CDIOWNasdaqIn Vitro & In Vivo Diagnostic SubstancesUS GAAP · USD

Cardio Diagnostics Holdings, Inc.

Cardio Diagnostics Holdings, Inc. develops and commercializes AI-driven DNA biomarker tests for cardiovascular disease. Its core products, Epi+Gen CHD and PrecisionCHD, are designed to help assess coronary heart disease risk and support diagnosis and management of disease. The company was formed around technology invented at the University of Iowa and is building a business around clinical adoption through providers, channel partners, and employers. It operates as an early-stage diagnostic company with a single operating segment focused on product testing and a business model that depends on expanding test utilization and reimbursement acceptance.

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Revenue0.0m USD
−57.5 %y/y
Operating profit (EBIT)-6.5m USD
+22.5 %y/y
EBIT margin-43,737.5%
−19,759.6 ppy/y
Net income-6.5m USD
+22.5 %y/y
Free cash flow-5.9m USD
−13.6 %y/y

Fiscal year 2025 · change from previous year

Development 2021–2025

-10-8-6-4-202m USD2021: 0.00 m USD2021: EBIT -0.62 m USD20212022: 0.00 m USD2022: EBIT -4.5 m USD20222023: 0.02 m USD2023: EBIT -7.2 m USD20232024: 0.03 m USD2024: EBIT -8.4 m USD20242025: 0.01 m USD2025: EBIT -6.5 m USD20250.01-6.5
RevenueOperating profit (EBIT)

Business

Share of revenue
Cardiovascular diagnostic tests100 %

Commercial blood- and DNA-based tests used to assess coronary heart disease risk and support diagnosis/management.

Testing platform and clinical workflow0 %

The underlying AI-driven biomarker technology and lab-enabled workflow used to deliver the tests.

Customers

Cardio sells primarily to provider organizations that order tests for patients and use the results in clinical decision-making. The company also serves employers and channel partners that use the tests in screening, prevention, or wellness-oriented programs. Its tests can be paid for by provider organizations, patients, and/or employers, which means buying decisions depend on clinical utility, pricing, and whether the customer can drive sufficient test volume. The company has also referenced expansion through community and partner organizations, indicating a mix of direct clinical and partnership-led demand generation.

Provider organizations

Clinics and medical groups order Epi+Gen CHD and PrecisionCHD to assess cardiovascular risk and support diagnosis/management.

Employers

Employers buy testing for prevention and health-screening programs, often through minimum-volume arrangements.

Channel partners

Partners help distribute the tests and expand access into new verticals and local markets.

Patients

Patients may pay directly when the test is not fully covered or when it is offered through a provider program.

Strategy

Cardio’s strategy is to drive adoption of its clinical solutions among providers, channel partners, and employers. The company is trying to build a broader sales and partnership pipeline while expanding into new vertical markets, which is important because its tests require time to ramp after onboarding. It is also investing in a CLIA-compliant high-complexity laboratory capability, which supports clinical credibility and operational control. International expansion, starting with India, suggests a longer-term effort to broaden the addressable market beyond the initial U.S. base.

Provider adoption and test utilization rampShort term

Revenue depends on onboarding organizations and then increasing test volume over the following quarters.

Partnership-led commercializationMedium term

Channel partners and employers can broaden access without relying only on direct sales.

Geographic expansionMedium term

New markets can diversify demand and reduce dependence on a small number of U.S. initiatives.

Clinical and operational credibilityShort term

A CLIA-compliant high-complexity lab supports regulated clinical testing and customer confidence.

Geography

Cardio is headquartered in the United States and its business is still primarily domestic. The company stated that it is expanding into additional markets domestically and internationally, with first international expansion into India. Because the business depends on provider onboarding and local commercial relationships, geography matters more as a go-to-market execution issue than as a manufacturing footprint issue. The company also referenced partnerships with U.S.-based organizations such as YMCA affiliates, showing that market development is still early and relationship-driven.

Risks

Cardio is an early-stage diagnostic company with limited operating history and no significant revenue base, so execution risk is high. Its commercialization depends on convincing providers, employers, and partners that its tests offer better value than established serum lipid, proteomic, and imaging alternatives that already have reimbursement pathways and scientific support. The company also faces long sales and partnership cycles, customer onboarding delays, and the risk that new verticals may not generate enough volume to offset marketing spend. As a diagnostic business handling protected health information, it also faces cybersecurity, data privacy, regulatory, and CLIA compliance risks, while broader healthcare consolidation and reimbursement pressure can slow adoption.

Sorted by severity
LowMediumHighLowMediumHighImpact →Likelihood →Limited operating history and early-stage revenue base1Regulatory and laboratory compliance2Slow provider onboarding and long sales cycles4Cybersecurity and PHI protection5
Impact is the risk’s severity and likelihood how probable it is over the next few years, both assessed from the company’s reports. Numbers match the list.
  1. Limited operating history and early-stage revenue baseImpact: HighLikelihood: High

    The company has not yet generated significant revenue from product sales and has incurred losses since inception.

    Exposure: Company-wide commercialization and funding needs

  2. Regulatory and laboratory complianceImpact: HighLikelihood: Low

    Clinical testing depends on CLIA-compliant operations and adherence to licensing obligations.

    Exposure: Ability to operate and commercialize tests

  3. Intense competition from established diagnostic modalitiesImpact: High

    Serum lipid, proteomic, and imaging-based tests have larger market share, more resources, and established reimbursement strategies.

    ExposureMarket sharePricingAdoption
  4. Slow provider onboarding and long sales cyclesImpact: MediumLikelihood: High

    Management disclosed partnership and sales cycles as long as 24 months and a one- to three-quarter ramp after onboarding.

    Exposure: Revenue timing and forecasting

  5. Cybersecurity and PHI protectionImpact: MediumLikelihood: Low

    The company relies on third parties for storage and transmission of customer and patient data.

    ExposureData privacyLegal liabilityReputation

Accounting

Judgemental items
Revenue recognition for test services

Revenue depends on minimum committed volumes and variable pricing by customer type and size, making timing and measurement important.

Impact: Can create quarter-to-quarter volatility and affect comparability

Stock-based compensation

The company disclosed stock compensation as a driver of prior-period general and administrative expense changes.

Impact: Can materially affect operating loss and non-cash expense trends

Estimates and judgments

Management states that financial statements require estimates affecting assets, liabilities, revenue, costs, and contingent liabilities.

Impact: Reported results may differ materially from future outcomes

License agreement and intangible rights

The core technology is tied to an exclusive license that could terminate if obligations are breached.

Impact: Could affect access to the underlying technology and going-concern analysis

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Last updated: 24/09/2026