Zimmer Biomet wins expanded FDA safety claim for Gel-One knee injection

Zimmer Biomet (NYSE:ZBH) said today that the FDA granted an expanded safety claim for its Gel-One cross-linked hyaluronate knee injection indicating that the treatment is safe to use more than once.

Gel-One is used to treat knee osteoarthritis that hasn’t responded to non-drug therapy, non-steroidal anti-inflammatory drugs or simple analgesics, Warsaw, Ind.-based Zimmer Biomet said. It’s designed to help lubricate the knee joint, the company said.

“Our expanded FDA safety claim for Gel-One hyaluronate is an exciting development for our growing portfolio of joint preservation treatments, as well as the millions of patients who can benefit from this simple, in-office solution for chronic knee pain,” biologics, extremities, sports medicine, surgical, trauma and foot & ankle president David Nolan said in prepared remarks. “Zimmer Biomet is committed to alleviating pain and restoring mobility for patients at every stage of the continuum of musculoskeletal care, including conservative and non-surgical options. By enabling physicians to administer Gel-One hyaluronate over multiple treatment cycles, we can offer patients a new option for longer-term osteoarthritis management.”

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