Orthocell Limited (ASX:OCC) Gains Thai FDA Approval for Remplir™
Regulatory Approval and Market Expansion
Orthocell Limited has been granted a licence by the Thai Food and Drug Administration to commence sales of Remplir™ in the US$84 million nerve repair market, adding Thailand to its approved regions including the US, Australia, New Zealand, and Singapore. This approval enables Orthocell to tap into a significant market opportunity estimated to be in excess of US$3.5 billion globally.
Revenue Growth and Future Outlook
The company has achieved strong revenue growth over the past 12 months and anticipates a step change in revenue with the new approvals in the US and Thailand. Orthocell plans to partner with an exclusive distributor in Thailand, expecting first sales in the second half of 2025. Existing cash reserves of $31.7 million as of 31 March 2025 ensure the company is fully funded for global expansion.
Executive Comments
Orthocell CEO and MD, Paul Anderson, said: “We are delighted to receive regulatory approval for Remplir in Thailand far sooner than we expected which shows the quality of the product and our clinical data. Thailand is an influential medical market in the Asian region and the second largest market for Remplir, after the US, that we have received approval for. This approval significantly enhances our Asia Pacific presence for Remplir with approvals already having been received in Australia, Singapore and New Zealand. This is in addition to the US FDA clearance received earlier this month.”
“We continue to be well capitalised to roll out our expansion plans for both Striate+ and Remplir in the growing number of jurisdictions that we have received approvals throughout the world. The growing global footprint we are experiencing is adding a step change in value to our product portfolio with each additional regulatory approval achieved.”
“All products will be manufactured at our Perth facility to deliver into these markets.”
Motley Fool contributor Lauren Surplice has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has recommended Orthocell. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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