Caristo's CaRi-Heart® FAI-Score™ Demonstrates Superior Prognostic Capability in Landmark Study of 19,110 Patients Published in JAMA Cardiology

• Very high coronary inflammation assessment in patients with a calcium score of zero associated with a 14.1x higher risk of cardiovascular death
• Very high coronary inflammation assessment without calcified or non-calcified plaque associated with a 10.4x higher risk of cardiovascular death
• The study also revealed a research expansion to Caristo's technology that could bring FAI-Score for coronary inflammation assessment to the millions of asymptomatic individuals undergoing routine non-contrast scans used for calcium scoring

OXFORD, England, Nov. 11, 2026 /PRNewswire/ -- Caristo Diagnostics, a global leader in AI-powered cardiovascular technology, today announced the publication in JAMA Cardiology of landmark University of Oxford-led research validating its CaRi-Heart technology in 19,110 patients. The study shows that measuring coronary inflammation adds significant prognostic value beyond coronary artery calcium (CAC) scoring, non-calcified plaque, and traditional cardiovascular risk factors. These findings have important implications for cardiovascular risk assessment and clinical management.

The study highlights Caristo's one-of-a-kind ability to identify cardiovascular risk driven by coronary inflammation, accurately predict events, and reclassify patient risk. The study showed that patient classes previously considered to be low-risk accounted for large percentages of overall cardiovascular deaths.

• 51% of major cardiovascular events and 42% of cardiovascular deaths occurred in patients with a CAC score below 100.
• Among patients with CAC score zero who subsequently died from cardiovascular causes, FAI-Score correctly reclassified nearly half as high- or very high-risk.

"Unlike calcium and plaque, which reflect the result of atherosclerotic disease, coronary inflammation is the biology driving the disease," said Professor Charalambos Antoniades, British Heart Foundation Chair of Cardiovascular Medicine at the University of Oxford and senior author of the study. "Our research shows that coronary inflammation is an independent predictor of cardiovascular death, adding vital prognostic information even in the absence of calcified or non-calcified plaque."

"This groundbreaking research reinforces the importance of looking beyond plaque, calcium scores, and traditional risk factors to understand the coronary inflammation driving cardiovascular disease and provide patients with highly accurate, personalized risk predictions," said Steve Deitsch, CEO of Caristo Diagnostics. "Importantly, Caristo's technology reveals otherwise invisible coronary inflammation using an existing, standard CCTA scan. This new dimension of cardiovascular care is now in the hands of physicians around the world, improving clinical management and patient outcomes."

About Caristo Diagnostics 

Caristo Diagnostics is a global leader in AI technologies for cardiovascular disease, founded as a spin-out from the University of Oxford. Its award-winning CaRi-Heart® technology helps detect hidden heart disease and identify people at risk of heart attack before symptoms appear. Working with leading hospitals, research institutions, and pharmaceutical partners, Caristo aims to save lives through early detection and personalized prevention. The company was named a 2026 Technology Pioneer by the World Economic Forum in June 2026. Learn more at www.caristo.com and follow Caristo on LinkedIn, YouTube, and X. 

About CaRi-Heart^® Technology and FAI-Score™ 

FAI-Score is the core measurement behind CaRi-Heart^®, the first and only FDA-authorized technology to quantify coronary inflammation. FAI-Score™ is Caristo's validated, proprietary biomarker of coronary inflammation. Using AI, it analyzes the fat surrounding the coronary arteries, known as pericoronary adipose tissue (PCAT), on a routine coronary CT angiogram (CCTA), correcting for technical and biological factors so results are standardized across patients and imaging environments. In the ORFAN study, coronary inflammation measured by FAI-Score predicted cardiovascular death independently of traditional risk factors and plaque and added prognostic value beyond calcium scoring. Application of FAI-Score to non-contrast CT scans is investigational.  

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SOURCE CARISTO DIAGNOSTICS