Regenerative medicine company Orthocell Limited (ASX:OCC) has announced receipt of European regulatory approval (CE Mark) for its CelGro collagen medical device.
CelGro, for a range of dental bone and soft tissue regeneration procedures, can now be marketed and sold within the European Union (EU).
“European regulatory approval for CelGro marks a major milestone for Orthocell as it enables commercial rollout in the lucrative dental bone and soft tissue regeneration market, where there is a significant and growing demand and market opportunity. This provides a strong foundation for Orthocell to progress additional dental regulatory applications in key markets, such as the US, Japan and Australia,” said managing director Paul Anderson.
“The CE Mark also validates the potential of the entire technology platform by endorsing CelGro’s clinical performance and quality manufacturing. In addition, the achievement of this CE Mark supports regulatory applications for additional indications.”
Orthocell says it has a clear commercialisation strategy in place to drive sales of CelGro and is in discussion with strategic commercial partners for product distribution in Europe and other key regions.
CelGro is manufactured by Orthocell at its Good Manufacturing Practices (GMP) licensed facility in WA, using the company’s proprietary SMRTTM tissue engineering process, developed in conjunction with Professor Minghao Zheng and the University of Western Australia.
According to oral and maxillofacial surgeon, Dr Brent Allan, “CelGro is an exciting new product with clear advantages over the available alternatives. I prefer to use CelGro over existing scaffolds. It is easy to handle and enables a high quality tissue repair.”
CelGro’s dental addressable market is estimated to be worth more than US$600 million per annum, with approximately 1.5 million procedures that utilise these types of scaffolds completed each year, said the company.
Market growth is expected to be underpinned by an aging population, significant growing demand for dental therapies and the surgeons’ preference for quality and functional bioabsorbable membranes.