Orthocell Ltd (ASX:OCC) is moving towards Therapeutic Goods Administration (TGA) approval of its CelGro® collagen medical device for introduction into the Australian dental bone and tissue regeneration market.
The TGA has completed its review of the company’s regulatory application and confirmed that Orthocell successfully demonstrated compliance with the requirements of the Medical Device Regulations (Conformity Assessment) with respect to the safety and performance of CelGro® in dental bone and tissue regeneration procedures.
The assessment included a review of Orthocell’s quality management system and manufacturing processes.
CelGro® market authorisation
The company has initiated an application to include CelGro® Dental on the Australian Register of Therapeutic Goods (Market Authorisation) to market and supply CelGro® in dental bone and tissue regeneration procedures.
This application is largely administrative and is anticipated to be finalised in quarter one of 2021.
Orthocell managing director Paul Anderson said: “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 US FDA regulatory approval.”
Shares have been up almost 4% to an intra-day high of 43.5 cents and the company's market cap sits at approximately $77.6 million.
Reimbursement application pending
The company has also progressed its application to the Prostheses List Advisory Committee for inclusion on the Prostheses List (PL) enabling reimbursement by insurers.
Inclusion on the PL may be finalised by the fourth quarter of 2021.
Well-positioned for US FDA approval
With EU approval achieved, KOL’s in place and successful completion of the Australian TGA Conformity Assessment process, Orthocell is well-positioned to gain US FDA approval in 2021 and establish CelGro® as the best-in-class collagen membrane.
Clinical studies and post-market feedback have demonstrated that CelGro® provides distinct advantages to assist surgeons to deliver improved patient outcomes through superior handling characteristics, tissue integration qualities and higher bone quality compared to the market-leading dental membrane product.