Artrya Wins FDA Clearance to Advance Rollout of Salix Coronary Plaque Module

Artrya (ASX: AYA) has received clearance from the US Food and Drug Administration for its Salix Coronary Plaque module.

The regulatory milestone enables the company to charge per-scan fees in its largest market, significantly enhancing revenue potential.

The approval follows Artrya’s recent US launch and builds on momentum established with its Salix Coronary Anatomy platform.

Major Regulatory Milestone

The Salix Coronary Plaque module is an AI-powered tool that detects and quantifies high-risk coronary artery plaque, a key indicator of heart attack medical staff often miss in current manual practices.

FDA 510(k) clearance allows Artrya to deploy the module immediately within the company’s existing Salix Coronary Anatomy platform, already in use at Tanner Health.

Chief executive officer John Konstantopoulos said the approval was “a much greater revenue opportunity for us in the US” and a critical step towards scaling commercial adoption.

Artrya plans to build its US rollout around three strategic partnerships with mid-sized hospital systems—beginning with Tanner Health, which signed a commercial agreement in July for clinical use of the anatomy platform.

Integrations with Northeast Georgia Health and Cone Health are also underway, an approach the company said provides a scalable entry point to the US market by working with regional networks that can expand use across multiple sites.

Commercial Implications

Each coronary CT angiogram assessed with the plaque module will attract a US Category 1 Current Procedural Terminology reimbursement of US$950 from January 2026.

More than 4.4 million CCTA scans are performed annually across the US, with volumes growing by more than 6% each year.

The company noted that reimbursement will allow hospitals and clinicians to integrate the technology into routine practice with a clear financial incentive, creating a recurring revenue stream for Artrya.

The plaque module – which is embedded into the same user interface as the anatomy platform, meaning it can be switched on immediately for existing customers – delivers assessments in less than 10 minutes, reducing delays in diagnosis and avoiding the need to move between multiple systems.

Mr Konstantopoulos said clinicians highly value this efficiency as they seek to deliver timely and potentially lifesaving interventions for patients at risk of heart attack.

Clinical and Economic Drivers

Coronary artery disease is the leading cause of death in the US and accounts for the country’s largest healthcare expenditure, with costs forecast to exceed US$1 trillion by 2035.

In over half of all cases the first sign of the disease is sudden death, underscoring the need for earlier detection and intervention.

Government recognition of this burden has led to higher reimbursement rates for advanced diagnostic technologies such as plaque analysis of CCTA scans.

Unlike some competing solutions that require separate platforms or manual review, the Salix system integrates anatomy and plaque analysis in a single workflow, allowing for consistent and reproducible results, while helping clinicians make decisions faster and with greater confidence.

Artrya said its technology provides not only diagnostic clarity but also operational efficiency, two key factors in encouraging hospital adoption.

Blood Flow Assessment

The company is preparing its next submission for the Salix Coronary Flow module, which will extend the platform’s capability into assessing blood flow alongside plaque.

At the same time, Artrya is collaborating with major US hospital centres in the SAPPHIRE study, which will evaluate the clinical utility of the plaque module, with participation set to build awareness among leading cardiac specialists and support the transition of research partners into commercial customers.

Mr Konstantopoulos, who will host an investor webinar on 22 August to discuss the FDA clearance and provide a broader update on the company’s US strategy, said the ability to generate per-scan revenue represented a step change for Artrya.

The company said it will maintain focus on deepening penetration in its existing partner networks before moving to additional customers, ensuring a sustainable growth trajectory.

With regulatory clearance achieved, reimbursement secured, and hospital integrations underway, Artrya has positioned itself to accelerate its expansion into the world’s largest healthcare market.