• New study demonstrates Remplir results in superior nerve regeneration and earlier return of muscle function compared to suture-only repair
• Use of Remplir reduces sutures required, mitigating adverse tissue reactions that compromise nerve regeneration
• Compelling study results to underpin US sales rollout and drive Remplir to become new gold standard in nerve repair surgery

Orthocell Limited (ASX:OCC) has announced interim results from a new study evaluating the impact of sutures on nerve regeneration and functional recovery in surgical repair of severed peripheral nerves. The study, conducted in collaboration with Orthocell's Chief Scientific Officer and the University of Western Australia, demonstrates that nerve repair with Remplir results in superior regeneration of nerve tissue and earlier return of muscle function, compared to the current standard of care involving suture-only repair. The use of sutures to reconnect severed nerves is the global standard of care, accounting for around 90% of the 700,000 nerve repair procedures performed in the US each year. However, outcomes remain inconsistent and unpredictable, with evidence suggesting adverse tissue reaction to suture material is a significant contributing factor. The study found that the use of Remplir allowed surgeons to reduce the number of sutures required, mitigating the inflammatory reactions and scarring that can compromise nerve regeneration, nerve gliding, and functional outcomes. Remplir promoted earlier establishment of blood vessels and re-establishment of the protective soft tissue around the nerve, which facilitates free gliding during movement.In contrast, the suture-only groups showed consistently severe inflammation and foreign body response adjacent to the suture material, resulting in poorer quality nerve regeneration and slower functional recovery.Orthocell believes these compelling study results, combined with published clinical data and rapid product adoption in existing markets, position Remplir to redefine the global nerve repair market and become the new gold standard in nerve repair surgery. The interim results will be presented at an upcoming medical conference, with final results to be released and prepared for publication.With circa $30 million in cash and no debt, Orthocell is well-positioned to successfully complete first US sales and drive rapid product adoption to deliver a step change in revenue in FY26. The company is also accelerating the launch of Remplir in Canada and remains on schedule to submit its EU/UK application in Q4 CY25.

Orthocell is ultimately targeting a Total Addressable Market ('TAM') in selected jurisdictions in excess of US$3.5 billion, with the current TAM in markets where Remplir is approved already equating to US$1.8 Billion.

Orthocell remains focused on the Remplir rollout in the US$1.6 Billion US market, with in-country representatives making significant progress towards imminent first sales and first US surgical use of Remplir. The company is also accelerating the launch of Remplir in Canada and remains on schedule to submit its EU/UK application in Q4 CY25.