Orthocell Ltd has continued its global expansion for its dental guided bone regeneration membrane, Striate+™, paving the way for entry into the A$100 million (US$65 million) Brazilian market.
The company has received regulatory approval from the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária or ANVISA), to enter the market – a key step in the OCC’s strategy to penetrate select jurisdictions across the A$1.1 billion (US$735 million) global market for dental membranes.
“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,” Orthocell CEO and MD, Paul Anderson, said.
“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.”
Strategic gateway
Brazil represents a strategically important gateway for Orthocell’s broader Latin American expansion, with ANVISA approvals often recognised by other regulatory agencies in the region. Commercial distribution of Striate+ is scheduled to begin in the fourth quarter of calendar year 2025, in collaboration with Orthocell’s exclusive global distribution partner, BioHorizons.
This approval adds to the growing list of jurisdictions where Striate+ is authorised for sale, including the United States, Europe, the United Kingdom, Australia, New Zealand, Canada and Singapore. The product is gaining strong traction, supported by robust sales growth and positive clinical outcomes, including a 98.6% success rate from a post-market clinical study.
Orthocell’s latest milestone follows the recent clearance by the United States Food and Drug Administration (FDA) for its nerve repair device, Remplir™, underlining the company’s progress in its global commercialisation strategy.
With approximately A$32 million in cash at bank, Orthocell is well-funded to expand its commercial footprint and drive revenue growth across new and existing markets.