Artrya Achieves FDA Clearance for Salix® Coronary Plaque Module Significantly Boosting U.S. Market Opportunities

Artrya's Game-Changing FDA Clearance

In a significant move for the medical technology field, Artrya Limited (ASX: AYA) has announced the receipt of FDA 510(k) clearance for its innovative Salix® Coronary Plaque module. This milestone is paramount as it allows for an enhanced approach in detecting and managing coronary artery disease (CAD), which is the leading cause of death globally.

What is the Salix® Coronary Plaque Module?

The Salix® Coronary Plaque module utilizes artificial intelligence (AI) to facilitate near real-time assessment of coronary artery plaque following coronary CT angiography (CCTA) scans. This technology supports timely and accurate diagnosis of high-risk plaques, which are crucial indicators of potential heart attacks that might be missed by traditional methods.

John Konstantopoulos, Co-Founder and CEO of Artrya, expressed excitement about the potential impact of this clearance, stating, "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." This statement underscores the relevance of this technology amidst alarming CAD statistics, with healthcare costs projected to surpass $1 trillion by 2035.

Benefits of the Module

The Salix® Coronary Plaque module distinguishes itself by providing prompt analysis within 10 minutes, giving clinicians not only a seamless user interface but also rapid access to critical patient assessment. The integration of this module within the existing Salix® Coronary Anatomy platform allows healthcare providers to avoid the complications often faced with competing technologies.

Another significant advantage is the monetary aspect; the U.S. Centers for Medicare & Medicaid Services (CMS) has increased reimbursement rates to $950 per CCTA assessment starting January 1, 2026. This financial incentive enhances the commercial landscape for Artrya as hospitals and healthcare providers can recoup a portion of their expenses while improving patient outcomes.

Strategic Partnerships and Market Approach

Artrya's market strategy entails collaborating with mid-sized hospital systems across the U.S., focusing primarily on Tanner Health, which has already entered into a commercial agreement for using the Salix® Coronary Anatomy platform. The integration projects with Northeast Georgia Health and Cone Health are in progress, targeting successful implementation in the near future.

Moreover, Artrya aims to further engage prominent U.S. hospital centers through participation in clinical studies such as the upcoming SAPPHIRE study, which will spotlight the Salix® Coronary Plaque module’s effectiveness. These partnerships are not just crucial for market presence but also for accumulating data on the technology's clinical benefits.

Future Outlook

As Artrya proceeds, the team is directing efforts toward additional submissions, including the upcoming Salix® Coronary Flow module. The FDA clearance signifies a rolling momentum for the company, engaging more healthcare providers and ultimately, patients in need of timely coronary artery disease diagnosis.

In light of these developments, interested parties can attend an investor webinar hosted by John Konstantopoulos on August 22, 2025, at 11.30 AEST to discuss further insights into the FDA clearance and the business trajectory.

With the Salix® Coronary Plaque module's FDA clearance, Artrya is well-positioned to redefine the landscape of coronary artery disease diagnostics and treatment, emphasizing precision medicine's vital role in contemporary healthcare.

Conclusion

The FDA's approval of Artrya's Salix® Coronary Plaque module marks a crucial turning point not only for the company but also for patients and healthcare professionals dealing with coronary artery disease. This forward-thinking approach can potentially save lives by facilitating earlier diagnosis and treatment interventions, and the financial framework surrounding the technology refocuses the healthcare conversation toward innovative and effective solutions.