Alafair Biosciences’ Nerve-Protecting Implant Receives FDA OK
Alafair Biosciences has received 510(k) marketing clearance from the FDA for its VersaWrap Nerve Protector, a hydrogel implant used to cover and protect peripheral nerves.
The suture-less, bioresorbable implant forms a gelatinous layer on or around peripheral nerves to protect them while patients heal.
The device is now indicated for managing peripheral nerve injuries that have seen no substantial loss of nerve tissue. The company said it anticipates filing for additional 510(k) clearances to expand the implant’s clinical applications.