Alafair Biosciences, a leading innovator in medical device solutions for soft-tissue protection in orthopedic surgery, has received FDA 510(k) clearance for its Versacoat™ nerve protector and tendon protector, launched as a single product: Versacoat™ flowable hydrogel.

Designed to reduce post-operative tethering in procedures involving skeletal muscle, peripheral nerves, ligaments, and tendons, Versacoat provides a safe, gliding surface that enhances healing across a broad range of age groups and surgical specialties.

The hydrogel utilizes Alafair’s proprietary alginate-based, collagen-free formulation—the same technology behind the company’s successful Versawrap™ hydrogel sheet. The product delivers hyaluronic acid, known to aid early soft tissue recovery by reducing inflammation and promoting hydration, while the alginate bioresorbs, ensuring natural tissue recovery without residual material.

This latest clearance strengthens Alafair’s position in the expanding surgical biomaterials market. Versawrap™, with over 30,000 successful implants, has already gained widespread recognition among surgeons and healthcare organizations, setting the stage for Versacoat’s adoption.

Dr. Samuel B. Adams Jr., M.D., FAAOS, FAOA, Associate Professor of Orthopedic Surgery at Duke University Medical Center, praised the new development:

“Post-operative complications like pain and limited mobility can be significant. Versawrap has consistently helped my patients recover more quickly, and I see great promise in Versacoat’s ability to treat complex injuries with its syringe-deliverable format.”

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John Joyoprayitno, President and CEO of Alafair Biosciences, added:

“Versawrap’s success has been a testament to our technology’s effectiveness. With Versacoat flowable hydrogel, we’re addressing surgeon feedback for a more versatile and high-volume format, making it suitable for minimally invasive procedures and hard-to-reach tissues across multiple specialties like sports medicine, trauma, and extremities.”

This milestone marks a significant advancement in post-surgical soft tissue care, with Versacoat poised to make a meaningful impact on patient outcomes and recovery efficiency.

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