Orthocell (ASX:OCC), a Perth-based regenerative medicine company, has successfully completed a pivotal US FDA 510(k) regulatory study for its nerve repair product, Remplir. The study validated Remplir as safe and effective for use in the surgical repair of peripheral nerves, meeting all required endpoints. This achievement paves the way for the submission of a marketing application in December 2024, with US FDA clearance anticipated in the first quarter of 2025.
A 510(k) study focuses on demonstrating that the device is substantially equivalent in safety and efficacy to an already FDA-cleared device. This type of study generates critical data required for a 510(k) submission, enabling the product to be marketed in the US.
The growing US nerve repair market is valued at over $1.6bn annually.
Remplir, already approved in Australia, New Zealand, and Singapore, is designed to facilitate high-quality nerve regeneration. The product is a collagen nerve wrap that provides compression-free protection to the nerve, generating an ideal microenvironment to aid healing. Clinical data has demonstrated that 85% of nerve reconstructions using Remplir resulted in functional recovery of muscles controlled by the repaired nerve.
The study was conducted in collaboration with renowned researchers, including Professors Bill Walsh of UNSW and Minghao Zheng of the University of Western Australia. It involved evaluating nerve regeneration in 72 rats using Remplir, a comparator product, and a control group. Results showed Remplir’s effectiveness in restoring motor and sensory functions, without inducing inflammation or scarring.
Orthocell CEO Paul Anderson remarked: “These results validate the superior outcomes of Remplir and provide critical data for FDA clearance. We are excited about bringing this transformative product to the world’s largest healthcare market.”
Shares have spiked up 14.81% to 93 cents on the back of the news.