Orthocell Remplir Shows 90% Success in Expanded Nerve Repair Study
Orthocell’s Remplir achieves 90% success rate in expanded nerve repair study
Orthocell Limited (ASX: OCC) has reported an 89.7% overall treatment success rate from its Remplir Real World Evidence study, based on expanded performance data from 66 patients across 78 nerve repair procedures. The study cohort has doubled from 33 patients reported in September 2025, with patients aged 14 to 82 years. No post-treatment complications or adverse effects were reported, reinforcing the product’s safety profile at a critical commercial inflection point as US distribution scales and European regulatory approval approaches in the second half of 2026.
The expanded dataset strengthens Remplir’s clinical evidence base across both motor nerve reconstruction and nerve decompression procedures. Motor nerve reconstruction achieved a 90.3% success rate (28 of 31 procedures), whilst nerve decompression procedures demonstrated an 89.4% success rate (42 of 47 procedures). This real-world evidence supports continued US sales rollout and positions the company for market entry in the UK and Europe, with regulatory approval expected in H2 CY26.
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What is Remplir and why does nerve repair matter?
Remplir is a collagen nerve wrap used in peripheral nerve surgery to support nerve healing and functional recovery. The product addresses both traumatic nerve injuries resulting from motor vehicle, workplace, and sporting accidents, and chronic conditions such as carpal tunnel syndrome and cubital tunnel syndrome. Peripheral nerve damage causes muscle paralysis, pain, numbness, and burning or tingling sensations that significantly impair daily function.
Patients seek surgical intervention when conservative treatments fail to restore function or relieve symptoms. Remplir is applied during peripheral nerve repair procedures to create a protective environment that facilitates nerve regeneration and reduces scar tissue formation. The product’s role is to optimise healing conditions whilst surgeons reconstruct or decompress damaged nerve tissue.
Nerve repair represents an underserved surgical category with significant unmet need. A product demonstrating consistent high success rates across diverse patient populations and injury types addresses a meaningful commercial addressable market, particularly where chronic conditions require revision surgeries following failed initial procedures.
Procedure breakdown shows consistent results across indications
The study evaluated two distinct procedure categories: motor nerve reconstruction and nerve decompression. For motor nerve reconstruction, 31 procedures were performed across 19 patients, with 90.3% achieving functional muscle recovery (MRC Grade M3 or M4) at an average of 10.8 months post-surgery. The British Medical Research Council grading system defines successful outcomes as voluntary movement with improved strength and range of motion, representing the maximum level of functional recovery expected in nerve transfer and grafting procedures.
A notable subgroup comprised six tetraplegic patients with C4–C7 spinal cord injury, who achieved 100% treatment success (14 of 14 nerve repairs) with clinically meaningful restoration of hand function. This cohort had previously experienced limited or no use of the affected limb prior to surgical intervention with Remplir.
For nerve decompression, 47 procedures were performed across 47 patients, achieving an 89.4% success rate defined as significant improvement or complete relief of symptoms. The decompression cohort included 18 carpal tunnel revision surgeries and 16 cubital tunnel releases (14 primary cases and two revisions). Carpal tunnel revision patients had undergone previous decompression surgery but experienced persistent or recurrent symptoms associated with scar tissue formation or impaired nerve gliding. Critically, no patients required additional surgical intervention during the follow-up period.
| Procedure Type | Patients (n) | Nerve Procedures (n) | Treatment Success |
|---|---|---|---|
| Motor nerve reconstruction | 19 | 31 | 90.3% (28 of 31) |
| Nerve decompression | 47 | 47 | 89.4% (42 of 47) |
| Total | 66 | 78 | 89.7% (70 of 78) |
Consistent results across both reconstructive and decompression procedures suggest broad clinical utility. This is not a niche single-indication product but a platform technology applicable across multiple nerve repair scenarios, from traumatic injury reconstruction to chronic condition management requiring revision surgery.
Commercial traction building across key markets
Current adoption metrics demonstrate accelerating market penetration:
- Australia: More than 300 surgeons across 220+ hospitals using Remplir
- United States: More than 49 surgeons across 55+ hospitals using Remplir
- US Department of Defense: First surgical case completed following recent approval across a network of 221 hospitals
The company has positioned Remplir as the best-performing nerve wrap in Australia based on cumulative real-world evidence and published clinical trial data. The product is cleared for use in the US, Australia, New Zealand, Singapore, Canada, Hong Kong, and Thailand, with UK and European regulatory approval expected in H2 CY26.
The US Department of Defense hospital network approval represents institutional validation and a potential high-volume channel. Military healthcare systems typically conduct rigorous product evaluations before granting network-wide access, and DoD hospital approval can influence broader institutional adoption patterns. European approval would open a significant new geographic market where nerve repair procedures are well-established but product options remain limited.
CEO commentary
Paul Anderson, Managing Director
“These latest results further strengthen Remplir’s position as the best-performing nerve wrap available in Australia, demonstrating strong and consistent clinical outcomes across a broad range of nerve repair procedures, supported by an excellent safety profile. Importantly, this expanding evidence base is also supporting surgeon adoption and commercial expansion in the U.S. and other key markets.”
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What comes next for Orthocell
The Remplir Real World Evidence study continues in the recruitment phase, with further data expected as additional patients complete follow-up assessments. Cumulative results will be presented at key medical conferences, providing ongoing visibility within the surgical community and supporting evidence-based adoption discussions.
Commercial priorities focus on continued US sales rollout through the company’s network of specialist distributors and the upcoming UK and European market launch following expected regulatory approval in H2 CY26. The expanding real-world evidence dataset provides the clinical credibility required for surgeon adoption in new markets, particularly in Europe where evidence-based medicine frameworks influence product selection decisions.
Regulatory approval timing in H2 CY26 creates a defined catalyst for investors to monitor. The European market entry represents a significant geographic expansion opportunity, whilst the growing US DoD hospital network adoption and specialist surgeon uptake demonstrate commercial momentum in the company’s largest target market. The study’s expanding dataset serves as the evidence base underpinning international expansion at a stage where clinical proof points directly influence market access and reimbursement discussions.
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