Cardio Diagnostics Holdings, Inc.

What they do

Cardio develops and commercializes clinical blood tests for cardiovascular disease using its AI-driven Multi-Omics Engine, which combines genetic and epigenetic data. Its launched products include Epi+Gen CHD, a three-year symptomatic coronary heart disease risk test launched in 2021, and PrecisionCHD, a coronary heart disease detection test launched in March 2023. It also offers CardioInnovate360, a research-use-only solution for biopharmaceutical discovery, and HeartRisk, a cardiovascular risk intelligence platform launched in February 2024. Tests are marketed through provider organizations, channel partners, employers, payors and life insurers.

Revenue drivers

• PrecisionCHD — Integrated epigenetic-genetic blood test for detection of coronary heart disease, launched March 2023 and coupled to the Actionable Clinical Intelligence platform; the company reports no product-level revenue breakout.
• Epi+Gen CHD — Three-year symptomatic CHD risk assessment blood test launched in 2021 via telemedicine and concierge practices; management says initial channel volumes were minimal before the go-to-market strategy was revamped.
• CardioInnovate360 — Research-use-only offering launched May 2023 to support discovery, development and validation of cardiovascular biopharmaceuticals; positioned as a separate revenue line from clinical testing.
• HeartRisk — Cardiovascular disease risk intelligence platform launched February 2024; no revenue contribution disclosed in the filings.

Recent performance

Annual revenue was $14,825 in 2025, down from $34,890 in 2024; quarterly revenue was $2,855 (Q3 2025), $3,555 (Q4 2025), $2,680 (Q1 2026) and $5,360 (Q2 2026). Net loss was $6,498,167 in 2025 versus $8,383,453 in 2024, with an accumulated deficit of $29,250,000 at December 31, 2025. Operating cash flow was negative $5.7M in 2025 and negative $5.0M in 2024. At June 30, 2026, total assets were $7.9M, total liabilities $499,780, shareholder equity $7.4M, and cash and equivalents $0.00.

Strategy

Management says it is driving adoption of its clinical solutions mainly among providers, channel partners and employers, and expanding domestically and internationally, with a first international expansion to India. It cites partnerships with channel partners such as YMCA of East Tennessee and Southdale YMCA to offer testing to members and communities. The company also reports progress in setting up its laboratory as a high-complexity testing laboratory in compliance with CLIA, and points to leveraging its CPT PLA codes as part of its expansion strategy. It notes sales and partnership cycles can run as long as 24 months.

Risks

• Minimal revenue and continuing losses — The company generated $14,825 of revenue in 2025 against a $6,498,167 net loss and an accumulated deficit of $29,250,000 at December 31, 2025.
• No cash on the balance sheet — Cash and equivalents were $0.00 at June 30, 2026, with total assets of $7.9M and total liabilities of $499,780.
• Regulatory risk for laboratory-developed tests — The company states Epi+Gen CHD and PrecisionCHD are categorized as LDTs, and its own risk factors flag changes in applicable laws or regulations, particularly LDT regulation, as potentially harmful to its business plans.
• Material weakness in internal control — Management identified inadequate segregation of duties in financial reporting due to limited staff resources during the six months ended June 30, 2026, and remediation efforts were not fully implemented or tested as of that date.

Outlook

Management expects sales and partnership cycles to remain long, especially with current economic uncertainty, and does not predict when the company will become profitable. It says it will continue expanding adoption among providers, channel partners and employers and pursuing domestic and international markets. Stated priorities include leveraging its CPT PLA codes and completing CLIA high-complexity laboratory setup. The company also expects losses to continue as it increases adoption, seeks market acceptance and expands marketing channels.