• Orthocell granted license by Thai FDA to sell Remplir in US$84M Thai nerve repair market
• Remplir now approved in US, Australia, NZ, Singapore, and Thailand, a $1.7B market opportunity
• Expects step change in revenue once sales traction achieved in new markets

Orthocell Limited (ASX:OCC) has received a license from the Food and Drug Administration (FDA) of Thailand for its flagship nerve repair product Remplir. The license clears the way for commercial distribution of Remplir in Thailand, which has a high-quality, well-developed healthcare system and a strong medical tourism sector. The Thai nerve repair market is estimated to be worth US$84 million. Orthocell leveraged an expedited registration pathway available for medical devices already approved by the Health Sciences Authority (HSA) in Singapore, which Orthocell received in October 2024. This significantly reduced the review time and registration cost, demonstrating the company's ability to rapidly expand into the wider Asian region. Orthocell plans to partner with an exclusive local distributor in Thailand and expects first sales from this region in the second half of 2025. Remplir is now approved in the US, Australia, New Zealand, Singapore, and Thailand, which equates to a significant market opportunity of $1.7 billion. Orthocell continues to be well-capitalized to roll out its expansion plans for both Striate+ and Remplir in the growing number of jurisdictions where it has received approvals. The company is also evaluating other potential markets in the Asia-Pacific region, including Taiwan, Vietnam, Indonesia, Philippines, and Hong Kong.

Orthocell expects a step change in revenue once sales traction is achieved in the new markets of the US and Thailand, where it has recently received regulatory approvals for its Remplir nerve repair product.