American BioMed Inc. clinical trial update.THE WOODLANDS, Texas--(BUSINESS WIRE)--June 19, 1997--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 EBB:ABMI ABMI Autologous Bone Marrow Infusion ) Thursday announced that its prospective, randomized clinical trials randomized clinical trial, n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies. comparing the immediate effectiveness of the company's Thrombectomy thrombectomy /throm·bec·to·my/ (throm-bek´tah-me) surgical removal of a clot from a blood vessel. throm·bec·to·my n. Excision of a thrombus. Catheter versus the Baxter Balloon Catheter balloon catheter n. A catheter with an inflatable balloon at its tip, used especially to expand a partially obstructed blood vessel or bodily passage and to measure blood pressure in a blood vessel. Also called balloon-tip catheter. is now 65% complete and all cases have demonstrated initial technical success. Dr. Samuel S. Ahn, the company's chief clinical investigator stated: "I am pleased with the overall performance of American BioMed's product line. The thrombectomies performed with its catheters resulted in a lower number of ruptured balloons, thus possibly reducing the time and cost of thrombectomy procedures." The company expects to complete the trials in 60 days and file for 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. 510K approval shortly thereafter. The company also announced it has added two participating investigational sites for its OmniCath(r) Peripheral and AV Fistula fistula (fĭs`ch  lə), abnormal, usually ulcerous channellike formation between two internal organs or between an internal organ and the skin. clinical trials. The Sir Mortimer B. Davis-Jewish General Hospital, associated with Magill University, Montreal; and Edwards Eve Clinic, associated with Vanderbilt University, Nashville, Tenn. are the additional new investigational sites, bringing to eight the number of sites participating in the clinical trials. To date, 35% of the required clinical trials are complete and all cases have demonstrated early clinical success as stated by Dr. Ahn. The company expects to complete the clinical trials later this year and will submit the results for FDA approval as soon as possible after the trials' conclusion. 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 26 patents cover its portfolio of technologies competing in an industry with a combined worldwide market estimated at over $10 billion annually. CONTACT: Thomas E. Waite & Associates Inc. 407/324-1606, fax 407/324-0664 |
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