Key Highlights

• Artrya (ASX:AYA) closed at A$3.50, gaining 4.79% on 05 November 2026, as the ASX 200 Health Care index rose 3.64%

• Huntsville Hospital Health System signed a five-year commercial agreement, becoming Artrya's largest customer and first SAPPHIRE study participant to convert to full commercial use

• Pro forma cash position of $67.2 million at 30 September 2026 with an additional $4.8 million R&D rebate claim in process

Shares of Artrya Ltd (ASX:AYA) closed at A$3.50 on 05 November 2026, advancing 4.79% during the session. The S&P/ASX 200 (XJO) gained 2.61%, adding 230.60 points to close at 9,065.10, while the S&P/ASX 200 Health Care index (XHJ) rose 3.64%, gaining 1,240.30 points to reach 35,329.10. Overnight gains on Wall Street, following the Democrats' decisive victory in the U.S. midterm elections, supported positive sentiment across global Equity markets. Artrya is a Perth-based medical technology company commercialising its Salix AI-powered cloud platform for the real-time assessment and management of coronary artery disease.

Huntsville Hospital Becomes Largest Commercial Customer

In a post-quarter development, Artrya converted its first SAPPHIRE Study participant into a commercial customer, signing a five-year commercial agreement with Huntsville Hospital Health System. The agreement includes a minimum value of US$0.5 million, with HH Health licensing Salix Coronary Anatomy on a subscription basis. Additional fees per scan will be generated from Salix Coronary Plaque usage and Salix Coronary Flow once cleared. HH Health spans 15 hospitals across Alabama and Tennessee, 19 heart centres, and more than 1,000 cardiac staff including 58 cardiologists, conducting approximately 60,000 non-invasive cardiology tests annually.

U.S. Commercial Rollout Gaining Traction

Beyond Huntsville, Artrya's U.S. commercial activities continued to advance during the September quarter. Northeast Georgia Health System began expanding beyond its initial launch site, while Cone Health progressed towards clinical deployment. At Tanner Health, implementation of a pre-authorisation workflow in mid-September addressed a key reimbursement barrier and was followed by a material increase in Salix Coronary Plaque utilisation that continued into October. The company reported growing inbound interest from additional U.S. health systems based on the clinical, workflow, and economic value demonstrated by the platform.

Salix Coronary Flow Timeline Adjusted

Artrya disclosed that the timeline for its Salix Coronary Flow FDA submission has been extended. The company had previously indicated an imminent submission with FDA clearance anticipated by end of 2026. However, a review of clinical study data identified inconsistencies in expert reader assessments within a clinical sub-study. Combined with recent regulatory outcomes in the sector, Artrya has decided to strengthen its evidence package and undertake an additional reader study before filing.

ASX 300 Inclusion and Leadership Changes

During the quarter, Artrya was included in the S&P/ASX 300 Index. The company also appointed Prof Christine Jenkins AM as a Non-Executive Director and Julian Sutton as Executive Chair, strengthening board and executive leadership to support its next phase of commercial growth.

About Artrya – Business Overview

Artrya is a medical technology company focused on coronary artery disease, developing the Salix AI-powered cloud platform for point-of-care assessment. The platform includes multiple modules including Salix Coronary Anatomy, Salix Coronary Plaque, and the forthcoming Salix Coronary Flow. The company's SAPPHIRE program serves as both a clinical evidence generation initiative and a pathway to commercial customer conversion across U.S. health systems.

Sector Context

The ASX healthcare sector gained 3.64% on 05 November 2026, supported by the global risk-on environment. MedTech companies participated in the rally alongside large-cap healthcare names. Artrya's 4.79% gain was modestly above the sector benchmark, reflecting the company's positioning within the growing AI-driven medical technology space.

Risks

Key risks include the delay to the Salix Coronary Flow FDA submission, which could push back clearance and Revenue from that module. The company remains in early-stage commercialisation with limited revenue relative to its operating costs. Regulatory clearance timelines, competition from established cardiac imaging providers, and the pace of hospital system adoption represent ongoing uncertainties. Customer concentration is also a consideration as the commercial base is still developing.

Catalysts on Watch

Key catalysts include the pace of Huntsville Hospital network integration, conversion of additional SAPPHIRE participants to commercial customers, and the timing of the revised Salix Coronary Flow FDA submission. Revenue growth from increased scan volumes and the expansion of the Salix Coronary Plaque module across existing customers will be closely monitored. Any additional U.S. health system contract announcements could also be material.

Looking Ahead

Artrya's Q1 FY2027 update highlighted the conversion of its first SAPPHIRE participant to a commercial customer and growing traction across the U.S. market, balanced against a delayed FDA submission for Coronary Flow. With a pro forma cash position of $67.2 million, the company has financial runway to pursue its commercial execution strategy in the U.S. market.