Orthocell has announced compelling new data from its ongoing Remplir™ Real World Evidence (RWE) study, demonstrating strong and consistent clinical outcomes across a broad range of peripheral nerve repair procedures.
The latest results show an overall treatment success rate of 89.7%, based on performance data from 66 participants undergoing 78 nerve repair procedures.
This expanding dataset reinforces Remplir’s clinical utility and supports the Company’s ongoing commercial rollout in the United States, alongside planned regulatory approvals in Europe and the UK.
Cumulative study results
The latest data represents a doubling of the study cohort from 33 to 66 participants, with outcomes remaining consistent with earlier findings and previously published clinical trial data in the Journal of Reconstructive Microsurgery Open.
The study evaluated both motor nerve reconstruction and nerve decompression procedures in participants aged 14-82 years, demonstrating strong and consistent clinical performance:
- 90.3% of motor nerve repairs resulted in functional muscle recovery
- 89.4% of nerve decompression procedures resulted in significant improvement or complete symptom relief
- Importantly, no post-treatment complications or adverse effects were reported, further supporting Remplir’s safety profile and biocompatibility.
The study includes patients with both acute traumatic injuries and chronic nerve conditions, highlighting Remplir’s versatility across a broad range of clinical applications — from restoring hand function following spinal cord or brachial plexus injury to relieving symptoms in conditions such as carpal tunnel syndrome.
Supporting commercial growth
The expanding clinical dataset is translating into growing adoption of Remplir, with more than 300 surgeons across 220+ hospitals in Australia now using the product, and more than 49 surgeons across 55+ hospitals in the U.S. having purchased it.
Orthocell Managing Director Paul Anderson said the results reinforce confidence in the product’s performance and scalability:
“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 .”
The data is expected to play a key role in driving continued U.S. commercial growth and supporting regulatory submissions in Europe and the UK, with approvals anticipated in the second half of CY2026.
Orthocell will continue enrolling patients in the study and presenting results at major medical conferences as part of its strategy to establish Remplir as a leading solution in nerve repair surgery.