ReNerve Ltd (ReNerve) today announced that it has received market clearance from the FDA for its NervAlign® Nerve Cuff medical device. This means that the company can now market and sell the product in the United States. The NervAlign Nerve Cuff is a Class II medical device. “Well done to the team. This is a […]

ReNerve Ltd (ReNerve) today announced that it has entered into an agreement with Emerging Surgical in San Diego for the launch, promotion and sales of its NervAlign® Nerve Cuff. ReNerve has filed with the FDA for marketing clearance for its NervAlign® Nerve Cuff and anticipates getting FDA approval in the first half of 2022. Emerging […]

ReNerve has partnered with VivaZome Therapeutics to develop therapeutic solutions for spinal cord repair. The collaboration aims to combine ReNerve’s NervAlignTM Nerve Cuff, which is expected to receive marketing approval from the FDA by early 2022, with VivaZome’s proprietary exosome technology to enhance regrowth in damaged spinal cords.  ReNerve’s NervAlignTM Nerve Cuff is comprised of […]

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 […]

ReNerve showcased its novel tissue-based products at the Royal Australasian College of Surgeons’ Annual Scientific Congress, held in Melbourne in May. The conference, which had both face-to-face and virtual attendees, is the largest multi-disciplinary meeting held in Australia and New Zealand, providing a valuable opportunity to raise the company’s profile.   During the conference ReNerve met […]