Alafair Biosciences FDA 510(k) Clearance Expands VersaWrap® Patient Population

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Nov 30, 2023, 09:57 ET

AUSTIN, Texas, Nov. 30, 2023 /PRNewswire/ -- Alafair Biosciences announced today that VersaWrap has received 510(k) clearance from the FDA, enabling application of VersaWrap in all populations, regardless of age. The additional clearance allows pediatric surgeons and facilities the flexibility to use VersaWrap in treating younger populations. VersaWrap, a class II medical device, is a bioresorbable hydrogel implant that forms a gelatinous layer around target tissues such as tendons, peripheral nerve and surrounding soft tissues, allowing gliding during healing and reducing postoperative tethering to give consistent results. VersaWrap may be implanted as a sheet or as a gel and is used primarily by orthopedic, reconstructive plastic, and spine surgeons in a wide variety of tendon and peripheral nerve procedures.

This clearance is another milestone reached in the Alafair Biosciences mission to provide tools to surgeons that improve patient outcomes related to unwanted postoperative tethering. Alafair continues to expand its portfolio of indications for use and populations that it serves.

"VersaWrap is designed to be gentle and intuitive to improve health outcomes for all ages, including the youngest and most vulnerable populations," said Sarah Mayes, PhD, chief scientific officer at Alafair. "VersaWrap is simple to implant as it can be tailored to the size, geometry, and location of target tissues. Specifically, the gel version is designed to meet the needs of anatomically challenging injuries, making the device attractive for use in smaller patients."

This clearance opens additional markets for Alafair as it further expands use of VersaWrap in the surgical repair of injuries prevalent in younger populations, including congenital abnormalities or fractures resulting from falls, accidents, and sports-related activities. Alafair is honored to provide a solution to common challenges in pediatric surgery and postoperative recovery and to have the opportunity to positively impact the lives of children and adolescents.

"Postoperative scarring is prevalent in all ages. Scarring is compounded in children as early motion is often a challenge in this incredibly active patient population. The ability to use VersaWrap to avoid adhesions following complex repairs in the hands of young patients brings confidence that they can recover without the limitations associated with soft tissue tethering," stated Pamela Sherman, MD, Medical Director, Hand Surgery at Cook Children's Healthcare System.

This clearance is another milestone reached in the Alafair mission to provide tools to surgeons that improve patient outcomes related to unwanted postoperative tethering. Alafair continues to expand its portfolio of indications for use and populations that it serves.

About Alafair Biosciences, Inc. (www.alafairbiosciences.com)
Alafair is privately-held company developing HA-rich class II medical devices based on its proprietary technology with a portfolio of 28 issued and 8 pending patents. Alafair products are distributed through a dispersed network of independent distributors across the United States. The Inc. 5000 List ranks Alafair Biosciences as #23 in Health Products for 2023.

SOURCE Alafair Biosciences, Inc.