Cingal (sodium hyaluronate +triamcinolone hexacetonide) receives CE Mark to treat pain associated with osteoarthritis of the knee.-Anika Therapeutics

Anika Therapeutics, Inc., a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid "HA" technology, has announced that it received CE Mark approval for Cingal (sodium hyaluronate +triamcinolone hexacetonide) as a medical device to treat pain associated with osteoarthritis of the knee. Cingal is the first and only commercially-available combination viscosupplement, formulated with the Company's product Monovisc and triamcinolone hexacetonide, a well-established, FDA-approved steroid to treat inflammation. CingalL is Anika's third-generation viscosupplement, following the company's Orthovisc and Monovisc products, to treat pain associated with osteoarthritis of the knee.

Comment: In clinical trials, the device — which is administered by injection — demonstrated superiority over placebo at 12 weeks and patients experienced improvement in stiffness and physical function at 26 weeks. Cingal has been approved in Canada, and the company is pursuing an approval by the FDA.