Alafair Biosciences, a medical device company redefining soft-tissue protection in orthopedic surgery, announced 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 is a syringe-deliverable gel that provides a protective, gliding surface designed to limit post-operative tethering in surgical procedures involving tendons, ligaments, skeletal muscles, and peripheral nerves (including nerve roots) in patients of all ages.
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."
Building on these clinical benefits, VersaWrap Hydrogel Sheet has rapidly gained recognition as an effective solution for surgeons seeking to minimize post-operative complications and enhance patient recovery. This proven track record has driven strong commercial adoption across multiple specialties, laying a solid foundation for the introduction of VersaCoat Flowable Hydrogel.
"VersaWrap Hydrogel Sheet has generated meaningful adoption with more than 30,000 implants and consistent acceptance from surgeons and GPOs," stated John Joyoprayitno, President & 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."
