Anika Therapeutics wins CE Mark for Cingal knee treatment

Anika Therapeutics said today it won CE Mark approval in the European Union for its Cingal drug-combo designed to treat osteoarthritis-related knee pain. Cingal is a combined viscosupplement formulated with the company’s cross-linked sodium hyaluronate and triamcinolone hexacetonide, a steroid used to treat inflammation, the Bedford, Mass.-based company said. “The European approval of Cingal marks an important milestone for Anika as it advances our global expansion strategy, provides a platform for us to demonstrate our commercialization capabilities, and most importantly, reinforces the product’s tremendous clinical value to people struggling with the debilitating symptoms of osteoarthritis. We look forward to working with our distribution partners to commence our European launch in the coming months, while remaining steadfast in our commitment to collaborate with the FDA to bring this important treatment to the millions of Americans coping with chronic knee pain,” CEO Charles Sherwood said in a press release. Anika said it plans to strenthen its global commercialization of its Cingal as well as bolstering its European launch through new and existing commercial partnerships. “The availability of Cingal is welcome news for millions of Europeans living with osteoarthritis-related knee pain due to a lack of effective, long-lasting, non-surgical treatment options. Cingal combines 2 proven, approved therapies for pain and inflammation into a single injecti...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Drug-Device Combinations Orthopedics Regulatory/Clearance Anika Therapeutics Inc. Source Type: news