How Artrya’s FDA Clearance Fuels Its U.S. Launch Amid Rising Losses

Financial Performance and Strategic Progress

Artrya Limited, an Australian medical technology company specialising in AI-driven diagnostics for coronary artery disease, reported a net loss of $16.4 million for the financial year ended 30 June 2025. This represents a 17.2% increase compared to the previous year’s $14 million loss, reflecting ongoing investment in product development and commercialisation efforts.

Despite the widening loss, Artrya achieved significant milestones, notably securing 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Salix Coronary Anatomy platform in March 2025. This regulatory approval paved the way for the company’s commercial launch in the United States, a key growth market given the 4.4 million annual coronary computed tomography angiography (CCTA) scans performed there.

U.S. Market Entry and Partnerships

Following FDA clearance, Artrya commenced its U.S. commercial rollout in July 2025, entering a five-year agreement with Tanner Health valued at $0.6 million. Additional strategic collaborations with Northeast Georgia Health System and Cone Health are progressing towards commercial contracts, expected to contribute to revenue in the 2026 financial year. The Salix platform integrates directly into hospital clinical workflows, enabling near real-time AI analysis of CCTA scans to aid in early detection and management of coronary artery disease.

Australian Commercial Expansion

In Australia, Artrya has partnered with two of the country’s largest radiology providers, Sonic Healthcare and Lumus Imaging, under three-year commercial agreements signed in early 2025. These partnerships aim to drive adoption of the Salix platform and generate subscription-based revenues, with commercialisation expected to ramp up in the 2026 financial year. The platform is already in clinical use at The Cardiac Centre NSW, marking the company’s initial Australian revenue streams.

Product Development and Clinical Validation

Artrya’s product roadmap includes additional modules; Salix Coronary Plaque and Salix Coronary Flow; designed to expand clinical utility and addressable markets. The Plaque module dossier was submitted to the FDA in June 2025, with clearance anticipated in the second half of the year, enabling reimbursement under existing U.S. codes. The Flow module is slated for FDA submission by year-end. Concurrently, the company is advancing the SAPPHIRE clinical study in the U.S., aimed at validating the prognostic value of its AI-based plaque analysis to improve cardiovascular risk prediction.

Capital Raising and Leadership Changes

To support its growth trajectory, Artrya raised $20 million through equity placements during the year, bolstering its cash reserves to $11.3 million as of June 2025. The company also underwent key leadership changes post-year-end, with Mat Regan resigning as CEO and John Konstantopoulos appointed as his successor. Bernie Ridgeway, previously Non-Executive Chair, assumed the role of Executive Chair, bringing extensive ASX-listed company leadership experience.

Risks and Outlook

Artrya faces typical early-stage biotech risks including competitive pressures, regulatory hurdles, customer acquisition and retention challenges, and the need for ongoing capital. The company’s ability to secure FDA clearance for additional modules and convert clinical partnerships into sustainable revenue streams will be critical. Management remains focused on commercial execution in the U.S. and Australia, with a cautious but optimistic outlook on achieving profitability as adoption scales.