Orthocell Secures Canadian Distributor Ahead of December Quarter Sales

Orthocell’s Canadian Market Entry

Orthocell Limited (ASX – OCC) is advancing its global commercialisation strategy with the appointment of its first Canadian distributor for Remplir™, a pioneering nerve repair and regeneration device. This distributor will cover the key provinces of Alberta and British Columbia, with plans to expand distribution across other provinces to capture the full potential of the Canadian nerve repair market, estimated at US$75 million.

The official Canadian launch is scheduled for early October at the Annual Meeting of the American Society for Surgery of the Hand (ASSH) in Vancouver. This event will provide a high-profile platform to introduce Remplir to Canadian surgeons and healthcare providers, supported by Orthocell’s commercial team and US-based marketing and medical education staff.

Regulatory and Market Readiness

Orthocell secured its Medical Device Licence from Health Canada in April 2025, ahead of initial expectations. This regulatory milestone clears the way for the company to begin sales in Canada, with first surgical cases anticipated in the December quarter. The Canadian distributor brings deep expertise in nerve, spine, and orthopaedic implant distribution, backed by a network of five dedicated sales representatives and sub-agents to ensure broad hospital and surgeon engagement.

Orthocell’s CEO and Managing Director, Paul Anderson, highlighted the strategic importance of this appointment, noting that it provides immediate access to key provinces and will accelerate Remplir’s international growth. The company’s existing US teams are well-positioned to oversee the Canadian rollout, leveraging the overlap in clinical practice between the two countries.

Growth Prospects and Strategic Positioning

With approximately A$27.5 million in cash and no debt, Orthocell is financially well-positioned to support rapid adoption of Remplir in Canada and beyond. The Canadian launch complements ongoing momentum in the US market, where Orthocell has appointed 14 distributors and is steadily building surgical case volumes.

Looking ahead, Orthocell plans to secure additional distributors across Canada to ensure comprehensive market coverage. The company’s robust medical education programs and scientific data underpinning Remplir’s efficacy are expected to facilitate surgeon adoption and hospital approvals.

This Canadian expansion represents a critical chapter in Orthocell’s broader strategy to establish Remplir as a next-generation solution in the global nerve repair market, which remains underserved by existing therapies.