Artrya Ltd

Invention:	ML CCTA analysis
Name:	Salix®
Patents:	25 (filed)
FDA Approval:	Yes
Pathway:	Class II 510(k)
ASX:	AYA

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EXECUTIVE SUMMARY

Salix is a point-of-care SaaS platform that delivers realtime machine learning analysis of coronary CT angiograms (CCTA). While CCTA is the first-line, non-invasive modality for assessing coronary artery disease and is effective at detecting luminal stenosis, it has limited ability to characterize the vulnerable plaque within the arterial wall that precipitates most acute coronary syndromes. Salix overcomes this limitation by applying algorithms trained to identify the correlates of vulnerability, including positive remodelling and low-attenuation plaque. 

Salix is the first and only platform to deliver machine learning analysis of CCTA scans in real time at the point of care. Following FDA 510(k) clearance of its plaque analysis module in Q3 2025, the company is now preparing for full commercial deployment into U.S. hospitals, addressing an estimated $4 billion market opportunity.
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Source: https://artrya.com/physicians/

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THE INVENTION

Salix has been trained on thousands of coronary CT angiograms from leading centres in the United States, Australia, and Canada, giving it a strong foundation for accuracy across patient populations. The software utilizes convolutional neural networks (CNNs) to map the coronary arteries, tracing their pathways and segmenting the vessel walls to highlight areas of narrowing. It then analyses the tissue between the inner and outer walls of the arteries to detect high-risk plaque features such as low-attenuation regions, positive remodelling, and small calcifications, while also quantifying plaque volume.

The results are presented to the clinician as a detailed, interactive 3D model of the patient’s heart and arteries. This allows doctors not only to see the degree of stenosis but also to explore the vulnerable plaque burden in real time.

The Salix software solution consists of three seperate components, comprising a base platform and two modules, each of which is subject to FDA approval: 

• Salix Coronary Anatomy (SCA): Core platform, which enables visualisation of coronary artery anatomy, workflow optimisation, physician productivity, and CCTA reporting
• Salix Coronary Plaque (SCP): Detailed plaque characterisation, dispersion and stenosis
• Salix Coronary Flow (SCF): Non-invasive blood flow assessment

TOTAL ADDRESSABLE MARKET

Each year, over four million CCTA scans are performed in the United States, a volume that is steadily increasing as clinicians favour non-invasive imaging over catheter-based diagnostics. 
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The American Medical Association has assigned a Category I CPT code (CPT 0625T) for plaque analysis, and the Centers for Medicare & Medicaid Services (CMS) has established reimbursement at US$950 per scan. This combination creates a recognised and billable service for hospitals, translating into an addressable market of roughly US$4 billion annually for AI-driven plaque assessment.
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​THE COMPETITION
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Artrya’s principal competitor is the U.S.-based company HeartFlow Inc (NASDAQ: HTFL). HeartFlow's technology converts a standard coronary CT angiogram into a three-dimensional model of the arteries and applies computational modelling to estimate blood pressure, flow and plaque burden. The result is a combined anatomical and physiological assessment of disease severity.
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A distinguishing feature of HeartFlow’s platform is its human-in-the-loop workflow. Each case is processed by automated algorithms but reviewed by trained analysts before results are released. While this process ensures that segmentation, modelling and plaque measurements meet strict accuracy standards, it also adds cost and limits throughput compared with fully automated systems, such as Salix.

Like Salix, the HeartFlow platform is modular, comprising a RoadMap Analysis product for anatomical visualization, an FFR-CT Analysis product for non-invasive blood flow analysis, a Plaque Analysis product, and a PCI Planner product (expected to be released in 2026) for advanced visualization and clinical insights. 

As of Q1 2025, the HeartFlow platform has been used to assess CAD in more than 400,000 patients, and its CCTA database currently comprises 110 million images
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FFR-CT

HeartFlow’s original product is an FFR-CT solution, which calculates fractional flow reserve (FFR) from CT data using computational fluid dynamics. Fractional Flow Reserve (FFR) is a measure of how much a coronary narrowing restricts blood flow, expressed as the ratio of pressure after the stenosis to pressure before it; for example, an FFR of 0.8 means blood flow past the narrowing is about 80% of normal, indicating a 20% reduction caused by the lesion.
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Clinical studies including NXT, PRECISE and PACIFIC demonstrated strong correlation with invasive FFR measurements, leading to regulatory approval and inclusion in major U.S. and European guidelines. The technology has since been adopted across hospital networks, supported by reimbursement codes in the United States and Europe. While the company continues to report losses after a long development period, FFR-CT has become a recognised non-invasive alternative to pressure-wire testing.

