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Kane Biotech Gets 510(k) Nod for coactiv+ Antimicrobial Wound Gel

May 31, 2023

Kane Biotech’s coactiv+ wound hydrogel for treatment of ulcers and burns has received FDA 510(k) clearance for adults.

The gel is cleared for management of diabetic foot and leg ulcers, pressure ulcers, first and second degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions. Treatment of chronic wounds is a major challenge to healthcare providers, with a high failure rate leading to amputation, sepsis and death, the company said.

The gel is easy to apply, stays on the wound and is easy to remove, the company said, adding that it is priced to fit “within Medicare and private payer allowables.”

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