Positive results in Phase III trial of BST-CarGel (Piramal Healthcare) for Tissue Repair

A pivotal Phase III clinical trial of BST-CarGel, from Piramal Healthcare, reveals that when used for Tissue Repair, the treatment results in more repair cartilage of higher quality at 12 months than microfracture, the current orthopaedic standard of care, with a similar safety profile. The trial also met both primary endpoints by reaching statistical significance over microfracture in the degree of filling treated lesions and the quality of the new tissue. The trial was conducted to evaluate BST-CarGel efficacy at 12 months in repairing cartilage lesions and improving patient clinical symptoms, compared to a surgical control called microfracture, the current standard of care. BST-CarGel is a novel chitosan-based liquid scaffold (EU class III Med. Dev.) that is first mixed with autologous whole blood and then implanted into a debrided cartilage defect prepared with bone marrow stimulation where it provides biodegradable scaffolding for cartilage regeneration. BST-CarGel is CE mark approved in the EU and Piramal Healthcare plans to launch BST-CarGel for commercial sale in the fourth quarter of the 2012.