BioSyntech to conclude enrollment for cartilage repair device trial

To date, the company has enrolled more than 70 subjects and participating clinical sites will be permitted to enroll additional subjects until February 10, 2009.

This randomized trial compares the treatment of cartilage lesions using BST-CarGel 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 10cm2 located on the femoral condyles of the knee. Subjects are further stratified by their lesion type, either characterized as acute or chronic.

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. Secondary endpoints are safety and knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities osteoarthritis index questionnaire. Results from this study are intended to support marketing applications in Canada and Europe.

Michel Lagueux, chairman of the board of directors, said: 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 12-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.