Orthocell Ltd (ASX:OCC, OTC:ORHHF) has moved to unlock access to the EU and UK’s US$750 million nerve repair market, submitting its regulatory application to the British Standards Institution (BSI) for commercial approval of its Remplir™ device.
The submission opens the pathway into a combined market that sees an estimated 500,000 peripheral nerve repair procedures each year. Orthocell expects to receive the required CE and UKCA certifications in the third quarter of CY26.
The move builds on growing momentum for Remplir, which is already approved and selling in Australia, New Zealand, Singapore, the US and Hong Kong, with first sales in Canada and Thailand anticipated near term.
Strong clinical evidence underpins submission
Orthocell’s application is supported by real-world evidence from its ongoing multi-centre post-market clinical follow-up study, showing an overall treatment success rate of 81.1% across procedure types.
Interim data highlighted:
- 81.2% of innervated muscles achieved functional motor recovery.
- 89.5% of nerve decompression procedures resulted in significant symptom improvement or complete relief.
- No post-treatment complications or adverse reactions were reported.
The company says these outcomes align with previously published clinical trial data and provide a robust package for EU–UK Medical Device Regulation certification.
CEO and managing director Paul Anderson said the application represents “an important milestone in our global expansion strategy”, adding that the company expects BSI clearance in the second half of 2026.
“In the interim, we’ll be focused on advancing our go-to-market strategy to be prepared to generate sales as soon as possible thereafter,” he said. “The EU and UK has the potential to be our second largest market after the US and is therefore a pivotal component of our global expansion strategy.”
Building distribution and surgeon engagement
Orthocell is now implementing its EU–UK commercial strategy, centred on partnerships with in-country specialist distributors. The company is also establishing a Key Opinion Leader panel of surgeons to support clinical adoption and target high-value hospital networks once regulatory approval is in hand.
The expansion aligns with Orthocell’s broader ambitions to pursue a total addressable market of more than US$3.5 billion across selected jurisdictions.
Strong balance sheet supports rollout
Orthocell reports a cash position of around A$50 million and no debt, providing what it describes as a strong foundation to progress regulatory programs and accelerate Remplir’s commercial rollout in existing and new markets.
The company has continued to add new geographies this year, including Hong Kong where it recorded its first commercial sales in October, and Canada where distribution agreements were recently finalised.
With surgeon adoption rising and clinical evidence continuing to build, Orthocell says Remplir is increasingly positioned to support improved outcomes for patients with traumatic and chronic nerve injuries as it enters new global markets.