Alafair Biosciences Receives 510(k) Clearance for VersaCoat™ Tendon Protector and VersaCoat™ Nerve Protector

AUSTIN, Texas, July 30, 2025 /PRNewswire/ -- Alafair Biosciences, a medical device company redefining soft-tissue protection in orthopedic surgery, announced today 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."

About Alafair Biosciences, Inc.
Alafair is a privately held medical device company developing and marketing an innovative product portfolio based on its proprietary hydrogel technology. The mission of Alafair is to revolutionize surgical care with our versatile hydrogel technology, delivering unparalleled value to patients, surgeons, and healthcare facilities by enhancing soft tissue protection and by elevating patient outcomes. Alafair products are distributed through a dispersed network of independent distributors across the United States.

About VersaCoat™ Flowable Hydrogel
VersaCoat Flowable Hydrogel (VersaCoat Tendon Protector, VersaCoat Nerve Protector) is an FDA-cleared medical device implant (not tissue) comprising hyaluronic acid (HA) and alginate that provides a gelatinous encasement. VersaCoat Tendon Protector is indicated to manage and protect injured tendons where there is no substantial loss of tendon tissue, to manage and protect surrounding tissues such as ligaments and skeletal muscles, and may encounter structures such as anchors, grafts, staples, and sutures. VersaCoat Nerve Protector is indicated to manage peripheral nerve injuries where there is no substantial loss of nerve tissue. Our innovative technology allows tissues to glide and to remain untethered, thereby reducing reoperations and improving patient outcomes. The gel form is designed to delicately deliver precise volumes onto complex geometries that are difficult to visualize or reach.

About VersaWrap^® Hydrogel Sheet 
VersaWrap Hydrogel Sheet (VersaWrap Tendon Protector, VersaWrap Nerve Protector) is an FDA-cleared medical device implant (not tissue) comprising hyaluronic acid (HA) and alginate that provides a gelatinous encasement. VersaWrap Tendon Protector is indicated to manage and protect injured tendons where there is no substantial loss of tendon tissue, to manage and protect surrounding tissues such as ligaments and skeletal muscles, and may encounter structures such as anchors, grafts, staples, and sutures. VersaWrap Nerve Protector is indicated to manage peripheral nerve injuries where there is no substantial loss of nerve tissue. Our innovative technology allows tissues to glide and to remain untethered, thereby reducing reoperations and improving patient outcomes. The sheet form is designed to easily apply an ultrathin, uniform layer or to circumferentially wrap injured tissue.

SOURCE Alafair Biosciences, Inc.