Orthocell (ASX:OCC) said today that its CelGro collagen medical device won CE Mark approval for a range of dental bone and soft tissue regeneration procedures.
The company said it’s in talks with the strategic commercial partners to distribute its product throughout Europe and other key regions. Orthocell is also reportedly holding discussions with key opinion leaders in the dental and bone regeneration fields.
“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,” managing director Paul Anderson said in prepared remarks.
“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.”
“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,” Dr. Brent Allan, oral and maxillofacial surgeon, added.
