Alafair Biosciences Gets FDA Clearance for Versacoat™ Flowable Hydrogel for Nerve and Tendon Protection

Alafair BioSceinces Received Confirmation for Versacoat™ Nerve Protector and Versacoat™ Tendon Protector

Announcement

Alafair Biosciences, a well-established medical device company reshaping soft-tissue protection in orthopedic surgery, received a 510 (k) clearance from the FDA for Versacoat nerve protector and Versacoat tendon protector, commercialized as a single product, Versacoat flowable hydrogel. Versacoat is a reliable gel that enables a safe, gliding surface built to set limitations in post-operative tethering in various surgical procedures consisting of skeletal muscles, peripheral nerves (nerve roots), ligaments, and tendons in all age patients. This will enhance the existing medication and aid in the product's development within the large healthcare market. The clearance confirms the safety of this product.

Versacoat Flowable Hydrogel Built

Versacoat flowable hydrogel initiates the same proprietary, alginate formulation and collagen-free hyaluronic with Versawrap hydrogel sheet. Hyaluronic acid is important in its early stages of soft tissue recovery as it contributes to reducing inflammation and fuel hydration. The alginate factor eventually bioresorbs, successfully revealing bioavailable hyaluronic acid via the recovery process. These two components bioresorb without eliminating residual material, and permitting tissue to return to its pre-injury state.

Expanding to these clinical benefits, the Versawrap hydrogel sheet has increasingly gained recognition as a reliable and approachable solution for surgeons, looking forward to reducing post-operative complications and improving patient status. This validated track record has fueled robust marketing adoptions throughout various specialties, representing a solid foundation for the launch of Versacoat flowable hydrogel.

Views and Statements

Jr., M.D., FAAOS, FAOA, Associate Professor of Orthopedic Surgery at Duke University Medical Center, Samuel B. Adams, said, “The post-operative threat can lead to serious issues for patients, including ongoing pain, less mobility, and the need for additional surgery. In my practice, I’ve noticed Versawrap's consistency in diminishing these complications and supporting my patients to regain comfort and mobility quickly. What interests me most about Versacoat is its potential to identify vast complex injuries with a syringe-deliverable gel.”

President and CEO of Alafair Biosciences, John Joyoprayitno, said, “Versawrap hydrogel sheet has discovered meaningful adoption with more than 30,000 implants and strong-rooted acceptance from surgeons and GPOs. By providing our validated alginate formulation and hyaluronic acid in a flowable format, Versacoat flowable hydrogel answers to surgeons' feedback for the highest volumes and enables hard-to-reach tissues, consisting of minimal invasive approaches. Its n addition to the extensive use in a variety of specialities, it also includes sports medicine, trauma, and extremities.”