Orthocell Ltd (ASX:OCC) has started a study to compare its nerve repair device Remplir with traditional methods of healing that it hopes will help support international regulatory approval and product marketing and reimbursement efforts.
The pre-clinical study, using a well-established rat sciatic nerve injury model, is intended to evaluate the safety, mechanism of action and product performance of Remplir, when used as a nerve wrap in peripheral nerve repair, compared to traditional repair methods.
Professor Bill Walsh, director of Surgical and Orthopaedic Research Laboratories (SORL) at the Prince of Wales Hospital in Sydney and the University of New South Wales, will conduct the study, which is expected to be completed in the first quarter of next year.
Positive clinical study
Orthocell believes surgeons will prefer the fit-for-purpose Remplir as it is easy to use and reduces the need for damaging sutures to facilitate nerve regeneration and better patient outcomes.
The regenerative medicine company recently completed a clinical study showing nerve repair with Remplir following injury to the spinal cord, brachial plexus and other nerves of the upper limbs consistently restores arm and hand function to previously paralysed limbs.
Importantly, functional recovery of muscles controlled by the repaired nerve was observed in 85% or 23 out of 27 nerve repairs at 24 months post-treatment.
Without surgery, patients who suffered traumatic nerve injuries following motor vehicle, sporting and/or work-related incidents would not have regained normal use of their injured arm and hand, the study showed.
Superior product
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.”
Billion dollar market
Remplir received regulatory approval in Australia in February 2022 and was included on the Prosthesis List for reimbursement nine months later.
The addressable market in peripheral nerve repair in the US is estimated to be worth more than US$1.1 billion per annum, with approximately 700,000 procedures that could use Remplir each year, Orthocell said.
To that end, the company will continue to work closely with US regulatory advisers to evaluate opportunities for expedited approval of alternative devices that may attract a high reimbursement value.
New expert appointments
Orthocell recently appointed internationally recognised orthopaedic surgeons, Professor Christopher Dy and Professor David Brogan, to its Medical Scientific Advisory Board.
Professors Dy and Brogan, who specialise in nerve transfer and peripheral nerve repair, are based at Washington University and Barnes-Jewish Orthopedic Center, and among the US’ leading academic research institutions and hospitals.
The two highly qualified and experienced surgeons will assist with clinical development and US market access for the company’s nerve repair medical device.