Regenerative medicine company Orthocell (ASX:OCC) reports it has started a comparator study as part of a comprehensive preclinical and clinical development program in nerve repair and regeneration.
The company says the study provides information regarding mechanisms of action that is not possible to collect in human clinical trials. The outcome of this study will support product marketing initiatives and international regulatory approval and reimbursement strategies for its nerve repair device, Remplir.
This study will be conducted using a well-established rat sciatic nerve injury model, and it is intended to evaluate safety, mechanism of action, and product performance of Remplir, when used as a nerve wrap in peripheral nerve repair, compared to traditional repair methods. The repair of surgically transected sciatic nerves will be evaluated in 72 rats across 3 study groups.
“This study is an important next step in our international market access program with the potential to provide data demonstrating the impact and advantages of using Remplir over traditional nerve repair methods”
These study groups will consist of repairing using suture only (control group), repairing with Remplir, and repairing with a comparator. Nerve regeneration will be measured at 4, 8, and 24 weeks post-treatment to assess the performance of Remplir in facilitating ‘high-quality’ nerve regeneration, as well as restoration of motor and sensory functions.
Commenting on the study, Orthocell Managing Director Paul Anderson said: “Remplir has shown, in previous studies, to be the superior product for nerve regeneration when compared to an FDA approved comparator device. We are confident that the outcomes of this study will be consistent with the clinical performance of Remplir to date, and validate that Remplir is easier to use, reduces the need for sutures and results in more consistent and predictable return of muscle function.
This study is an important next step in our international market access program with the potential to provide data demonstrating the impact and advantages of using Remplir over traditional nerve repair methods. Orthocell remains committed to providing patients access to this life changing treatment.”
Orthocell reports the preclinical study will be conducted by the Director of Surgical and Orthopaedic Research Laboratories (SORL), Professor Bill Walsh at the Prince of Wales Hospital in Sydney, and the University of New South Wales. SORL is dedicated to developing biomedical, biotechnology, and engineering solutions to improve clinical outcomes in injured and diseased states.
The company believes Remplir has the potential to become the market-leading nerve repair device with uptake driven by surgeons’ preference for an easy to use, fit for purpose device that reduces the need for damaging sutures, and provides an enhanced biological environment to facilitate nerve regeneration and better patient outcomes.
In a recently completed clinical study completed by Orthocell, positive clinical data demonstrated that nerve repair with Remplir following injury to the spinal cord, brachial plexus, and other nerves of the upper limbs consistently restores arms and hand functions to previously paralysed limbs. Importantly, functional recovery of muscles controlled by the repaired nerve was observed in 85% of nerve repairs at 24 months post treatment.
Without surgery, patients who suffered traumatic nerve injuries following motor vehicle, sporting, and work related incidents would not have regained normal use of their injured arm of hand. Remplir achieved regulatory approval in Australia in February 2002 and was included on the Prosthesis List for reimbursement in November 2022.
Orthocell reports Remplir’s US addressable market in peripheral nerve repair is estimated to be worth more than US$1.1 billion per annum, with about 700,000 procedures that could use Remplir completed each year. The company says it is continuing to work closely with US regulatory advisers to evaluate opportunities for expedited approval of alternative devices that may attract a high reimbursement value.
Orthocell is an ASX-listed regenerative medicine company dedicated to the development of breakthrough products for the treatment of musculoskeletal disorders.