Orthocell submits Australian TGA regulatory application for CelGro® nerve regeneration platform

Orthocell Ltd (ASX:OCC) has taken another commercialisation step for its CelGro® product for peripheral nerve regeneration applications by completing a submission to the Australian Therapeutic Goods Administration (TGA) seeking approval for marketing.

This application follows recent study results showing that at 12 months after CelGro surgery, voluntary muscle movement was restored in 96% of nerve repairs, and 86% of patients who required prescription pain medication (including opioid-based medications), were able to significantly reduce or stop their medication completely.

CelGro's addressable market in nerve repair is estimated to be worth more than US$2 billion per annum with around 750,000 procedures that could use CelGro completed each year.*"Superior product"*

Orthocell managing director Paul Anderson said: "Our research to date indicates that CelGro is a superior product for facilitating complex nerve regeneration when compared to current alternatives and we are optimistic in achieving regulatory clearance to enable Australian patients to access its life-changing impact.

"We have seen incredible results so far. As an example, one of our quadriplegic patients progressed from having no strength in his arms and no movements in his fingers and thumb, to playing wheelchair rugby.

"This is extremely exciting for our researchers, doctors and patients, and we remain confident that we are on the cusp of a significant breakthrough for the repair of damaged nerves."