Piramal gets EU approval to sell BST-CarGel
Mumbai: Piramal Healthcare Ltd Wednesday announced that it has received European regulatory approval to sell BST-CarGel, a bio-orthopaedic product.
The European regulatory approval will enable Piramal Helthcare to commercialize BST-CarGel in all of the countries in the European Union. This approval will also serve as the basis to obtain commercial authorization for the product in other geographic areas of the world such as the Middle East, the Asia Pacific region, South America and other countries including India.
Piramal Healthcare plans to launch BST-CarGel for commercial sale in the fourth quarter of the 2012 calendar year after completing user studies with key opinion leaders.
"Following approval of Piramal's first innovative product for regenerative medicine, we are looking forward to launch BST-CarGel to treat patients with cartilage injuries of the knee around the world," Piramal Healthcare director Swati Piramal told reporters here.
Commenting on the development, Ajay Piramal, Chairman, Piramal Group said, "BST-Cargel provides us with a superior way to address significant unmet medical needs in the global knee cartilage repair market. The current European approval provides access to a USD 200 million market in Europe with the potential for a larger market with greater penetration of treatment in Europe."
BST-CarGel, a EU class III medical device, is a novel natural polysaccharide based liquid scaffold which, combined with the patient's whole blood, is then implanted into a debrided cartilage lesion prepared with bone marrow access. As demonstrated in a controlled clinical trial, this procedure results in a superior cartilage repair volume and quality compared to the standard of care treatment with the goal of offering a more durable longer term treatment.
Piramal Healthcare originally invested into the BST-CarGel technology in 2006 and subsequently in 2010, acquired the assets relating to BST-CarGel from BioSyntech
Technologies Inc, a company located in Montreal, Canada.