Orthocell (ASX:OCC) has announced the commencement of a nerve repair study aimed at supporting product marketing initiatives and international regulatory and reimbursement strategies for its nerve repair device, Remplir.
The comparator study aims to evaluate the safety, mechanism of action and product performance of Remplir™, when used as a nerve wrap in peripheral nerve repair, compared to traditional repair methods. The study forms part of a comprehensive pre-clinical and clinical development program in nerve repair and regeneration and will be conducted in collaboration with leading orthopaedic researcher, Professor Bill Walsh, at the University of New South Wales.
Orthocell Managing Director, Paul Anderson, said:
“Remplir™ has shown, in previous studies, to be the superior product for nerve regeneration when compared to an FDA-approved comparator device. We are confident that the outcomes of this study will be consistent with the clinical performance of Remplir™ to date, and validate that Remplir™ is easier to use, reduces the need for sutures and results in more consistent and predictable return of muscle function.”