Cardio Diagnostics Announces Publication of Study Showing That its PrecisionCHD™ Test Could Save Health Insurers Over $113 Million Annually

Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), a leader in the next generation of precision cardiovascular medicine technologies that combine proprietary AI algorithms with epigenetic and genetic biomarkers, today announced the publication of results from a budget impact modeling study for PrecisionCHD™, the Company’s AI-powered multiomic coronary heart disease detection test. The peer-reviewed study “The Use of Precision Epigenetic Methods for the Diagnosis and Care of Stable Coronary Heart Disease Reduces Healthcare Costs” published in Advances in Therapy, reported that the use of PrecisionCHD can significantly reduce the cost of secondary prevention for stable coronary heart disease (CHD) by up to $113.6 million per year for a typical health insurance plan with one million members.

PrecisionCHD is an AI-powered multiomic DNA test using epigenetic and genetic biomarkers to aid in the detection of stable CHD. This blood-based test evaluates six DNA methylation and ten genetic biomarkers and uses a proprietary machine learning model to interpret the genetically contextual methylation signals from these biomarkers. The sensitivity and specificity of this test are 79% and 76%, respectively, with the clinical validation study in collaboration with Intermountain Healthcare and University of Iowa Hospitals and Clinics being recently published in the Journal of American Heart Association.

The PrecisionCHD budget impact model was designed to evaluate the cost savings associated with using PrecisionCHD as the primary method of initial CHD assessment in place of current commonly used tests such as exercise electrocardiograms, coronary computed tomography angiography (CCTA), and angiograms. The model considered factors such as the number of tests performed, the cost of each test, and the impact of test results on treatment decisions. The results suggest that using PrecisionCHD could lead to significant cost savings for payers, with an estimated $113.6 million saved per year for a plan with one million members. These savings are primarily driven by the lower cost of PrecisionCHD compared to traditional tests and the reduced need for additional testing. The model also found that the cost savings were not sensitive to patient demographics, or insurance plan design, with similar results being observed for plans that exclude Medicare enrollees, only include Medicare enrollees (Part B or Medicare Advantage), offer large co-insurance rates, and offer larger co-pays.

“The data from this study suggests that the broader use of PrecisionCHD as the initial test for detecting coronary heart disease can yield significant savings to payers," said David Frisvold, PhD, Associate Professor in the Department of Economics at the University of Iowa and lead author of this study. “More importantly, the reported cost savings were shown to be generalizable to various health plans, potentially leading to increased access to care and improved outcomes for patients with CHD.”

PrecisionCHD was recently awarded the Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code, 0449U, by the American Medical Association that went effective on April 1, 2024. PrecisionCHD was also awarded the Innovation Technology contract from Vizient, the nation’s largest group purchasing organization, whose customer base encompasses over 60% of hospitals and 97% of academic medical centers in the United States.

The Multimodal Delivery of PrecisionCHD Could Further Increase Access to Earlier CHD Detection for Patients and Potentially Drive Larger Cost Savings for Payers

Heart disease remains the leading cause of death among Americans and one of the largest cost centers for payers. If the barriers to obtaining early cardiovascular care persists, the prevalence and costs associated with heart disease are only likely to increase. Currently, exercise electrocardiogram, CCTA and single photon emission computed tomography (SPECT) are some of the initial tests used to diagnose CHD. These tests are resource intensive, and require expensive infrastructure and specialized personnel, creating inherent barriers to broader adoption especially in rural America. The continued reliance on these tests as the initial testing mode for CHD diagnosis could mean that more Americans are receiving earlier testing and care, potentially leading to higher costs for payers. Some of the current tests also have risks associated with being exposed to radiation and contrast dyes that could affect the health of the patient long term and the cost incurred by payers.

In contrast, PrecisionCHD is a blood-based test that could serve as a more cost efficient, highly scalable, and less resource intensive alternative for initial CHD detection testing. Its highly sensitive and specific performance minimizes the likelihood of false positives and negatives, potentially decreasing the need for costly follow up tests and procedures. PrecisionCHD can be implemented fully virtually via telemedicine and at-home blood sample collection, can be deployed in community settings via a mobile health clinic or in a more traditional provider setting. This multimodal delivery approach is a win-win with broader access for patients and potential additional cost savings for payers with earlier detection and management of CHD. Furthermore, PrecisionCHD not only undercuts the expenses associated with conventional tests like CCTA and angiograms but also avoids the risks related to radiation and contrast dyes found in many imaging procedures by providing a cost-effective alternative for initial CHD diagnosis. This reduces potential costs tied to managing side effects.

"We believe that PrecisionCHD has the potential to revolutionize how coronary heart disease is diagnosed and managed," said Robert Philibert, MD, PhD, Chief Medical Officer and Co-Founder of Cardio Diagnostics, and the senior author of the study. "We are confident that PrecisionCHD will drive value for many healthcare stakeholders including the patient, provider and payer."

Optimizing Cost-Efficiency Among Payers and Provider-Led Health Plans

Health plans increasingly prioritize precision medicine solutions to enhance patient outcomes and optimize cost-efficiency, reflecting an industry-wide transition from personalized to precision medicine. This evolution is underpinned by integrating genomic, clinical, and socio-economic data, enabling healthcare providers to customize treatment approaches and advance therapeutic innovation. Similarly, provider-led health plans, face the same challenges in optimizing patient care while reducing unnecessary medical spend.

PrecisionCHD stands out as an instrumental resource for health insurers and healthcare providers aiming to streamline the management and financial burden of CHD. As health systems increasingly adopt value-based care (VBC) models, the focus intensifies on achieving superior patient outcomes and improved population health while maintaining cost-effectiveness. Throughout 2023, the expansion and refinement of VBC models have underscored a concerted effort among healthcare providers, payers, and policymakers to enhance patient care and manage expenses effectively.

This strategic alignment with VBC frameworks highlights the significant role of tools like PrecisionCHD. These tools support targeted, data-driven decisions in CHD treatment and management, potentially revolutionizing approaches to healthcare delivery and cost management.

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 results are discussed in the Current Report on Form 10-K for the period ended December 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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