Orthocell has secured Health Canada approval for its nerve repair product Remplir™, adding the US$75 million Canadian market and expanding its total addressable market to US$1.8 billion. The company plans to appoint local distributors and expects first sales in H2 2025.
- Health Canada grants Medical Device Licence for Remplir™
- Canadian nerve repair market valued at US$75 million added to approved markets
- Total addressable market for Remplir™ now estimated at US$1.8 billion
- Orthocell to appoint local distributors in Canada with sales starting in second half of 2025
- Strong cash position of A$31.7 million supports global rollout and revenue growth
Orthocell Secures Canadian Regulatory Approval Ahead of Schedule
Regenerative medicine company Orthocell Limited (ASX:OCC) has received a Medical Device Licence (MDL) from Health Canada for its flagship nerve repair product, Remplir™. This approval, granted earlier than anticipated following a submission lodged in February 2025, allows Orthocell to enter the Canadian nerve repair market, valued at approximately US$75 million. The early approval underscores the robust clinical data and regulatory track record supporting Remplir™.
Expanding a Growing Global Footprint
With Canada added to its list of approved jurisdictions, Orthocell now addresses a total market estimated at US$1.8 billion across Australia, New Zealand, Singapore, the United States, Thailand, and Canada. This milestone complements recent regulatory clearances in the US and Thailand, positioning Remplir™ as a growing presence in the global nerve repair sector. The company is also preparing regulatory submissions for the EU and UK within the next 6 to 12 months, aiming to further broaden its commercial reach.
Strategic Distribution Partnerships to Drive Canadian Sales
Orthocell plans to leverage non-exclusive, specialist local distributors to penetrate the Canadian market efficiently. Negotiations are underway to appoint partners with established customer relationships and sales channels, enabling Orthocell to focus its internal resources primarily on the larger US market. The company anticipates initial sales in Canada during the second half of 2025, marking a significant step in its global commercial rollout.
Financial Strength Supports Growth Ambitions
Orthocell reported a strong cash position of A$31.7 million as of 31 March 2025, with no debt, providing a solid financial foundation for expanding its product portfolio and market presence. The company has experienced robust revenue growth over the past year and expects a step change in revenue as sales gain traction in newly approved markets. Orthocell’s CEO, Paul Anderson, highlighted the importance of each new regulatory approval in enhancing the company’s overall value and commercial potential.
Remplir™ and the Future of Nerve Repair
Remplir™ is a collagen wrap designed to assist surgeons in improving outcomes for peripheral nerve repair and regeneration. Its growing list of approved markets reflects increasing recognition of its clinical benefits. Orthocell’s broader regenerative medicine portfolio also includes products for dental and tendon repair, with ongoing development and regulatory efforts aimed at expanding their availability globally.
Bottom Line?
Orthocell’s Canadian approval marks a pivotal expansion, setting the stage for accelerated revenue growth and further global market penetration.
Questions in the middle?
- Which distribution partners will Orthocell appoint in Canada, and how quickly can they scale sales?
- How will Orthocell prioritize resources between the US market and emerging international markets like Canada and Thailand?
- What is the timeline and likelihood for regulatory approvals in the EU and UK, and how will these impact overall market potential?