CelGro, which is used for a range of dental bone and soft tissue regeneration procedures, can now be marketed and sold within the European Union (EU).
Significantly, the CE mark validates the potential of the entire technology platform by endorsing CelGro’s clinical performance and quality manufacturing.
CelGro is manufactured by Orthocell at its quality controlled Good Manufacturing Practices (GMP) licensed facility in Western Australia.
The company uses its proprietary SMRT tissue engineering process, developed in conjunction with
Professor Minghao Zheng and the University of Western Australia.
CelGro plays a critical role in dental bone and soft tissue regeneration therapy as it offers superior functionality over existing products for improved tissue repair.
CelGro’s dental addressable market is estimated to be worth more than US$600 million per annum, with circa 1.5 million procedures that utilise these types of scaffolds being completed each year.
A key advantage of CelGro over other scaffolds is that it integrates with the soft tissue under repair and also degrades at the same rate as the body heals.
The approval provides a strong foundation for the company to progress additional dental regulatory applications in key markets, such as the U.S., Japan and Australia.