ReNerve’s first product, the NervAlign® Nerve Cuff has reached a major milestone in its pathway to market, with its marketing approval application progressing to the substantial review stage at the FDA. The application was initially submitted in August 2020 and is expected to be approved by early 2022. The NervAlign® Nerve Cuff is a soft, tissue compatible, protective wrap that is used to protect injured nerves. It consists of a pliable scaffolding material that can be wrapped around the nerve, protecting surgical repairs and conforming to the nerve’s final shape, allowing regeneration to occur. It is easily sutured and over time is bio-absorbed, leaving the repaired nerve in its native state. The product can easily be wrapped around nerves of different sizes, making it readily adaptable to many surgical uses including nerve repairs, to protect nerve graft implants and as a protective wrap for nerve transfers
ReNerve’s NervAlign Nerve Cuff is one step closer to approval
