FDA Clears Alafair’s VersaCoat Tendon & Nerve Protector

Alafair Biosciences, a company specializing in soft-tissue protection in orthopedic surgery, has received two U.S. Food and Drug Administration (FDA) 510(k) clearance for its VersaCoat tendon protector and VersaCoat nerve protector, marketed as the single VersaCoat flowable hydrogel.

VersaCoat is a gel delivered via syringe that provides a protective, gliding surface to limit post-op tethering in surgeries involving tendons, ligaments, skeletal muscles, and peripheral nerves in patients of any age. It uses the same collagen-free hyaluronic acid and alginate formulation with VersaWrap hydrogel sheet.

Hyaluronic acid is crucial during early soft-tissue healing because it supports hydration and reduces inflammation. Both components fully resorb without leaving residual material so tissue can 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.”

The VersaWrap hydrogel sheet has gained recognition as an effective solution for surgeons looking to minimize post-op complications and enhance recovery, Alafair Biosciences said. This track record has driven commercial adoption in multiple specialties to lay foundation for introducing VersaCoat.

“VersaWrap Hydrogel Sheet has generated meaningful adoption with more than 30,000 implants and consistent acceptance from surgeons and GPOs,” said John Joyoprayitno, President and CEO of Alafair Biosciences. “By delivering our proven hyaluronic acid and alginate formulation in a flowable format, VersaCoat Flowable Hydrogel responds to surgeon feedback for larger volumes and delivery to hard‑to‑reach tissues, including minimally invasive approaches. This added versatility supports expanded use in a variety of specialties including extremities, sports medicine, and trauma.”