Orthocell has submitted a regulatory application to the British Standards Institution (BSI) seeking approval to commercially distribute Remplir™ in the European Union and United Kingdom, a combined nerve repair market valued at approximately US$750 million and comprising an estimated 500,000 peripheral nerve repair procedures each year.
The application seeks CE and UKCA certification under EU and UK Medical Device Regulations (MDR), with regulatory approval expected in the third quarter of calendar year 2026.
This submission is supported by compelling real-world clinical evidence from Orthocell’s recent Remplir post-market clinical follow-up study, which demonstrated an overall treatment success rate of 81.1% across nerve repair procedures. The data forms a critical component of the technical documentation required for MDR certification.
Orthocell CEO and MD, Paul Anderson said
“We are thrilled to submit our EU and UK regulatory application for Remplir, marking an important milestone in our global expansion strategy. The application is underpinned by the compelling 81.1% treatment success rate from our recent Real World Evidence study, together with previously published clinical data and rapidly increasing surgeon use.
“We expect to receive clearance from the BSI in 3Q of CY 2026 and 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. 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.”