- Regenerative medicine company Orthocell (OCC) has completed a submission to the U.S. Food and Drug Administration (FDA) for its CelGro device
- CelGro is a medical device that increases tissue repair and regeneration, while helping to re-join severed or damaged peripheral nerves.
- The company is seeking 510(k) clearance which, once approved, will confirm that CelGro is a safe and effective product
- This submission follows positive results from a U.S. FDA guided bone study that showed CelGro is effective in easing bone regeneration when used alongside a bone substitute and a dental implant
- Orthocell is up 4.11 per cent and shares are trading for 38 cents each
Regenerative medicine company Orthocell (OCC) has completed submission to the U.S. Food and Drug Administration (FDA) for its CelGro device.
The company is seeking 510(k) clearance which, once approved, will confirm that CelGro is a safe and effective product.
This submission follows positive results from a U.S. FDA guided bone study that showed CelGro is effective is easing bone regeneration when used alongside bone substitute and a dental implant.
“This is a significant milestone for Orthocell as we drive our innovative regenerative medicine products into the U.S., the largest global healthcare market,” Managing Director Paul Anderson said.
“We are in a strong position to gain U.S. approval and are actively progressing our U.S. market launch strategy,” he added.
The U.S. submission compliments Orthocell’s current regulatory submissions in Australia for dental bone and soft tissue regeneration applications.
This will be followed by submissions to the States, E.U., and Australia for CelGro to treat crushed or severed nerves and increase tendon repair.
What is CelGro?
CelGro is a unique medical device that increases tissue repair and regeneration, while helping to re-join severed or damaged peripheral nerves.
It has a bilayer structure which features smooth and rough sides to create a bioactive chamber to guide new tissues formations and protect the repair site.
The smooth layer is made up of densely packed collagen (a protein that provides structure to the body) grouped in bundles with abundant pores that allow fluids and nutrients to flow through.
It also prevents external tissue coming to the site of repair.
The rough layer is made up of loosely arranged collagen bundles to provide a scaffold to support new cell growth.
CelGro can be used to treat nerve and tendon repair, as well as dental bone and soft tissue applications.
Orthocell is up 4.11 per cent and shares are trading for 38 cents each at 10:58 am AEST.