This B.R.A.A.D study, which stands for "Better Recovery, Hyaluronic Acid (HA) and Alginate Device" represents Alafair's commitment to improving surgical outcomes and reducing the burdens often associated with tendon repair. Designed with and conducted by investigators across multiple sites in the United States, the study will assess the performance of VersaWrap 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," 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."
Tendons play a vital role in joint movement by connecting muscle to bone and by transmitting force. However, 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 how 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," added Chief Scientific Officer, Sarah Mayes, Ph.D. "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.
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 VersaWrap® Hydrogel Sheet:
VersaWrap is an FDA-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. Our innovative technology allows tissues to glide and to remain untethered, thereby reducing reoperations 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.
