Proactive - Interviews for investors

Just the Facts: Orthocell submits Thai market application for Remplir nerve repair product

Episode Summary

Orthocell Ltd has submitted an application to the Thailand Food and Drug Administration seeking approval for the sale of its nerve repair product, Remplir™, in the US$84 million Thai market. This move is part of the company’s broader global expansion strategy, following strong sales growth in Australia, New Zealand, and Singapore. Thailand has a well-developed healthcare system and a strong medical tourism sector, making it a key market in the Asia-Pacific region. Orthocell is also evaluating opportunities in Hong Kong, Taiwan, Vietnam, Indonesia, and the Philippines. The company is awaiting regulatory clearance in the US and Canada, with US FDA 510(k) approval expected in March or April 2025. This would allow Orthocell to commercially distribute Remplir in the US, a market valued at US$1.6 billion. Approval for the US$75 million Canadian market is anticipated in the second half of the year. Orthocell aims to capture 20% of the US$3.2 billion available across its selected markets. More than 180 orthopaedic and plastic surgeons currently use Remplir in peripheral nerve repair surgeries in Australia, New Zealand, and Singapore. #Orthocell, #MedicalTechnology, #NerveRepair, #HealthcareInnovation, #RegulatoryApproval, #Remplir, #Surgery, #CollagenWrap, #MedicalDevices, #Thailand, #AsiaPacific, #MarketExpansion, #USFDA, #Canada, #Orthopaedics, #PlasticSurgery, #Healthcare, #Investment, #Growth, #Revenue