Enrollment Begins in Study of Achilles Tendon Repair Tech

Alafair Biosciences Inc. has enrolled the first patient at UC Davis Foot and Ankle Orthopaedics Clinic in its study of VersaWrap for Achilles tendon repair.

This prospective, multi-center B.R.A.A.D study (Better Recovery, Hyaluronic Acid [HA] and Alginate Device) is Alafair’s attempt at improving surgical outcomes and reducing the burdens often associated with tendon repair. Designed with and conducted by investigators across multiple U.S. sites, the study will assess VersaWrap’s performance in reducing postoperative complications such as tendon tethering.

“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,” principal investigator Eric Giza, M.D., said. “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.”

Tendons play a vital role in joint movement by connecting muscle to bone and by transmitting force. But exposure to repetitive use, weight-bearing stress, and potential trauma makes tendons prone to injury. Traditional surgical repair techniques are limited by long healing times, a high likelihood of scar tissue formation, and revision surgery, which often results in reduced tendon gliding and limited postoperative range of motion.

The B.R.A.A.D study aims to evaluate the way(s) in which VersaWrap—a bioresorbable, sutureless tendon protection device—may alleviate these issues 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,” Alafair Biosciences Chief Scientific Officer Sarah Mayes, Ph.D., stated. “Its impact is broader than gathering clinical evidence of device effectiveness. The B.R.A.A.D. study will also inform ongoing product development and the future of addressing soft tissue motion preservation.”

With enrollment now active, Alafair is poised to gather real-world clinical data that may shape the future of tendon repair and reinforce the role of VersaWrap as a next-generation solution in soft tissue protection.

VersaWrap is a U.S. Food and Drug Administration-cleared medical device implant (not tissue) comprising hyaluronic acid (HA) and alginate that provides a gelatinous encasement for peripheral nerves, tendons, and surrounding tissues such as ligaments and skeletal muscles. The technology allows tissues to glide and to remain untethered, thereby reducing additional procedures and improving patient outcomes. VersaWrap offers unique surgical flexibility as the only tendon and nerve protector that can be delivered either as a sheet or as a flowable gel, according to Alafair Biosciences.

Privately-held Alafair Biosciences is developing and marketing products based on its proprietary hydrogel technology. The company aims to revolutionize surgical care with its 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 dispersed network of independent U.S. distributors.