Orthocell Ltd (ASX:OCC, OTC:ORHHF) has reported compelling interim results from a multi-centre real-world study of its flagship nerve repair device, Remplir™, delivering an overall treatment success rate of 81.1%.
The company said the results confirm Remplir™’s role as a safe and effective medical device for connecting severed nerves, protecting damaged nerves and capping nerve ends after amputation — outcomes that will underpin its US commercial rollout and upcoming regulatory submissions in Europe and the UK.
Strong outcomes across procedures
The study evaluated 49 patients, aged between 14 and 82, who underwent 67 peripheral nerve procedures at participating centres in Australia. Most were upper limb surgeries, with 61% involving nerve reconstruction for acute injury and 39% nerve decompression procedures for chronic injuries such as carpal tunnel syndrome.
Key findings included:
- Motor nerve reconstruction: 81.2% of muscles innervated by repaired nerves achieved functional motor recovery, on average within 8.3 months.
- Nerve decompression: 89.5% of procedures led to significant improvement or complete relief of symptoms.
- Safety: No post-treatment complications or adverse reactions to Remplir™ were reported.
The company said results were consistent with previously published clinical trial data in the Journal of Reconstructive Microsurgery Open.
Surgeons adopting Remplir™
Orthocell managing director Paul Anderson said the data reinforced confidence in Remplir™’s clinical utility and commercial potential.
“We are delighted with the interim results from our Remplir™ RWE Study, validating the superior Remplir™ clinical outcomes, previously published in a highly regarded, peer-reviewed journal,” Anderson said. “This performance is why more than 200 surgeons across more than 165 hospitals are now using Remplir™ and these numbers continue to grow.”
The company highlighted that more than 200 surgeons are now actively using Remplir™ across over 165 hospitals, with adoption accelerating in the US following initial sales earlier this year.
Read more: Orthocell advances Remplir™ commercialisation in US nerve repair market
Commercial and regulatory implications
Real-world evidence is increasingly recognised by regulators as a valuable complement to controlled clinical trials, providing data from routine clinical settings. Orthocell said these findings would strengthen its US sales efforts, where its in-country representatives are working with distributors to secure hospital approvals, onboard surgeons and establish accounts in a market valued at US$1.6 billion.
The company also expects to submit EU and UK regulatory applications for Remplir™ in the fourth quarter of calendar 2025, targeting a combined total addressable market of more than US$3.5 billion.
With around A$27 million in cash and no debt, Orthocell said it is well-positioned to support rapid adoption of Remplir™ in the US and to advance regulatory pathways in Europe and the UK. The company is also preparing for a Canadian launch and continues to develop its broader regenerative medicine portfolio, including tendon and cartilage cell therapies.