Orthocell (ASX: OCC) has secured a major regulatory win, with Brazil’s health authority ANVISA granting approval for its dental regeneration product Striate+™. This marks the company’s first regulatory tick in Latin America — and it’s a big one.
Brazil represents a US$65 million market opportunity on its own, and it’s a strategic launchpad into the broader Latin American region. Orthocell expects to kick off commercial distribution of Striate+ in Brazil in the fourth quarter of calendar 2025, working alongside its exclusive global distribution partner, BioHorizons.
Building global momentum
This latest approval adds to an already impressive list of cleared markets for Striate+, including the US, UK, Europe, Australia, New Zealand, Canada and Singapore. It also comes hot on the heels of last week’s pivotal FDA clearance for Orthocell’s nerve repair device, Remplir, further underscoring the company’s strong execution on its global growth strategy.
Striate+ is a collagen-based dental membrane designed for guided bone and tissue regeneration, especially in dental implant procedures. It’s winning favour among dental surgeons for its ease of use, conformance to complex surfaces, and reliable bone growth — not to mention a stellar 98.6% success rate from post-market clinical studies.
Eyes on Latin America
Beyond Brazil, Orthocell is preparing regulatory filings in other key Latin American markets — Colombia is expected to be next, with an application set to be submitted within three months. Thanks to BioHorizons’ established network in the region, Orthocell is well positioned to scale quickly once approvals come through.
Financial firepower in place
With approximately AU$32 million in cash and plenty of manufacturing capacity at its Perth facility, Orthocell is well-funded to meet growing demand for both Striate+ and Remplir. The company is targeting a 20% share of the estimated US$735 million global market for Striate+ — and growth into Latin America could lift those projections even further.
CEO Paul Anderson summed it up well: “This approval provides additional validation of Orthocell’s high-quality products and enhances our ability to drive revenue growth as our distribution partner expands into global markets.”
