ReNerve’s first product, the NervAlignTM 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 NervAlignTM 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.
Central to the manufacture of the cuff material is the proprietary eCOOTM technology, developed by partner Leader Biomedical in the Netherlands. This production method uses supercritical carbon dioxide to clean and sterilise the tissue scaffold, leaving it clean and free of any toxins or antigens that might cause an unwelcome inflammatory response. ReNerve and Leader have been working together on the tissue scaffold technology for three years.
Read the full press release here: renerve.com.au/company-press-releases/