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Alafair Biosciences Wins 510(k) Clearance from FDA for VersaWrap®

Alafair Biosciences Wins 510(k) Clearance from FDA for VersaWrap®
Alafair Biosciences Wins 510(k) Clearance from FDA for VersaWrap®

Alafair Biosciences Inc announced that it has secured the 510(k) clearance for VersaWrap® Nerve Protector from the FDA. Alafair Biosciences is a medical device a company focusing on commercializing and developing innovative wound care products and more. Like VersaWrap® Tendon Protector was specified for tendon, VersaWrap® Nerve Protector is a sutureless, ultrathin implant preferably suited for protecting and covering peripheral nerves. VersaWrap® offers a non-constricting interface between the surrounding tissues and the nerve by forming a penetrable, gelatinous layer on or around the peripheral nerve during healing.

A plastic surgeon in Gainesville, FL, MD, Dr. Harvey Chim called VersaWrap an exhilarating new product. Dr. Chim stated that they had been looking for a device like this, that would be flexible, improves gliding, and that bioresorbs. Due to the existence of hyaluronic acid in VersaWrap, the technology and its mechanism of action in peripheral nerve procedure and tendon sound relevant. DR. Chim confirmed that he has seen it work in various cases where scarring was a concern and he was using VersaWrap Tendon Protector for several years. He claimed that because his patients got better clinical outcomes, he uses VersaWrap.

Alafair Biosciences CEO, Greg Brophy stated that the company is delighted to get the 510(k) clearance for VersaWrap and they believe that they will witness a fast surgeon adoptions due to the exclusive characteristics of the product. Their patented hydrogel technology has varied applications in the regenerative medicine and medical device segments and the expansion of their product portfolio to add peripheral nerve procedures is a noteworthy achievement for the company, Brophy confirmed. 

In the VersaWrap® family of products, VersaWrap® Nerve Protector is the second product to receive the 510(k) clearance and is designated for the management of peripheral nerve injuries where no considerable loss of nerve tissue exists. Alafair expects additional 510(k) fillings as it looks forward to expanding the clinical applications for the usage of its hydrogel technology.

 

Source: https://www.prnewswire.com/news-releases/alafair-biosciences-receives-510k-clearance-for-versawrap-nerve-protector-301137515.html

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