HeartFlow's flow analysis is priced at USD $1,067 per scan, and comprised over 90% of HeartFlow's revenue in FY2025. 

Plaque Analysis

In 2022 HeartFlow received FDA clearance for Plaque Analysis, an AI-based module that quantifies and characterises plaque from the same CT dataset. It automatically measures calcified, fibrotic and lipid-rich components and integrates these findings with flow data to produce a more comprehensive profile of risk.

The product extends the company’s focus from hemodynamic significance to plaque vulnerability. Validation studies have shown close agreement with intravascular ultrasound, and large registries are underway to assess how plaque metrics influence treatment decisions and outcomes. 

HeartFlow's plaque analysis is priced at USD $300 per scan. 

​FINANCIALS

​COMPETITIVE DIFFERENTIATION

While analysis times for HeartFlow’s plaque and flow solutions can take several hours, Salix delivers results in 8-10 minutes. This speed is enabled by its fully automated, no-human-in-the-loop design, providing a near real-time advantage that enhances clinical efficiency and decision-making.

​CLINICAL STUDIES AND COMMERCIALIZATION

​Artrya’s SAPPHIRE study has entered its final design phase, with recruitment of clinical partners now underway. This flagship retrospective trial will evaluate the company’s proprietary Plaque Dispersion Score (PDS) — a metric that integrates AI-derived anatomical insights with traditional coronary artery disease risk factors.

In August and October 2025, the company announced the onboarding of two major U.S. hospital collaborators for the study — Piedmont Healthcare and Huntsville Hospital Heart Centre.

The goal of SAPPHIRE is to demonstrate how PDS can enhance cardiovascular risk prediction. Traditional measures, such as coronary calcium scoring, often fail to identify patients who are still at significant risk — many of whom experience major cardiac events despite being classified as “low risk.”

Beyond its scientific objectives, SAPPHIRE also plays a role in the company's go-to-market strategy. By collaborating with leading U.S. hospital systems, Artrya intends to convert participating sites into long-term commercial partners. The combined annual CCTA scan volume across the 6–8 hospital centers expected to participate in SAPPHIRE is estimated to be approximately 400,000 scans.

As of Q4 2025, the Salix Coronary Anatomy platform has been integrated with Tanner Health System, and additional integrations are underway with North East Georgia Health Ventures and Cone Health. 

RUNWAY

​In September 2025, Artrya successfully completed an AUD$80 million capital raise, securing more than three years of operating runway based on its 2025 cash burn of approximately AUD$20 million. With several commercial partnerships progressing, the board anticipates achieving cash flow break-even by FY2027.

SOURCES
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Artrya 2025 Annual Report: ​https://wcsecure.weblink.com.au/pdf/AYA/03007279.pdf

Artrya Investor Webinar 22 August 2025: https://artrya.com/investor-calls-webcasts/

Artyra Q4 FY2025 Quarterly Report 29 July 2025: ​https://artrya.com/investor-calls-webcasts/

Artrya Investor Presentation 1 September 2025: https://wcsecure.weblink.com.au/pdf/AYA/02987922.pdf

Artrya Market Announcement - Successful $75 million placement 9 September 2025: https://wcsecure.weblink.com.au/pdf/AYA/02991053.pdf

Artrya Market Announcement -  SAPPHIRE STUDY UPDATE 25 August 2025: https://wcsecure.weblink.com.au/pdf/AYA/02982715.pdf

Artrya Market Announcement -  Huntsville Hospital Heart Centre confirmed as participant in SAPPHIRE Study 7 October 2025: https://wcsecure.weblink.com.au/pdf/AYA/03004196.pdf

HeartFlow prospectus 2025: https://ir.heartflow.com/static-files/71bdecac-2df1-4e42-a20f-fa1d1fdd34c9​

https://cardiovascularbusiness.com/topics/cardiac-imaging/cms-increases-medicare-payments-cardiac-ct-ccta

​https://www.dicardiology.com/article/rising-demand-cardiac-ct-positions-market-major-growth