This is the second CPT PLA code the American Medical Association (AMA) granted for the Company’s AI-powered coronary heart disease tests. This significant milestone enables the acceleration of reimbursement for the Epi+Gen CHD test from federal and private payers, while increasing access to this precision cardiovascular medicine test.

Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the American Medical Association (AMA) has granted and assigned a dedicated Current Procedural Terminology (CPT^®) Proprietary Laboratory Analysis (PLA) code, 0439U, for the company’s AI-driven coronary heart disease (CHD) event risk assessment test, Epi+Gen CHD.

Receipt of this new CPT PLA code, which will be effective on April 1, 2024, is a significant step toward payer billing and payment, facilitating broader adoption of the first and only AI-powered integrated genetic-epigenetic clinical blood test for evaluating the likelihood of a patient experiencing a CHD event, mainly a heart attack, within the next three years.

Primary Prevention of Heart Attacks: The Clinical and Economic Benefits of Epi+Gen CHD

Every year, about 805,000 people in the United States have a heart attack, with someone experiencing a heart attack every 40 seconds. Heart disease is the leading cause of death for both men and women. In 2021, heart disease was responsible for the deaths of more than 695,000 Americans. Of those deaths, 310,661 occurred in women, which represents one in every five female deaths.

There are challenges in detecting women’s heart disease because, according to Johns Hopkins Medicine, women’s heart disease symptoms and signs can be atypical, which delays understanding of their risks for a heart attack. Epi+Gen CHD evaluates an individual’s unique genetic and epigenetics to predict their risk for a heart attack or sudden cardiac death associated with CHD with unrivaled personalized insights driven by the company’s groundbreaking epigenetic-genetic technology. By leveraging the power of AI, the company’s technology can provide patient-specific epigenetic and genetic drivers of CHD to help guide preventive care and potentially save lives.

In peer-reviewed studies, Epi+Gen CHD was more cost-effective and more sensitive for assessing heart attack risk compared to standard lipid-based risk calculators. Specifically, in a validation study conducted with Intermountain Healthcare, Epi+Gen CHD was shown to be, on average, about twice as sensitive in detecting risk for a CHD event in women than lipid-based calculators.

Enhancing Employer Risk Mitigation Strategies with Epi+Gen CHD

For employers, the financial burden of heart attacks includes direct costs related to diagnosing, managing and treating heart disease, as well as indirect costs such as lost productivity due to employee absenteeism and short-term disability. Employee absenteeism and short-term disability resulting from cardiovascular disease can cost employers about $1,119 more in the first month following a cardiovascular event. The cardiovascular health of U.S. employees costs $363 billion annually, including $216 billion in direct medical costs and nearly $147 billion in indirect costs.

Uniquely, Cardio Diagnostics combines the ability to offer employees the advanced Epi+Gen CHD heart attack risk test with aggregated risk data for employers to help inform their benefits offerings. Cardio Diagnostics’ Employer Risk Intelligence^TM platform provides employers and brokers with the first-of-its-kind cardiovascular employee population health intelligence backed by a clinical test and layered insights in a compliant manner.

“Cardio Diagnostics is committed to driving widespread adoption of our solutions, and obtaining a reimbursement code for Epi+Gen CHD is a critical milestone in our commercialization strategy and for gaining reimbursement from federal and private payers,” said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics.

For employers, this means potentially greater access to a technology that enables a healthier workforce and significant savings in healthcare costs related to heart disease. Cardio Diagnostics continues to lead the way in precision cardiovascular medicine, leveraging the power of AI and epigenetics to help prevent heart attacks. The company's commitment to making heart disease risk assessment, detection, and management more accessible, personalized, and precise is key to winning the fight against the leading cause of death in the United States.

About Cardio Diagnostics

Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine (“Core Technology”) for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. For more information, please visit www.cardiodiagnosticsinc.com.

Forward-Looking Statements

Certain statements and information included in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, the words or phrases “will”, "will likely result," "expected to," "will continue," "anticipated," "estimate," "projected," "intend," “goal,” or similar expressions are intended to identify "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of the Company. Such uncertainties and risks include but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, dependence on management, dilution to stockholders, lack of capital, the effects of rapid growth upon the Company and the ability of management to effectively respond to the growth and demand for products and services of the Company, newly developing technologies, the Company’s ability to compete, regulatory matters, protection of technology, the effects of competition and the ability of the Company to obtain future financing. An extensive list of factors that can affect future results are discussed in the Current Report on Form 10-K for the period ended December 31, 2022 and Form 10-Q for the period ended March 31, 2023 under the heading “Risk Factors” in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission. Such factors could materially adversely affect the Company's financial performance and could cause the Company's actual results for future periods to differ materially from any opinions or statements expressed within this press release.

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