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Reimbursement / Regulatory

Anika Therapeutics Receives Canada Regulatory Approval for CINGAL Viscosupplement -

Health Canada approved Anika Therapeutics' CINGAL® viscosupplement as a medical device to treat knee osteoarthritis pain. 

CINGAL, a 3rd-generation viscosupplement, combines an FDA-cleared steroid with the company's proprietary cross-linked sodium hyaluronate. Essentially, CINGAL is MONOVISC® plus a steroid. 

This represents the 1st regulatory approval for CINGAL. Anika applied for CE Mark approval and filed its PMA with FDA for the product in mid-1Q15. Within 3Q, the company released study results in support of labeling for repeat injections with the product. 

Anika's orthopaedic portfolio includes ORTHOVISC® and MONOVISC products presently on the market, and CINGAL and HYALOFAST® products in the U.S. pipeline. Anika claims that ORTHOVISC and MONOVISC hold a combined 25% share of the U.S. viscosupplementation market.

Source: Anika Therapeutics, Inc.

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