LAVAL, QC, Jan. 14 /PRNewswire-FirstCall/ - BioSyntech, Inc. , a biotechnology company developing biotherapeutic thermogels for regenerative medicine, today announced that it will conclude enrolment next month for the Canadian-European pivotal trial of its cartilage repair device, BST-CarGel(R). 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."
This randomized trial compares the treatment of cartilage lesions using BST-CarGel(R) applied following microfracture to treatment with microfracture alone. The trial is enrolling subjects aged 18 to 55 years of age with focal cartilage lesions less than 10 cm2 located on the femoral condyles of the knee. Subjects are further stratified by their lesion type, either characterized as acute (i.e. traumatic) or chronic (i.e. degenerative). The primary endpoint for this trial is cartilage repair at twelve months, defined by the quantity and quality of the repaired tissue as measured with quantitative magnetic resonance imaging (MRI). Secondary endpoints are safety and knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire. Results from this study are intended to support marketing applications in Canada and Europe.
BioSyntech is a medical device company specialized in the development, manufacturing and commercialization of advanced biotherapeutic thermogels for regenerative medicine (tissue repair) and therapeutic delivery. BioSyntech's platform technology is a family of hydrogels called BST-Gel(R), some of which are liquid at low temperature and solid at human body temperature. These gels can be injected or applied to a specific local site and offer beneficial properties for the local repair of damaged tissue such as cartilage, bone and chronic wounds and provide the benefit of avoiding invasive surgery. For additional information, visit www.biosyntech.com.
This press release contains forward-looking statements and information which are subject to material risks and uncertainties. Such statements are not historical facts and are based on the current expectations of management. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause actual results, future circumstances, or events to differ materially from those projected in the forward-looking information. These risks include, but are not limited to, those associated with our capacity to finance our activities, the adequacy, timing, and results of our clinical trials, the regulatory approval process, competition, securing and maintaining corporate alliances, market acceptance of the Company's products, the availability of government and insurance reimbursements for the Company's products, the strength of intellectual property, the success of research and development programs, reliance on subcontractors and key personnel, and other risks and uncertainties detailed from time-to-time in our filings with the Canadian securities commissions.
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