Orthocell appoints first Canadian distributor for Remplir™

Key highlights: 

• Canada entry secured: Exclusive distributors appointed for Alberta and British Columbia; more provinces to follow for nationwide coverage. First sales targeted for the December quarter. 
• Go-to-market timing: Official Canadian launch in early October at the American Society for Surgery of the Hand (ASSH) Annual Meeting in Vancouver. 
• Commercial footing: Health Canada licence granted in April 2025; rollout will be overseen by Orthocell’s US-based marketing & medical education teams. 
• Market sizes & cash: Company sizes the Canadian nerve repair market at ~US$75m, with the US at ~US$1.6bn; ~A$27.5m cash and no debt support scaling. 
• Share snapshot: OCC A$1.47 (+18.07%), market cap ~A$362m, 1-yr return +246%, 52-week A$0.41–1.79. 

Orthocell (ASX: OCC) has named its first Canadian distributor for Remplir™, the company’s nerve repair and regeneration device, marking the start of a province-by-province rollout in a market it estimates at ~US$75 million. The initial focus is Alberta and British Columbia, where exclusive distributorships are now in place; Orthocell says it expects to appoint additional provinces to secure broad national coverage. First sales are targeted for the December quarter, with the in-country launch set for early October at the ASSH Annual Meeting in Vancouver. 

The Canadian expansion follows Health Canada approval (MDL) in April 2025, granted only months after submission—timing the company describes as ahead of initial expectations. Orthocell’s US-based marketing and medical education teams—already active for the US rollout—will oversee Canadian market entry, leveraging the reality that many hand and peripheral nerve surgeons operate across both jurisdictions. 

What the on-the-ground strategy looks like

Orthocell says the newly appointed distributor specialises in nerve, spine and orthopaedic implants, with five dedicated sales reps supported by sub-agents across urban and rural areas. The practical next step is initiating hospital approval processes (credentialing, formularies, procurement), allowing surgeons to book early cases and build reference centres. The company notes that Remplir’s Canadian promotion will mirror the US playbook, using the same medical education and data that underpinned initial US uptake. 

The near-term commercial objective is straightforward: convert education and trialing into repeatable surgical use, first in Alberta/BC, then across additional provinces as distributors are appointed and hospitals approve the device. In parallel, the US rollout continues, with Orthocell reporting 14 distributors appointed, initial cases completed and accounts being established. 

CEO commentary

Orthocell CEO and Managing Director Paul Anderson said:

“Securing our first Canadian distributor provides immediate access to key provinces and will build Remplir’s profile as a next-generation nerve repair solution. 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.

Our existing US Marketing and Medical Education teams are ideally placed to oversee our Canadian market entry given the significant crossover between jurisdictions with many surgeons operating in both countries.

We expect to see early surgical cases commence in Canada late this year.” 

Where Remplir fits in Orthocell’s portfolio

Orthocell describes Remplir™ as its flagship peripheral nerve reconstruction device, now cleared for use in the US and approved in Australia, New Zealand, Singapore, Thailand and Canada. The company’s broader portfolio includes Striate+™ (dental GBR membrane) which is cleared across major markets and distributed globally by BioHorizons, and SmrtGraft™ (tendon repair), currently available in Australia under Special Access Scheme or clinical trials. Orthocell is also advancing autologous cell therapies for tendon and cartilage, with US tech transfer and FDA engagement under way to define the path to market and support partnering discussions. 

This multi-asset approach matters for investors because it diversifies use-cases and payors (dental, orthopaedics, hand surgery) while sharing commercial infrastructure (education, KOL networks, distributor relationships).

The commercial math

• Market sizes: Orthocell pegs Canada at ~US$75m and the US at ~US$1.6bn for nerve repair—useful yardsticks for potential revenue, not guarantees. Early case numbers, average selling price, and account activation will determine how quickly revenues build. 
• Route to scale: Start with reference surgeons and centres, establish proof points (operative ease, outcomes, theatre economics), then expand province by province with distributor support. That’s a repeatable template the company is already applying in the US. 
• Cash runway: With ~A$27.5m in cash and no debt, Orthocell argues it is funded to drive adoption into FY26—timed to when hospital approvals and surgeon onboarding should translate to meaningful revenue uplift. 
  
   

Risks and what to watch

Hospital approvals and procedure coding/reimbursement are the typical gating items in new-market medtech launches. Even with a licence in hand, timelines vary by hospital and province. As distribution expands beyond Alberta and BC, watch for named provinces, number of active accounts and case volumes to gauge traction. In the US, the pace of account activation and repeat usage will be equally telling. Orthocell’s own forward-looking statements also flag execution, regulatory and market risks, as is standard for early-commercial medtech. 

Share price context (session data)

At A$1.47, OCC shares surged by 18.07% on ~2.56m shares around 1:11pm AEST, valuing the company at ~A$362m. The stock is up ~246% over the past year and has ranged between A$0.41 and A$1.79 in the last 52 weeks. 

Bottom line

Orthocell is executing the playbook for a specialist surgical device: build clinical advocacy, win approvals, appoint capable distributors, and sequence the rollout so each new geography compounds sales effort already made. Canada now joins the US, creating two large English-speaking markets with overlapping surgeon bases and a single commercial team to educate, support and scale. With cash in the bank, no debt, and first Canadian cases targeted for late 2025, the path to a step-change in FY26 revenue is clearer—though, as ever in medtech, adoption will be as fast as hospitals and surgeons move. For investors, the next proof-points are additional provincial appointments, hospital approvals, and a rising cadence of surgical cases on both sides of the border.