Orthocell Ltd (ASX:OCC, OTC:ORHHF) has welcomed the publication of results from the clinical trial of its flagship Remplir™ nerve regeneration remedy, which demonstrate the success of the asset in repairing nerve function.
Return of nerve function
The study, featured in the Journal of Reconstructive Microsurgery Open, points to a medical solution to peripheral nerve repair, particularly for upper limb paralysis caused by injuries such as spinal cord damage and brachial plexus afflictions.
Orthocell chief scientific officer Professor Minghao Zheng said: “This study validated Remplir’s unique mechanism of action mimicking the native structure of epineurium, providing a protective barrier and neurotrophic microenvironment for nerve regeneration.
“Remplir’s unique biological characteristics underpinned the consistent return of function to paralysed upper limbs, the primary goal in this study.
“We are delighted to see this compelling research now published in JRMO and look forward to working with surgeons to consistently return muscle function following Remplir nerve regeneration treatment.”
The clinical study demonstrated that 85% – or 23 out of 27 – of nerve repairs using Remplir led to functional recovery of muscles controlled by the repaired nerves 24 months post-treatment.
Validation that Remplir works
These results validate Remplir’s efficacy as an optimal medical device for connecting severed nerves, safeguarding damaged nerves or capping amputated nerves.
Lending their credibility to these findings is a constellation of experts including Dr Alex O’Beirne from the Western Orthopaedic Clinic, Jaslyn Cullen from Jaslyn Cullen Occupational Therapy and Professor Minghao Zheng, Orthocell's inventor and chief scientific officer, based at the Perron Institute and the University of Western Australia.
The published study not only reinforces the clinical benefits of Remplir but also positions Orthocell to potentially lead the US market in nerve repair solutions, bolstering its profile among potential partners, medical practitioners and patients.
This, in turn, strengthens Orthocell's strategic position within an addressable market projected to exceed US$1.1 billion annually.
With the top-line results from the US FDA study of Remplir expected in the third quarter of 2024, Orthocell remains on track to submit its US 510(K) market authorisation application in the fourth quarter, with sales anticipated shortly thereafter.