Expanded FDA Safety Claim for Zimmer Biomet’s Knee Therapy

Zimmer Biomet Holdings, Inc. recently announced that its Gel-One Cross-linked Hyaluronate, an advanced joint preservation treatment for knee osteoarthritis has received expanded safety claim from the U.S. Food and Drug Administration (FDA). As per this expanded FDA safety claim, this single-injection viscosupplement is safe for repeat treatments.

According to Zimmer Biomet, Gel-One Hyaluronate is the first low-volume viscosupplement available in a single-injection formulation for knee osteoarthritis patients, who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, such as acetaminophen.

Hyaluronic acid (HA) products such as Gel-One Hyaluronate work as a supplement for the natural lubrication of the joint. With the expanded safety claim, physicians will now be able to safely utilize Zimmer Biomet’s knee joint solution in repeat treatment courses if required, to provide continued pain relief for patients. The decision comes as an encouraging development for Zimmer Biomet’ as it will help substantially expand the company’s portfolio of joint preservation treatments.

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