Orthocell Ltd (ASX:OCC, OTC:ORHHF) has secured a significant expansion of its US market opportunity, gaining approval for its Remplir nerve repair device to be used across the US Department of Defense (DoD) and Veterans Affairs (VA) hospital networks.
The approval opens the door to 221 facilities — 51 military hospitals and 170 VA medical centres — adding to Orthocell’s US commercial footprint as it builds on recent regulatory clearance and early sales traction.
Access to key US healthcare systems
The DoD and VA networks represent a substantial segment of the US healthcare system, particularly in the treatment of traumatic injuries and complex nerve damage.
Orthocell said the approval enables it to directly target surgeons operating within these institutions, leveraging its existing distributor footprint, which already spans 17 states. A meaningful portion of the newly accessible hospitals falls within this established network, supporting a more efficient path to market penetration.
The company has also been steadily building access through hospital-level approvals, with 32 Value Analysis Committee (VAC) approvals already secured — covering more than 115 hospitals — and a further 57 applications currently in progress.
Military validation strengthens clinical case
The expansion into US defence and veterans healthcare systems comes alongside growing real-world validation for Remplir in high-intensity clinical settings.
Orthocell highlighted the device’s recent use in 23 surgical procedures on injured soldiers in Ukraine, spanning both primary and secondary nerve repair applications.
According to the company, these cases demonstrate key attributes of the product in conflict environments, including portability, ease of use and suitability for treating major traumatic injuries — factors that align closely with the needs of military healthcare systems.
This real-world evidence is expected to support adoption among military and VA surgeons, who frequently deal with complex peripheral nerve injuries arising from trauma.
Building momentum in the US
The latest approval adds to a series of developments as Orthocell accelerates its US strategy for Remplir, following its April 2025 regulatory clearance and initial commercial rollout.
The company has been expanding its distributor network and building clinical awareness, with increasing signs of revenue momentum emerging from early-stage sales activity in the market.
Recent updates have also pointed to growing engagement with healthcare providers and distribution partners, alongside broader efforts to scale manufacturing and support higher volumes as adoption increases.
Orthocell managing director Paul Anderson described the DoD and VA access as a “significant milestone” that strengthens the company’s commercial position in the US.
“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 said.
Expanding commercial pathways
With access now extending across civilian hospitals, military facilities and veterans’ healthcare systems, Orthocell is broadening its addressable market in what remains the world’s largest healthcare market.
The company expects to continue pursuing additional hospital approvals and expanding utilisation across key segments, including trauma, orthopaedic and reconstructive surgery.
The timing also aligns with upcoming investor engagement, with Orthocell set to provide further updates on its commercial progress and strategy at a scheduled webinar later this month.
As the rollout continues, the combination of regulatory clearance, expanding distribution coverage and increasing clinical validation is beginning to translate into tangible commercial traction — with the latest defence network approval adding another layer to that growth pathway.