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Highlights
- Orthocell (OCC) completes pivotal US FDA 510(k) study for nerve repair product Remplir.
- Study confirms Remplir's safety and effectiveness, enabling US marketing application submission.
- Anticipated US FDA clearance set for the first quarter of 2025.
Orthocell (ASX:OCC), a regenerative medicine company based in Perth, has marked a significant milestone with the successful completion of a US FDA 510(k) study for its innovative nerve repair product, Remplir. The study established that Remplir is safe and effective for surgical nerve repair, meeting all regulatory endpoints. With this achievement, Orthocell is preparing to submit a marketing application in December 2024, with US FDA clearance expected in early 2025.
The 510(k) regulatory process focuses on demonstrating that a new medical device is substantially equivalent in safety and performance to an already approved device. This crucial study generates the necessary data to meet US FDA requirements, paving the way for a product's entry into the competitive US medical device market. The US nerve repair market alone is valued at over $1.6 billion annually, highlighting the significant potential for Orthocell’s product.
Remplir, already approved for use in Australia, New Zealand, and Singapore, is designed to optimize nerve regeneration. It is a collagen nerve wrap that provides compression-free protection, creating an environment conducive to healing. Clinical studies have shown that 85% of nerve reconstructions using Remplir achieve functional recovery in muscles controlled by the repaired nerve, underscoring its effectiveness.
The recently completed study involved collaboration with renowned researchers, including Professors Bill Walsh of UNSW and Minghao Zheng of the University of Western Australia. Using a sample of 72 rats, the study compared Remplir’s performance with another product and a control group. Results revealed that Remplir effectively restored motor and sensory functions without causing inflammation or scarring. These findings demonstrate the product’s superiority and its potential to transform nerve repair outcomes.
Orthocell CEO Paul Anderson highlighted the achievement, stating that the study results validate Remplir’s capabilities and offer critical data required for US FDA approval. The company is enthusiastic about introducing its advanced nerve repair solution to the US, the world’s largest healthcare market.
As Orthocell moves toward final regulatory approvals, its progress positions the company to significantly impact the growing nerve repair sector and expand its global reach.
