Orthocell Ltd (ASX:OCC) has received the green light to introduce its CelGro® collagen medical device into the Australian dental bone and tissue regeneration market.
CelGro® Dental is now included in the Australian Register of Therapeutic Goods (ARTG).
The approval positions Orthocell well for US Food and Drug Administration (FDA) approval, targeted for 2021.
Validates CelGro® platform technology
Orthocell managing director Paul Anderson said: “Gaining Australian approval is a significant inflection point for our 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.
“I am excited by this strategic milestone and the positive step it represents on our continued pathway to making a meaningful impact in the US market.”
Shares were as much as 13.5% higher to 46.5 cents intra-day with almost 2.274 million traded.
Focused on reimbursement
The company is now focused on seeking reimbursement by insurers and has progressed its application to the Prostheses List Advisory Committee for inclusion on the Prostheses List (PL).
Inclusion on the PL may be finalised by the second quarter of 2021.
FDA approval targeted
With the EU and Australian market approval achieved, and key opinion leaders (KOLs) actively engaging with the program, Orthocell is well-positioned to gain the key US FDA approval, targeted for 2021 and to establish CelGro® as the best-in-class collagen membrane.
Use of the product in Australia and the EU will assist with further technical and market validation for CelGro® as the US FDA approval approaches.
Offers distinct advantages
Orthocell believes CelGro®, manufactured by Orthocell in Western Australia, represents a breakthrough in bone and tissue reconstruction and is an area of significant clinical interest to the dental community.
Clinical studies and post-market feedback have demonstrated that CelGro® provides distinct advantages to assist surgeons deliver improved patient outcomes through superior handling characteristics, tissue integration qualities and higher bone quality compared to the market-leading dental membrane product.