AMERICAN BIOMED, INC. RECEIVES CONDITIONAL APPROVAL FROM FDA FOR PHASE II TRIALS OF OMNICATH.THE WOODLANDS, Tx.--(BUSINESS WIRE)--March 7, 1995--American BioMed, Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB: ABMI ABMI Autologous Bone Marrow Infusion ) announced today that it has received conditional approval by 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. to immediately implement Phase II clinical studies of its OmniCath peripheral atherectomy catheter. The FDA and American BioMed, Inc. have agreed upon Adj. 1. agreed upon - constituted or contracted by stipulation or agreement; "stipulatory obligations" stipulatory noncontroversial, uncontroversial - not likely to arouse controversy the requirement and content of the protocol; however, until the agreed upon modifications are received in writing by the FDA, the application is considered conditionally approved. American BioMed, Inc. completed Phase I human clinical trials. This data was submitted to the FDA to provide a foundation for the decision to move into the larger Phase II human studies. Phase II human clinical studies are required by the FDA in order to demonstrate the safety and efficacy of atherectomy catheter devices. American BioMed, Inc.'s business is focused in the high growth interventional cardiology/radiology market. The Company's coronary and peripheral atherectomy and stent stent (stent) 1. a device or mold of a suitable material, used to hold a skin graft in place. 2. a slender rodlike or threadlike device used to provide support for tubular structures that are being anastomosed, or proprietary technologies are designed for use in minimally invasive procedures Minimally invasive surgical procedures avoid open invasive surgery in favor of closed or local surgery with less trauma. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an . The atherectomy procedure involves the cutting and subsequent vacuum removal of plaque, whereas the stent device is positioned within the artery to maintain an open lumen. Industry sources state that the atherectomy device market is in excess of $500 million. The growth of the stent market is projected to be in excess of $200 million. The Company is reviewing alternative sources of funding to finance these studies. CONTACT: Geoffrey J. Eiten OTC Communications (617) 444-6100 |
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