Alafair Biosciences Receives 510(k) Clearance for VersaCoat™ Tendon Protector and VersaCoat™ Nerve Protector

AUSTIN, Texas, July 30, 2025 /PRNewswire/ -- Alafair Biosciences, a medical device company redefining soft-tissue protection in orthopedic surgery, announced today that it has received two 510(k) clearances from the FDA for VersaCoat™ Tendon Protector and VersaCoat™ Nerve Protector, marketed as a single product, VersaCoat™ Flowable Hydrogel.

VersaCoat Flowable Hydrogel uses the same proprietary, collagen-free hyaluronic acid and alginate formulation with VersaWrap® Hydrogel Sheet (VersaWrap® Tendon Protector, VersaWrap® Nerve Protector). Hyaluronic acid is essential during the early stages of soft-tissue healing as it supports hydration and reduces inflammation. The alginate component gradually bioresorbs, progressively exposing bioavailable hyaluronic acid throughout the healing process. Both components fully bioresorb without leaving residual material, allowing tissue to return to its pre-injury state.

“Post-operative scarring can lead to significant issues for patients, including ongoing pain, limited mobility, and even the need for additional surgery,” said Samuel B. Adams, Jr., MD, FAAOS, FAOA, Associate Professor of Orthopedic Surgery at Duke University Medical Center. “In my practice, I’ve seen VersaWrap consistently reduce these complications and help my patients regain mobility and comfort more quickly. What intrigues me most about VersaCoat is the ability to address larger more complex injuries with a syringe deliverable gel.”

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