- Regenerative medicine company Orthocell (OCC) has received approval for its nerve repair device CelGro to be used in the Australian dental market
- The medical device will be used for dental bone and tissue regeneration procedures
- Notably, this approval will position Orthocell to achieve further approvals in the nerve and tendon repair market
- Managing Director Paul Anderson says the approval is a “significant inflection point” for the company
- On the market this morning, Orthocell is up 4.88 per cent and trading at 43 cents per share
Orthocell (OCC) has received Australian market approval to supply its nerve repair device in dental bone and tissue regeneration procedures.
This means CelGro dental is now approved Australian Register of Therapeutic Goods(ARTG). The medical device will be used in dental bone and tissue regeneration procedures.
Notably, this approval will position Orthocell to achieve further approvals in nerve and tendon repair. The company is well-positioned to gain key U.S. food and drug administration approval which is targeted for 2021.
Managing Director Paul Anderson says the approval is a “significant inflection point for the company”.
“This validates the CelGro platform technology with a respected regulator and positions us well to achieve further approvals for the manufacture and supply of
CelGro in nerve and tendon repair — key growth areas for our business, responding to significant unmet need,” he said.
“I am excited by this strategic milestone and the positive step it represents on our
continued pathway to making a meaningful impact in the U.S. market,” he added.
Orthocell is now focused on receiving reimbursement from insurers and has progressed its application to the Prostheses List Advisory Committee. It’s aiming to be included on the Prostheses List.
The company expects this to be finalised by the second quarter of 2021.
On the market this morning, Orthocell is up 4.88 per cent and trading at 43 cents per share at 11:30 am AEDT.