Quarterly Activities/Appendix 4C Cash Flow Report

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Stock ARTRYA Ltd (AYA.ASX)
Release Time 27 Oct 2025, 9:29 a.m.
Price Sensitive Yes
 Quarterly Activities/Appendix 4C Cash Flow Report
Key Points
  • Growing commercial momentum with key U.S. launch partners, funding secured and plans underway to build U.S. leadership team
  • FDA clearance for Salix® Coronary Plaque module - significantly expands U.S. commercial opportunity
  • SAPPHIRE study on track to commence early 2026 with Piedmont Healthcare and Huntsville Hospital Heart Centre confirmed
Full Summary

Artrya Limited (ASX: AYA) has achieved several significant operational, regulatory, and financial milestones during the quarter ended 30 September 2025, all of which expand the company's commercial opportunity. The business has progressed strongly from the development phase into commercial operations, highlighted by securing Tanner Health as Artrya's first U.S. commercial customer, now generating the first U.S. revenues. The FDA 510(k) clearance of the Salix® Coronary Plaque module in August 2025 further strengthened the value proposition and revenue opportunity, attracting positive attention from hospitals, clinicians, industry stakeholders, and investors. With strong support from existing and new institutional shareholders, the company completed an upscaled $80M capital raising during the quarter, providing sufficient capital to build out and expand U.S. commercial operations and infrastructure. The planned SAPPHIRE study also advanced significantly during the quarter, with Piedmont Health and Huntsville Hospital Heart Centre confirmed as the first two high-quality U.S. centres to participate. Artrya also successfully completed a Q-Submission meeting with the FDA for the Salix® Coronary Flow module, guiding the planned 510(k) submission. The company is focused on reaching commercial agreements with Northeast Georgia Hospital System and Cone Health, securing the final SAPPHIRE partners, earning first commercial revenues from the Salix® Coronary Plaque module, and completing the Salix® Coronary Flow module studies prior to filing the FDA 510(k) application.

Guidance

No high-importance, price-sensitive forward-looking financial metrics provided.

Outlook

Artrya is focused on the following key commercial, operational and regulatory near-term priorities: - Reaching commercial agreements with Northeast Georgia Hospital System and Cone Health - Securing the final SAPPHIRE partners to support the Study launch in 2026 - Earning first commercial revenues from the Salix Coronary Plaque (SCP) module - Employing the key U.S. Go to Market personnel, initially focused on the Atlanta customer support hub - Completing the Salix Coronary Flow (SCF) module studies prior to filing the FDA 510(k) application