FDA confirms CelGro® Nerve regeneration study design meets US 510(k) submission requirements
US 510(k) study expected to commence Q1 CY2020
Follows recent study results showing CelGro® facilitates high quality nerve repair and restores function to previously paralysed muscles
Orthocell is well positioned to accelerate US, EU and AUS regulatory approvals and commercialisation of CelGro®
CelGro®’s addressable market in peripheral nerve repair is estimated to be worth more than US$1.1 billion per annum
Perth, Australia; 16 December 2019: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell”, or the “Company” ) is pleased to announce that it has received confirmation from the FDA that the proposed CelGro® nerve regeneration animal study protocol meets requirements to support the near term 510(k) submission. The Company has now accelerated ethics applications to commence the study in Q1 CY2020.
Following recent successful CelGro® nerve repair study results and growing demand from industry leading clinicians and potential partners for superior nerve repair medical devices, the Company commenced pre- submission activities with the FDA to confirm the requirements for US market approval.
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” and is designed to provide evidence of safety and performance of CelGro® in peripheral nerve repair using the well-established animal model.
The study will involve the treatment of severed sciatic nerves in approximately seventy two (72) rats in three (3) study groups (control, CelGro® and comparator) 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 aims to complete the study and submit the 510(k) application in Q3 CY2020.
Significance of recent CelGro® nerve repair study results
Recent results indicated nerve repair using CelGro® resulted in improvements in muscle power at 12 months that were comparable to repair typically achieved at 24 months with other methods.
The consistent and predictable outcomes of nerve repair with CelGro® achieved in a shorter time, will empower surgeons to improve the lives of patients with these complex injuries.
lGro® facilitates tensionless repair of peripheral nerves and is of significant clinical interest to the surgical community (eg. Orthopaedics and neurosurgery) due to its potential to improve the efficacy and efficiency of surgical procedures. Tensionless repair helps to reduce surgery time and the risk of additional trauma to soft tissue through the use of sutures.
CelGro® addressable market in peripheral nerve repair In the US alone, over 20 million people suffer from peripheral nerve injury as a result of motor vehicle, sporting or work-related incidents, at an annual cost of approximately US$150 billion. Many of these injuries require surgical nerve reconstruction involving the use of artificial “conduits” or synthetic sheaths that are sutured to the nerve.
To address the disadvantages of suturing, Orthocell designed CelGro®, with handling characteristics to assist surgeons with performing complex reconstructive surgical procedures and to enable the tensionless repair of soft tissue defects.
CelGro®’s addressable market in peripheral nerve repair is estimated to be worth more than US$1.1 billion per annum, with approximately 700,000 procedures that could use CelGro® completed each year. Market growth is expected to be underpinned by surgeons’ preference for quality and functional bio-absorbable membranes.
The Company believes CelGro® represents a breakthrough in soft tissue reconstruction and offers significant global commercial potential in its existing addressable markets of bone, tendon, nerve and cartilage as well as much wider applications in general surgical and soft tissue reconstructive applications.
Orthocell has a clear commercialisation strategy for the CelGro® nerve regeneration indication and intends to accelerate US, EU and AUS regulatory submissions.
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