The TGA has approved Orthocell's (ASX:OCC) Remplir peripheral nerve repair device.
Managing director Paul Anderson said, “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.
"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 company said it is now focused on achieving reimbursement by insurers and has progressed its application for inclusion on the Prostheses List.
Remplir is produced by Orthocell at its facility in Western Australia using the company’s SMRT manufacturing technology. This technology was developed in conjunction with Professor Minghao Zheng at the University of Western Australia and the Perron Institute.