Orthocell (ASX: OCC) has secured significant market access for its Remplir peripheral nerve repair device, announcing approval to be sold across 51 US Department of Defence (DoD) hospitals and 170 Veterans Affairs (VA) medical centres.
This expansion builds on recent positive developments and provides a substantial new channel for commercial growth by significantly expanding the addressable market for Remplir in the US.
The company plans to leverage its existing distributor network in the country, which currently covers 17 states, to target military and VA surgeons.
Orthocell cited 23 surgical procedures of Remplir performed on injured soldiers in Ukraine, demonstrating the device's portability, ease of use, and suitability for major trauma, supporting its adoption in defence settings.
The company has been monitoring outcomes from these procedures to support future defence-sector engagements globally.
Building on Existing US Approvals
The new DoD and VA approval complements Orthocell's existing progress with Value Analysis Committee (VAC) approvals.
The company has already secured 32 VAC approvals, granting access to over 115 hospitals, with an additional 57 VAC applications pending as of 31 March 2026.
The US expansion follows recent appointments of exclusive distributors in the UK (LEDA Orthopaedics) and Canada.
Orthocell reported HY26 revenue of A$6.2 million (up 49% YoY) and holds approximately A$49.4 million in cash reserves, bolstering its capacity for global commercialisation.
Regulatory submissions for Remplir in Europe and the UK were filed in December 2025, with approvals anticipated in the third quarter of 2026.
Orthocell's US Defence Market Expansion
The approval to access 221 U.S. military and VA medical centres represents a significant step forward for Orthocell's Remplir device, greatly expanding its addressable market.
Combined with prior international distribution agreements and strong cash reserves, this move enhances the company's commercialisation momentum, though execution and adoption rates will be key.
Managing Director Paul Anderson called the deal a "significant milestone for Orthocell and a major step forward in our US commercial strategy."
"This approval enables us to engage directly with military and VA surgeons treating complex nerve injuries and to leverage our existing distributor network to drive adoption of Remplir across these key institutions," he added.
