Leveraging AI To Accurately Identify Patients At Risk Of Coronary Artery Disease
Pictured: The BioMedTech Horizons program funding enabled Artrya to refine its Salix® Coronary Anatomy software, clinically validate its solution for regulatory approval and complete commercialisation.
Artrya, a Perth-based digital health company, is set on improving clinical outcomes for those at risk of heart attack through its Artificial Intelligence-based tools to analyse coronary computed tomography angiography (CCTA) images. Artrya’s approach is to minimise requirements for highly invasive tests and to extend the insight available through the non-invasive CCTA.
Coronary heart disease (CHD) is the leading cause of death in Australia, accounting for 17,300 deaths1 in 2021 – representing 10 per cent of all deaths and 41 per cent of cardiovascular disease deaths. In 2020, the estimated direct health expenditure on CHD in Australia was $2.4 billion1 and in 2022, CHD remained the leading specific cause of burden in Australia, with 306,000 years of healthy life lost.
CHD occurs when the major blood vessels that supply the heart (coronary arteries) struggle to send enough blood, oxygen and nutrients to the heart muscle. Atherosclerotic plaques (cholesterol deposits) in the arteries and inflammation are typically the cause.
Heart attack risk and the benefits of coronary revascularisation are determined by the susceptibility of atherosclerotic plaque to rupture and the burden of restricted blood flow (ischaemia).
Common current test is expensive and exposes patients to potentially serious complications
An invasive coronary angiography (ICA) is the most common test to detect CHD, yet it provides no direct assessment of ischaemic burden, is associated with considerable cost and exposes patients to potentially serious complications. Assessing ischaemia requires an additional invasive test, the fractional flow reserve (FFR).
To reduce ICA risks and costs, non-invasive stress tests (treadmill, stress echocardiogram, myocardial perfusion imaging [MPI] and coronary computed tomography angiography [CCTA]) are used. Except for CCTA, these tests have limited accuracy and provide no information about coronary plaque characteristics.
CCTA has greater than 95 per cent predictive value in excluding the presence of CHD2, but is unable to assess ischaemia, which requires an additional test. Recent advances in computational fluid dynamics (CFD) address this limitation by estimating FFR non-invasively from a standard CCTA scan. However, the only commercially available non-invasive CCTA-based FFR assessment is costly and requires offsite analysis for up to two days, severely limiting its use.
Using custom AI to analyse CCTA for blockages and build-up of high-risk plaque
Artrya’s non-invasive point-of-care software solution uses its custom AI to analyse CCTA for blockages and build-up of high-risk plaque in blood vessels. The cloud-based tool’s assessment process is completed within 15 minutes, offering substantial time and cost savings compared to competing technologies and current industry practices, which often take 45 minutes or longer for complex cases.
The software can identify two forms of plaques: those that limit blood flow, causing ischemia, and those not presently hemodynamically significant, but prone to rupture and consequently cause heart attack – vulnerable plaques that will evolve and eventually lead to acute coronary syndrome (ACS). Accurately identifying the former could reduce the healthcare costs associated with the management of symptomatic patients, while the latter could reduce both the economic and societal costs of ACS, which The Heart Foundation estimated to be $6.8 billion in 2017–183.
The BioMedTech Horizons (BMTH) program funding enabled Artrya to refine its beta product, clinically validate its solution for regulatory approval and complete commercialisation. Additionally, it supported the development of a novel method to measure blood flow non-invasively off the same CCTA scan. This method helps clinicians identify areas where there is not enough blood reaching the heart due to blockages, using the principles of fluid dynamics to pinpoint these blockages without the need for invasive procedures like angiograms.
Remarkable technology – identifies arterial narrowing & targets challenging imaging biomarkers
Artrya’s Chief Scientific Officer, Professor Girish Dwivedi, said of the project’s success: "Our work through the BMTH program has led to the development of ‘Salix’, an advanced AI-powered solution that assesses heart CT scans. This remarkable technology not only identifies arterial narrowings, but also targets challenging imaging biomarkers that often go unnoticed and aren’t reported. Our internal studies have demonstrated Salix's immense promise, positioning it as a true game changer in the field of cardiac CT scans."
