CDIO 8-K — Smart Summary

Cardio Diagnostics Holdings, Inc. released a February 2025 investor presentation highlighting its epigenetics and AI-driven precision cardiovascular medicine platform. The company offers launched and in-development clinical and non-clinical products addressing coronary heart disease (CHD), stroke, congestive heart failure, and diabetes, targeting a total U.S. addressable market of over $300B by 2026. Key milestones include awarded CPT PLA® codes, a Vizient contract covering ~60% of US hospitals and 97% of academic medical centers, and a completed FDA pre-submission for PrecisionCHD.

• Total U.S. addressable market across launched and in-development products exceeds $300B by 2026, comprising: Epi+Gen CHD ($51B; 146M adults at $350/test), PrecisionCHD ($134B; 157M adults at $850/test), CHF Risk ($53B; 152M adults at $350/test), Stroke Risk ($53B; 153M adults at $350/test), and Diabetes Risk ($49B; 140M adults at $350/test).
• Epi+Gen CHD demonstrated 76% sensitivity for men and 78% sensitivity for women, which is 1.7x and 2.4x more sensitive for men and women, respectively, compared to the average sensitivity of the Framingham Risk Score (FRS) and ASCVD Pooled Cohort Equation (PCE); FRS & PCE average sensitivity was 44% in men and 32% in women.
• PrecisionCHD demonstrated 80% sensitivity for men and 76% sensitivity for women, compared to exercise ECG sensitivity of 45–68%; clinical evidence was peer-reviewed and published in the Journal of American Heart Association.
• Epi+Gen CHD showed up to $42,000 in cost savings per quality adjusted life year and improved survival in a health economic study.
• Awarded CPT PLA® codes by the American Medical Association: 0439U for Epi+Gen CHD and 0440U for PrecisionCHD, effective April 1st, 2024.
• Secured an Innovative Technology contract with Vizient, Inc. (the nation's largest provider-driven healthcare performance improvement company), placing Cardio Diagnostics on contract with about 60% of hospitals and 97% of academic medical centers in the US.
• Completed first pre-submission with the FDA pertaining to PrecisionCHD and received FDA feedback; also completed pre-submission with MolDX and received feedback for Medicare coverage determination; obtained gapfill pricing determination from CMS for Epi+Gen CHD and PrecisionCHD.
• Key commercial milestones include: launched Heart Attack Prevention Initiative with Family Medicine Specialists; expanded to their Walmart location in Q2 2024 and Meijer location in Q3 2024; entered agreement with Aimil Ltd to introduce technology in India.
• Patents granted in India, China, Australia, and the United States (second patent); company is setting up a new operations hub including a high complexity CLIA lab, kitting and fulfillment, and research lab to scale operations and reduce operating costs.
• Cardiovascular disease accounts for nearly 19 million deaths per year globally (~32% of all global deaths), with a projected cumulative output loss of $47 trillion from 2011 to 2030; in the US, heart disease causes approximately 659,000 deaths annually (1 in every 4 deaths) and nearly $1 billion/day in medical costs and lost productivity.