- Regenerative medicine company Orthocell (OCC) receives regulatory approval for its Remplir peripheral nerve repair device to be introduced into the Australian nerve repair and regeneration market
- The approval includes Remplir on the Australian Register of Therapeutic Goods (ARTG) and allows Orthocell to progress its application for inclusion on the prostheses list, planned for submission in Q2 CY2022
- Orthocell says clinical studies show nerve repair with Remplir consistently restores arm and hand function, with 82.6 per cent of nerve repairs using Remplir resulting in functional recovery of muscles controlled by the repaired nerve based on interim results
- The company says the results are of significant interest to patients and clinicians due to the potential improvement in the efficiency and efficacy of nerve repair procedures
- OCC shares 15.4 per cent higher at 45 cents
Orthocell (OCC) shares spiked after the company announced it had secured regulatory approval for its Remplir peripheral nerve repair device to be used in peripheral nerve repair procedures.
The Australian Therapeutic Goods Administration (TGA) go-ahead allows the company to launch Remplir on the Australian nerve repair and regeneration market.
Orthocell said the inclusion of Remplir on the Australian Register of Therapeutic Goods (ARTG) will pave the way for its application for the device to be included on the prostheses list, planned for submission in Q2 CY2022.
“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,” Managing Director Paul Anderson said.
Remplir is manufactured in WA by Orthocell using its proprietary SMRT manufacturing technology developed in conjunction with Professor Minghao Zhang, the University of Western Australia and the Perron Institute.
Orthocell said clinical studies show nerve repair with Remplir consistently restores arm and hand function, with 82.6 per cent of nerve repairs using Remplir resulting in functional recovery of muscles controlled by the repaired nerve based on interim results.
The interim results reported were a continuation of Orthocell’s 2021 clinical study and, according to the company, of significant interest to patients and clinicians due to the potentially improved efficiency and efficacy of nerve repair procedures.
The company said it was well-positioned to achieve further international approvals for Remplir in nerve repair.
OCC shares were trading 15.4 per cent higher at 45 cents at 1:53 pm AEDT.