Artrya (AYA) FDA Announcement summary

Introduction and purpose

• Investor call held to discuss FDA 510(k) clearance of an AI-powered module for detecting and quantifying coronary artery plaque, highlighting its significance as a pivotal milestone for improving coronary artery disease management.

• The technology aims to enhance detection and management of coronary artery disease, the leading cause of death in the U.S.

Details of approval or decision

• FDA clearance enables immediate integration of the plaque module into the existing platform for U.S. customers, providing real-time, automated plaque analysis at the point of care.

• The module processes CCTA scans without human intervention, differentiating it from competitors.

• The module qualifies for a Category I CPT code, enabling $950 reimbursement per assessment from January 1, 2026.

Impact on industry and stakeholders

• Expands commercial opportunities by enabling per-scan fees and rapid scaling in the U.S. market, with a $4.4 billion opportunity identified.

• Structured rollout focuses on initial hospital systems performing 15,000 scans annually, with future expansion to SAPPHIRE partners handling 400,000 scans per year.

• Strategic partnerships with U.S. hospital systems are in place, with further integrations planned.

• Hospitals can become profit centers due to the pricing model, improving adoption incentives.