Artrya is advancing its commercial footprint in the US with two health systems now generating revenue and FDA clearance for its Salix Coronary Flow module expected in H2 2026.
- Two US health systems generating revenue from Salix platform
- FDA submission for Salix Coronary Flow module near completion
- SAPPHIRE Study initiated to support clinical validation and adoption
- Pro forma cash position of $74 million including term deposits
- Operating cash outflows reduced to $4.75 million for the quarter
Commercial Momentum Builds Across US Health Systems
Artrya Limited (ASX:AYA) is steadily expanding its US commercial presence with its AI-powered Salix platform now generating revenue at two major health systems. Tanner Health leads the charge with Salix fully live across its five hospitals, supporting routine clinical use and increasing scan volumes. Northeast Georgia Health System (NGHS) followed, completing deployment in July 2026 and becoming Artrya's second revenue-generating customer. Meanwhile, Cone Health is progressing through integration stages, with clinical deployment expected soon.
These developments reflect a deliberate scaling strategy focused on embedding Salix into clinical workflows and accelerating adoption. The company aims for all three foundation customers to be revenue-generating for both Coronary Anatomy and Plaque modules by the end of the September quarter.
FDA Submission for Coronary Flow Module Nears Completion
Artrya has wrapped up validation and pre-submission activities for its Salix Coronary Flow module, a physiological assessment tool that provides near real-time fractional flow reserve (FFR) measurements from standard CT scans. This module promises to help clinicians identify patients who can safely avoid invasive angiography.
The company secured the necessary US clinical datasets during the quarter, enabling finalisation of its 510(k) application to the FDA. Clearance is targeted for the second half of calendar 2026, after which Salix Coronary Flow assessments will be eligible for reimbursement under an existing Category I CPT code, currently reimbursed at US$877 per scan. This addition will complete Artrya’s integrated coronary artery disease assessment platform.
SAPPHIRE Study Launches to Bolster Clinical Evidence and Commercialisation
The SAPPHIRE Study officially commenced in July with an investigator meeting held at the Society of Cardiovascular Computed Tomography’s Annual Scientific Meeting in San Diego. This study will evaluate Salix Coronary Plaque and the proprietary Plaque Dispersion Score for improved disease identification and risk stratification.
Importantly, SAPPHIRE doubles as a commercialisation vehicle, allowing participating US health systems to gain hands-on experience with Salix while generating evidence to support broader adoption. The study also fosters long-term commercial relationships with leading hospitals.
Strengthening Clinical Leadership and Strategy
Artrya has advanced the formation of its Clinical Advisory Board, securing commitments from prominent US cardiovascular imaging specialists. The board will guide clinical practice integration, product development, and evidence generation. Dr Ron Blankstein of Mass General Brigham and Harvard Medical School, who also serves as Principal Investigator of the SAPPHIRE Study, will chair the board, enhancing Artrya’s clinical credibility and strategic alignment.
Financial Position and Operating Cashflows
For the quarter ended 30 June 2026, Artrya reported operating cash outflows of $4.75 million, down from $6.8 million in the previous quarter, reflecting reduced R&D expenses and ongoing operational support for US commercial rollout. Customer receipts remained modest at $60,000, primarily from Tanner Health subscription and per scan revenues.
The company holds a pro forma cash position of $74.0 million, including $44.0 million in cash and a $30.0 million six-month bank term deposit classified as a financial asset. Financing inflows of $2.3 million from option exercises also contributed to liquidity. Net cash outflows for the quarter were $2.6 million, underscoring prudent cash management as Artrya scales its business.
Investor engagement continues to build, with recent participation in the 2026 Morgan Stanley Australian Summit and ongoing broker coverage from Barrenjoey, Petra Capital, Bell Potter, and Venn Brown.
Bottom Line?
Artrya’s near-term FDA submission and expanding US commercial footprint set the stage for a pivotal second half of 2026, though execution risks remain as adoption scales.
Questions in the middle?
- Will FDA clearance for the Coronary Flow module unlock meaningful reimbursement revenue streams?
- How quickly can Artrya convert its commercial pipeline into paying customers beyond the three foundations?
- What impact will the SAPPHIRE Study data have on accelerating adoption among cautious US health systems?