• Major milestone as Artrya receives FDA 510(k) clearance for the Salix® Coronary Plaque module
• Salix® Coronary Plaque module enables near real-time, point-of-care detection of high-risk plaque
• Significantly expands U.S. commercial launch with ability to charge a fee per scan assessed

Artrya Limited (ASX: AYA), a medical technology company commercialising its Salix® AI-powered cloud platform for the assessment and management of coronary artery disease, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary Salix® Coronary Plaque module. This regulatory clearance is a major milestone in Artrya's U.S. market launch, which commenced in July, and will greatly expand the revenue opportunity with current and future customers. The Salix® Coronary Plaque module enables a near real-time, point-of-care assessment of plaque and stenosis for patients who have undergone a coronary CT angiogram (CCTA). It is already embedded within the same user interface as the FDA-cleared Salix® Coronary Anatomy platform and can immediately be enabled in the live version of the platform following this FDA clearance. This makes the expanded Salix® technology offering available to clinicians, with assessments available to them in less than 10 minutes and without changing or using multiple systems, as required with competing technology. Coronary artery disease (CAD) remains the leading cause of death and the largest category of U.S. healthcare expenditure, with costs projected to exceed US$1 trillion by 2035. More than 4.4 million CCTA scans are performed each year in the U.S., growing at over 6% annually. The U.S. government has also increased reimbursement rates paid for assessing CCTA scans, due to the high incidence and benefits for earlier intervention. Now that Artrya's Salix® Coronary Plaque module is cleared, it automatically qualifies for a Category I CPT code for automated plaque analysis of CCTA scans, with reimbursement of US$950 per assessment from January 1, 2026.

Artrya's go to market strategy for the U.S. is built around three strategic partnerships with mid-sized U.S. hospital systems. The first of these, Tanner Health, signed a commercial agreement for clinical use of the Salix® Coronary Anatomy platform in July 2025, and the integration of Northeast Georgia Health and Cone Health is progressing and will be completed in coming months.

Artrya is also collaborating with several major U.S. hospital centres to participate in the upcoming SAPPHIRE study. These centres will use the Salix® Coronary Plaque module and will gain awareness and understanding of the benefits that Salix® can provide. A key strategy moving forward will be to build on this awareness and clinical utility to seek to transition these centres to commercial customers.