To: Lhn5 who wrote (554 ) 4/25/1998 11:00:00 AM From: Jeffrey L. Henken Respond to
Larry the OmniCath trials are set to resume phase II testing soon at 10 different sites here in the US, Japan and Europe as well. Here is some information from the 10K on the US clinical trials which are set to resume with the company's new protocols which will speed FDA approval:The Company had commenced limited human clinical trials in the United States with the 8 French OmniCath(R) for peripheral use. The device was initially used on patients during 1991 and 1992. Although no adverse effects or complications were observed or reported from the use of the OmniCath(R) on any patient, the trials indicated that the OmniCath(R) needed certain modifications. In July 1992, the Company contracted with an independent third party to conduct a product design review of the OmniCath(R). Based on the results of that review, improvements to the OmniCath(R) were made including increasing battery and motor power for guiding the catheter through the body, strengthening the deflector wires which hold the catheter in place, enhancing the cutter and debris-removal system, and creating a better ergonomically profiled product for the end user. The Company informed the FDA of the improvements in July 1992, and the FDA requested additional information on the modifications before human clinical testing could resume. The Company submitted the additional information and received permission from the FDA to resume Phase I clinical trials in July 1993. The Company completed its Phase I trials and submitted its data to FDA. The Company received approval by the FDA for its Phase II peripheral OmniCath(R) atherectomy clinical trials in 1995 and commenced Phase I on August 1, 1996 at the University of California at Los Angeles. However, the clinical trials are temporarily suspended as the Company has filed an amended protocol with the FDA. The Company expects these clinical trials to be resumed during the second quarter of 1998 and submission to the FDA approximately 18 months later. Currently the Company has eight clinical sites and intends to expand the number of sites to 10 in 1998. In the event of a buy out I think ABMI is worth more. WHY? If the company is never acquired and actually brings these products to market itself, the markets for ABMI products could far exceed $1 billion a year.
