 407/324-1606, Fax 407/324-0664 email: tewinc@aol.com |
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