Orthocell Ltd (ASX:OCC)’s shares were as much as 33.35% higher to $0.52 on receiving market and regulatory approval from the Australian Therapeutic Goods Administration for its Remplir™ peripheral nerve repair device.
This milestone approval will allow the device’s introduction to the Australian nerve repair and regeneration market.
Orthocell says its nerve repair device represents a paradigm shift in product design and application, facilitating a new approach to the regeneration of damaged peripheral nerves.
Nerve repair and regeneration is a large addressable market, representing 11,780 surgical repairs in Australian public and private hospitals in the 2019/20 financial year alone.
Improving nerve repair outcomes
“Remplir™ represents a paradigm shift in product design and application,” Orthocell chief science officer and Professor of the University of Western Australia, Perron Institute of Neurological and Translational Research, Minghao Zheng said.
“It provides a barrier structure to protect the nerve and generates an ideal microenvironment for the regeneration of damaged peripheral nerves.
“Remplir™ reduces the need for suturing, is easy to use and results in consistent and predictable return of muscle function to paralysed limbs.
“This will empower surgeons to improve the lives of patients with complex nerve injuries.”
Clinical studies have shown nerve repair undertaken with Remplir™ support consistently restores arm and hand function. The process works as follows:
Interim results from Orthocell’s nerve repair clinical study showed an 82.6% (19 of 23) success rate in nerve repairs with Remplir™ at 24 months post treatment, which resulted in functional recovery of muscles controlled by the repaired nerve.
These interim results are a continuation of the clinical study announced previously on June 21, 2021.
Read: Orthocell unveils positive CelGro® nerve regeneration results in quadriplegic patients
First step toward global market impact
“Remplir™ is the first of its kind biological scaffold designed by an Australian team of researchers to mimic the outer layer of the peripheral nerve and facilitate high-quality nerve repair,” Othocell managing director Paul Anderson said.
“Remplir™ is the only Australian manufactured medical device for nerve repair to gain Australian regulatory approval and is a significant inflection point for our company.
“This is an important step on our continued pathway to making a meaningful impact in the global market.”
The TGA’s approval validates Orthocell’s CelGro® platform technology and positions the company well to achieve further international regulatory approvals in nerve repair.
Orthocell plans to move toward an Australian reimbursement application in the second quarter of this year, which will define the minimum benefit value private insurers pay for Remplir™.
About Orthocell
Orthocell is focused on regenerating mobility for patients by developing innovative products for the repair of a variety of bone and soft tissue injuries.
Orthocell’s portfolio of products includes CelGro®, a collagen medical device that facilitates tissue repair and healing in a variety of orthopaedic, reconstructive, and surgical applications.
Striate+™ was the first product approved for dental guided bone regeneration (GBR) applications and is cleared for use in US FDA, Australia (ARTG) and Europe (CE Mark).
Remplir™, for peripheral nerve repair, recently received approval in Australia (ARTG).
SmrtGraft™, for tendon repair, is available in Australia under Special Access Scheme or participation in a clinical trial.
The company’s other major products are autologous cell therapies which aim to regenerate damaged tendon and cartilage tissue.