• Receives FDA 510(k) clearance for Salix® Coronary Anatomy for commercial sale in the US
• Secures 3-year contracts with Sonic Healthcare Australia and Lumus Imaging in Australia
• Progresses clinical validation of Salix® Coronary Plaque and development of Salix® Coronary Flow

Artrya Limited, a medical technology company focused on commercialising its patented AI platform that detects, diagnoses, and helps address coronary artery disease, has released its activities report for the quarter ended 31 March 2025. Key highlights include:- Receives milestone Food and Drug Administration (FDA) 510(k) clearance for Salix® Coronary Anatomy for commercial sale in the US, enabling Artrya to commence commercial deployment across 15 hospitals, outpatient centres, and heart and vascular facilities in the US Southeast.- Secures three-year commercial contracts with Sonic Healthcare Australia - Radiology and Lumus Imaging, two of Australia's largest and leading diagnostic imaging providers, for the use of Salix® Coronary Anatomy platform.- Good progress made on clinical validation of Salix® Coronary Plaque (SCP) in preparation for FDA 510(k) submission, and ongoing development and calibration of Salix® Coronary Flow (SCF) product in preparation for FDA clinical study.- Development of flagship study, SAPPHIRE, which seeks to assess Artrya's novel Plaque Dispersion Score and accelerate commercialisation in the US.- Successful completion of a $15 million capital raise, with Tranche 1 proceeds of $4.65 million (net) received during the quarter and Tranche 2 proceeds of $9.38 million (net) received subsequently.- Cash on hand at 31 March is $7.63 million, totalling approximately $17 million including Tranche 2 funds received post Q3 FY25, with operational cash burn of $4.60 million for the quarter.

Artrya expects to lodge a 510(k) submission on Salix Coronary Flow in Q3 CY2025 with FDA clearance by end CY2025. Once cleared, Salix® Coronary Flow will be eligible for a Category 1 reimbursement code for non-invasive blood flow assessment, valued at US$1,017.

Artrya's focus over the coming months is to accelerate the commercial rollout of Salix® Coronary Anatomy (SCA) in both the US and Australia, deepen clinical adoption, and expand through strategic partnerships. The company is also advancing its broader product pipeline, including Salix® Coronary Plaque (SCP) and Salix® Coronary Flow (SCF), and ramping up its US commercialisation efforts and launching its flagship plaque study, SAPPHIRE.