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Piramal Healthcare reported Wednesday that it received European CE mark approval for BST-CarGel, its bio-orthopaedic product for knee cartilage repair. Piramal said it plans to launch the product, which combines a natural polysaccharide based liquid scaffold with patient’s whole blood, in the fourth quarter.
BST-CarGel is the first patented product to be unveiled by the company, which has typically focused on generic products. Piramal acquired the assets relating to BST-CarGel from BioSyntech in 2010. Piramal sold its local generic drugs businsess to Abbott in 2010.
Swati Piramal, director of Piramal, suggested that the approval will give the company access to a market that could potentially generate sales of $200 million annually, which could increase to as much as $400 million with greater penetration of the treatment in Europe. However, Elara Securities analyst Surajit Pal said that before the product can generate income, Piramal would need to invest further time and money to convince the medical community about the safety and efficacy of the product.
Piramal said that the approval will serve as the basis to obtain commercial authorisation for the product in other geographic areas such West Asia, Asia Pacific region, South America and other countries including India.
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