Orthocell (ASX:OCC) has taken an important step in its international expansion plans, submitting a regulatory application to the British Standards Institution (BSI) seeking approval to commercially distribute its nerve repair device, Remplir, across the European Union and the United Kingdom.
The markets are collectively worth an estimated US$750 million and represent roughly 500,000 peripheral nerve repair procedures each year.
The Perth-based regenerative medicine company said it expects to receive the required CE and UKCA certifications in the third quarter of 2026, a milestone that would open access to what Orthocell describes as its potential second-largest market after the United States.
The submission is backed by evidence from Orthocell’s post-market clinical follow-up study, which reported an overall treatment success rate of 81.1 per cent across nerve repair procedures. The data included functional motor recovery in 81.2 per cent of innervated muscles and symptom improvement or complete relief in 89.5 per cent of nerve decompression procedures. Notably, the study reported no treatment-related complications or adverse reactions, with outcomes consistent with previously published clinical trial data.
Orthocell CEO and Managing Director Paul Anderson said the submission marks an important inflection point in the company’s global growth strategy. “We are thrilled to submit our EU and UK regulatory application for Remplir, marking an important milestone in our global expansion strategy,” Anderson said. “The application is underpinned by the compelling 81.1 per cent treatment success rate from our recent Real World Evidence study, together with previously published clinical data and rapidly increasing surgeon use.”
Ahead of the anticipated 2026 approval, Orthocell is progressing a go-to-market strategy that includes partnering with specialist in-country distributors and forming a key opinion leader panel of surgeons to support targeted engagement with hospitals in priority markets.
Remplir is already approved and sold in Australia, New Zealand, Singapore, the United States and Hong Kong, with first sales expected soon in Canada and Thailand. In total, Orthocell is targeting a global addressable market exceeding US$3.5 billion.