Orthocell gains Brazil regulatory approval for dental regeneration product Striate+

• Orthocell receives regulatory approval in Brazil for dental guided bone regeneration product Striate+

• Company working with global distribution partner BioHorizons on initial market launch in Brazil in Q4

• Orthocell has applied for regulatory approval for nerve repair device Remplir in Hong Kong

Special Report: Regenerative medicine company Orthocell (ASX:OCC) has received authorisation from Brazilian health authorities to sell its market-leading dental membrane Striate+ for use in guided bone and tissue regeneration applications.

After receiving pivotal US Food and Drug Administration (FDA) approval for its nerve repair device Remplir last week, Brazilian health regulatory agency Agencia Nacional de Vigilancia Sanitaria (ANVISA) has granted regulatory approval for Striate+.

The product is Orthocell’s proprietary resorbable collagen membrane for use in dental bone and tissue regeneration applications, including dental implant procedures.

Striate+ is designed to protect the bone defect from ingrowth of gingival (gum) tissue, to provide a favourable environment for new bone to form and heal strongly.

Orthocell said it was working with its global marketing and distribution partner for Striate+ BioHorizons, on an initial launch into the US$65 million Brazilian dental membrane market and expected to start commercial distribution in Q4 2025.

Strong uptake in existing markets

Approval in Brazil adds to existing Striate+ approvals in the US, Europe, UK, Australia, New Zealand, Canada and Singapore.

Remplir is approved for sale in Australia, New Zealand, Singapore and now the US, with pending approvals in Canada and Thailand in the next six months.

Orthocell has also applied to the Department of Health’s Medical Device Division (MDD) in Hong Kong to sell Remplir with approval to begin sales there expected in Q4 2025.

The company said Hong Kong was an attractive market in the region as a recognised leader in medical services across Asia.

Orthocell said the Brazilian approval of Striate+ would further support the robust sales growth achieved in existing markets, which has been fuelled by overwhelmingly positive feedback from dental surgeons.

A 98.6% success rate from the Striate+ dental implant post-market clinical study has further supported growth in key markets.

The company said the product's unique features, such as its ease of use, ability to conform to treatment surfaces and promotion of more efficient bone growth, had driven high adoption and contributed significantly to its success.

Orthocell said Striate+’s approval in Brazil and its high-quality performance was driving BioHorizons’ pursuit of other large, attractive Latin American markets where they have established accounts and/or distribution networks.

A regulatory application for Striate+ in Colombia is anticipated within the next three months, with further regulatory applications under review.

The combined global market opportunity for Striate+ is estimated to be ~US$735m with Orthocell targeting a 20% market share.

Effective expansion into other markets would see an increase in these projections, demonstrating significant near-term growth potential for the company.

Orthocell has a strong balance sheet with ~$32m cash and is well funded to continue to broaden its commercial footprint and grow revenues in existing and new markets.

‘Ability to drive revenue growth’

Managing director and CEO Paul Anderson said the Brazilian approval of Striate+ provided 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,” he said.

“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.”

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as Orthocell gains Brazil regulatory approval for dental regeneration product Striate+