Orthocell’s Nerve Repair Product Faces Regulatory and Market Adoption Tests Ahead

Strong Real-World Evidence Validates Remplir’s Clinical Performance

Orthocell Limited has unveiled interim results from its ongoing Remplir Real World Evidence (RWE) study, revealing an impressive 81.1% overall treatment success rate across a range of peripheral nerve repair procedures. This multi-centre post-market clinical follow-up study, conducted in Australia, captures outcomes from routine clinical practice, providing a robust complement to previous controlled clinical trials.

The study evaluated 67 nerve repair procedures in 49 patients aged 14 to 82, predominantly involving upper limb surgeries. The data showed that 81.2% of muscles innervated by repaired nerves achieved functional motor recovery, while 89.5% of nerve decompression procedures resulted in significant symptom improvement or complete relief. Importantly, no post-treatment complications or adverse reactions to Remplir were reported, underscoring the product’s safety profile.

Commercial Momentum and Market Potential

Remplir’s real-world success is reflected in its rapid adoption, with over 200 surgeons across more than 165 hospitals now using the product. Orthocell’s CEO, Paul Anderson, highlighted that these results validate Remplir’s superior clinical outcomes and support the company’s aggressive US sales rollout. The US nerve repair market alone is valued at approximately US$1.6 billion, while Orthocell estimates a total addressable market exceeding US$3.5 billion across key jurisdictions including Australia, New Zealand, Singapore, Canada, Brazil, Japan, Thailand, the US, and Europe.

Orthocell is actively working with distributors and hospital systems in the US to onboard surgeons and establish accounts, with initial surgical cases already underway. The company also plans to submit regulatory applications for the EU and UK markets by the end of 2025, leveraging the RWE study data to bolster its submissions.

Implications for Nerve Repair Surgery

The Remplir RWE study encompasses a broad spectrum of nerve injuries, from acute traumatic cases such as motor vehicle accidents to chronic conditions like carpal tunnel syndrome. The product’s ability to facilitate nerve reconnection, protect damaged nerves, and cap nerve ends after amputation positions it as a potential new gold standard in peripheral nerve repair. The study’s ongoing recruitment and future presentations at medical conferences will further illuminate Remplir’s clinical impact.

With a strong cash position of approximately A$27 million and no debt, Orthocell is well-positioned to accelerate market penetration and revenue growth in fiscal 2026. The company is also advancing plans to launch Remplir in Canada, expanding its global footprint.