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Highlights
- Orthocell (OCC) approved for Striate+ in Brazil.
- Strategic entry into a $65 million market.
- Planned expansion across Latin America.
Orthocell (ASX:OCC), an innovator in regenerative medicine, has successfully obtained regulatory approval from Brazil's Health Regulatory Agency, ANVISA, for its dental guided bone regeneration membrane, Striate+. This approval marks a significant step in the company's strategy to access the burgeoning Brazilian market, valued at approximately US$65 million.
The clearance of Striate+ in Brazil not only validates the high standards of Orthocell’s product and manufacturing processes but also sets the stage for the company to strengthen its footprint in the global dental membrane market, which is estimated to be worth US$735 million. Paul Anderson, CEO and Managing Director of Orthocell, expressed his enthusiasm about the approval, noting that it enhances the company's potential for revenue growth as they continue to expand globally.
Brazil serves as a key gateway for Orthocell’s expansion into the Latin American market. ANVISA's approval is often recognized by other regulatory agencies in the region, which could facilitate smoother entries into neighboring markets. Orthocell plans to commence commercial distribution of Striate+ in the fourth quarter of 2025 through its exclusive global distribution partner, BioHorizons.
This strategic move is supported by the product's impressive track record in other markets, including the United States, Europe, the United Kingdom, Australia, New Zealand, Canada, and Singapore. Striate+ has demonstrated a high success rate in clinical outcomes, evidenced by a 98.6% success rate in a post-market clinical study, and is backed by robust sales growth.
Further bolstering its global strategy, Orthocell recently received clearance from the United States Food and Drug Administration (FDA) for its nerve repair device, Remplir™. This achievement underlines the company's ongoing commitment to expanding its suite of innovative medical products.
With a strong financial position, including approximately A$32 million in cash reserves, Orthocell is well-equipped to pursue its aggressive expansion plans. The company's manufacturing facility in Perth stands ready to support the production demands for both Striate+ and Remplir, ensuring a steady supply to its expanding market base. This strategic approach not only aims to drive revenue growth but also to establish Orthocell as a leader in regenerative medical solutions globally.
