Compelling 81% Success Rate for Remplir
| Stock | Orthocell Ltd (OCC.ASX) |
|---|---|
| Release Time | 8 Sep 2025, 9:03 a.m. |
| Price Sensitive | Yes |
Orthocell Announces Compelling 81% Success Rate for Remplir
- Interim results from a new Remplir study demonstrated an 81.1% overall treatment success rate
- 81.2% of muscles innervated by repaired nerves achieved functional motor recovery
- 89.5% of nerve decompression procedures resulted in significant improvement or complete relief of symptoms
Orthocell Ltd announced interim results from a new Remplir multi-centre post-market clinical follow-up study, which demonstrated a compelling overall treatment success rate of 81.1%. The Remplir RWE Study collected and analysed treatment outcomes generated during the routine clinical practice of nerve repair procedures. The study population included patients with acute traumatic nerve injuries and chronic nerve injuries. Safety data was available for all 67 procedures, and no post-treatment complications or adverse reactions to Remplir were reported. Performance data showed that 81.2% of muscles innervated by repaired nerves achieved functional motor recovery, and 89.5% of nerve decompression procedures resulted in significant improvement or complete relief of symptoms. The results are consistent with previously published clinical trial outcomes and confirm the superior and predictable outcomes that Remplir delivers. Orthocell believes Remplir has the potential to redefine the global nerve repair market and rapidly become the new gold standard in nerve repair surgery. The interim study results will be presented at key medical conferences, and the study continues in the recruitment phase. Orthocell is well-positioned to drive rapid product adoption and deliver a step change in revenue in FY26, with the company also accelerating the launch of Remplir in Canada and on schedule to submit its EU/UK application in Q4 CY25.
Orthocell is ultimately targeting a Total Addressable Market ('TAM') in selected jurisdictions in excess of US$3.5 billion.
Orthocell remains focused on the Remplir rollout in the US$1.6 Billion U.S. market, with in-country representatives making significant progress working with distributors to gain hospital approvals, on-board surgeons and establish active accounts. Initial US surgical cases continue to build.