Orthocell’s Remplir™ Posts Near 90% Success in Expanded Nerve Repair Study

Expanded Clinical Data Confirms Remplir’s Effectiveness

Orthocell (ASX:OCC) has delivered compelling evidence for its Remplir™ nerve repair device, announcing an 89.7% overall treatment success rate from a real-world study involving 66 patients and 78 nerve procedures. This expanded dataset doubles the cohort size since the initial results in September 2025, underscoring consistent, high-performance outcomes across motor nerve reconstruction and nerve decompression surgeries.

The study’s patient age range spanned from 14 to 82 years, with most procedures targeting upper limb injuries including complex nerve transfers and grafts. Notably, motor nerve reconstruction showed a 90.3% success rate, measured by functional muscle recovery, while nerve decompression procedures achieved an 89.4% rate of symptom relief or significant improvement. These results align closely with previously published clinical trial data and reinforce Remplir’s position as a leading nerve wrap in Australia.

Safety and Adoption Drive Market Expansion

No complications or adverse effects were reported, bolstering Remplir’s reputation for biocompatibility and safety. This has translated into strong surgeon adoption, with over 300 surgeons across 220 Australian hospitals now using Remplir. In the US, more than 49 surgeons in 55 hospitals have adopted the device, including its inaugural use in a US Department of Defense hospital following network-wide approval. This milestone builds on Orthocell’s recent first Remplir surgery in US military hospital and expands its footprint in a critical healthcare segment.

The company’s Managing Director Paul Anderson highlighted that the growing evidence base is pivotal in supporting both clinical confidence and commercial momentum. Orthocell’s recent quarterly revenue surge, driven by US sales, reflects this trend, with the company maintaining a robust cash position to fuel further expansion.

Regulatory Pathway and European Market Entry

Orthocell is targeting regulatory approval for Remplir in the UK and European markets by the second half of calendar year 2026. The device’s demonstrated clinical performance and safety profile will be key in navigating these markets, which represent a substantial opportunity given the prevalence of peripheral nerve injuries. The company has already secured an exclusive UK distributor, positioning itself for a rapid commercial launch upon approval.

Orthocell plans to present the cumulative study results at upcoming medical conferences, continuing patient recruitment to further validate Remplir’s benefits. The company’s strategy to broaden Remplir’s indications and geographic reach is supported by a pipeline of clinical and commercial activities, including expanding applications in tendon repair and autologous cell therapies.

With Remplir’s US rollout accelerating and European entry imminent, Orthocell is poised at a pivotal juncture. The consistent clinical data underpinning Remplir’s efficacy and safety will be critical to sustaining surgeon adoption and navigating competitive and regulatory challenges ahead.