Alafair’s VersaWrap receives 501(k) clearance from FDA

versawrapAlafair Biosciences Inc., a start-up medical device company based on technology from the Schmidt Lab, announced today that it received 510(k) clearance from the FDA to market and sell its tendon product, VersaWrap™ Tendon Protector, in the US.  VersaWrap™ Tendon Protector is an ultrathin, sutureless, bioresorbable hydrogel that protects tendon gliding by separating injured tendon from surrounding tissues. The VersaWrap™ sheet is composed of hydrophilic polysaccharides; it is easy to handle, can be cut to size, and is designed for placement on or around injured tendon. VersaWrap™ is a non-inflammatory, non-toxic, non-irritating, terminally-sterilized, implantable hydrogel. It is supplied dry but hydrates immediately and can be implanted wet or dry. VersaWrap™ is designed to be applied to delicate, injured tendon tissue and tendon repairs. Alafair will formally introduce the VersaWrap™ Tendon Protector to surgeons at the American Society for Surgery of the Hand meeting in Austin, TX.

Schmidt Lab PhD alums, Drs. Sarah Mayes and Scott Zawko, are part of the scientific leadership team with Alafair. Alafair is also a UF BME Industry Partner and has participated actively in the Department’s Pruitt Research Day in the past.

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