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

The company’s commercialisation strategy for the product will leverage the TGA results for regulatory submission in the US.

Orthocell Ltd - Orthocell submits TGA regulatory application for CelGro® nerve regeneration platform
The peripheral nerve repair market is estimated to be worth more than US$2 billion per annum

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.”

Commercialising CelGro

The marketing and sale of CelGro for nerve repair applications in Australia can commence after TGA regulatory approval, which would give the company extended reach and accessibility for the treatment to be used by surgeons.

CelGro facilitates tensionless repair of peripheral nerves and market growth is expected to be underpinned by the surgeons’ preference for quality and functional bio-absorbable membranes which reduces surgery time, and the risk of additional trauma to soft tissue as a results of sutures to join nerves and other tissues.

Anderson said: “This is a very important milestone for Orthocell as we continue to commercialse our collagen medical device platform and prepare for strategic entry into additional global markets.”

Market opportunities

In the US alone, more than 20 million people suffer from peripheral nerve injury as a result of motor vehicle, sporting or work-related incidents every year, at an annual cost of approximately US$150 billion.

Many of these injuries require surgical nerve reconstruction involving the use of artificial ‘conduits’ or tubes that are secured in place with sutures.

The company believes CelGro represents a breakthrough in soft tissue reconstruction and offers significant global commercial potential in its existing addressable markets of bone, tendon, nerve and cartilage as well as much wider applications in general surgical and soft tissue reconstructive applications.

Quick facts: Orthocell Ltd

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