Orthocell prepares Remplir™ for US market with new executives

Proactive - Interviews for investors

Proactive’s Tylah Tully breaks down ‘Just the Facts’ of the latest news from Orthocell Ltd (ASX:OCC, OTC:ORHHF). The company is preparing to launch its nerve repair product, Remplir™, in the United States, with FDA approval anticipated in early 2025. To facilitate this, the company has appointed John Walker and Phillip Edmondson, both experienced in the US nerve repair sector, to lead sales and marketing initiatives aimed at establishing Remplir within the US$1.6 billion nerve repair market. Successful in Australia, with more than 150 surgeons adopting the product, Remplir is expected to gain traction quickly in the US, which Orthocell projects will become its largest market. Over the past two years, Orthocell has partnered with US surgeons, Centres of Excellence and research institutions to facilitate FDA approval and market readiness. CEO Paul Anderson highlighted the thorough preparation efforts, which are expected to accelerate revenue and adoption once FDA clearance is secured. The company is well-funded, with A$35 million to support this launch and further expansion plans targeting Singapore, Southeast Asia, Canada and Europe. Top-line results from Orthocell’s US market authorisation study are due in Q4 2024, supporting its upcoming 510(K) application and targeted market entry. #ProactiveInvestors #Orthocell #ASX #JusttheFacts #Remplir, #NerveRepair, #USMarketLaunch, #FDAApproval, #MedicalDevices, #HealthcareInnovation, #PaulAnderson, #JohnWalker, #PhillipEdmondson, #MedicalTechnology, #SurgicalProducts, #MarketExpansion, #OrthocellGrowth, #MedicalAffairs, #AxogenExperience, #SurgeonAdoption, #HealthcareMarket, #510KApplication, #OrthocellFunding