Artrya Limited (ASX:AYA) Receives FDA Clearance for Salix® Coronary Plaque Module
FDA Clearance
Artrya Limited has received FDA 510(k) clearance for its Salix® Coronary Plaque module, a proprietary AI-enabled tool for detecting and quantifying coronary artery plaque. This clearance marks a significant milestone in Artrya’s U.S. market launch, enabling the company to charge a fee of US$950 per scan assessed.
Commercial Opportunity
The Salix® Coronary Plaque module integrates seamlessly with the FDA-cleared Salix® Coronary Anatomy platform, currently commercial with Tanner Health. With over 4.4 million CCTA scans performed annually in the U.S. and a 6% annual growth rate, the module is poised to significantly expand Artrya’s revenue opportunities. Strategic partnerships with Tanner Health, Northeast Georgia Health, and Cone Health are progressing, with the module providing clinicians detailed plaque assessments in under ten minutes.
Executive Comments
John Konstantopoulos, Co-Founder and CEO of Artrya, stated: “We are thrilled to have received FDA clearance of our Salix® Coronary Plaque module, which opens up a much greater revenue opportunity for us in the U.S., our largest market. The team have worked tremendously hard to prepare and support the submission which we lodged on the 16th of June, and we intend to build on this as we approach our next submission for the Salix® Coronary Flow module.
Our momentum is definitely building, with the core Salix® Coronary Anatomy platform now commercial in Tanner Health, and integration of Northeast Georgia Health System and Cone Health progressing well. Once live, we simply enable the Salix® Coronary Plaque module in their workstream, providing their clinicians access to our highly detailed assessment of coronary artery plaque in under ten minutes. We know these clinicians tremendously value the speed, ease and efficiency that our Salix® platform and plaque module offers, as they seek to rapidly diagnose patients and provide those in need with lifesaving treatment.
As we move forward, our ability to generate revenue from our U.S. customers for each CCTA scan they assess with our Salix® Plaque module, provides us the ability to scale rapidly. This is underpinned by the ability of our customers to receive an attractive Category I reimbursement of US$950 for each plaque assessment they perform.”
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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