Piramal Healthcare Limited has received the electromagnetic compatibility (CE) mark approval from the European regulatory authorities for its innovative bio-orthopaedic product for cartilage repair, `BST-CarGel'.
This enables the company to commercialise BST-CarGel in all of the countries in the European Union, the company said in a filing with the Bombay Stock Exchange (BSE).
This approval will also serve as the basis to obtain commercial authorisation for the product in other geographic areas such as the Middle East, Asia Pacific, South America and other countries, including India, the company said.
''We are excited with the approval of Piramal's first innovative product for regenerative medicine and we are looking forward to launch BST-CarGel to treat patients with cartilage injuries of the knee around the world. The approval of this product is a testimony of Piramal Healthcare's commitment to become an innovation-led healthcare company'', said Dr Swati Piramal, director, Piramal Healthcare.
BST-CarGel, an 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.
In controlled clinical trial, this procedure has resulted in a superior cartilage repair volume and quality compared to the standard of care treatment that aims at a more durable longer term treatment, the company said.