Orthocell Ltd (ASX:OCC, OTC:ORHHF) has recorded its first 100 unit sales of peripheral nerve repair product Remplir™ in the US, marking an early adoption milestone as the company builds out its commercial footprint in a market it estimates at US$1.6 billion.
Overall, OCC is targeting a total addressable market across selected jurisdictions of more than US$3.5 billion
The company attributed the initial sales to a combination of surgeon education activity and a specialist distributor network spanning 25 US states, which it says covers about 40% of the US population.
Orthocell chief executive and managing director Paul Anderson said the sales outcome supports its rollout strategy and early hospital access progress.
“Reaching 100 US unit sales is an important validation of our commercial strategy and of Remplir’s potential to reshape nerve repair practice. The early case experience, growing surgeon engagement and increasing hospital VAC approvals give us confidence that we are building the right foundations for sustained growth in the US.
“The early surgical adoption is ahead of our expectations and closely following the trends we saw with the early take-up of Remplir in Australia. Given the materially larger market size in the US, we see significant upside if we continue on this trajectory.”
Surgeon education and supply chain readiness as rollout continues
Orthocell's early US cases have followed the submission of 61 applications to hospital Value Analysis Committees (VACs), with 17 approvals secured “ahead of schedule”. The VAC process is typically required to enable purchasing and ongoing use across hospital networks.
On the clinical engagement side, Orthocell said it has engaged more than 250 surgeons through medical education programs and has 14 Medical Advisory Board members under contract.
The company has shipped 4,000 units of Remplir from Australia to the US, warehoused through a US-based fulfilment partner to support availability as demand and case volumes increase.
Expanding into other markets
Orthocell also flagged plans to use the growing US surgical experience to support expansion into other markets, including Canada, where first surgeries are targeted to start in early 2026 via specialist distributors.
The company has around A$50 million cash and no debt as it continues to invest in clinical evidence and education initiatives.