Data to support US sales roll out and EU  + UK regulatory submission s  

• Interim results from a new Remplir™ study demonstrated a compelling overall treatment success rate of 81.1% following nerve repair procedures.
• Real World Evidence (RWE) patient data collected in the study confirms Orthocell's nerve repair product, Remplir, as the ideal medical device for connecting severed nerves, protecting damaged nerves, or capping nerve ends after amputation.
• The data demonstrated:
  • 83.9% of muscles innervated by repaired nerves achieved functional motor recovery.
  • 89.5% of nerve decompression procedures resulted in significant improvement or complete relief of symptoms.
  • No post-treatment complications or adverse reactions to Remplir were reported in any patient.
  • Results consistent with previously published clinical trial outcomes.
• The data confirms the superior and predictable outcomes that Remplir delivers and is testament to why over 200 surgeons across more than 165 hospitals (and growing) are now using the product.
• Study data will be an important addition to Orthocell's medical education efforts in US sales roll out and provide supporting evidence for the EU + UK regulatory submission expected in Q4 CY25.
• Orthocell ultimately targeting a Total Addressable Market ("TAM") in selected jurisdictions in excess of US$3.5 billion ^[1] .
• Internal resources remain focused on the Remplir rollout in the US$1.6 Billion U.S. market ^[2] , with in-country representatives making significant progress working with distributors to gain hospital approvals, on-board surgeons and establish active accounts. Initial US surgical cases continue to build.

PERTH, Australia , Sept. 8, 2025 /PRNewswire/ -- Regenerative medicine company Orthocell Limited (ASX:OCC, "Orthocell" or the "Company") is pleased to announce interim results from a new Remplir multi-centre post-market clinical follow-up study ("Remplir Real World Evidence study" or "Remplir RWE Study"). The overall treatment success rate for all procedure types included in the study was a compelling 81.1%. The Remplir RWE Study will be used by Orthocell to support US Remplir sales roll out and the regulatory submissions in the UK and EU, which is expected to be submitted late Q4 CY25.

This interim analysis demonstrates the utility of Remplir in surgical procedures for a range of peripheral nerve conditions, including restoration of hand function after cervical spinal cord or brachial plexus injury, and relief of symptoms in chronic nerve injuries such as carpal tunnel syndrome. Importantly, the results are consistent with the compelling clinical trial outcomes previously published in the Journal of Reconstructive Microsurgery Open.  

The Remplir RWE study is designed to collect and analyse treatment outcomes generated during the routine clinical practice of nerve repair procedures. RWE is an increasingly valuable contributor to regulatory decision-making, as it provides evidence of product safety and performance from everyday clinical settings, in contrast to the carefully controlled patient populations and conditions of clinical trials.

The Study was conducted in collaboration with Dr Alex O'Beirne at the Western Orthopaedic Clinic; A/Prof Matthew Lawson-Smith at the Murdoch Orthopaedic Clinic; and Jaslyn Cullen at Innervate Occupational Therapy, and Hand Works Occupational Therapy.

Orthocell CEO and MD, Paul Anderson, said: "We are delighted with the interim results from our Remplir RWE Study, validating the superior Remplir clinical outcomes, previously published in a highly regarded, peer reviewed journal. This performance is why more than 200 surgeons across more than 165 hospitals are now using Remplir and these numbers continue to grow.

" This  data is incredibly valuable from a commercial and regulatory perspective as it demonstrates the performance  of Remplir across a heterogen ous patient population in the real world, as distinct from a tightly controlled clinical trial environment.

" It is imperative that we continue to collect performance data to drive  the rapid market adoption in the US and support the EU & UK regulatory applications."

Remplir RWE Study Overview

The Remplir RWE study is an ongoing, multi-centre prospective and retrospective post-market clinical follow-up study being conducted in Australia (ACTRN12624001213538). The study is designed to collect safety and efficacy data on the use of Remplir in a real-world setting. Patients are eligible for inclusion in the study if they receive Remplir during any peripheral nerve procedure at a study site. Procedures ranged from complex nerve transfers and lower limb nerve repairs to more common surgeries used to treat carpal tunnel syndrome.  

The study population includes patients with acute traumatic nerve injuries (e.g. motor vehicle, work-related and sporting accidents), and chronic nerve injuries (e.g. carpal or cubital tunnel syndrome). Patients seek surgical treatment because their nerve injuries cause significant issues, such as muscle paralysis, pain, numbness, or burning/tingling sensations. The study collects data on outcomes related to the goals of surgical treatment (e.g. restoration of hand function after cervical spinal cord injury, relief of symptoms caused by carpal tunnel syndrome) for up to 24 months after treatment with Remplir.

Study Results

Data on 49 patients, aged 14 to 82 years, was included in the interim analysis. The patients underwent a total of 67 peripheral nerve procedures, most commonly in the upper limb (82%). The majority (61.2%) were nerve reconstruction procedures for acute injury (including nerve transfer and nerve grafting), and 38.8% were nerve decompression procedures using Remplir as a protective wrap in patients with chronic nerve injuries.  

Safety data was available for all 67 procedures, and no post-treatment complications or adverse reactions to Remplir were reported in any patient. Performance data was available for 43 procedures (53 therapeutic targets^[3]). The overall treatment success rate for all procedure types was 81.1% (43 of 53 therapeutic targets). Results are summarised by the main procedure types below.

Significance of Study results and next steps

Considering these study results, published clinical data, and the rapid product adoption in existing markets, Orthocell believes Remplir has the potential to redefine the global nerve repair market and rapidly become the new gold standard in nerve repair surgery to return function to paralysed limbs and provide relief of symptoms. Interim study results will be presented at key medical conferences and the study continues in the recruitment phase.

Release authorised by:
Paul Anderson
Orthocell Ltd CEO and MD 

For more information, please contact:

About Orthocell Limited 
ACN 118 897 135
Registered Office – Building 191 Murdoch University, 90 South Street, Murdoch WA 6150 Australia.

For more information on Orthocell, please visit www.orthocell.com

View original content:https://www.prnewswire.com/news-releases/remplir-study-delivers-compelling-81-success-rate-302548953.html

SOURCE Orthocell Limited