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BioSyntech Reports Positive Results from Pivotal Trial for BST-CarGel(R) Cartilage Repair Device
Date:6/17/2009

the Interim Analysis. Secondary endpoints of safety and knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire are also being compiled for the Interim Analysis. All of this end point data and analysis continues to form part of the ongoing Interim Analysis and results are expected in the next few months.

About the Canadian-European BST-CarGel trial

The ongoing, randomized BST-CarGel pivotal trial compares the treatment of cartilage lesions using BST-CarGel applied following microfracture to treatment with microfracture alone as a control. The trial enrolled 80 patients aged 18 to 55 years of age with focal cartilage lesions less than 10 cm(2) located on the femoral condyles of the knee. Patients were 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 12 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. A previous interim analysis demonstrated the safety of BST-CarGel to be comparable to the Microfracture control on the first 23 patients at 6 months.

About BioSyntech

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.
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SOURCE BioSyntech, Inc.
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