John Van Der Wielen-chaired Orthocell has received another timely boost, as it aims to further a push into Latin America.
John Van Der Wielen-chaired Orthocell has received another timely boost, as it aims to further a push into Latin America.
The Murdoch-based regenerative medicine company told the market on Wednesday it had received regulatory approval from the Brazil-based Agencia Nacional de Vigilancia Sanitaria, to sell its Striate+ dental guided bone regeneration product.
Orthocell said it had teamed up with BioHorizons, Striate+’s global distribution and marketing partner, and expects to begin commercial distribution in Brazil during the final quarter of the 2025 calendar year – where the dental membrane market is valued at an estimated $US65 billion.
This follows news last month that Singapore’s Health Science Authority had given the green light for Striate+ – a product which offers bone defects protection from the potential in-growth of gingival tissue – to be sold in the country.
During the update, Orthocell had said it was hopeful of receiving Brazilian regulatory approval by September.
“We are delighted to receive regulatory approval for Striate+ in Brazil,” Orthocell chief executive and managing director Paul Anderson said.
“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.”
Orthocell said on the back of the Brazilian approval, BioHorizons would look to expand Striate+ into other Latin American countries, including Colombia.
Last week, the US-based Food and Drug Administration also provided Orthocell regulatory approval for its nerve repair product, Remplir.
As of 10.45am AWST, Orthocell shares were up 2 per cent to $1.31.
