Artrya’s Half-Year Loss Widens 44% Amid US Commercial Launch and FDA Clearance
Artrya Limited reported a 44% increase in its half-year loss to $10.7 million as it transitioned from development to commercial operations in the US, securing FDA clearance and signing three foundation customers. An $80 million capital raise underpins its ambitious US expansion and ongoing product development.
- 44.4% increase in half-year loss to $10.7 million
- FDA clearance obtained for Salix Coronary Plaque module
- Three US foundation customers contracted with long-term agreements
- Successful $80 million capital raise to fund US commercialisation
- Development of Salix Coronary Flow module progressing with planned 2026 FDA submission
Financial Results and Commercial Transition
Artrya Limited has reported a net loss of $10.743 million for the half-year ended 31 December 2025, marking a 44.4% increase compared to the previous corresponding period. This widening loss reflects the company’s strategic shift from a development-focused entity to a commercial enterprise, particularly in the United States market.
The company’s cash position strengthened significantly, with cash and term deposits rising to $76.67 million, bolstered by a successful $80 million capital raising. This capital injection is earmarked to accelerate the rollout of Artrya’s Salix software suite in the US, support regulatory efforts, and scale operational capabilities.
FDA Clearance and US Market Entry
A pivotal milestone was achieved in August 2025 when the US Food and Drug Administration granted 510(k) clearance for Artrya’s Salix Coronary Plaque module. This approval enhances the diagnostic capabilities of the Salix Coronary Anatomy platform by enabling near real-time detection of high-risk coronary plaque, a critical factor in assessing coronary artery disease risk.
Following FDA clearance, Artrya secured three foundation commercial customers in the US: Tanner Health, Northeast Georgia Health System (NGHS), and Cone Health. Each has entered into multi-year contracts with minimum values ranging from US$0.3 million to US$0.6 million, incorporating monthly subscription fees and fee-per-scan payments. Tanner Health notably became the first to generate fee-per-scan revenue after deploying the Plaque module in December 2025.
Product Development and Clinical Validation
Artrya continues to develop the Salix Coronary Flow module, aiming for FDA clearance in 2026. This module will complement the existing platform by providing AI-enabled assessments of coronary blood flow, completing the suite’s comprehensive diagnostic offering.
In parallel, the SAPPHIRE Study is progressing, with six major US hospital systems agreeing in principle to participate. This clinical study is designed to generate real-world evidence supporting the prognostic and clinical utility of Salix technology, which will be crucial for broader adoption and reimbursement discussions.
Governance and Leadership
The company appointed Dr Jeffrey LeBenger as a Non-Executive Director in February 2026, strengthening its board with additional clinical expertise. The leadership team, including CEO John Konstantopoulos appointed mid-2025, has been instrumental in driving the company’s US commercial strategy and customer success initiatives.
While the company’s reported revenue remains modest, reflecting early-stage commercialisation, subscription income and fee-per-scan revenues are expected to grow as integration across customer networks progresses. Non-cash expenses related to share options granted to foundation partners have impacted reported earnings but do not affect cash flow.
Bottom Line?
Artrya’s successful FDA clearance and capital raise set the stage for scaling US commercial operations, but execution risks remain as it seeks to convert clinical validation into sustained revenue growth.
Questions in the middle?
- How quickly will the Salix Coronary Flow module achieve FDA clearance and commercial adoption?
- What is the expected timeline for revenue growth beyond the three foundation US customers?
- How will non-cash option expenses impact reported earnings in future periods?
