Alafair Biosciences has enrolled the first patient in a prospective, multi-center controlled case series evaluating its VersaWrap hydrogel device for Achilles tendon repair. The enrollment took place at UC Davis Foot and Ankle Orthopaedics Clinic as part of the B.R.A.A.D study, which stands for "Better Recovery, Hyaluronic Acid (HA) and Alginate Device."
The study represents Alafair's commitment to improving surgical outcomes and reducing burdens associated with tendon repair. Designed with investigators across multiple sites in the United States, the study will assess VersaWrap's performance in reducing postoperative complications such as tendon tethering.
Clinical Need and Study Rationale
"Tendon injuries, especially those involving the Achilles, are challenging cases to treat due to the anatomical and mechanical demands placed on the foot and ankle," said Principal Investigator Eric Giza, MD. "We've been utilizing VersaWrap in tendon procedures for a substantial period of time and we're now excited to take the next step and formally quantify these results."
Traditional surgical repair techniques face significant limitations, including long healing times, high likelihood of scar tissue formation, and revision surgery, which often result in reduced tendon gliding and limited postoperative range of motion. Tendons play a vital role in joint movement by connecting muscle to bone and transmitting force, but their exposure to repetitive use, weight-bearing stress, and potential trauma makes them prone to injury.
Device Technology and Mechanism
VersaWrap is an FDA-cleared bioresorbable, sutureless tendon protection device comprising hyaluronic acid and alginate. The device provides a gelatinous encasement for peripheral nerves, tendons, and surrounding tissues such as ligaments and skeletal muscles. The innovative technology allows tissues to glide and remain untethered, potentially reducing reoperations and improving patient outcomes.
The device offers unique surgical flexibility as the only tendon and nerve protector that can be delivered either as a sheet or as a flowable gel, providing surgeons with versatile application options.
Study Objectives and Future Impact
The B.R.A.A.D study aims to evaluate how VersaWrap may alleviate issues associated with traditional tendon repair by reducing tendon tethering. "The B.R.A.A.D. study's longer-term impact on patient outcomes will be the design of more efficient medical devices that reduce tendon scarring and enhance tendon gliding, thereby decreasing postoperative burden such as limited range of motion and pain," said Chief Scientific Officer Sarah Mayes, Ph.D.
Beyond gathering clinical evidence of device effectiveness, the study will inform ongoing product development and the future of addressing soft tissue motion preservation. With enrollment now active, Alafair is positioned to gather real-world clinical data that may shape the future of tendon repair and reinforce VersaWrap's role as a next-generation solution in soft tissue protection.
Company Background
Alafair Biosciences is a privately held medical device company developing and marketing an innovative product portfolio based on its proprietary hydrogel technology. The company's mission focuses on revolutionizing surgical care with versatile hydrogel technology, delivering value to patients, surgeons, and healthcare facilities by enhancing soft tissue protection and elevating patient outcomes. Alafair products are distributed through a network of independent distributors across the United States.
