CDIO 8-K — Smart Summary

Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO) released its March 2024 investor presentation highlighting its AI-driven precision cardiovascular medicine products, commercial milestones, and market opportunity. The company has launched multiple epigenetics-based clinical tests and platforms targeting a total U.S. addressable market exceeding $300 billion. Key 2023 and Q1 2024 milestones include new commercial partnerships, CPT code awards, FDA pre-submission, new product launches, and international patent grants.

• Market cap of $31 million as of 3/21/2024; listed on NASDAQ under ticker CDIO.
• Launched Epi+Gen CHD (only epigenetics-based test for coronary heart disease risk assessment, $51B US TAM at $350/test for ~146M Americans ages 35-75) and PrecisionCHD (only epigenetics-based test for coronary heart disease detection, $134B US TAM at $850/test for ~157M Americans ages 35-80), for a combined $185B US TAM.
• Pipeline tests in development include CHF Risk ($53B TAM, expected 2024/2025), Stroke Risk ($53B TAM, expected 2024/2025), and Diabetes Risk ($49B TAM, expected 2025/2026), targeting a total US addressable market of $340B by 2026.
• Epi+Gen CHD demonstrated 76% sensitivity for men and 78% sensitivity for women — 1.7x and 2.4x more sensitive than the average sensitivity of FRS and PCE, respectively — and showed up to $42,000 in cost savings per quality adjusted life year.
• PrecisionCHD demonstrated 80% sensitivity for men and 76% sensitivity for women, compared to the sensitivity of exercise ECG of 45-68%.
• Awarded CPT PLA® codes by the American Medical Association: 0439U for Epi+Gen CHD and 0440U for PrecisionCHD (also referenced as 0449U for PrecisionCHD in one slide); completed first pre-submission with the FDA pertaining to PrecisionCHD and received FDA feedback.
• Secured Innovative Technology contract with Vizient, Inc., placing Cardio Diagnostics on contract with about 60% of hospitals and 97% of academic medical centers in the US.
• Secured a contract with Family Medicine Specialists (a risk-bearing provider) to test at least 1,200 patients on BlueCross BlueShield and other health plans, with announced expansion to their Walmart location in Q2 2024.
• Entered into an agreement with Aimil Ltd to introduce the company's technology in India; patents granted in India, China, Australia, and the United States (second patent).
• Launched HeartRisk (SaaS cardiovascular risk intelligence platform), Actionable Clinical Intelligence, and CardioInnovate360 (research-use-only biopharmaceutical research solution); also announced a new operations hub including a high complexity CLIA lab, kitting and fulfillment, and research lab to scale operations and reduce operating costs.