As part of its global expansion, Orthocell Ltd has submitted an application to Health Canada for a Medical Device Licence (MDL) to commercialise its nerve repair product Remplir™ in the Canadian market, which is valued at approximately US$75 million per annum.
Health Canada, the regulatory body overseeing medical devices, is reviewing the application, with clearance expected in the second half of 2025.
The application comes as Orthocell remains on track to gain US Food and Drug Administration (FDA) 510(k) regulatory clearance to commercially distribute Remplir into the US$1.6 billion US market.
The company expects US approval in March/April 2025.
Orthocell’s global outlook is set to substantially enhance its revenue potential with the company aiming for a 20% share of the US$3.2 billion market across its targeted regions including Thailand, targeted for the March quarter of 2025; UK and EU targeted for the September quarter of 2025 and Brazil targeted for the December quarter of 2025.
Readying for US launch
Orthocell is advancing preparations for its US launch, with market clearance from the FDA expected by late March or early April 2025 under the standard 90-day review period for 510(k) submissions.
The US market is estimated at US$1.6 billion annually and represents the largest and most valuable opportunity for the company.
Orthocell has brought on board two experienced US-based executives to spearhead its market entry, alongside key opinion leader (KOL) engagement, distributor appointments and medical education initiatives.
Beyond North America
Beyond North America, the company is accelerating expansion plans into several key markets throughout 2025, including Thailand, the United Kingdom, the European Union and Brazil, with additional ASEAN and Latin American markets under evaluation.
Regulatory submissions are scheduled for Thailand by March 2025, the UK and EU by September and Brazil by December.
With approximately A$33 million in cash reserves, Orthocell is well-funded to execute its commercial strategy and drive revenue growth. The company is targeting a 20% market share within an estimated US$3.2 billion global addressable market, with further expansion potentially increasing these projections.
Established markets
Remplir, a collagen-based wrap designed to enhance nerve repair surgery outcomes, is already approved for sale in Australia, New Zealand and Singapore.
Since its Australian launch in November 2022, the product has gained strong market traction, contributing to three consecutive quarters of record revenue.
Currently, about 180 orthopaedic and plastic surgeons across these regions utilise Remplir in peripheral nerve repair procedures.