Proactive’s Tylah Tully breaks down ‘Just the Facts’ of the latest news from Orthocell Ltd. Orthocell has applied for regulatory approval from Health Canada to sell its nerve repair product, Remplir™, in the Canadian market, which is valued at approximately US$75 million. The company expects regulatory clearance in the second half of 2025. Remplir™ is a collagen wrap used in nerve repair surgeries and is already approved for use in Australia, New Zealand and Singapore, where it has experienced strong sales growth. Orthocell is actively expanding into new markets, with regulatory submissions planned for Thailand in the March quarter of 2025, the UK and EU in the September quarter and Brazil in the December quarter. In addition to these markets, Orthocell anticipates receiving US FDA 510(k) clearance for Remplir™ by late March or early April 2025, which would enable its entry into the US nerve repair market, valued at US$1.6 billion. Orthocell has approximately AU$33 million in cash reserves to support its expansion efforts. The company aims for a 20% market share within a combined global market estimated at US$3.2 billion. To facilitate its US market entry, Orthocell has appointed US-based executives and is developing key opinion leader engagements, distributor partnerships, and medical education initiatives. #Orthocell #Remplir #MedicalDevices #NerveRepair #HealthCanada #FDAApproval #SurgicalInnovation #RegenerativeMedicine #Healthcare #MedicalTechnology #MarketExpansion #GlobalHealth #Orthopaedics #PlasticSurgery #HealthcareInnovation #ASX #InvestorNews #Biotech #MedTech #Surgery