Cardio Diagnostics Holdings Inc (NASDAQ: CDIO) is a medical diagnostics company that develops and commercializes epigenetic and genetic blood tests for cardiovascular disease detection and risk assessment. Revenue is generated on a transactional, per-unit basis through sales of clinical tests to healthcare providers and channel partners, with reimbursement from Medicare and other payors as a key commercial dependency noted in the FY2025 10-K. The company's core products include Epi+Gen CHD, PrecisionCHD, and HeartRisk, a cardiovascular disease risk intelligence platform, all built on a proprietary AI-driven Multi-Omics Engine. CDIO operates in an early-stage, fragmented epigenetic diagnostics market that the company describes as relatively new as of the filing dated March 13, 2026. Primary financing through the period ending December 31, 2025 was an at-the-market equity offering, and the company reported accumulated net losses on its balance sheet as of December 31, 2025.
- Revenue model
- Per-unit transactional revenue from clinical blood test sales to healthcare providers and channel partners, with reimbursement from Medicare and commercial payors as a stated prerequisite for scaling revenue (per FY2025 10-K). The ATM equity offering was the primary financing source for the two years preceding the March 2026 filing.
- Products and services
- Epi+Gen CHD (epigenetic and genetic coronary heart disease test), PrecisionCHD (coronary heart disease test), HeartRisk (cardiovascular disease risk intelligence platform), and pipeline tests targeting stroke, congestive heart failure, and diabetes, all built on the AI-driven Multi-Omics Engine (per FY2025 10-K).
- Customers and end markets
- Healthcare providers, health systems, and channel partners focused on cardiovascular disease prevention and primary care. End market is cardiovascular diagnostics and epigenetic testing. The company is developing go-to-market approaches across multiple vertical markets as of the FY2025 10-K filing.
- Value-chain role
- Test developer and diagnostics provider. Relies on a limited number of suppliers, contract manufacturers, and logistics providers for test production and delivery (per FY2025 10-K). Offers channel partnerships with per-unit pricing structured to partner network size.
- Geographic exposure
- United States, based on regulatory references to Medicare reimbursement and CDC citations. No international operations disclosed in the filing excerpts.
Source: SEC 10-K, filed 2026-03-13
Industry:
In Vitro & In Vivo Diagnostic Substances
Peers:
Achieve Life Sciences Inc
Alzamend Neuro Inc
Bioxytran Inc
Candel Therapeutics Inc
Damora Therapeutics Inc
HOOKIPA Pharma Inc
Dianthus Therapeutics Inc
Maia Biotechnology Inc
KINETA, INC./DE