Artrya Limited marked its first full year of US commercial operations with a $25.18 million loss, driven by regulatory clearances, customer contracts, and an $80 million capital raise.
- FY26 loss after tax increased 53.5% to $25.18m
- First US commercial revenues from Salix® platform
- FDA clearance for Coronary Plaque module secured
- Three US health systems signed long-term contracts
- SAPPHIRE Study launched with six major US health systems
Transition to Revenue-Generating US Commercial Stage
Artrya Limited (ASX:AYA) recorded a loss after tax of $25.18 million for the year ended 30 June 2026, a 53.5% increase from the prior year’s $16.41 million. This widening loss reflects the company’s transition from development to commercial operations in the United States, its primary target market. While revenues remained modest at $28,000, subscription-based SaaS revenue rose to $177,000 before non-cash adjustments related to partner agreements.
The 2026 financial year was pivotal, marking Artrya’s first full year of commercial activity. The company successfully deployed its AI-powered Salix® platform at Tanner Health, its inaugural US customer, embedding the technology into routine clinical workflows. Two additional US health systems, Northeast Georgia Health System and Cone Health, transitioned from early validation partners to long-term commercial customers on multi-year contracts, collectively validating the platform’s clinical and operational value.
Regulatory Milestones and Product Expansion
Artrya secured FDA 510(k) clearance for its Salix® Coronary Plaque module in August 2025, expanding the platform’s clinical utility to automated quantification of coronary plaque, a key predictor of heart attacks. This clearance unlocked a fee-per-scan reimbursement pathway under an established US Category I CPT code, generating the company’s first scan-based revenues.
Development progressed on the Salix® Coronary Flow module, designed to provide non-invasive assessment of coronary blood flow, avoiding costly and invasive procedures. Following extensive calibration and validation, Artrya prepared its 510(k) submission, targeting FDA clearance in the second half of calendar 2026. This module will complete the integrated Salix® platform, combining anatomy, plaque, and flow assessment from a single coronary CT angiogram (CCTA) scan.
SAPPHIRE Study Launches to Build Clinical Evidence
Central to Artrya’s commercial strategy is the SAPPHIRE Study, a multi-centre, retrospective clinical evidence program involving six leading US cardiovascular health systems, including Mass General Brigham and Piedmont Healthcare. The study aims to validate Salix® Coronary Plaque Analysis and the proprietary Plaque Dispersion Score across diverse, real-world patient populations, supporting earlier and more accurate coronary artery disease assessment.
A dedicated sub-study, SAPPHIRE-WIN, focuses on improving diagnosis in women, a historically underserved group often presenting atypical symptoms. By embedding Salix® into routine workflows at these institutions, the study is designed to accelerate adoption and create influential reference sites for broader commercial uptake.
Financial Position Bolstered by $80 Million Capital Raise
To fund its US commercial expansion, regulatory activities, and clinical programs, Artrya completed an $80 million capital raising during the year, comprising a two-tranche placement and a strongly supported share purchase plan. The company ended the year with $44 million in cash and an additional $30 million in term deposits, significantly strengthening its balance sheet and operational runway.
Operating expenses increased to support product development, regulatory submissions, and the build-out of a dedicated US Customer Success organisation based in Atlanta. This team underpins customer integration, training, billing, and ongoing support, establishing a scalable blueprint for future deployments across the US healthcare system.
Leadership Enhancements and Governance
Artrya enhanced its leadership team with the appointment of Clayton Hatch as Chief Financial Officer and Dr Jeffrey Le Benger as a US-based Non-Executive Director. Le Benger brings extensive experience leading large-scale healthcare organisations, including Summit Health. Executive Chair Bernie Ridgeway and CEO John Konstantopoulos continue to steer the company through this critical growth phase.
The company also emphasized its commitment to ethical and sustainable growth, diversity, and robust governance practices, including compliance with ISO standards and HIPAA requirements for data privacy and security.
Risks and Outlook
Despite the commercial progress, Artrya remains in an early revenue stage with significant losses reflecting ongoing investment. Key risks include competitive pressures in the AI cardiac diagnostics market, the timing and success of FDA clearance for the Coronary Flow module, customer retention, pricing pressures, intellectual property protection, and cybersecurity threats.
Looking ahead, Artrya’s priorities for FY2027 include expanding scan volumes and customer adoption across its US foundation partners, adding new health systems, obtaining FDA clearance for the Coronary Flow module, and advancing the SAPPHIRE Study towards data publication. The company’s ability to convert clinical evidence into broader market adoption will be critical to achieving sustainable revenue growth.
Bottom Line?
Artrya’s FY26 results underscore the costly but essential transition from development to commercialisation in the US; the coming year’s FDA decisions and clinical data will be pivotal for its growth trajectory.
Questions in the middle?
- Will FDA clearance for the Salix® Coronary Flow module arrive on schedule and catalyse new revenue streams?
- How quickly can Artrya expand beyond its three US foundation customers to build a scalable recurring revenue base?
- What impact will competitive dynamics and reimbursement changes have on Artrya’s pricing and market penetration?