Regenerative medicine company Orthocell (ASX:OCC) told investors that it had achieved positive results from its US 510(k) animal pilot study, indicating that that company’s CelGro product facilitates superior nerve regeneration when compared to the current market-leading nerve repair device.
As a result of the breakthrough data, and in light of the previously released interim human clinical data, the company is evaluating the medical device US regulatory pathways to identify opportunities for expedited approval of CelGro and the ideal route to the highest reimbursement value.
US 510(k) pilot study results
Orthocell completed the pilot stage of its 510(k) animal study titled “Evaluation of collagen nerve wraps used in peripheral nerve repair in a rat sciatic nerve injury model”. The pilot study involved augmenting the repair of severed sciatic nerves in four rats in two separate study groups (CelGro and an FDA approved nerve repair device) with outcome measures focused on the facilitation of nerve regeneration recorded at four weeks post-treatment.
Nerves repaired with CelGro exhibited no inflammation, scar tissue formation or fibro-adhesions. CelGro also had better handling properties in surgery. It was easier to cut to size, manipulate and position when wrapping around the injured nerve, and hydrated immediately upon contact with tissue fluid.
Significance of CelGro nerve repair study results
The 510(k) animal study results suggest that restoration of the damaged nerve to its pre-injured state can translate to a faster and more predictable return of upper arm and hand function. In light of these study results and the previously released interim human clinical data, Orthocell believes that CelGro represents a breakthrough in nerve regeneration and is an important development in nerve repair surgery to return function to paralysed upper limbs.
Study data compels review of US regulatory and market access pathway
Orthocell is on track to announce further clinical data which will guide the company’s approach with FDA and US payers to determine whether an expedited regulatory approval, pursuant to a “De Novo” or “Pre-Market Approval”, is possible and what this will mean for reimbursement value for the product.
The 510(k) pathway essentially caps the potential reimbursement value paid by private insurers, regardless of any additional patient or economic benefits delivered by the use of the new nerve repair device. While De Novo, Pre-Market Approval pathways and expedited programs allow for increased interaction with the FDA and provide the opportunity for Orthocell to gain a stand-alone approval for a novel nerve repair device, based on the unique clinical benefit delivered by that device. These pathways also allow the company to maximise the value ultimately paid by US payers for the new product, rather than referencing the existing price for currently marketed products.
Orthocell 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.”