The Orthocell Ltd (ASX: OCC) share price is rising today following news of a successful pilot animal study. The company states that as a result of the study, it's seeking to fast-track US approval for its CelGro product.
The Orthocell share price is currently trading at 54 cents, up 4.85% from yesterday's closing price.
Let's take a closer look at the latest news released by the regenerative medicine company.
Positive study results
Orthocell released the news today that the results of its pilot animal study indicate that CelGro facilitates nerve regeneration in a superior manner compared to current market-leading nerve repair devices. It was found to effectively regenerate nerves. In particular, it is able to restore an injured sciatic nerve to its former state.
As a result, Orthocell is looking to speed up the product's approval in the US. Additionally, it seeks to establish a plan to receive the highest reimbursement value.
According to independent principal investigator, Dr Zoran Pletikosa at the University of Western Sydney, using CelGro to repair nerves resulted in no inflammation, scar tissue formation, or fibro-adhesions. After 4 weeks, the repaired nerve looked as though it had not been injured at all.
Further, it was stated that CelGro is easier to use in surgery than the current market-leading equivalent.
The company said the results from the animal study suggested that by restoring the damaged nerve, a patients' return of upper arm and hand function is faster and more predictable.
Orthocell also expects to announce more data from its CelGro nerve regeneration human clinical study in the second quarter of 2021, focusing on the return of arm and hand function at 12 months post-treatment.
This data will guide the company's approach to seeking regulatory approval from the Food and Drug Administration (FDA), US Medicare, Medicaid, private payers, and the Veteran's Administration.
Commentary from management
Orthocell's managing director Paul Anderson commented on the study's results, saying:
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.
Orthocell share price snapshot
The Orthocell share price is having a fantastic 2021 on the ASX, with today's news bringing its latest boost.
Currently, the Orthocell share price is up 13% year to date. It's also up 73% over the last 12 months.
The company has a market capitalisation of around $97 million, with approximately 189 million shares outstanding.
