Regenerative medicine company Orthocell (ASX:OCC) has submitted an application to the TGA seeking the approval of the CelGro collagen medical device.
The company's application to the TGA follows its recent approval in Europe (CE Mark).
According to Orthocell managing director, Paul Anderson, “This is a very important milestone for the Company as we continue to commercialise our collagen medical device platform and prepare for entry to additional strategic markets.
"CelGro has shown to be the superior product when compared to current alternatives and I am excited by the commercial opportunities that lie ahead as we establish CelGro as the best in class collagen membrane.”
CelGro is a biological medical device used as a barrier membrane in various dental procedures such as dental implants. The success of dental implants relies on the solid anchorage and integration between the implant and dental bone.
The company said it estimates the current global market for dental barrier membranes used in conjunction with bone graft substitutes at approximately 1.5 million units per year with a total value of over US$600 million.