- Orthocell (OCC) is a step closer to market after gaining Conformity Assessment approval from the Therapeutic Goods Administration (TGA)
- The company’s CelGro bone and tissue regeneration tech is now expected to be authorised for commercialisation in Australia early next year
- According to the company, the final market approval assessment is “largely administrative,” so the product is likely to hit Australian shelves in early 2021
- With approval already granted in Europe and Australia seemingly not far behind, Orthocell Managing Director Paul Anderson says the U.S. is the next target
- Orthocell is up 1.19 per cent, trading for 42.5 cents
Orthocell (OCC) is a step closer to market after gaining Conformity Assessment approval from the Therapeutic Goods Administration (TGA).
The company’s CelGro bone and tissue regeneration tech is now expected to be authorised for commercialisation in Australia early next year.
Big tick
The TGA has completed its review of the company’s regulatory application, confirming CelGro complies with the requirements of the Medical Device Regulations (Conformity Assessment).
The Conformity Assessment included a review of Orthocell’s quality management system and manufacturing processes.
According to the company, the final Market Approval assessment is “largely administrative,” so the product is likely to hit Australian shelves in early 2021.
Orthocell has also progressed its application to the Prostheses List Advisory
Committee, which would enable patient costs for CelGro to be reimbursed by insurers. The company is hoping to be included on the Prostheses List by the end of next year.
With approval already granted in Europe and Australia seemingly not far behind, Orthocell Managing Director Paul Anderson says the company is next gunning for approval in the U.S.
“This is an important milestone for the company as we continue to commercialise our collagen medical device platform and I am excited to complete this important step towards gaining Australian and U.S. Food and Drug Administration (FDA) regulatory approval,” Paul said.
Outlook
Orthocell is now well positioned to market the CelGro tech to the global market, with FDA approval expected sometime during 2021.
The company believes CelGro represents a breakthrough in bone and tissue reconstruction, with clinical studies and market feedback indicating a best-in-class product in terms of patient outcomes.
Having surpassed the important TGA milestone, Orthocell is a step closer to market for its new cornerstone product.
Orthocell is up 1.19 per cent, trading for 42.5 cents at 1:19 pm AEDT.