Cardio Diagnostics is an early-stage medical technology company that develops and sells blood-based clinical tests for cardiovascular disease. Its two core products — Epi+Gen CHD and PrecisionCHD — use DNA methylation (epigenetic) and genetic biomarkers to assess near-term coronary heart disease (CHD) risk and detect existing CHD, respectively. Unlike static genetic tests, epigenetic markers can shift over time in response to lifestyle changes, meaning Cardio's tests can also monitor a patient's response to interventions like smoking cessation. Cardio sells primarily to healthcare organizations — providers, health systems, concierge practices, and self-insured employers — through direct sales and channel partnerships, with sales cycles often running up to 24 months. Revenue is generated on a per-test basis. Both tests have received CMS gapfill reimbursement rates of $854 per test, but broad payor coverage has not yet been secured, which meaningfully limits the addressable market. Cardio also offers HeartRisk, a software platform that aggregates population-level CVD risk data for health systems and employers, and CardioInnovate360, a research product for biopharma companies. Cardio processes tests in its own CLIA-certified lab and is investing in automation to improve margins. The company's core technology is a proprietary AI-driven Multi-Omics Engine developed over more than a decade, protected by two issued U.S. patents and additional patents pending globally, with foundational IP licensed from the University of Iowa through approximately 2037.
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