LAVAL, Quebec--(BUSINESS WIRE)--Nov. 16, 2005--BioSyntech, Inc. (“BioSyntech” or “the Company”) (TSX VENTURE:BSY) announced today that it has received approval from Health Canada, Therapeutic Products Directorate, Medical Devices Bureau, to begin its pivotal clinical trial for BST-CarGel(R). The Company expects the data from this trial to support Canadian and European regulatory approval of BST-CarGel(R), a medical device for cartilage repair designed to regenerate cartilage in a process called In Situ ChondroInduction (ICI). Subject enrolment and surgery will commence immediately and treatment will proceed according to surgical facility availability. “Historically, treatment of cartilage damage has been a problematic area for orthopaedics due to a continued lack of technological breakthroughs. This has left many patients without viable options, and many of these patients may eventually require total knee replacement,” said Mr. Claude LeDuc, President and CEO of BioSyntech. “We believe that BST-CarGel(R) is a potential solution to this growing need to repair cartilage damage and, to that end, have initiated a controlled and randomized clinical trial with a strong scientific design. Our trial data will not only support Canadian and European approval, but may be instrumental in gaining regulatory approval in the United States.”
