• The Food and Drug Administration (FDA) 510(k) has cleared Salix® Coronary Anatomy for commercial sale in the US
• Salix® is the first point of care approach in 50 years for assessing coronary artery disease, the world's leading cause of death
• Salix® Coronary Anatomy will be formally launched across the hospital groups in the US where Salix® has been integrated within hospital workflows

Artrya Limited (ASX:AYA), a medical technology company focused on commercialising its patented AI platform that detects key coronary artery disease imaging markers, has secured US Food and Drug Administration (FDA) 510(k) clearance for Salix® Coronary Anatomy which allows Artrya to now commercialise in the US market. Salix® Coronary Anatomy (SCA) delivers a non-invasive, point-of-care assessment within 10 minutes of a coronary computed tomography angiogram (CCTA) scan being taken, enabling physicians to quickly identify, analyse, and edit the extent and type of arterial plaque, the main cause of heart disease, along with stenosis and calcification, which provides a holistic view of patient risk. During FY24, Artrya established Strategic Agreements with three US hospital groups: Northeast Georgia Health Ventures (NGHV), a part of Northeast Georgia Health System (NGHS), Healthliant Ventures, a part Tanner Health System, and Cone Health. Under these agreements, the hospital groups worked with Artrya to non-clinically validate and integrate Salix® Coronary Anatomy in their workflows, while the product progressed through the FDA 510(k) clearance process. Now with FDA clearance, Artrya will work with these groups to commercially expand access to Salix® Coronary Anatomy across 15 hospitals, multiple outpatient centres, and dedicated heart and vascular centres across the US Southeast.

Artrya anticipates FDA clearance for Salix® Coronary Plaque and Salix® Coronary Flow by the end of this calendar year, unlocking access to two distinct reimbursement codes for detailed plaque and blood flow analysis in the US healthcare market.

With FDA clearance, Artrya can immediately begin the sales cycle, starting with its established hospital partnerships. This will allow the company to accelerate commercialisation in the US market, where an estimated 4.4 million CCTA scans are performed annually, growing at over 6% per year.