How Artrya’s $0.6M U.S. Contract Signals a Commercial Breakthrough
Artrya has launched its AI-powered Salix Coronary Anatomy platform in the U.S. and submitted its Coronary Plaque module for FDA clearance, marking a key step in its commercial expansion. A new five-year contract with Tanner Health signals the start of U.S. revenues.
- U.S. commercial launch of Salix Coronary Anatomy platform completed
- FDA submission filed for Salix Coronary Plaque module
- Secured US$0.6 million five-year contract with Tanner Health
- Leadership transition with Co-Founder John Konstantopoulos appointed CEO
- Cash position of $11.3 million with expected R&D rebate by year-end
Commercial Launch Marks New Phase
Artrya Limited has officially transitioned from development to commercial operations with the U.S. launch of its Salix Coronary Anatomy platform. This AI-powered cloud solution enables real-time assessment of coronary artery disease at the point of care, a critical advancement in cardiac diagnostics. The launch was supported by extensive integration and regulatory work throughout the quarter, culminating in the platform going live with Tanner Health in July.
FDA Submission and Regulatory Progress
A major milestone was the submission of the Salix Coronary Plaque module for FDA 510(k) clearance. This module enhances the platform by detecting high-risk coronary plaque, a key predictor of heart attacks. Importantly, it qualifies for a Category I CPT reimbursement code in the U.S., potentially unlocking a payment of US$950 per assessment starting in 2026. Clearance of this module is Artrya’s highest near-term priority, as it will significantly expand the platform’s clinical utility and revenue potential.
Strategic Contract and Revenue Outlook
In a clear sign of commercial traction, Artrya secured a five-year contract valued at US$0.6 million with Tanner Health. The agreement includes a SaaS license fee for the Salix platform and fee-per-scan revenues once the plaque module gains FDA clearance. This contract represents Artrya’s first U.S. commercial revenue and sets the stage for further hospital partnerships. The company is actively progressing agreements with other U.S. health systems, aiming to build a robust sales pipeline.
Leadership Aligned for Growth
To steer this commercial phase, Co-Founder John Konstantopoulos was appointed CEO, bringing deep product expertise and strong clinical networks in both the U.S. and Australia. The leadership reshuffle also included the appointment of an Acting CFO and an Executive Chair to support corporate governance and commercial strategy. This team is focused on onboarding hospital partners, expanding product offerings, and executing a staged U.S. market rollout.
Financial Position and Future Focus
Artrya ended the quarter with $11.3 million in cash, bolstered by a recent capital placement and an anticipated R&D tax rebate of up to $5 million. Operating cash outflows increased due to scaling commercial activities and regulatory submissions, but the company expects monthly cash burn to moderate going forward. The next key steps include integrating current hospital partners, advancing the Salix Coronary Flow module through FDA study preparations, and launching the SAPPHIRE clinical study to validate the platform’s predictive capabilities.
Bottom Line?
With FDA clearance pending and initial U.S. revenues secured, Artrya is poised at a pivotal juncture between innovation and commercialisation.
Questions in the middle?
- When will the FDA clearance for the Salix Coronary Plaque module be granted?
- How quickly can Artrya expand its U.S. hospital partnerships beyond Tanner Health?
- What impact will the upcoming SAPPHIRE study results have on market adoption and reimbursement?
