By Jeremy Golden, Benzinga

Cardio Diagnostics’ AI-driven coronary heart disease (CHD) tests have taken another promising step in their evolution.

Cardio Diagnostics (NASDAQ: CDIO), an artificial intelligence-powered precision cardiovascular medicine company, has been assigned two dedicated Current Procedural Terminology (CPT) Proprietary Laboratory Analysis (PLA); 0440U for the company’s AI-driven CHD detection test, PrecisionCHD, and 0439U for the company’s AI-driven CHD event (heart attack) risk assessment test, Epi+Gen CHD.

Assigned by the American Medical Association (AMA), these two new CPT PLA codes – effective April 1, 2024 – mark a significant step toward payer billing and payment for the company’s groundbreaking tests. The designation will facilitate the broader adoption of PrecisionCHD, an integrated genetic-epigenetic clinical blood test to aid in the diagnosis of CHD, and Epi+Gen CHD for evaluating the likelihood of a patient experiencing a CHD event – mainly a heart attack – within the next three years.

Treating A Growing Problem

Every year, about 805,000 people in the United States have a heart attack, meaning someone experiences a heart attack every 40 seconds. Heart disease is the leading cause of death for both men and women. According to the CDC, in 2021, heart disease was responsible for the deaths of more than 695,000 Americans – representing one in every five deaths.

The most common type of heart disease and the major cause of heart attacks, CHD was responsible for over 375,000 deaths in 2021, and CHD-associated medical costs are estimated to be about $239.9 billion according to an estimate by the CDC in its heart disease fact sheet.

Combating this growing problem, Cardio Diagnostics reports that PrecisionCHD is the first integrated genetic-epigenetic test for the detection of CHD. The PrecisionCHD test has the ability to aid in the diagnosis of CHD and provide personalized insights to help prevent a heart attack and improve outcomes.

With the introduction of PrecisionCHD, clinicians are armed with a powerful, scalable and non-invasive alternative that comes in the form of a blood-based test that uses artificial intelligence, along with personalized genetic and epigenetic information, to sensitively detect the presence of CHD.

Identifying patients with CHD and intervening before a heart attack occurs are essential to reducing the unprecedented economic and health burden associated with CHD. Until now, the lack of readily accessible and cost-effective diagnostic solutions for CHD has posed a challenge leading to delayed diagnosis and care, particularly among underserved and minority populations.

Increasing access, the PrecisionCHD test only requires a simple blood draw and can be deployed remotely, allowing it to be scaled without the need for specialized infrastructure. This enables more timely intervention and management.

“Receiving a dedicated CPT PLA code for PrecisionCHD is a critical milestone in our commercialization strategy,” said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics. “With PrecisionCHD, we believe that expanding equitable access to CHD diagnostics and improving patient health outcomes while reducing healthcare expenditure is possible.”

While PrecisionCHD aids in diagnosing CHD, Cardio Diagnostics’ Epi+Gen CHD evaluates an individual’s genetic and epigenetics to predict their risk for a heart attack or sudden cardiac death associated with CHD. By leveraging the powerful personalized insights driven by the company’s groundbreaking epigenetic-genetic technology, the company can provide patient-specific epigenetic and genetic drivers of CHD to help guide preventive care that could potentially save lives.

In peer-reviewed studies, Epi+Gen CHD was more cost-effective and sensitive for assessing heart attack risk when 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.

For employers, the financial burden of heart attacks includes direct costs related to diagnosing, managing and treating heart disease. Indirect costs include lost productivity due to employee absenteeism and short-term disability, which can indirectly cost employers about $1,119 per month for upwards of three years.

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

As such, Epi+Gen CHD’s new reimbursement code could mean greater access to technology that enables a healthier workforce and significant savings in healthcare costs related to heart disease.

“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,” Dogan said.

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 is committed to making heart disease risk assessment, detection and management more accessible, and it believes personalized and precise diagnostics are key to winning the fight against the leading cause of death in the United States.

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.

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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Contact Details

Gene Mannheimer - Investor Relations

+1 855-226-9991

investors@cardiodiagnosticsinc.com

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