LAVAL, QC, Feb. 2 /PRNewswire-FirstCall/ - BioSyntech, Inc. (TSX: BSY), a biotechnology company developing biotherapeutic thermogels for regenerative medicine, today announced that it has completed enrolment for the Canadian-European pivotal trial of its cartilage repair device, BST-CarGel(R). The Company achieved its planned objective of enrolling 80 patients into the randomized trial.
"We are grateful to the distinguished group of orthopaedic surgeons who participated in this trial and were instrumental in achieving this milestone, despite the challenges presented by our strict eligibility criteria," said Michel Lagueux, Chairman of the Board of Directors. "With enrolment now complete, we look forward to the final results from this pivotal trial, which will be available in the first quarter of 2010 and will support marketing applications for BST-CarGel(R) in Canada and Europe. We also continue to advance the IDE (Investigational Device Exemption) application process with the US FDA, for BST-CarGel(R) in the US."
This randomized trial compares the treatment of cartilage lesions using BST-CarGel(R) applied following microfracture to treatment with microfracture alone. The trial enrolled subjects aged 18 to 55 years of age with focal cartilage lesions less than 10 cm(2) 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.
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.
Readers should not place undue reliance on the forward-looking information, given that (i) our actual results could differ materially from a conclusion, forecast or projection in the forward-looking information, and (ii) certain material factors or assumptions which were applied in drawing a conclusion or making a forecast or projection as reflected in the forward-looking information, could prove to be inaccurate. Additional information about (i) the material factors that could cause actual results to differ materially from the conclusion, forecast or projection in the forward-looking information, and (ii) the material factors or assumptions that were applied in drawing a conclusion or making a forecast or projection as reflected in the forward-looking information, is contained in the Company's annual report and other documents filed from time to time with the Canadian securities commissions which are available at www.sedar.com. These statements speak only as of the date they are made, and we assume no obligation to revise such statements as a result of any event, circumstance or otherwise, except in accordance with law.
|SOURCE BioSyntech, Inc.|
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