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.