- Orthocell (OCC) kicks off a ‘comparator’ study as part of its pre-clinical and clinical development program in nerve repair and regeneration
- OCC will use a rat sciatic nerve injury model to evaluate the safety, mechanism of action and product performance of its Remplir device when used as a nerve wrap
- The repair of surgically severed sciatic nerves will be evaluated in 72 rats split into three study groups: a control group, a Remplir group, and a comparator group
- The company says Remplir has the potential to become the “leading device” in a US market estimated to be worth more than US$1.1 billion per year
- OCC shares are up 2.38 per cent to 43 cents at 11:34 am AEST
Regenerative medicine company Orthocell (OCC) has begun a ‘comparator’ study as part of its pre-clinical and clinical development program in nerve repair and regeneration.
The study follows the regulatory approval of the company’s nerve-repair device, Remplir, for peripheral nerve repair in Australia, in February 2022, with inclusion on the Prosthesis List for reimbursement in November 2022.
Under the study, OCC will use a well-established rat sciatic nerve injury model 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.
OCC said it expected the study to provide information regarding a mechanism of action that would be impossible to collect in human clinical trials.
The repair of surgically severed sciatic nerves will be evaluated in 72 rats split into three study groups: a control group, a Remplir group, and a comparator group.
According to OCC, the outcomes of the study are expected to support product marketing initiatives as well as international regulatory approvals and reimbursement strategies for Remplir.
“Remplir has shown, in previous studies, to be the superior product for nerve regeneration when compared to an FDA-approved comparator device,” OCC Managing Director Paul Anderson said.
“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.”
The study will be managed in collaboration with Professor Bill Walsh from the University of New South Wales, with study completion targeted by the first quarter of 2024.
The company said Remplir had the potential to become the “leading device” in a US market estimated to be worth more than US$1.1 billion per year.
OCC shares were up 2.38 per cent to 43 cents at 11:34 am AEST.