Orthocell (ASX: OCC) has reported significant real-world validation for its Remplir nerve repair device, with 23 surgeries performed on Ukrainian soldiers.
This represents a crucial step in demonstrating the device's utility in challenging environments and supports future defence sector engagements.
The Remplir nerve repair device was used on the Ukrainian soldiers following a humanitarian delivery in April 2025.
Surgeons received remote training from Key Opinion Leader Dr Alex O'Beirne, with feedback described as positive regarding clinical utility.
The device's portability, room-temperature storage, and three-year shelf life make it particularly suitable for major trauma in defence settings.
Defence Sector Engagement Planned
Orthocell plans to monitor patient outcomes and collect data from these procedures.
This collected data will support future defence-sector engagements worldwide, building on this real-world application.
The Ambassador of Ukraine to Australia has been acknowledged for facilitating engagement with Ukrainian stakeholders.
Global Market Expansion Continues
Orthocell continues its global expansion efforts, having appointed LEDA Orthopaedics as the exclusive UK distributor for Remplir.
A UK regulatory submission to BSI was made in December 2025, with approval anticipated in Q3 FY26.
Remplir is already approved and selling in Australia, New Zealand, Singapore, the US, and Hong Kong, with Canada sales expected in 2H FY26.
Financial Health Supports Growth
Orthocell's financial health remains robust, supporting its global ambitions.
HY26 revenue reached $5.417 million, an increase of 49% year-on-year, with a gross margin of 55%.
Cash reserves stood at approximately $49.369 million as of 31 December 2025, following a $30.000 million placement.
A $3.0 million R&D tax refund further bolstered cash to $49.6 million, providing non-dilutive funding for ongoing commercialisation efforts.
Outlook and Risks
The real-world application of Remplir in conflict zones provides crucial clinical validation, supporting Orthocell's global expansion strategy, particularly in defence sectors.
However, risks remain regarding the timing of regulatory approvals in the UK and EU, the pace of commercial adoption in the US and Canada, and managing the company's cash burn rate while scaling global operations.
