Orthocell (ASX:OCC) submitted a medical device license application in Canada for its nerve repair product Remplir, according to a Monday Australian bourse filing.
The company expects the product to be approved in Canada in the second half of 2025.
It is planning to submit regulatory applications in Thailand in the March quarter, in the UK and the European Union in the September quarter, and in Brazil in the December quarter.
It is also evaluating Southeast Asian and Latin American markets.
It added that it expects US Food and Drug Administration approval in March or early April. Preparations for a market launch in the US are underway.
The company's shares fell past 3% in recent Monday trade.
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