BST-CarGel was granted CE mark in Europe last month.

Piramal Healthcare presented positive data from a pivotal Phase III study evaluating its BST-CarGel® cartilage repair product, which achieved a European CE mark last month. The study demonstrated that BST-CarGel treatment was more effective than microfracture (the current standard of care) in terms of the degree of filling of treated lesions, and quality of new cartilage tissue. Treated cartilage was evaluated using a 3-D quantitative MRI technique that can compare both the quantity and quality of repaired cartilage structure.

“The significant level of evidence from the BST-CarGel clincial trial, using multiple and independent methodologies, truly supports the positive effect of BST-CarGel over the standard of care on both the quantity and quality of regenerated cartilage tissue,” comments William Standish, M.D., principal trial investigator who is professor of surgery at Dalhousie University in Halifax, Nova Scotia. “This represents a cost-effective, off-the-shelf surgical alternative that may dramatically improve cartilage repair over traditional methods in a minimally invasive manner.”

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