Orthocell Ltd (ASX:OCC, OTC:ORHHF) has strengthened the international rollout of its flagship nerve repair device Remplir™, appointing its first Canadian distributor ahead of a formal launch at the Annual Meeting of the American Society for Surgery of the Hand (ASSH) in Vancouver this October.
The agreement secures exclusive distributorships for Alberta and British Columbia, with additional appointments planned to ensure nationwide coverage of the US$75 million Canadian nerve repair market. First Canadian sales are expected in the December quarter, with uptake forecast to build into 2026.
Launch at major surgical meeting
Orthocell’s commercial team will attend the ASSH meeting to support the launch, building on momentum already established in the United States. The new distributor specialises in nerve, spine and orthopaedic implants, with a strong reputation and established networks across hospitals and surgeons in both urban and regional areas.
CEO and managing director Paul Anderson said the appointment marked another important step in Remplir™’s international expansion.
“Securing our first Canadian distributor provides immediate access to key provinces and will build Remplir™’s profile as a next-generation nerve repair solution,” he said. “This is a major step in accelerating Remplir™’s international growth, and our team is looking forward to supporting Canadian clinicians in delivering improved patient outcomes.”
Regulatory pathway cleared
Orthocell obtained its Canadian Medical Device Licence for Remplir™ in April, just two months after lodging the submission. Approval processes for individual hospitals will begin immediately, backed by a dedicated team of five sales representatives and sub-agents.
The company’s existing US-based marketing and medical education teams will oversee the rollout in Canada, leveraging synergies between the two markets where many surgeons practise across both jurisdictions.
Building global momentum
Orthocell is progressing an ambitious international strategy for Remplir™, which recently gained US clearance and is already generating initial surgical sales through a network of 14 US distributors. The company is also advancing hospital onboarding and surgeon training programs across the US$1.6 billion American nerve repair market.
The Canadian entry follows encouraging results from the company’s Remplir™ clinical study, which demonstrated an 81% success rate in nerve repair procedures. These outcomes have bolstered confidence in the product’s adoption potential across new markets.
Read more: Orthocell’s Remplir study shows 81% success rate, bolstering US rollout and EU/UK plans
Orthocell remains well funded to drive this growth, with $27.5 million cash on hand and no debt, positioning it to deliver a step forward in revenue through FY26.
Broader portfolio
Beyond Remplir™, Orthocell’s portfolio includes the Striate+™ collagen membrane for dental applications, distributed globally by BioHorizons, and SmrtGraft™ for tendon repair, currently available in Australia under special access schemes. The company is also advancing tendon and cartilage cell therapy programs, with US technology transfer and FDA engagement underway.
With early Canadian sales on the horizon and US adoption continuing to build, Orthocell is firmly focused on scaling Remplir™’s presence across multiple geographies in the coming year.