Orthocell (ASX:OCC)Perth-based regenerative medicine company has successfully completed a pivotal US FDA 510(k) regulatory study for its neurorepair product Remplir. This study validated that Remplir is safe and effective for use in peripheral nerve surgical repair, meeting all required endpoints. This achievement paves the way for a marketing application submission in December 2024, with US FDA approval expected in the first quarter of 2025.

The 510(k) study is focused on demonstrating that the device is substantially equivalent in safety and effectiveness to devices that already have FDA clearance. This type of investigation generates the critical data needed for a 510(k) application and allows the product to be sold in the United States.

The growing U.S. nerve repair market is valued at more than $1.6 billion annually.

Remplir is already approved in Australia, New Zealand and Singapore and is designed to promote high-quality nerve regeneration. This product is a collagen nerve wrap that protects nerves without compressing them and creates an ideal microenvironment that promotes healing. Clinical data demonstrates that 85% of nerve reconstructions using Remplir restore function to the muscles controlled by the repaired nerve.

The study was conducted in collaboration with leading researchers including Professor Bill Walsh from UNSW and Professor Minghao Zheng from the University of Western Australia. This included evaluating nerve regeneration in 72 rats using a comparison product, Remplir, and a control group. The results showed Lempria’s effectiveness in restoring motor and sensory function without causing inflammation or scarring.

Paul Anderson, CEO of Orthocell, said: “These results demonstrate Remplir’s excellent results and provide critical data for FDA approval. We are excited to bring this innovative product to the world’s largest healthcare market.” .”

The stock price jumped 14.81% to 93 cents on the news.