Cardio Diagnostics Holdings, Inc.

What Cardio Diagnostics Holdings, Inc. does

Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO) is a Chicago-based clinical diagnostics company founded in 2017 that develops AI-driven blood tests for the prevention and early detection of coronary heart disease (CHD). The company sells two prescription-only clinical products—Epi+Gen CHD, a three-year CHD event risk assessment priced at $350, and PrecisionCHD, a CHD diagnostic and management test priced at $850—to patients via a telemedicine partner, to healthcare providers through a dedicated Provider Portal and paper requisitions, and to self-insured employers as a workforce wellness benefit. Two complementary platforms extend the addressable surface: HeartRisk, a HIPAA-compliant population cardiovascular risk intelligence product for employers and benefits consultants, and CardioInnovate360, a biopharma research platform offering biomarker discovery, clinical trial optimization, and companion diagnostic development services to pharmaceutical customers.

The company's core technology is an AI-driven Multi-Omics Engine that integrates epigenetics (DNA methylation biomarkers), genetics (single nucleotide polymorphisms), and proprietary machine-learning models to interpret complex molecular patterns associated with cardiovascular disease. Models were trained on Framingham Heart Study data and validated against independent clinical datasets from Intermountain Health and the University of Iowa Hospitals and Clinics. Epi+Gen CHD evaluates 5 SNPs and 3 methylation biomarkers with reported 77% sensitivity and 74% specificity; PrecisionCHD evaluates 10 SNPs and 6 methylation biomarkers with reported 79% sensitivity and 76% specificity. The platform is protected by seven granted patents plus several pending applications worldwide—including a Japanese patent secured in June 2025—and tests are processed through the company's internal CLIA laboratory, which the company reports has delivered approximately 30% cost reduction.

Cardio Diagnostics generates revenue primarily through per-test clinical sales ($350-$850), with the final CMS gapfill Medicare reimbursement rate of $854 per test effective January 1, 2026 representing a material access milestone. Go-to-market spans direct-to-consumer (telemedicine), provider sales, employer benefits programs (onsite fairs, nearsite clinics), and channel partnerships (Atlas Healthcare Physicians in California; Aimil Ltd. and Dr. Lal PathLabs Limited in India). Capital has been sourced from a $11.2 million Yorkville Advisors facility (March 2023) and approximately $7.7 million in cumulative at-the-market equity proceeds through Craig-Hallum (2025 and post-period). The company went public in October 2022 via a Business Combination with Mana and completed a 1-for-30 reverse stock split on May 12, 2025.

Name

Cardio Diagnostics Holdings, Inc.

Legal name

Cardio Diagnostics, Inc.

Website

https://cdio.ai

Company type

Public

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

Cardio Diagnostics (NASDAQ: CDIO) develops AI-driven, epigenetics-based blood tests (Epi+Gen CHD and PrecisionCHD) for coronary heart disease risk assessment and diagnosis, selling to patients via telemedicine, to healthcare providers, to self-insured employers, and through U.S. and Indian distribution partners.

Ownership category

akta.pro rank

Product category

Cardiovascular Diagnostics

NAICS

Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Prognostic & Risk Stratification Biomarkers (disease progression, recurrence risk) (HLAAAMAF)

akta.pro secondary industries

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF), Preventive Cardiology & Lipidology (HLAKABAF)

Keywords

• Cardiovascular diagnostics
• Epigenetic biomarker tests
• AI-driven clinical tests
• Precision cardiovascular medicine
• Population heart health analytics

