New research led by the University of Oxford has validated Caristo Diagnostics’ fat attenuation index-score (FAI) biomarker’s role in coronary inflammation assessment, suggesting future applications for the company’s CaRi-Heart technology.
Findings from two separate analyses of Caristo’s ORFAN study (NCT05169333) on predicting future stroke risk with its AI-based CaRi-Heart technology were presented during the 2026 European Society of Cardiology (ESC) congress in Munich, Germany.
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The company said the findings build on the same coronary inflammation biology and AI technology underpinning CaRi-Heart and suggest what future advancements may be possible with the imaging software. CaRi-Heart secured de novo classification from the US Food and Drug Administration (FDA) in July 2026 for quantifying coronary inflammation from routine coronary CT angiography (CCTA). It obtained a European CE mark in 2021. The technology works by analysing CT scans to measure changes in fat tissue surrounding coronary arteries known as the FAI biomarker.
By using its FAI-Score biomarker, CaRi-Heart was able to assess coronary inflammation from a non-contrast CT – a first for the scan modality, Caristo stated.
The Oxford, UK-headquartered company highlighted that those with elevated FAI-Score had a significantly higher risk of cardiovascular mortality, even in patients with a zero-calcium score.
Another ORFAN sub-analysis found that coronary inflammation, as measured by FAI-Score, predicted cardiovascular death, even in patients who displayed none of the standard modifiable risk factors (SMuRFs), including diabetes, hypertension, and high cholesterol.
The predictive value was strongest in this group, underscoring the potential limitations of traditional risk-factor-based assessment alone, Caristo stated.
Steve Deitsch, CEO of Caristo Diagnostics said: “Nearly 50% of first-time heart attacks occur in people classified as ‘low risk’ by traditional cardiovascular risk assessments, underscoring the need for new ways to identify vulnerable patients earlier.
“The research presented at ESC congress 2026 shows how much further our technology could go, from detecting coronary inflammation on a routine non-contrast scan to catching the earliest signs of stroke.”
Predicting stroke independent of atrial fibrillation
Caristo also presented data from its decade-long ORFAN-MAESTRIA study of more than 81,000 patients at ESC.
Centred on predicting future stroke risk, researchers found that Caristo’s technology identified signs of left atrial myopathy on routine cardiac CT that predicted future stroke risk. Patients identified as high-risk had a 17-fold higher likelihood of cardioembolic stroke than those identified as low-risk, outperforming today’s standard clinical risk tool, according to Caristo.
Caristo highlighted that its algorithm flagged this risk independently of atrial fibrillation, indicating it can catch danger in patients who show no warning signs on a standard heart rhythm test.
Professor Charalambos Antoniades, British Heart Foundation chair of Cardiovascular Medicine at the University of Oxford and principal investigator of the ORFAN-MAESTRIA study, commented: “FAI-Score is helping us identify coronary inflammation and better predict cardiovascular risk.
“Looking ahead, the same scientific approach could be applied to other disease pathways, including left atrial myopathy, to help predict future cardioembolic stroke. By applying the same biological framework to different pieces of the cardiovascular puzzle, we can help clinicians detect high-risk patients sooner and intervene earlier.”
Cardiovascular disease is the world’s leading cause of death, with roughly 85% of those deaths caused by heart attacks and strokes, as per the World Health Organization (WHO).
