US-based medical device company Alafair Biosciences has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VersaWrap Nerve Protector.
VersaWrap Nerve Protector, which similar to the company’s VersaWrap Tendon Protector indicated for tendon, is an ultra-thin, sutureless, bioresorbable hydrogel implant.
It is indicated for the management of peripheral nerve injuries, in which there has been no substantial loss of nerve tissue.
The device is designed to create a permeable, gelatinous layer on or around the peripheral nerve to provide a non-constricting interface between nerve and surrounding tissues during healing.
Furthermore, VersaWrap Nerve Protector enables better clinical outcome in patients when scarring is a concern.
Alafair CEO Greg Brophy said: “We are pleased to have received 510(k) clearance for VersaWrap and believe that we will see rapid surgeon adoption given the unique characteristics of our product.
“Our patented hydrogel technology has diverse applications in the medical device and regenerative medicine segments, and the extension of our product portfolio to include peripheral nerve procedures is a substantial milestone for our organisation.”
Alafair plans to approach the US FDA with additional 510(k) filings to expand the clinical applications for the use of its hydrogel technology.
The company has a portfolio of 25 issued and ten pending patents, covering a range of clinical applications based on its patented hydrogel technology.
Alafair focuses on building its product pipeline based on proprietary technology. The company distributes its products through a network of independent distributors across the US.