Regenerative medicine company Orthocell (ASX:OCC) says it has received confirmation from the US FDA that the proposed CelGro nerve regeneration animal study protocol meets requirements to support the near term 510(k) submission.
The said it has now accelerated ethics applications to commence the study in the fist quarter of 2020.
According to managing director Paul Anderson, “With the safety and efficacy of the CelGro nerve repair product established, Orthocell is accelerating its regulatory program to gain approval in the US, EU and AUS. We are very pleased with the FDA feedback and are well positioned to gain approval of CelGro in the US, the largest health care market.”
Orthocell said recent feedback from the FDA confirmed the proposed CelGro nerve regeneration animal study protocol was suitable to support an evaluation of substantial equivalence to an approved nerve repair device, meeting the requirements of the US 510(k) predicate product regulatory pathway.
The study is titled 'Evaluation of collagen nerve wraps used in peripheral nerve repair in a rat sciatic nerve injury model'. It is designed to provide evidence of safety and performance of CelGro in peripheral nerve repair using the animal model.
The study will involve the treatment of severed sciatic nerves in approximately 72 rats in three three study groups with outcome measures recorded at four, eight and twenty weeks post-treatment.
The key outcome measures include the performance of CelGro in facilitating high-quality nerve regeneration and restoration of motor and sensory function. The company said it aims to complete the study and submit the 510(k) application in the third quarter of next year.