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1. Like Grail, but focused on predicting and preventing heart disease using AI-powered genetic and epigenetic tests.

2. Think of it as 23andMe specifically for heart disease, enhanced with AI for proactive prediction and management.

3. It's like Exact Sciences, but for heart disease diagnostics, leveraging AI and advanced genetic insights.

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• PrecisionCHD™: An AI-powered epigenetic test for the early detection and management of Coronary Heart Disease risk.
• PrecisionAF™: An AI-powered epigenetic test for assessing an individual's risk of developing Atrial Fibrillation.
• PrecisionGx™: A pharmacogenomic test that provides genetic insights to guide optimal medication selection for cardiovascular conditions.
• PrecisionADA™: A multi-omic test leveraging AI to assess the risk of developing diabetic complications.

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Cardio Diagnostics (symbol: CDIO) primarily sells its precision cardiovascular medicine tests to other companies and organizations within the healthcare sector, rather than directly to individual consumers. The company's business model involves providing its epigenetic tests, such as the Epi+Gen CHD test, to healthcare providers who then use them to assess the risk of coronary heart disease in their patients.

Based on publicly available information, Cardio Diagnostics does not disclose specific major customer companies that would individually account for a significant portion of its revenue, nor does it list specific public companies as major customers with their stock symbols. Instead, its customer base is composed of a broad network of healthcare providers and systems that integrate CDIO's tests into their diagnostic offerings. These customers generally fall into the following categories:

• Cardiology Practices and Clinics: These are specialized medical practices and groups that focus on the diagnosis, treatment, and prevention of cardiovascular diseases. They order CDIO's tests to enhance their patient risk assessment and management strategies.
• Primary Care Physician (PCP) Offices: General practitioners and family doctors often serve as the first point of contact for patients and refer them for specialized diagnostic testing. These offices can integrate CDIO's tests to identify patients at risk for cardiovascular disease earlier.
• Hospitals and Health Systems: Larger integrated healthcare organizations encompassing multiple hospitals, clinics, and specialty centers. These systems may adopt CDIO's tests as part of their broader cardiology or preventative medicine programs.

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Meesha Dogan, PhD, Chief Executive Officer and Co-Founder

Dr. Meesha Dogan is the Co-Founder and Chief Executive Officer of Cardio Diagnostics Holdings, Inc., a role she assumed in May 2021. She is also a Co-Inventor of the company's proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine. Dr. Dogan has been recognized for her expertise, having been accepted into the Forbes Technology Council, an invitation-only community for world-class technology executives.

Elisa Luqman, JD MBA, Chief Financial Officer and Principal Accounting Officer

Elisa Luqman serves as the Chief Financial Officer and Principal Accounting Officer for Cardio Diagnostics Holdings, Inc. She holds both a Juris Doctor (J.D.) and a Master of Business Administration (M.B.A.) degree.

Timur Dogan, PhD, Chief Technology Officer

Dr. Timur Dogan is the Chief Technology Officer of Cardio Diagnostics Holdings, Inc. He holds a Ph.D.

Dr. Robert A. Philibert, M.D., Ph.D., Chief Medical Officer and Co-Founder

Dr. Robert A. Philibert is a Co-Founder and the Chief Medical Officer of Cardio Diagnostics Holdings, Inc. He is also a co-inventor of the Integrated Genetic-Epigenetic Engine, the core technology behind Cardio Diagnostics' solutions.

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Key Risks to Cardio Diagnostics (CDIO)

