Artrya Limited (ASX:AYA) Receives FDA Clearance for Salix® Coronary Anatomy
FDA Clearance Achieved
Artrya Limited (ASX:AYA) has secured US Food and Drug Administration (FDA) 510(k) clearance for Salix® Coronary Anatomy, enabling commercialization in the US market. Salix® is the first point-of-care approach in 50 years for assessing coronary artery disease, allowing physicians to rapidly evaluate arterial plaque, stenosis, and calcification within 10 minutes of a coronary CT angiogram scan.
Strategic Partnerships
During FY24, Artrya established strategic agreements with Northeast Georgia Health Ventures, Healthliant Ventures, and Cone Health. These partnerships involved non-clinical validation and integration of Salix® Coronary Anatomy into hospital workflows. With FDA clearance, Artrya will expand access across 15 hospitals, multiple outpatient centres, and dedicated heart and vascular centres in the US Southeast.
Executive Comments
CEO Mathew Regan stated, “I am delighted to announce Salix® Coronary Anatomy has secured FDA clearance, paving the way for the official commercial launch into the US market. For decades, heart disease has been treated reactively, waiting for symptoms to appear before taking action. With FDA clearance of Salix® Coronary Anatomy, hospitals and clinics can now move beyond traditional diagnostics to a truly proactive approach. Salix® is the first major advancement in 50 years that delivers a comprehensive point-of-care assessment within just 10 minutes. This not only improves the diagnosis and reporting workflow for coronary artery disease but also reduces unnecessary costs and can minimise patient readmissions.
“With FDA clearance we can immediately begin the sales cycle, starting with our established hospital partnerships. This will allow us to accelerate commercialisation in the US market, where an estimated 4.4 million CCTA scans are performed annually, growing at over 6% per year.”
Motley Fool contributor Lianne Eastty has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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