Regenerative medicine company Orthocell (ASX:OCC) has reported promising interim results from its ongoing Remplir Real-World Evidence (RWE) study, reinforcing the performance of its collagen nerve wrap in routine clinical practice and laying the groundwork for international expansion.
The study, conducted across multiple centres in Australia, found an overall treatment success rate of 81.1 per cent across a broad range of peripheral nerve procedures. Importantly, no complications or adverse reactions were reported in any of the 67 procedures included in the interim analysis.
Surgeons use Remplir to protect and guide nerve repair following traumatic injury or chronic nerve compression. The interim data demonstrated its value in restoring hand function after cervical spinal cord or brachial plexus injury, as well as alleviating symptoms in chronic conditions such as carpal tunnel syndrome. These findings echo results previously published in the Journal of Reconstructive Microsurgery Open, but now extend the evidence base into everyday clinical settings rather than tightly controlled trial environments.
“This performance is why more than 200 surgeons across more than 165 hospitals are now using Remplir, and these numbers continue to grow,” Orthocell CEO and Managing Director Paul Anderson said. “This data is incredibly valuable from a commercial and regulatory perspective as it demonstrates the performance of Remplir across a heterogenous patient population in the real world.”
The Remplir RWE study is both prospective and retrospective in design, capturing data from patients aged 14 to 82 who underwent procedures ranging from complex nerve transfers and grafting after trauma to more common decompression surgeries for carpal and cubital tunnel syndrome. Of the cases analysed, 61.2 per cent were reconstructions for acute injury and 38.8 per cent were decompression procedures for chronic conditions.
Performance data was available for 43 procedures, covering 53 therapeutic targets, and showed consistent improvements across the spectrum of interventions. Safety data confirmed the absence of adverse effects, strengthening confidence in Remplir’s role as a reliable adjunct in nerve repair.
Orthocell said it intends to use the results to support the rollout of Remplir in the United States and to underpin regulatory submissions in the United Kingdom and European Union, expected in late 2025. “It is imperative that we continue to collect performance data to drive rapid market adoption in the US and support the EU and UK regulatory applications,” Anderson added.
The study was conducted in collaboration with leading clinicians, including Dr Alex O’Beirne at the Western Orthopaedic Clinic, Associate Professor Matthew Lawson-Smith at the Murdoch Orthopaedic Clinic, and Jaslyn Cullen of Innervate Occupational Therapy and Hand Works Occupational Therapy.
For Orthocell, the interim results provide momentum as it seeks to establish Remplir globally. By combining strong clinical performance, a favourable safety profile, and growing surgeon adoption, the company is positioning the device as an emerging standard in peripheral nerve repair.