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By Jeremy Golden, Benzinga

Cardio Diagnostics (NASDAQ: CDIO), an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention and early detection more precise, has announced the publication of results from a budget impact modeling study for one of its leading clinical products.

PrecisionCHD is an integrated genetic-epigenetic test for the detection of coronary heart disease (CHD). The peer-reviewed study, The Use of Precision Epigenetic Methods for the Diagnosis and Care of Stable Coronary Heart Disease Reduces Healthcare Costs, highlights the tests promising developments.

The studys 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, including exercise electrocardiograms, coronary computed tomography angiography (CCTA) and angiograms.

It 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 patients, 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, along with the reduced need for additional testing.

Further, the model found that cost savings were not sensitive to patient demographics or insurance plan design. Similar results were observed for plans that exclude Medicare enrollees, only include Medicare enrollees (Part B or Medicare Advantage), offer large co-insurance rates and charge larger co-pays.

PrecisionCHD is a multiomic DNA test that aids in the detection of stable CHD. The 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 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. It became effective on April 1, 2024.

PrecisionCHD was also awarded the Innovation Technology contract from Vizient, the United States largest group purchasing organization, whose customer base encompasses over 60% of hospitals and 97% of academic medical centers in the country.

Increasing Access, Reducing Costs

Heart disease remains the leading cause of death among Americans. It is also one of the largest cost centers for payers. If the barriers to obtaining early cardiovascular care persist, the prevalence and costs associated with heart disease will likely increase.

Currently, exercise electrocardiogram, CCTA and single photon emission computed tomography (SPECT) are among 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 lead to higher costs for payers. Some of the current tests also involve risks that are associated with being exposed to radiation and contrast dyes that could affect the health of the patient long term.

Cardio Diagnostics says that PrecisionCHD, on the other hand, is a more cost-efficient, highly scalable and less resource-intensive alternative for initial CHD detection testing. Its sensitive and specific performance minimizes the likelihood of false positives and negatives, potentially decreasing the need for costly follow-up tests and procedures.

Furthermore, PrecisionCHD can be implemented virtually via telemedicine and at-home for blood sample collection. It can also be deployed in community settings via mobile health clinics as well as in a more traditional provider setting.This multimodal delivery approach means greater access for patients, and Cardio Diagnostics expects potential additional cost savings for payers as well, with earlier detection and management of CHD.

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

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 spending.

PrecisionCHD stands out as a 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 is increasingly on achieving superior patient outcomes and improved population health while maintaining cost-effectiveness.

Throughout last year, 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.

Featured photo by Testalize.me on Unsplash

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 Companys 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

Company Website

https://cardiodiagnosticsinc.com/

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Cardio Diagnostics Holdings, Inc

COMTEX_452008683/2655/2024-05-07T08:50:31