Biograph Completes First U.S. Study with Caristo Diagnostics’ AI-Powered Coronary Inflammation Detection, Finding Risk in Over 42% of Asymptomatic Patients

The study evaluated whether AI analysis of coronary inflammation in cardiac CT scans can help identify early cardiovascular risk before symptoms or obstructive plaque appear

SAN MATEO, Calif. & NEW YORK--(BUSINESS WIRE)--Biograph, the world’s most advanced preventive health and diagnostics clinic, today announced the completion of its first U.S. study using Caristo Diagnostics’ CaRi-Heart^® technology evaluating AI-powered coronary inflammation detection in asymptomatic, low-risk individuals. The research revealed that coronary inflammation is widespread among asymptomatic adults without known heart disease – and is undetected by standard blood tests and other traditional cardiovascular risk factors.

The study, available to clinically eligible Biograph Black tier members, combined Biograph’s advanced diagnostics – including high-resolution coronary computed tomography angiography (CCTA) imaging and cardiometabolic profiling – with Caristo’s CaRi-Heart and CaRi-Plaque® technologies*. This collaborative methodology enabled researchers to assess the prevalence of coronary inflammation using the AI-enabled CaRi-Heart technology to determine cardiovascular risk in individuals who may otherwise appear low risk through traditional screening.

The study found that coronary inflammation is common (42.9%) in asymptomatic, low-risk adults and frequently occurs without any plaque buildup or blockage. Specifically, 42.9% of participants exhibited elevated inflammation with 17.9% of participants exhibiting very high inflammation in at least one major heart artery. The results also suggest a potential limitation in standard assessment: About 47% of participants with no detectable coronary plaque exhibited elevated coronary perivascular inflammation. By evaluating coronary inflammation alongside traditional imaging assessment of plaque burden and stenosis, we get a more complete picture of cardiovascular risk.

Importantly, routine bloodwork and clinical tools – including cholesterol markers (ApoB, non-HDL-C), blood sugar (HbA1c), systemic inflammation (hs-CRP), and a widely used cardiovascular risk calculator (AHA PREVENT-ASCVD) – showed no correlation with the presence of coronary inflammation and failed to identify which patients had inflamed arteries. These results reinforce Biograph’s core philosophy: standalone bloodwork and isolated metrics do not tell the full story. By directly analyzing the biology of the tissue surrounding the coronary arteries, this non-invasive AI technology uncovers potential cardiovascular risk years before the onset of irreversible heart disease.

“Coronary heart disease, whether plaque accumulation or arterial stenosis, is likely a late consequence of an active inflammatory process in the vessel wall," said Michael Doney, MD, MPH, MS, Executive Medical Director at Biograph. "What is striking about our findings is that more than 42% of asymptomatic, conventionally low-risk adults had elevated coronary inflammation, and many individuals with the highest inflammatory levels had completely normal coronary anatomy on CT. Crucially, no routine blood biomarker, lipid metric, or clinical risk score could identify these individuals with inflamed coronary arteries. This study suggests we may be identifying an upstream phase of disease and a window for proactive intervention. More research is needed to validate this finding and establish the prognostic value and benefit of care directed at coronary perivascular inflammation.”

For Biograph, the completion of this study reflects its broader mission to advance proactive, personalized healthcare through comprehensive diagnostics, clinical interpretation, and earlier insight into long-term health risks. To review the clinical study manuscript, readers can access the published preprint here.

*CaRi-Heart^® has received U.S. Food and Drug Administration (FDA) De Novo marketing authorization and is the first and only solution to quantify coronary inflammation from routine coronary CT angiography (CCTA). CaRi-Plaque^® has received U.S. FDA clearance for AI-assisted coronary plaque and stenosis analysis, complementing CaRi-Heart by evaluating quantitative plaque.

About Biograph

Biograph is on a mission to drive meaningful advances in human healthspan and lifespan, combining advanced diagnostics with ongoing physician-led care to help members detect disease earlier and improve long-term health. With an emphasis on human-centered design, its New York City and San Francisco Bay Area clinics defy industry norms and continuously incorporate new research into its method to remain on the cutting edge of medicine. It delivers a comprehensive experience during a single visit day lasting approximately five to six hours – services that traditionally may require nearly three months and visits to nine different medical facilities. Follow Biograph on X and LinkedIn.