European Society of Cardiology (ESC) Congress 2025 Late Breaking Results Confirm Caristo FAI-Score™ Technology's Superior and Complementary Predictive Value for Cardiac Death Beyond hsCRP

• FAI-Score has stronger predictive value than hsCRP for 10-year cardiac death, even among those with zero calcium score and no visible coronary plaque
• In patients with low hsCRP, high FAI-Score predicts 7-fold higher risk of cardiac death

OXFORD, England, Sept. 11, 2025 /PRNewswire/ -- Caristo Diagnostics, announced the late breaking scientific evidence presented at the 75^th annual ESC Congress 2025, confirming CaRi-Heart® Fat Attenuation Index Score (FAI-Score™) technology's superior and complementary predictive value for cardiac death beyond high-sensitivity C-reactive protein (hsCRP), a systemic inflammation biomarker.

At the recent ESC late-breaking clinical science session, Oxford University researchers reported their study findings on the interplay between hsCRP and FAI-Score for cardiovascular risk prediction. hsCRP captures systemic inflammatory pathways in a blood test, while FAI-Score measure coronary inflammation specifically by mapping perivascular adipose tissue changes in routine coronary computed tomography angiography (CCTA). The study recruited 103 patients undergoing coronary artery bypass graft (CABG) surgery from the Oxford Heart Vessel and Fat study, while it included also a series of post-mortem CT scans linked with histological preparations of the coronary arteries to better understand the relationship between FAI-Score and coronary inflammation. Finally, the study enrolled 16,465 consecutive individuals from the Oxford Risk Factor and Non-Invasive Imaging (ORFAN) study (NCT05169333).

Study results confirmed FAI-Score's predictive value for cardiac mortality:

• FAI-Score is more specific in capturing certain types of inflammatory cells inside the human coronary artery which is directly related to atherogenesis, while hsCRP relates to a broader range of systemic inflammatory responses
• FAI-Score has very high prognostic performance for cardiac mortality and identifies high risk patients even in population without elevated hsCRP, especially among patients with zero calcium score and no visible coronary plaques, while risk prediction is consistent for over a decade after the CCTA scan
• FAI-Score and hsCRP are complementary - if both are elevated, cardiac mortality risk is more than 25 times higher

Caristo's FAI-Score technology was originally developed at Oxford University with funding from The British Heart Foundation (BHF).

Professor Charalambos Antoniades, BHF Chair of Cardiovascular Medicine at the University of Oxford and lead investigator of the study, commented: "Inflammation is a key process for coronary atherosclerosis, and FAI-Score is known to predict inflammatory risk. Interestingly, our study unveils the specific inflammatory pathways within the human arteries that are captured by FAI-Score, and confirms its specificity for local inflammatory pathways within the human arteries different to what is captured by hsCRP. This opens up new opportunities for using the CaRi-Heart FAI-Score technology to guide treatments in clinical practice."

Caristo Diagnostics is on a mission to transform the diagnosis and treatment of cardiovascular disease, and its CaRi-Heart technology is the only product around the world with the FAI-Score capabilities. CaRi-Heart technology is regulatory cleared for use in Europe, UK, Australia, and is pending FDA clearance for U.S. clinical use. In the meantime, the company has achieved two significant U.S. regulatory milestones in 2025. The AMA CPT Panel approved a new Category III CPT® for the CaRi-Heart technology. In addition, the Food and Drug Administration (FDA) granted clearance for Caristo's CaRi-Plaque™ technology for plaque and stenosis quantification.

About Caristo Diagnostics
Caristo Diagnostics is a global leader in AI-powered heart disease detection. A spinout from the University of Oxford, Caristo's award-winning technology is transforming cardiovascular care by identifying hidden heart attack risks before symptoms appear. Backed by leading hospitals and scientists, Caristo is on a mission to save lives through early detection and personalized prevention. For more information, visit caristo.com. Find Caristo online on LinkedIn, YouTube, and X.

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