Company News 09 Apr 2025 Orthocell Receives Regulatory Approval for Striate+ in Brazil Orthocell has announced that Brazilian Health Regulatory Agency, ANVISA, has granted regulatory approval for the Company’s market-leading dental membrane, Striate+â„¢,… Orthocell
Company News 04 Apr 2025 US FDA grants 510(k) clearance for Orthocell’s flagship Remplirâ„¢ nerve repair product Orthocell has announced that the US Food and Drug Administration has granted regulatory clearance under the 510(k) pathway for the… Orthocell
Company News 26 Mar 2025 First Sales of Striate+â„¢ in DACH Region Orthocell has today announced that our exclusive global distribution partner BioHorizons has officially completed first sales of Orthocell’s dental product,… Orthocell
Company News 18 Mar 2025 Orthocell Receives Regulatory Approval for Striate+ in Singapore Orthocell has received regulatory approval from Singapore's Health Sciences Authority (HSA) for its market leading dental guided bone regeneration product,… Orthocell
Company News 21 Feb 2025 Thailand Regulatory Application for Remplirâ„¢ Orthocell has submitted a regulatory application to the FDA of Thailand to commence sales of its groundbreaking nerve repair device… Orthocell
Company News 03 Feb 2025 Orthocell Submits Canada Regulatory Application to Commence Sales of Remplirâ„¢ into US$75million Canadian market Orthocell has announced it has submitted an application to Health Canada for a Medical Device Licence (MDL) to sell its… Orthocell
Company News 22 Jan 2025 Orthocell Accelerates Global Expansion: Five New Country Regulatory Submissions Planned in 2025 On the back of outstanding early sales traction for Remplirâ„¢ in Australia, New Zealand and Singapore, Orthocell has announced that… Orthocell
Company News 20 Jan 2025 Orthocell receives $3.18m R&D tax incentive refund Orthocell has announced that it has received a $3.18 million R&D Tax Incentive Refund for the 2023/2024 financial year. Orthocell
Company News 08 Jan 2025 OCC Quarterly Report | Quarter ended 31 December 2024 Orthocell has recorded a third consecutive quarter of record revenue, reporting $2.21 million in the December ‘24 Quarter. Orthocell
Company News 19 Dec 2024 Orthocell Submits U.S. FDA Regulatory Application Orthocell has announced the submission of its U.S. FDA 510(k) regulatory application for clearance to commercially distribute Remplirâ„¢ into the… Orthocell
