- Orthocell (OCC) has received confirmation from the FDA that its CelGro nerve repair study design meets U.S. 510(k) submission requirements
- This means the company can pursue studies and commercialise CelGro in the U.S.
- In the U.S., over 20 million people suffer from peripheral nerve injury which causes an annual burdening cost of US$150 billion
- Celgro is designed to assist surgeons with performing complex reconstructive surgical procedures for people with damaged nerves or paralysed muscles
- Orthocell expects to commence its study in Quarter 1 2020
- Orthocell is up 2.08 per cent and shares are trading for 49 cents each
Orthocell (OCC) has received confirmation from the Food and Drug Administration (FDA) that its nerve repair study design meets U.S. 510(k) submission requirements.
The nerve repair study is testing CelGro’s efficacy in restoring function to damaged nerves and paralysed muscles.
Following recent successful CelGro nerve repair study results, the company commenced pre-submission activities with the FDA to confirm the requirement for U.S. market approval.
These results indicated CelGro improved muscle power at 12 months compared to the typically achieved 24 months using other methods.
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.
The study is titled “Evaluation of collagen nerve wraps used in peripheral nerve repair in a rat sciatic nerve injury model.”
It will involve the treatment of severed sciatic nerves in approximately 72 rats in three study groups with outcomes recorded at four, eight and 20 weeks post treatment.
Orthocell aims to complete the study and submit the 510(k) application by Quarter 3 of the 2020 calendar year.
CelGro facilitates tensionless repair of peripheral nerves and has gained significant clinical interest from the surgical community. Tensionless repair helps to reduce surgery time as well as the risk of additional trauma to soft tissue through the use of sutures.
In the U.S., over 20 million people suffer from peripheral nerve injury which causes an annual burdening cost of US$150 billion. Many of these injuries require surgical nerve reconstruction which involves artificial “conduits” of synthetic sheaths.
To address the disadvantages of suturing, Orthocell designed CelGro, to assist surgeons with performing complex reconstructive surgical procedures and to enable the tensionless repair of soft tissue defects.
Orthocell considers CelGro to be a breakthrough in soft tissue reconstruction and offers global commercial potential in its existing addressable markets of bone, tendon, nerve and cartilage.
Next, the company intends to accelerate regulatory submissions in Europe and Australia.
Orthocell is up 2.08 per cent and shares are trading for 49 cents each at 1:13 pm AEDT.