1. Financial Viability and Unproven Business Model: Cardio Diagnostics Holdings has an unproven business model and has not generated significant revenues or operating profit. The company reported only nominal revenues of $950 in 2022 and $17,065 in 2023, with substantial net losses totaling $4,660,985 and $8,376,834 for the same years, respectively, resulting in an accumulated deficit of $14,368,380 as of December 31, 2023. More recently, for the last twelve months as of Q3 2024, the company's revenue was $0.04 million, accompanied by an operating income margin of -23,513.43%, and is characterized by quickly burning through cash and not being profitable. The company continued to report net losses in Q3 2025, with a net loss of $(1,714,536) for the three months and $(5,032,799) for the nine months ended September 30, 2025.
2. Market Adoption and Growth Uncertainty: The company's market opportunity estimates and growth forecasts are subject to significant uncertainty, as they are based on assumptions that may not prove accurate. Even if the overall market for cardiovascular diagnostics grows as projected, Cardio Diagnostics' business may not achieve similar growth rates. The company is actively focusing on driving the adoption of its clinical solutions among providers, channel partners, and employers. However, the continued reliance on existing, resource-intensive tests for coronary heart disease (CHD) diagnosis presents a challenge for new entrants like Cardio Diagnostics to gain market share and broader adoption.
3. Regulatory and Reimbursement Challenges: As a medical diagnostic company, Cardio Diagnostics faces inherent regulatory hurdles and risks associated with obtaining favorable reimbursement. The American Medical Association is currently reviewing the company's integrated epigenetic-genetic cardiovascular medicine tests for CPT PLA Codes. Furthermore, the company's tests have received preliminary "gapfill" pricing determinations from the Centers for Medicare & Medicaid Services (CMS), which are pending finalization for claims starting January 1, 2025. This pending finalization introduces uncertainty regarding future reimbursement rates and broad coverage.

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Cardio Diagnostics (CDIO) primarily focuses on epigenetics-based clinical tests for cardiovascular disease, with its main products including Epi+Gen CHD and PrecisionCHD.

The estimated addressable market for Cardio Diagnostics' coronary heart disease (CHD) risk assessment tools is approximately $8.5 billion in the U.S. This market size pertains to their tools designed for assessing the risk of coronary heart disease.

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Expected Drivers of Future Revenue Growth for Cardio Diagnostics (CDIO)

Over the next 2-3 years, Cardio Diagnostics (CDIO) is expected to drive future revenue growth through several key initiatives:

• Expansion of Product Offerings: Cardio Diagnostics is strategically focused on expanding its product pipeline, including the launch of new clinical tests for stroke, heart failure, and diabetes. This expansion builds upon its existing offerings like Epi+Gen CHD and PrecisionCHD, leveraging its proprietary AI-driven Integrated Epigenetic-Genetic Engine to address a broader range of cardiovascular diseases and associated co-morbidities.
• Growth in Provider Partnerships and Market Adoption: The company has been actively expanding its sales efforts and entering into partnerships with new provider organizations across various states. These efforts are aimed at broadening market adoption of its clinical tests and solutions, including through enhanced commercialization strategies.
• Securing Payer Coverage: A significant driver of revenue growth will be the continued pursuit and securing of payer coverage for its diagnostic tests. The company has already made progress by receiving Gapfill Payment Rates for its AI-Driven Cardiovascular Tests from the Centers for Medicare and Medicaid Services (CMS), which is crucial for increasing accessibility and reimbursement for its services.
• International Market Expansion: Cardio Diagnostics is demonstrating a commitment to global expansion, as evidenced by securing a Japanese patent for its AI-driven cardiovascular disease detection technology. This highlights the company's intent to deliver its innovative, data-driven solutions in international markets, which could open new revenue streams.
• Leveraging CPT PLA Codes and Scaling Operations: The company plans to leverage its newly awarded CPT PLA codes, which are essential for billing and reimbursement of its specialized tests. Alongside this, Cardio Diagnostics is focused on scaling its internal operations to support the increased demand and broader reach of its products and services.

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Share Issuance

• The number of shares outstanding for Cardio Diagnostics increased by 123.30% in one year, indicating substantial shareholder dilution.
• The company executed a reverse stock split on May 13, 2025, with a ratio of 1:30.
• Cardio Diagnostics became a publicly listed company on May 27, 2022, through a business combination agreement with Mana Capital Acquisition Corp., a Special Purpose Acquisition Company (SPAC), which involved the issuance of new shares.

Inbound Investments

• Cardio Diagnostics became a public entity on May 27, 2022, by merging with Mana Capital Acquisition Corp.
• The SPAC merger was anticipated to generate approximately $10 million in gross proceeds from common stock equity investors in 2022 before the transaction closed.

Capital Expenditures

• Capital expenditures for Cardio Diagnostics were reported as -$51,367 in the last 12 months.
• Net capital expenditure figures have been very low or negative across recent periods.
• The company's primary focus is on the development and commercialization of AI-driven genetic-epigenetic clinical tests for cardiovascular diseases, suggesting investment in intellectual property and research & development rather than significant physical assets.