Cardio Diagnostics Holdings Inc. (NASDAQ: CDIO) Is ‘One to Watch’

• Cardiovascular disease remains the leading cause of death in the United States, representing a significant and persistent healthcare burden that the company’s solutions are designed to address.
• Cardio Diagnostics has developed a proprietary platform that integrates epigenetic and genetic biomarkers with artificial intelligence to generate personalized cardiovascular insights from a simple blood sample.
• The company’s clinical tests are non-invasive, require no fasting or radiation, and are designed to detect and assess coronary heart disease, including forms that may not be identified through traditional diagnostic methods.
• The company has established multiple commercialization channels, including provider networks, employer partnerships, and community-based programs, to expand access to its cardiovascular testing solutions.
• Recent developments include expanded provider partnerships across the United States, finalized CMS reimbursement rates of $854 for its clinical tests, initial international expansion into India, and clinical data presentations supporting its ability to detect forms of coronary heart disease that traditional tools may miss.

Cardio Diagnostics Holdings (NASDAQ: CDIO) is an artificial intelligence-powered precision cardiovascular medicine company focused on making cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The company’s approach is centered on advancing how cardiovascular disease is addressed by moving beyond traditional methods that rely on indirect or generalized indicators.

At the core of its strategy is the integration of epigenetics, genetics, and artificial intelligence to generate insights from a patient’s molecular profile. By analyzing both inherited predisposition and changes influenced by lifestyle and environment, the company’s platform is designed to provide a more complete view of cardiovascular disease.

Cardio Diagnostics was founded to develop and commercialize clinical tests and data solutions that enable earlier detection and more precise management of cardiovascular disease across clinical and non-clinical settings.

The company is headquartered in Chicago, Illinois.

Portfolio

The company’s portfolio brings together epigenetic and genetic insights with artificial intelligence to generate actionable information for cardiovascular care. This approach underpins a suite of blood-based tests and platforms designed for use across both individual patient care and broader population health settings.

Epi+Gen CHD(TM)

Epi+Gen CHD(TM) is a prescription-only blood test that assesses a patient’s three-year risk of a coronary heart disease (“CHD”) event, including heart attack and sudden death. The test evaluates three epigenetic and five genetic biomarkers and applies artificial intelligence to generate a personalized risk score. It is designed to assess risk regardless of the presence of traditional factors and is non-invasive, requiring no fasting or radiation. In clinical validation studies, the test has demonstrated approximately two times greater sensitivity than conventional risk calculators and enables ongoing monitoring through epigenetic biomarkers that can change in response to intervention.

PrecisionCHD(TM)

PrecisionCHD(TM) is a prescription-only blood test that aids in the detection and management of coronary heart disease by identifying molecular signals associated with the condition. The test evaluates 10 epigenetic and six genetic biomarkers and uses artificial intelligence to determine whether a disease signal is present. It provides patient-specific insights into the molecular drivers of disease, supporting more individualized care decisions, and is designed to detect both obstructive and non-obstructive forms of CHD in a non-invasive manner.

HeartRisk(TM)

HeartRisk(TM) is a population-level cardiovascular risk intelligence platform that integrates anonymized clinical, claims, industry, and geographic data to provide real-time insights into heart disease risk across defined populations. The platform enables organizations to quantify risk, project future healthcare costs, benchmark against peer groups, and track changes over time, supporting more informed planning and risk management strategies.

CardioInnovate360(TM)

CardioInnovate360(TM) is a biopharma research platform that leverages artificial intelligence and epigenetics to support the discovery, development, and validation of cardiovascular therapies. The platform is designed to identify novel biomarkers and disease pathways, optimize clinical trial design through improved patient stratification, and enable the development of scalable, non-invasive diagnostic tools.

Market Opportunity

Cardiovascular disease (“CVD”) is the leading cause of death in the United States, responsible for nearly one in three deaths. It encompasses a range of conditions, including CHD, stroke, heart failure, and peripheral artery disease, and continues to represent a significant and persistent healthcare burden.

Coronary heart disease is the most common form of CVD and often develops without symptoms, with a heart attack frequently serving as the first indication of disease. In the U.S., one in 20 adults over the age of 20 lives with CHD, and it is the second leading cause of hospitalization, adding approximately $13,000 in annual healthcare costs per patient. An additional three to four million Americans are affected by ischemia with no obstructive coronary arteries (“INOCA”), a subset of CHD.

Heart attacks occur approximately every 40 seconds in the U.S., with more than 800,000 events annually, and one in five occurring without warning. While an estimated 80–90% of cardiovascular disease is preventable through early detection and proactive management, traditional approaches can leave gaps, as approximately 50% of individuals with coronary heart disease do not present with traditional risk factors and conventional risk calculators have an average sensitivity of 39%.

Leadership Team

Meesha Dogan, PhD, Chief Executive Officer and Co-Founder, has served as CEO and a director since inception and co-founded the company alongside Dr. Philibert. She has more than a decade of experience working at the intersection of artificial intelligence, epigenetics, and genetics, leading the development and commercialization of DNA-based cardiovascular tests. Dr. Dogan is an inventor on multiple granted and pending patents and holds a PhD in Biomedical Engineering and BSE/MS degrees in Chemical Engineering from the University of Iowa.

Robert Philibert, MD, PhD, Chief Medical Officer and Co-Founder, has served as CMO and a director since inception and co-founded the company with Dr. Dogan. He is a professor at the University of Iowa with joint appointments across psychiatry, neuroscience, molecular medicine, and biomedical engineering, and has published more than 200 peer-reviewed manuscripts. Dr. Philibert has received numerous NIH grants and holds patents related to epigenetics, including work on behavioral biomarkers.

Tim Dogan, PhD, Chief Technology Officer, has served as CTO since May 2022 after joining the company in 2019 as its first employee. He played a key role in developing the company’s Integrated Multi-Omics Engine(TM) and is a co-inventor on multiple patent-pending technologies. Dr. Dogan holds a PhD and BSE/MS degrees in Mechanical Engineering from the University of Iowa.

Elisa Luqman, JD, MBA, Chief Financial Officer, has served as CFO since March 2021 and has experience in public company finance, compliance, and corporate governance. She has held senior leadership roles at Clinigence Holdings Inc. and currently serves as Chief Legal Officer (SEC) at Nutex Health Inc., overseeing SEC reporting and compliance. Ms. Luqman holds a JD and MBA in Finance from Hofstra University.

For company information, visit the company’s website at https://cdio.ai.

NOTE TO INVESTORS: The latest news and updates relating to CDIO are available in the company’s newsroom at https://ibn.fm/CDIO

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