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 Surgical is a specialist medical device distributor with an extensive track record of bringing new medical products to the US market. They will initially focus their activities on the West Coast region of the United States and will represent ReNerve in the United States
“It is great to be working with Emerging Surgical with their extensive clinical networks and experience in the US medical devices market” said Dr Julian Chick, Executive Director of ReNerve.
“We are excited to be working with ReNerve and see a great opportunity for ReNerve in the US market” said Emerging Surgical founder Karim Benhamida
NervAlign Nerve Cuff is a material ideally suited for use in the repair of transected and small gap peripheral nerve injuries where ends can be reapproximated. The nerve cuff is manufactured using a patented technology called supercritical CO2 which results in a clean, safe material that has had no exposure to highly toxic chemicals and therefore has no toxic residues yet retains its natural pliability and conformality, which is desired for nerve repairs and good patient outcomes. The product is bio- absorbed and promotes cell adhesion around the facial tissue, whilst protecting the regenerating nerve.