Orthocell appoints first Canadian distributor for Remplir™

Key highlights: 

• Canada entry: Exclusive distributors in Alberta and British Columbia; more provinces to be added for national coverage.
• Timing: On-the-ground debut slated for early October at the ASSH Annual Meeting in Vancouver; first sales targeted for the December quarter.
• Regulatory base: Health Canada licence granted in April 2025; rollout to be driven by Orthocell’s US-based marketing & medical education teams.
• Market size & cash: Company sizes Canadian nerve repair at ~US$75m and US at ~US$1.6bn; ~A$27.5m cash, no debt.
• Share snapshot: OCC A$1.47 (+18.07%), market cap ~A$362m; 1-yr return +246%; 52-week range A$0.41–1.79.

Orthocell (ASX: OCC) has appointed its first Canadian distributor for Remplir™, opening a province-by-province push into a market the company pegs at ~US$75 million. The opening moves cover Alberta and British Columbia under exclusive deals, with further provinces expected to follow for nationwide reach. The formal Canadian launch is timed for early October at the American Society for Surgery of the Hand (ASSH) meeting in Vancouver, with first sales aimed for the December quarter.

Why now?

The expansion follows Health Canada approval (MDL) in April 2025—earlier than the company initially expected. Orthocell will lean on its US commercial engine—marketing and medical education already built for the American rollout—to support Canada, noting many hand and peripheral nerve surgeons practice across both jurisdictions.

How the rollout works

The newly appointed distributor focuses on nerve, spine and orthopaedic implants, fielding five dedicated reps backed by sub-agents across metro and regional areas. Near-term priorities are the usual hospital gatekeepers—credentialing, formularies and procurement—so surgeons can book early cases and seed reference centres. Messaging and training in Canada will mirror the US playbook to speed uptake.

The near-term goal

Convert education and trial cases into repeat surgical use—first in Alberta/BC, then across additional provinces as appointments and hospital approvals land. In parallel, the US program continues with 14 distributors appointed, initial cases completed and accounts being established.

From the CEO

Paul Anderson, CEO and Managing Director:

“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 sits in the kit

Remplir™ is Orthocell’s flagship peripheral nerve reconstruction device, now cleared in the US and approved in Australia, New Zealand, Singapore, Thailand and Canada. The portfolio also includes Striate+™ (dental GBR membrane) distributed globally by BioHorizons, and SmrtGraft™ (tendon repair) available in Australia via Special Access Scheme or clinical trials. Autologous cell therapy programs in tendon and cartilage are advancing, with US tech transfer and FDA engagement under way to chart a commercial path and support partnerships.

Why it matters for investors: multiple products, multiple payors (dental, orthopaedics, hand surgery) and shared commercial infrastructure (education, KOLs, distributors) create operating leverage as geographies are added.

The commercial maths (at a glance)

Market yardsticks: ~US$75m (Canada) vs ~US$1.6bn (US) for nerve repair—useful for sizing, but revenue will hinge on case volumes, average selling price and account activation.

Route to scale: Anchor reference surgeons/centres, prove operative ease/outcomes/economics, then expand province by province with distributor support—a template already in motion in the US.

Runway: ~A$27.5m cash, no debt—management says this funds adoption initiatives into FY26, when approvals and onboarding should convert to a more meaningful revenue curve.

Market check

At A$1.47, OCC shares rallied 18.07% on ~2.56m shares around 1:11pm AEST, valuing the company at ~A$362m. The stock is up ~246% over 12 months, trading between A$0.41 and A$1.79 in the past year.

Orthocell is following the speciality-device playbook: win approvals, enlist capable distributors, cultivate clinical advocates and sequence geographies so each new market compounds prior effort. With Canada joining the US—two large, English-speaking markets with overlapping surgeon bases and a single commercial team—the ingredients for a step-up in FY26 are in place. Next proof points: more provinces, more hospital approvals, more cases—on both sides of the border.