Once in market, Salix has the potential to deliver significant value – empowering clinicians and patients to improve diagnosis in a more time-efficient manner and with greater accuracy and precision. It will also enhance understanding for all stakeholders in the care pathway, guide personalised treatment (whether lifestyle or medical therapy) and track therapeutic success by assessing disease progression and plaque transformation.
To drive approval and adoption of its solution, Artrya has assembled a highly skilled global team with impressive credentials, leveraging Salix's unique value proposition to improve outcomes and productivity for patients, providers and payers.
For the BMTH project, a key objective was to refine and validate the underlying algorithms. Artrya forged strategic partnerships with prominent institutions in Australia and internationally. The Harry Perkins Institute of Medical Research in Western Australia played a vital role, by offering invaluable clinical insights and subject matter expertise for the development and evaluation of the vulnerable plaque algorithm. Canada’s University of Ottawa Heart Institute played a key role in providing valuable clinical expertise, and also granted access to a substantial CCTA dataset.
Key opinion leaders involved with validating Artrya’s algorithms’ efficacy
Several distinguished key opinion leaders from Stanford University, Mayo Clinic and the Huntsville Hospital Heart Center in the US participated in various studies. Their involvement contributed significantly to validating Artrya’s algorithms' efficacy. These partnerships also played a crucial role in providing insights and feedback for the refinement and development of the company’s software products.
As part of the BMTH project, Artrya conducted an extensive market assessment and sizing, segmentation, competitors’ analysis and pricing strategies for Australia, the US, the European Union (EU), the UK and Canada, utilising the services of EVERSANA. This analysis has further solidified and validated the company’s business case for Salix, while also revealing additional opportunities for Artrya's products.
The funding also allowed Artrya to develop unique intellectual property, differentiating its solution from competitors, safeguarding the software and establishing a competitive advantage in key areas. This achievement included the submission of eight patents currently under review by patent offices, as well as the approval of 12 trademarks. To ensure adherence to quality standards and software development as a medical device, Artrya obtained several essential ISO certifications.
Regulatory approvals in Australia, the UK, Europe and the US
The company also gained several regulatory approvals, including Therapeutic Goods Administration (TGA), UK Conformity Assessed (UKCA) and Conformité Européenne (CE). Additionally, Artrya initiated the regulatory approval process with the US Food and Drug Administration (FDA).
During the project period, Artrya progressed through a pre-initial public offering (IPO) fundraising round of $15 million and an IPO round of $40 million and was successfully listed on the Australian Securities Exchange (ASX:AYA) in 2021.
As Artrya CEO Mathew Regan explained: “Artrya is very focused on saving lives using our breakthrough AI technology. The BMTH program has provided important support to our dedicated team as they have developed the product. We are moving rapidly to the commercialisation phase of our development here in Australia and working hard to secure FDA approval.”
Expanding its footprint in the US and commencing commercial operations in Australia
Artyra has recently expanded its footprint in the US, signing strategic commercial agreements with Northeast George Health Ventures in November 2023 and with the US hospital group Tanner Health System and Healthliant Ventures in March 2024.
In early April 2024, Artrya announced it was commencing commercial operations in Australia with an agreement with The Cardiac Centre NSW and The Cardiac CT Centre NSW, based in the Illawarra and south coast of New South Wales. Cardiovascular imaging specialists will use Artrya’s Salix® Coronary Anatomy software to detect vulnerable plaque in patients across four specialist cardiac centres in Wollongong, Shellharbour, Bowral and Nowra. First revenues are expected in Q4 FY24, with fees generated through a subscription model to the Salix platform.
1. Australian Institute of Health and Welfare. Heart, stroke and vascular disease: Australian facts.
3. Economic Cost of Acute Coronary Syndrome in Australia, 2018.