BioSyntech, Inc., a biotechnology company developing biotherapeutic thermogels for regenerative medicine, announced that it has completed enrolment for the Canadian-European pivotal trial of its cartilage repair device, BST-CarGel®. 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® in Canada and Europe. We also continue to advance the IDE (Investigational Device Exemption) application process with the US FDA, for BST-CarGel® in the US.”
This randomized trial compares the treatment of cartilage lesions using BST-CarGel® 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.