Findings Presented for Caristo’s FAI-Score Biomarker and Other NC Cardiac CT Applications 

September 4, 2026—Caristo Diagnostics announced new research demonstrating that the company’s FAI-Score biomarker can unlock coronary inflammation assessment in noncontrast cardiac CT, identifying high risk even in patients with a zero coronary calcium score.

According to the company, the findings build on the same coronary inflammation biology and artificial intelligence (AI) technology underpinning the CaRi-Heart technology, which is Caristo’s FDA-authorized and commercially available product for coronary inflammation assessment from routine coronary CT angiography. CaRi-Heart is intended to help detect hidden heart disease and identify people at risk of heart attack before symptoms appear.

Caristo Diagnostics, which is a spin-out from the University of Oxford in Oxford, United Kingdom, stated that the independent Oxford-led research was presented at the European Society of Cardiology’s 2026 ESC congress.

The presented data reinforce the evidence that coronary inflammation can provide additional risk information from scans already used in routine cardiovascular care, stated Caristo.

As summarized in the company’s press release, the FAI-Score biomarker was the focus of two separate analyses from ORFAN, the Oxford Risk Factors and Noninvasive Imaging study.

The first analysis showed FAI-Score unlocked coronary inflammation assessment from a noncontrast CT. Even in patients with a zero-calcium score, those with elevated FAI-Score had a significantly higher risk of cardiovascular mortality.

The second analysis found that coronary inflammation, measured by FAI-Score, predicted cardiovascular death even in patients with none of the standard modifiable risk factors of diabetes, hypertension, high cholesterol, smoking, and obesity. The predictive value was strongest in this group, underscoring the potential limitations of traditional risk-factor-based assessment alone.

Additionally, the decade-long ORFAN-MAESTRIA study of more than 81,000 patients found that Caristo’s AI 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 the current standard clinical risk tool. The algorithm flagged this risk independently of atrial fibrillation, meaning it can catch danger in patients who show no warning signs on a standard heart rhythm test, noted the company.

In a separate investigator-led ORFAN analysis, investigators developed an AI signature designed to create a “virtual biopsy” of cytokine-driven inflammation in the artery wall across more than 80,000 patients in the United Kingdom and the United States.

As reported in the company’s press release, the signature predicted long-term cardiac mortality in the cohorts, along with an elevated risk of heart failure and kidney disease among patients with the highest inflammation signal. The findings support the value of assessing biological inflammation with routine CT imaging and may inform patient selection for anti-inflammatory therapies. This analysis remains investigational and is not currently available as a commercial Caristo product, advised the company.