Orthocell (ASX:OCC) has released its Quarterly Report for the quarter ended 30 June 2026, reporting record quarterly and full-year revenue, continued growth in the United States and further expansion across international markets.
Key highlights from this quarter include:
- Orthocell delivered record quarterly revenue of $3.8 million, representing a 20% increase on the March quarter and a 36% increase on the corresponding quarter last year. This quarter continues a three-year trajectory of consistent commercial growth.
- Full-year revenue reached a record $13.2 million, up 44% on FY2025, underpinned by continued adoption of Remplir™ and Striate+™ across Australia, the United States and new international markets.
- The Company maintains a strong financial position, with $44.1 million in available funds at 30 June 2026, supporting ongoing commercial expansion, manufacturing scale-up and regulatory initiatives.
Accelerating US commercialisation
Commercialisation of Remplir in the United States continues to track ahead of expectations, with growth across all key commercial metrics.
- U.S. revenue reached $0.33 million, increasing 10% on the March quarter
- Distribution network expanded, covering approximately 50% of the U.S. population
- VAC approvals increased 38% to 44, providing access to 151 hospitals, with another 64 applications in progress
- Approval secured across the U.S. Department of Defense and Veterans Affairs healthcare networks, providing access to 221 military and veterans’ medical centres
- 70 hospitals are now purchasing Remplir, an increase of 27% during the quarter
- Surgeon adoption increased 55% to 76 surgeons, with 119 units sold
These achievements provide a strong foundation for further revenue growth as hospital penetration, procedural adoption and repeat surgeon use continue to build.
Expanding global reach
Orthocell continues to advance its international commercialisation strategy.
- Ukraine: Additional Remplir devices are being deployed to support the treatment of complex battlefield and civilian trauma injuries through The Ukraine Crisis Appeal
- UK and EU: The regulatory pathway remains on schedule, with approval anticipated by the end of CY2026 and commercial launch preparations continuing with LEDA Orthopaedics
- Canada and Thailand: Distributors have been appointed, supporting further international revenue growth
- Colombia and Ecuador: Regulatory approval received for Striate+, with commercial distribution expected to commence in the second half of CY2026
The continued growth of both Remplir and Striate+ supports shared manufacturing scale-up and production efficiencies across Orthocell’s proprietary collagen product platform.
New prostate surgery opportunity gathers momentum
More than 250 nerve-sparing prostate cancer procedures have now been performed using Remplir by 39 surgeons across Australia’s five most populous states. The new application presents an opportunity to expand Remplir’s estimated U.S. total addressable market from US$1.6 billion to approximately US$2 billion.
Initial clinical performance data are being compiled, with publication of a surgeon-led academic paper and release of results anticipated in the second half of CY2026. No additional FDA approval is required to pursue this indication in the United States.
Orthocell CEO and Managing Director Paul Anderson said:
“Our record FY2026 results reflect the successful execution of Orthocell Limited’s global commercialisation strategy, with strong momentum across Australia and early scale-up in the United States. U.S. surgeon adoption and hospital engagement continue to build, and we expect this to be a key driver of revenue growth as our distribution footprint expands.
Looking ahead, we are entering a significant near-term catalyst phase. In the United States, we expect continued growth in procedural adoption and hospital penetration as our commercial platform matures. In parallel, we are progressing toward anticipated regulatory approval for Remplir in the UK and EU, which will unlock one of the largest peripheral nerve repair markets globally.
During the quarter, we also commenced the U.S. regulatory program for a tendon repair application based on our collagen technology platform. This represents a natural extension of our regenerative medicine portfolio, leveraging our existing manufacturing capability and commercial infrastructure to address a significant unmet clinical need. Importantly, it expands our addressable market through a complementary product offering for our existing surgeon customer base.”