Artrya Limited has secured FDA clearance for its Salix Coronary Plaque module and raised $80 million to fuel its U.S. commercial expansion, marking a pivotal step in its transition from development to revenue generation.
- FDA clearance obtained for Salix Coronary Plaque module with $950 scan reimbursement
- First U.S. commercial revenues recorded from Tanner Health integration
- $80 million capital raise completed to support U.S. market growth
- SAPPHIRE clinical study partners Piedmont Healthcare and Huntsville Hospital Heart Centre confirmed
- Hiring underway for U.S.-based commercial and clinical support teams
Building Momentum in the U.S. Market
Artrya Limited, an Australian medical technology company specialising in AI-driven coronary artery disease diagnostics, has reported a strong quarter ending 30 September 2025. The company is transitioning from a development phase into active commercial operations in the United States, a critical market for its Salix AI-powered platform.
Key to this progress was the FDA clearance of the Salix Coronary Plaque module in August 2025, a milestone that significantly enhances Artrya's commercial proposition. This clearance not only validates the technology but also enables U.S. healthcare providers to receive category 1 CPT reimbursement of US$950 per scan, a substantial incentive for adoption.
First Revenues and Growing Partnerships
Artrya's first U.S. commercial customer, Tanner Health, was successfully integrated during the quarter, generating initial subscription revenues. This marks a tangible shift from research to revenue generation. The company is actively advancing commercial agreements with Cone Health and Northeast Georgia Hospital System, aiming to onboard these partners by the end of 2025.
Further bolstering its clinical footprint, Artrya secured Piedmont Healthcare and Huntsville Hospital Heart Centre as partners for the upcoming SAPPHIRE study, set to commence in early 2026. This multi-centre study aims to validate the platform's ability to identify high-risk coronary artery disease patients, with a particular focus on women, a demographic often underdiagnosed.
Financial Strength Fuels Expansion
Supporting these operational advances, Artrya completed an $80 million capital raising during the quarter. This funding will underpin the build-out of its U.S. commercial infrastructure, including the hiring of a senior Customer Success Director and additional integration and clinical support specialists based in the U.S.
Despite operating cash outflows of $6 million for the quarter, largely driven by commercial scale-up and regulatory activities, the company ended September with a robust cash balance of $62.8 million. Including subsequent share purchase plans and placement tranches, pro forma cash stands at approximately $82.5 million, providing a solid runway for 2026 initiatives.
Looking Ahead
Artrya is preparing for the FDA submission of its next product, the Salix Coronary Flow module, following a successful pre-submission meeting with the FDA. The company’s near-term priorities include finalising commercial agreements, expanding the SAPPHIRE study network, and continuing to build its U.S. team to support a broader commercial launch next year.
With regulatory approvals in hand and a clear path to market, Artrya is positioning itself to become a significant player in the AI-powered cardiac diagnostics space, leveraging technology to improve patient outcomes and capture a growing share of the U.S. healthcare market.
Bottom Line?
Artrya’s strategic investments and regulatory wins set the stage for a transformative U.S. commercial rollout in 2026.
Questions in the middle?
- How quickly will Artrya convert ongoing U.S. hospital negotiations into revenue-generating contracts?
- What impact will the SAPPHIRE study results have on broader clinical adoption and reimbursement?
- When can investors expect FDA clearance and commercial launch of the Salix Coronary Flow module?