Artrya Advances US Expansion with $80M Raise and FDA Clearance Momentum

Commercial Launch and Customer Wins

Artrya Limited (ASX:AYA) has marked a significant milestone by successfully launching its AI-driven Salix® platform commercially in the United States. The company secured three foundation customers; Tanner Health, Northeast Georgia Health System, and Cone Health; establishing a foothold in a lucrative $4.4 billion US cardiac CT market. Tanner Health is already live across five hospitals and generating revenue, with Northeast Georgia Health System having gone live clinically in July 2026 and Cone Health preparing for deployment shortly.

This commercial traction is notable given the platform’s ability to deliver real-time, point-of-care analysis of coronary CT angiograms (CCTA), addressing a critical bottleneck as CT-first diagnostic guidelines drive rapidly rising scan volumes that outpace hospital reporting capacity.

FDA Clearance and Clinical Validation

In August 2025, Artrya secured FDA clearance for its Salix® Coronary Plaque module, a key product that quantifies and characterises coronary plaque to aid in cardiovascular risk assessment. The company is targeting FDA clearance for the Salix® Coronary Flow module by the end of 2026, which promises to enhance clinical decision-making by assessing blood flow non-invasively.

Supporting these regulatory milestones is the SAPPHIRE Study, a multicentre clinical trial involving six major US health systems including Mass General Brigham, HCA Midwest, and Ascension. The study aims to validate Salix®’s novel Plaque Dispersion Score, particularly focusing on cardiovascular risk stratification in women, and is expected to accelerate clinical adoption and commercial conversions.

Financial Position and Investment in Growth

Artrya reported statutory revenue of A$28,000 for FY26, reflecting the early stage of commercialisation, alongside other income of A$5.6 million primarily from R&D rebates. The company recorded an operating loss before tax of A$25.2 million, driven by increased investment in US commercial infrastructure, regulatory submissions, and headcount growth.

Crucially, the company ended FY26 with a robust cash balance of A$74 million and no debt, underpinned by an $80 million capital raise completed during the year. This financial strength supports ongoing US expansion, including sales pipeline development and operational readiness to handle increasing scan volumes and revenue growth across foundation customers.

Platform Differentiation and Market Opportunity

Artrya’s Salix® platform integrates anatomy, plaque, and flow analysis into a single, cloud-based reporting system embedded directly into clinical workflows. This real-time, 8–10 minute turnaround at the point of care contrasts sharply with current fragmented workflows that can involve 4–8 week backlogs and off-site analysis, delaying treatment decisions.

The platform’s streamlined reimbursement workflow, including proprietary real-time prior-authorisation processes, reduces administrative friction and accelerates revenue conversion for hospitals. This integrated approach creates a high barrier to entry for competitors, embedding Salix® deeply into hospital operations and physician routines.

Outlook and Growth Catalysts

Looking ahead, Artrya plans to increase scan volumes and recurring revenue across its foundation customers, convert SAPPHIRE study participants into commercial clients, and accelerate its US sales pipeline targeting multiple new live sites. The anticipated FDA clearance of the Coronary Flow module is a key upcoming catalyst that could significantly expand clinical utility and pricing power.

With a clear commercial strategy focused on foundation partnerships, clinical validation, and key opinion leader engagement, Artrya is positioning itself to scale its Salix® platform as cardiac CT adoption grows under evolving clinical guidelines and reimbursement incentives.