Headquarters

HQ city

Chicago

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Services

Cost components

Personnel, Technology or R&D, Marketing or Sales, Operations, Others

Revenue model

1. Clinical Test Sales: Direct sales of Epi+Gen CHD ($350) and PrecisionCHD ($850) tests to patients, providers, and employers. Tests are prescription-only blood tests available via telemedicine or provider ordering with at-home sample collection kits.
2. Medicare Reimbursement: CMS gapfill payment rate of $854 per test effective January 1, 2026, providing Medicare reimbursement for AI-driven cardiovascular tests. This represents a critical step toward expanded access for Medicare beneficiaries.
3. At-the-Market Equity Sales: Ongoing at-the-market equity sales under Craig-Hallum agreement yielding $3.9 million in gross proceeds during 2025 and an additional $3.8 million post-period.
4. Employer Wellness Programs: Employers implement testing at scale through benefit programs, onsite heart health fairs, and onsite/nearsite clinic partnerships. Custom pricing may be available for employers implementing testing at scale.
5. Biopharma Research Services: CardioInnovate360 platform provides biomarker discovery, clinical trial optimization, and custom companion diagnostic development services to pharmaceutical companies for cardiovascular drug development.

Pricing tiers

Go-to-market motion3 records

Distribution channels6 records

Marketing channels7 records

Core offering

Cardio Diagnostics develops and commercializes clinical blood tests for cardiovascular disease risk assessment and detection using an AI-driven Multi-Omics Engine that combines epigenetics (DNA methylation) and genetics (SNPs). Its core clinical tests are Epi+Gen CHD (three-year CHD event risk) and PrecisionCHD (CHD diagnosis and management). It also offers the HeartRisk population health analytics platform for employers and the CardioInnovate360 research platform for biopharmaceutical clients.

Product overview

Cardio Diagnostics offers an integrated portfolio of clinical diagnostic tests and data intelligence platforms for precision cardiovascular medicine. The core clinical products are Epi+Gen CHD (risk assessment) and PrecisionCHD (disease detection), both blood-based tests combining epigenetics, genetics, and AI. These are complemented by HeartRisk population health platform for employer and healthcare system insights, and CardioInnovate360 for biopharma research. The company pioneered an AI-driven Multi-Omics Engine that analyzes DNA methylation and genetic biomarkers to detect cardiovascular disease earlier than traditional methods.

Differentiator

Problem solved

Functional benefit

Brands

• HeartRisk: Real-time population cardiovascular risk intelligence platform that integrates HIPAA-compliant anonymized clinical, industry, claims, and geographic data for employers and healthcare organizations.
• CardioInnovate360

Products and services

• Epi+Gen CHD

Quantifiable outcome

• 77% sensitivity and 74% specificity for Epi+Gen CHD (2x more sensitive than conventional risk calculators)
• +5 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature6 records

Partnerships

Eight partnerships are on record, tiered flagship, minor and core.

• Atlas Healthcare PhysiciansflagshipChannel Partner/ Reseller/ Distributor · 24 June 2026Independent physician association serving managed care populations in Los Angeles and Orange counties will provide coverage for Epi+Gen CHD and PrecisionCHD cardiovascular tests for eligible members with prior authorization beginning May 2026. Expands access to precision cardiovascular medicine across community healthcare networks in California.
• IBN (Investor Brand Network)minorGTM or Marketing Partner · 8 April 2026Engagement with IBN for corporate communications strategy assistance to enhance visibility, investor outreach, and overall corporate communications capabilities.
• Dr. Lal PathLabs LimitedflagshipChannel Partner/ Reseller/ Distributor · 7 January 2026Strategic partnership to launch PrecisionCHD test for detecting and managing coronary heart disease in India. Initial phase integrates into Dr. Lal PathLabs network of 290+ clinical laboratories with commercial rollout expected in 2026. Test uses epigenetics, genetics, and AI to detect both obstructive and non-obstructive CHD at molecular level.
• Aimil Ltd.coreChannel Partner/ Reseller/ Distributor · 7 January 2026Partnership with Aimil Ltd. and Dr. Lal PathLabs to launch PrecisionCHD test in India, marking Cardio Diagnostics' first expansion outside the United States. Leverages established Indian diagnostic infrastructure for market entry.
• Southdale YMCAcoreStrategic or Co-development Partner · 6 January 2026Partnership to provide AI-powered cardiovascular testing and heart health education to Edina, Minnesota community. Offers YMCA members access to Epi+Gen CHD and PrecisionCHD tests at discounted prices, with educational event on January 26 and Heart Health Fair on February 25, 2026. Serves approximately 14,000 individuals across Edina, Richfield, Bloomington, and South Minneapolis. Second YMCA partnership nationally.
• YMCA of East TennesseecoreStrategic or Co-development Partner · 28 October 2025Inaugural YMCA partnership providing heart health education and advanced testing to East Tennessee community members starting November 2025. Program promotes cardiovascular wellness through education, early detection tests, and community events.
• 15 New Provider OrganizationscoreChannel Partner/ Reseller/ Distributor · 21 October 2025Partnership with 15 new provider organizations across the United States to expand provider network and promote AI-driven blood tests for cardiovascular disease prevention and management.
• AGEPHA PharmaminorStrategic or Co-development Partner · 8 July 2025Agreement to advance precision assessment and management of inflammation associated with coronary heart disease. Collaboration focused on combining Cardio Diagnostics' molecular testing with AGEPHA's pharmaceutical expertise.

