• Orthocell submits regulatory application to distribute Remplir in EU and UK markets
• Remplir demonstrated 81.1% treatment success rate in recent real-world evidence study
• Regulatory approval expected in 3Q CY26, with go-to-market strategy underway

Orthocell Limited has submitted a regulatory application for approval to commercially distribute its nerve repair product, Remplir, into the EU and UK markets. These markets represent a Total Addressable Market (TAM) of US$750 million with approximately 500,000 peripheral nerve repair procedures undertaken annually. Orthocell has submitted its regulatory application for Remplir for evaluation by the approved EU and UK notified body, British Standards Institution (BSI). The Company expects to receive the required 'CE' (European Conformity) and 'UKCA' (UK Conformity Assessed) certification, allowing commercial distribution of Remplir, in 3Q CY26. The EU and UK submission is underpinned by interim data from Orthocell's ongoing multi-centre Remplir real world evidence (RWE) post-market clinical follow up (PMCF) study. The study demonstrated an overall treatment success rate of 81.1% across procedure types, with 81.2% of innervated muscles achieving functional motor recovery and 89.5% of nerve decompression procedures resulting in significant improvement or complete symptom relief. Importantly, no post treatment complications or adverse reactions to Remplir were reported in any patient, with outcomes consistent with previously published clinical trial data. Orthocell's go-to-market strategy will involve independent in-country distributors and the process of sourcing and assessing distributors is underway in conjunction with a local expert consultant. The Company has also commenced the process of forming a Key Opinion Leader panel of surgeons with a view to targeting specific strategically important hospitals once regulatory clearance is obtained.

Orthocell ultimately targets a Total Addressable Market in selected jurisdictions of more than US$3.5 billion for its Remplir nerve repair product. The Company remains focused on driving rapid market adoption of Remplir supported by a strong balance sheet (circa A$50 million in cash and no debt) and ongoing investment in clinical evidence and medical education initiatives.