FDA Delays Could Test Artrya’s US Commercial Rollout Plans

Regulatory Momentum Builds

Artrya Limited (ASX: AYA), the Perth-based medical technology company specialising in AI-driven coronary artery disease diagnostics, has reported encouraging developments in its second quarter of fiscal 2025. Central to its progress is the ongoing 510(k) application with the US Food and Drug Administration (FDA) for its flagship Salix® Coronary Anatomy product. While the FDA has requested additional information, ranging from demographic data to cybersecurity clarifications, the company remains on track to secure clearance by the end of March 2025.

Beyond this, Artrya is advancing its product pipeline with Salix® Coronary Plaque and Salix® Coronary Flow, both anticipated to receive FDA clearance within the calendar year. These approvals are strategically significant as they unlock access to two separate reimbursement codes in the US healthcare market, potentially accelerating adoption and revenue generation.

Financial Fortification and Strategic Partnerships

In parallel with regulatory efforts, Artrya successfully completed a A$5 million placement at A$0.42 per share, attracting sophisticated and institutional investors including Healthliant Ventures, the venture arm of Tanner Health, a US hospital system. This capital injection bolsters the company’s balance sheet, providing a net $4.7 million after costs, and extends its operational runway through the critical FDA clearance period and beyond.

Artrya’s cash position stood at $7.6 million as of 31 December 2024, with a quarterly net cash inflow of $1.1 million despite an operating cash burn of $3.6 million. The company has prudently reduced its average monthly cash outflow from $1.4 million to $1.2 million, reflecting disciplined cost management focused on regulatory approvals, clinical validation, and commercial readiness.

Market Development and Commercial Outlook

On the commercial front, Artrya is deepening relationships with medium to large healthcare systems in the US, including pre-FDA agreements with Northeast Georgia Health System, Tanner Health, and Cone Health. Integration of Salix® Coronary Anatomy into Tanner Health’s operations marks a tangible step towards full commercial rollout post-FDA clearance. Additional agreements with major US health systems are expected to materialise throughout 2025.

Domestically, Artrya is negotiating with two of Australia’s largest radiology groups, leveraging the local market as a proving ground for clinical validation and software refinement. The company has also commenced processing scans under a commercial agreement with The Cardiac Centre in New South Wales.

Looking Ahead

CEO Mathew Regan emphasised the company’s readiness to capitalise on upcoming regulatory milestones and commercial opportunities. With FDA clearance anticipated soon, Artrya is poised to launch its life-saving AI technology across established hospital networks, while continuing to expand its product portfolio and market reach.

Investors will be watching closely as Artrya navigates the final stages of FDA review and accelerates its commercialisation strategy in two key markets. The company’s ability to convert regulatory progress into sustainable revenue streams will be critical to its next phase of growth.