- Regenerative medicine company Orthocell (OCC) has noted its CelGro scaffold has been proven to be the superior product for nerve regeneration compared to the leading market alternative
- Orthocell’s U.S. 510(k) animal pilot study reported nerves repaired with CelGro exhibited no inflammation, scar tissue formation or fibro-adhesions and were easier to cut to size and manipulate, unlike the FDA approved comparison product, while also facilitating superior nerve regeneration
- Orthocell is now evaluating the medical device U.S. regulatory pathways for expedited approval of CelGro
- The company says it’s on track to announce further clinical data from its CelGro nerve regeneration human clinical study in Q2 2021
- OCC shares are up 5.83 per cent, treading at 54.5 cents
Regenerative medicine company Orthocell (OCC) has noted its CelGro medical scaffold has been proven to be the superior product for nerve regeneration compared to the leading market alternative.
Orthocell’s U.S. 510(k) animal pilot study, titled “Evaluation of collagen nerve wraps used in peripheral nerve repair in a rat sciatic nerve injury model”, was designed to provide evidence of safety and efficacy of CelGro for peripheral nerve repair.
The study involved augmenting the repair of severed sciatic nerves in four rats within two separate study groups, focussing on the facilitation of nerve regeneration recorded four weeks after treatment.
The study results proved CelGro facilitated superior nerve regeneration when compared to the market leading nerve repair device, effectively restoring the sciatic nerve to a pre-injured state.
The principal investigator, Dr Zoran Pletikosa from the University of Western Sydney, reported nerves repaired with CelGro exhibited no inflammation, scar tissue formation or fibro-adhesions, and were easier to cut to size, manipulate and position when wrapping around the injured nerve, unlike the FDA approved comparison product.
As a result of the study, and in light of the previously released interim human clinical data, Orthocell is now evaluating the medical device U.S. regulatory pathways for expedited approval of CelGro. This includes seeking the highest reimbursement value.
The company says CelGro represents a breakthrough in nerve regeneration and is an important development in nerve repair surgery to return function to paralysed upper limbs. Combined with CelGro’s excellent handling characteristics, surgeons will be able to improve the lives of more patients suffering from complex spinal cord or traumatic nerve injuries.
“We are excited by the opportunity to provide patients access to this life changing treatment,” said Orthocell Managing Director Paul Anderson.
“Importantly, this evaluation of regulatory and reimbursement pathways positions the company towards a more attractive reimbursement value increasing the market opportunity.”
Orthocell says it’s on track to announce further clinical data from its CelGro nerve regeneration human clinical study in Q2 2021, focussing on the return of arm and hand function of all trial participants from 12 months post treatment.
This study data will direct the company’s approach with FDA and U.S. payers to determine whether an expedited regulatory approval is possible and the reimbursement value for the product.
Orthocell shares are up 5.83 per cent, treading at 54.5 cents at 11:40 am AEST.