Orthocell has announced that Brazilian Health Regulatory Agency, ANVISA, has granted regulatory approval for the Company’s market-leading dental membrane, Striate+™, allowing the Company to commence sales in the large and important market of Brazil.
Orthocell is working with its exclusive global distribution partner BioHorizons on an initial market launch and expects to commence commercial distribution of Striate+ in Q4 CY 2025.
This marks the first market authorisation that the Company has achieved in Latin America. Brazil is an important market opportunity valued at US$65 million, and represents a strategic entry point for future expansion into other Latin American countries.
Orthocell CEO and MD, Paul Anderson, said:
“We are delighted to receive regulatory approval for Striate+ in Brazil. This approval provides additional validation of Orthocell’s high-quality products, manufacturing processes and quality systems. Moreover, it enhances our ability to drive revenue growth as our distribution partner expands into global markets. Importantly, we remain well capitalised to roll out our expansion plans for our collagen regenerative membranes Striate+ and Remplir in eight jurisdictions throughout the world. We have ample manufacturing capacity at our Perth facility to deliver both products into these markets.”