Orthocell Ltd (ASX:OCC, OTC:ORHHF) has achieved first commercial sales of its flagship nerve repair device Remplir™ in Canada, marking the start of revenue generation in the country’s estimated US$75 million nerve repair market.
The milestone follows Health Canada approval and distributor appointments in 2H CY25, which give Orthocell majority national coverage and a pathway to surgeon and hospital adoption across Canada.
The first Canadian sales strengthen Orthocell’s North American commercial footprint at a time when the company is also building momentum in the US, where recent approvals provide access to about 336 hospitals, including 221 US military medical centres.
Canada is being served through Orthocell’s distributor-led model, a capital-light approach designed to use established hospital and surgeon relationships while allowing the company to focus internal resources on the larger US market, estimated at US$1.6 billion.
Launch activity in Canada included a key opinion leader-led roadshow from Vancouver to Toronto, featuring Australian orthopaedic surgeon Dr Stuart Kirkham, who presented his clinical experience using Remplir to plastic and orthopaedic peripheral nerve surgeons.
Managing director Paul Anderson said the first Canadian sales were “a key milestone” and an early step in the company’s Canadian commercialisation strategy.
“We are delighted to announce the first commercial sales of Remplir in Canada, a key milestone following Health Canada approval and the roll out of our distributor-led model, which provides coverage across the majority of this ~US$75 million market. This milestone represents an important early step in our Canadian commercialisation strategy and reinforces the strength of our execution. We expect increasing surgeon engagement to support continued adoption and further revenue growth.”
What’s next
Orthocell now plans to work with its distributor network to onboard surgeons, establish active accounts and support clinical education through its US-based marketing and medical education teams.
The company is also pursuing expansion into the US$750 million EU/UK market, with approval expected in 2H CY26.
Orthocell remains well funded, with more than A$48 million in cash as at March 31, 2026, and no debt, supporting continued commercial expansion.