Scale indicators12 records

Recent moves9 records

Expansion highlights6 records

Broad incumbents

• Cleveland HeartLab (Quest Diagnostics): Quest Diagnostics acquired Cleveland HeartLab to enter the cardiovascular biomarker testing market. It is a direct comparitor in blood-based cardiovascular diagnostics, though it operates as part of a much larger reference laboratory business with broader menu offerings.
• Cleerly Health: Cleerly applies AI to coronary CT angiography imaging for cardiovascular disease detection. While modality-different (imaging vs blood-based biomarkers), Cleerly targets the same clinical use case of earlier, more accurate CHD detection and competes for the same provider budgets.
• Exact Sciences: Exact Sciences is a leading molecular diagnostics company with Cologuard for colorectal cancer screening and expanding into other disease areas. It serves as a comparable public-market peer for a multi-omics, blood-based molecular diagnostic business at scale.
• Guardant Health: Guardant Health is a leading liquid biopsy and molecular diagnostics company. While primarily oncology-focused, it represents a comparable public-market peer for blood-based molecular diagnostics with AI integration.
• Veracyte: Veracyte is a genomic diagnostics company focused on urology, pulmonology, and breast cancer. It is a comparable commercial-stage molecular diagnostics platform with similar go-to-market into physician practices and payer reimbursement dynamics.
• Natera: Natera operates a cell-free DNA and molecular diagnostics platform with focus on oncology, women's health, and organ health. Comparable as a public-market molecular diagnostics peer with multi-product platform and CLIA lab operations.
• NeoGenomics: NeoGenomics is a leading oncology-focused clinical laboratory and molecular diagnostics company. While primarily oncology, it is a comparable public peer in the specialty molecular diagnostics space with similar payor reimbursement dynamics and CLIA lab infrastructure.

Direct peers

• CardioDx: CardioDx developed the Corus CAD blood-based gene expression test for obstructive coronary artery disease, the closest historical direct peer to Cardio Diagnostics' PrecisionCHD. Both target non-invasive, blood-based molecular diagnostics for CHD assessment.

Emerging players

• Anumana: Anumana applies AI to ECG signals for early detection of cardiovascular conditions such as cardiac amyloidosis and pulmonary hypertension. It is a comparable AI-driven cardiovascular diagnostics company, though ECG-based rather than blood-based.
• SomaLogic: SomaLogic operates a proteomics biomarker discovery platform used in clinical research and drug development, with growing focus on cardiovascular and metabolic disease applications. Both companies leverage novel biomarker modalities with AI for clinical insights.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/cardio-diagnostics-inc
• Xx.com/precisionheart
• Facebookfacebook.com/CDIncPreventHeartDisease

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cardio Diagnostics Holdings, Inc.