Orthocell (ASX:OCC)a Perth-based regenerative medicine company, has successfully completed a landmark US FDA 510(k) regulatory study for its nerve repair product, Remplir. The study validated Remplir as safe and effective for use in surgical repair of peripheral nerves, meeting all required endpoints. This achievement paves the way for a marketing application to be submitted in December 2024, with US FDA approval expected in the first quarter of 2025.
A 510(k) study focuses on demonstrating that the device is substantially equivalent in safety and effectiveness to a device already approved by the FDA. This type of study generates critical data required for a 510(k) application, allowing the product to be commercialized in the United States.
The growing U.S. nerve repair market is worth more than $1.6 billion annually.
Remplir, already approved in Australia, New Zealand and Singapore, is designed to facilitate high-quality nerve regeneration. The product is a collagen nerve bandage that provides protection without compression to the nerve, generating an ideal microenvironment to promote healing. Clinical data demonstrated that 85% of nerve reconstructions using Remplir resulted in functional recovery of the muscles controlled by the repaired nerve.
The study was conducted in collaboration with renowned researchers, including Professors Bill Walsh from UNSW and Minghao Zheng from the University of Western Australia. The aim was to evaluate nerve regeneration in 72 rats using Remplir, a comparator, and a control group. The results showed the effectiveness of Remplir in restoring motor and sensory functions, without causing inflammation or scarring.
Paul Anderson, CEO of Orthocell, noted: “These results validate Remplir’s superior results and provide critical data for FDA clearance. We are excited to bring this transformative product to the largest healthcare market in the world.”
On the back of the news, shares rose 14.81% to 93 cents.