Proactive - Interviews for investors podcast

FDA approval sees Orthocell’s Remplir enter multi-billion dollar US nerve market

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Orthocell Ltd chairman John van der Wielen talked with Proactive about the company receiving FDA clearance for its nerve repair product, Remplir, paving the way for entry into the multi-billion US healthcare market. The approval marks a significant milestone in Orthocell’s international growth strategy and reflects the strength of its regulatory and clinical capabilities. Van der Wielen emphasised the significance of breaking into the US market in a challenging regulatory environment. “Not many people would have thought with the current US turmoil, a company like ours could achieve FDA clearance,” he said. Orthocell has established operations in the US with logistics and distribution already in place. The company is implementing a hybrid sales model using in-house personnel and regional distributors, aiming for rapid initial uptake with an eye on more exclusive arrangements in the future. Remplir’s three-year shelf life and no temperature control requirement make it ideal for streamlined deployment. He also highlighted that Orthocell has already performed over 2,000 procedures in Australia and anticipates the US market to be 20 to 30 times larger, creating a strong revenue opportunity. With $32 million in cash reserves, the company expects to become cash flow positive within two years. 👉 For more interviews and updates, head to Proactive’s YouTube channel. Don’t forget to like the video, subscribe, and turn on notifications. #Orthocell #FDAApproval #Remplir #NerveRepair #MedicalDevices #BiotechNews #USHealthcare #OrthocellRemplir #InvestorUpdate #ProactiveInvestors #SurgicalInnovation #ASX

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