CDIO 8-K — Smart Summary

Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO) held an investor conference call on February 19, 2026, presenting its 2026 investor presentation covering its AI- and epigenetics-driven cardiovascular diagnostic tests, Epi+Gen CHD and PrecisionCHD. The company highlighted recent clinical data presented at the American Heart Association and American College of Cardiology conferences, reimbursement milestones, and international expansion efforts. The presentation outlined a combined total addressable U.S. market estimated at over $176 billion across its two commercial tests.

• Cardio Diagnostics has developed what it describes as the first and only commercial solutions leveraging epigenetics and AI for cardiovascular disease prevention and early detection, with an internal estimate of over $176B total addressable market (TAM) across Epi+Gen CHD and PrecisionCHD.
• Epi+Gen CHD is intended for Americans aged 35–75 with no history of coronary heart disease (CHD); approximately 146M Americans are estimated to be eligible, with a final CMS payment rate of $854 and an estimated total addressable U.S. market of ~$125B; the test is 2.4x more sensitive for women and 1.7x more sensitive for men compared to the Framingham Risk Score and ASCVD Pooled Cohort Equation, and offers up to $42K in cost savings per quality adjusted life year (QALY).
• PrecisionCHD is intended for those aged 35–80 presenting to be evaluated for CHD; approximately 60M Americans are estimated to be eligible, with a final CMS payment rate of $854 and an estimated total addressable U.S. market of ~$51B; it is 1.3x more sensitive for women and 1.4x more sensitive for men compared to a stress ECG, and could save ~$113M in the first year if used as the primary method of initial CHD assessment for one million lives.
• The company's internal CLIA lab was recently launched; a survey on February 10, 2026 found no deficiencies and all CLIA conditions were met; the lab achieved an initial COGS reduction of ~30% with additional reduction expected at scale, and has a turnaround time (TAT) from sample receipt of approximately 7–10 business days.
• Clinical data on INOCA (Ischemia with No Obstructive Coronary Arteries) for PrecisionCHD was presented at the American Heart Association Conference; up to ~70% of patients referred for coronary angiography due to angina and evidence of ischemia have no obstructive coronary arteries.
• Data on ACS (Acute Coronary Syndrome) patient mortality was presented at the American College of Cardiology Conference; PrecisionCHD's methylation-sensitive digital PCR (MSdPCR) achieved an AUC of 0.701 vs. Duke Jeopardy Scores (DJS) AUC of 0.647, and the combined MSdPCR + DJS achieved an AUC of 0.729; approximately 1.4 million Americans are hospitalized with ACS each year.
• Both tests have assigned CPT PLA codes: Epi+Gen CHD (0439U) and PrecisionCHD (0440U), each with a final CMS payment rate of $854; Medicare coverage process is ongoing; out-of-network billing capability is expected in Q2 2026; commercial payer pilot program engagement is underway.
• International expansion includes an announced partnership in India with Aimil Ltd and Dr. Lal PathLabs; Dr. Lal PathLabs has 290+ clinical labs and 300+ MD pathologists in their internal network; the company is also exploring partner-led international expansion in Asia, Middle East, and Africa.
• Target gross margin at scale is 40–60% for the U.S. market.
• U.S. commercial targets include employers/unions (remote and heart health fair options), providers and health systems (telemedicine and onsite options with internists, PCPs, and preventive cardiologists), and channel partners focused on awareness, education, and access.