Regenerative medicine company Orthocell (ASX:OCC) has announced that Heath Canada has granted a Medical Device Licence (MDL) for its product, Striate+, for guided bone regeneration in dental implant procedures.
Orthocell managing director Paul Anderson said, “Canadian approval for Striate+ is further validation of Orthocell’s expanding global footprint. Approval in this market complements our FDA approval and strengthens the Company's position to increase revenue, in collaboration with our valued partner BioHorizons. Additionally, it reaffirms the high quality of our product and world-class, scalable manufacturing process.”
Striate+ is a collagen membrane used to support guided bone regeneration in dental implant procedures. It is approved for use in the US, Australia, New Zealand, Europe and the UK and is distributed globally by BioHorizons Implant Systems, one of the largest global dental implant companies.
Orthocell said it is working with BioHorizons to accelerate further development of the regulatory strategy for Striate+ to expand access into other regions as soon as possible.