Regenerative medicine company Orthocell (ASX:OCC) has announced what it describes as positive results from the US animal pilot study of its CelGro in nerve regeneration compared to the current market-leading device.
The company said the study showed CelGro facilitates superior nerve regeneration when compared to the other device in the restoration of the sciatic nerve to a pre-injured state.
Orthocell said as a result of this data, as well as previously released interim data from a human clinical study, it is now evaluating the medical device US regulatory pathways to identify opportunities for the expedited approval of CelGro.
Managing director Paul Anderson said, “CelGro has shown to be the superior product for nerve regeneration when compared to the market-leading alternative. We are excited by the opportunity to provide patients access to this life-changing treatment. Importantly, this evaluation of regulatory and reimbursement pathways position the Company towards a more attractive reimbursement value increasing the market opportunity.”
The company said study principal investigator Dr Zoran Pletikosa, who is based at the University of Western Sydney, reported nerve repaired with CelGro exhibited no inflammation, scar tissue formation or fibro-adhesions.
In addition, CelGro integrated into the host epineurium (outer layer of connective tissue of the nerve), was remodelled into natural tissue and, at four weeks post-treatment, resembled the native sciatic nerve in appearance. CelGro also had better handling properties in surgery.