Orthocell has secured a Medical Device Licence from Health Canada for Remplir™, opening access to the US$75 million Canadian nerve repair market.
This approval comes earlier than expected following our February submission, highlighting the exceptional quality of our product and clinical data.
Remplir™ is now approved across six key markets – the US, Canada, Thailand, Australia, New Zealand, and Singapore – representing a combined market opportunity of $1.8 billion.
Orthocell CEO and MD, Paul Anderson, said:
“We are building a significant portfolio of jurisdictions in which Remplir is approved for sale, and we’re delighted to add Canada to this growing list. Each new regulatory approval is an important addition to the overall value of our product portfolio and our Company.”