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BioSyntech To Conclude Enrolment For BST-CarGel Canadian-European Pivotal Trial

BioSyntech, Inc will conclude enrolment next month for the Canadian-European pivotal trial of its cartilage repair device, BST-CarGel. To date, the Company has enrolled more than 70 subjects and participating clinical sites will be permitted to enrol additional subjects until February 10th, 2009. “With the certainty provided by this date, we are now sure that the final results from this pivotal trial will be available in the first quarter of 2010, once the last treated subject has completed their twelve-month follow up period. Furthermore, we are confident that the current number of enrolled subjects already represents a sufficiently powered study and that with this data we can meet the overall objectives of the study,” said Michel Lagueux, Chairman of the Board of Directors. “At the same time, we remain sensitive to the fact that there are eligible individuals who still want a chance to participate in the study and we will work closely with our investigators over the next four weeks to ensure that as many as possible can be enrolled. “I am very proud to be involved in the clinical development of this important new therapy in what is the largest randomized clinical trial for cartilage repair ever conducted in North America. Enrolment was certainly the greatest challenge, given our adherence to strict subject eligibility criteria, but in the end this rigour will ensure trial data of the highest quality and integrity,” said Dr. William Stanish, Professor of Surgery at Dalhousie University in Halifax, Nova Scotia, and Principal Investigator for the trial. Mr. Lagueux continued, “BioSyntech would like to acknowledge the team of over 25 orthopaedic surgeons and their support staff for their sincere dedication and perseverance in achieving this enrolment milestone.” The randomized trial compares the treatment of cartilage lesions using BST-CarGel applied following microfracture to treatment with microfracture alone. This trial is enrolling subjects aged 18 to 55 years of age with focal cartilage lesions less than 10 cm square located on the femoral condyles of the knee. Patients are further stratified by their lesion type, either characterized as acute i.e. traumatic or chronic i.e. degenerative. The primary endpoint for the trial is cartilage repair at twelve months, defined by the quality and quantity of the repaired tissue as measured with quantitative magnetic resonance imaging (MRI). Secondary endpoints are safety and stiffness, knee-related pain and function as measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire. Results from the study are intended to support marketing applications in Europe and Canada.