Caristo Diagnostics

Executive Summary

Caristo Diagnostics is a UK-based medtech company founded in 2018 that leverages AI to transform cardiovascular care. Its flagship product, CaRi-Heart®, analyzes routine cardiac CT scans to quantify hidden coronary inflammation and plaque characteristics, generating individualized risk scores. This enables earlier detection of coronary artery disease, improved risk stratification, and tailored treatment planning. The company addresses a critical gap in preventive cardiology, where standard CT angiography often misses inflammatory activity that predicts future events. Caristo's technology has the potential to reduce heart attacks and healthcare costs by guiding proactive interventions. Backed by strong clinical evidence and partnerships with leading institutions, the company is well-positioned to commercialize CaRi-Heart in Europe and beyond. The global burden of cardiovascular disease and the growing adoption of cardiac CT present a substantial market opportunity. Caristo's first-mover advantage in AI-powered coronary inflammation analysis differentiates it from competitors focused solely on plaque quantification. The company is pursuing CE marking under the EU Medical Device Regulation (MDR) and preparing for US FDA submission. With a robust intellectual property portfolio and ongoing validation studies, Caristo is poised for near-term regulatory milestones and commercial partnerships. However, as a private company, visibility into funding and revenue is limited. The conviction score reflects strong technology differentiation and near-term regulatory catalysts balanced by early-stage commercial risk.

Upcoming Catalysts (preview)

• H2 2026CE Mark Approval under EU MDR for CaRi-Heart70% success
• Q3 2026Strategic Partnership with Major Cardiac Imaging Network60% success
• Q4 2026Publication of Pivotal Clinical Validation Study in Peer-Reviewed Journal80% success