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Artrya Advances US Rollout and Nears FDA Submission with $76.6M Cash Backing

Healthcare By Ada Torres 4 min read

Artrya has fully integrated its Salix platform at Tanner Health, is preparing two more US sites for launch, and is finalising FDA submission for its Coronary Flow module, backed by a strong cash position of $76.6 million.

  • Salix platform live across five Tanner Health hospitals
  • Northeast Georgia and Cone Health preparing FY27 go-live
  • Coronary Flow module in final clinical validation before FDA submission
  • SAPPHIRE Study ethics and contracting underway at six US health systems
  • Pro forma cash and term deposits total $76.6 million

Tanner Health Fully Deploys Salix Platform

Artrya Limited (ASX:AYA) has reached a significant milestone in its US commercial rollout by fully integrating its AI-powered Salix Coronary Anatomy platform and Plaque module across all five hospitals within Tanner Health. This marks the first US customer to adopt the technology into routine clinical practice, with monthly scan volumes steadily increasing, driven by outpatient use. Reimbursement processes are nearing completion within Tanner Health’s payor network, setting the stage for steady fee-per-scan revenue growth.

This progress builds on earlier commercial wins, with Tanner Health executives recently visiting Australia to deepen collaboration and explore emerging healthcare technologies. The company’s focus now shifts to leveraging Tanner Health as a reference site to accelerate adoption at other US health systems.

Preparations Underway at Northeast Georgia and Cone Health

Artrya is on track to bring its Salix platform live at Northeast Georgia Health System (NGHS) and Cone Health by the start of the 2027 financial year. NGHS’s integration aligns with a concurrent PACS upgrade, designed to streamline image routing and reporting workflows. Meanwhile, Cone Health is advancing IT infrastructure setup with ongoing support from Artrya’s Customer Success team. These deployments aim to broaden Salix’s footprint across major US cardiology networks, supporting the company’s ambition to scale its commercial presence.

These developments follow Artrya’s earlier conversion of foundation partners into paying customers, including a significant multi-year deal with Cone Health, underscoring the company’s growing commercial momentum in the US market five-year deal with Cone Health.

Coronary Flow Module Nears FDA Submission

A critical regulatory milestone is approaching as Artrya finalises clinical validation for its Salix Coronary Flow (SCF) module ahead of a planned FDA 510(k) submission. The module has been calibrated and locked down, demonstrating strong accuracy and promising clinical utility. The company is completing a clinical study to generate the technical data supporting a robust submission package.

This module complements the previously FDA-cleared Coronary Plaque module, which has already begun generating fee-per-scan revenues. The Flow module is targeted for commercial rollout in the second half of 2026, with preparations underway for training and reimbursement pathways to support adoption post-clearance.

SAPPHIRE Study Progressing with Six US Health Systems

Artrya’s multi-centre SAPPHIRE Study, designed to evaluate the prognostic value of Salix Plaque Analysis and the proprietary Plaque Dispersion Score, has secured contracting and ethics approvals across six major US hospital systems. These include Mass General Brigham, Piedmont Health, Ascension, Huntsville Hospital Heart Centre, Dignity Health Arizona, and HCA Midwest Health.

The study will also feature SAPPHIRE-WIN, a female-focused cohort addressing the diagnostic challenges of coronary artery disease in women. The six principal investigators are scheduled to convene at the Society of Cardiovascular Computed Tomography Annual Scientific Meeting in July 2026 to formally kick off the study. Early Salix demonstrations are already part of commercialisation efforts at these sites, reflecting integration of research and market expansion SAPPHIRE Study expanded.

Strengthened US Leadership and Governance

To support its US growth, Artrya appointed a General Manager for US Operations to build out infrastructure for customer management and support. Additionally, Dr Jeffrey Le Benger joined the board as the second US-based director, bringing experience from leading major health system transformations and multi-billion-dollar healthcare acquisitions.

These leadership enhancements aim to underpin operational scale-up and commercial adoption as the company moves from pilot to broader market penetration.

Financial Position and Cashflow

Artrya reported a pro forma cash position of $76.6 million at 31 March 2026, including a $30 million six-month term deposit. Operating costs increased to $6.8 million for the quarter, primarily driven by intensified R&D efforts on the Coronary Flow module and US expansion activities. Early commercial revenues from subscription and fee-per-scan assessments are emerging but remain modest.

The company received a $5.6 million R&D tax rebate for the 2025 financial year and earned $0.5 million in interest income. Net cash flow from operating activities was negative $672,000 for the quarter, reflecting the investment phase typical of medical technology commercialisation. Financing cash inflows of $750,000 from option exercises partially offset the outflows.

Artrya’s inclusion in the S&P/ASX All Ordinaries Index in March 2026 should enhance visibility among investors as it advances its AI-driven cardiac imaging platform.

Bottom Line?

Artrya’s US commercial rollout is gaining traction with key customers live and others poised to launch, while the imminent FDA submission for its Coronary Flow module could unlock significant market opportunity, watch for regulatory clearance and revenue ramp-up in FY27.

Questions in the middle?

  • How will FDA clearance timing for the Coronary Flow module influence Artrya’s US revenue trajectory?
  • What adoption rates can be expected at Northeast Georgia and Cone Health once live, and how quickly will fee-per-scan volumes grow?
  • Will the SAPPHIRE Study’s results validate Salix’s clinical utility sufficiently to drive broader market acceptance?