CHICAGO – 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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Investors:

Gene Mannheimer

Investor Relations

855-226-9991

investors@cardiodiagnosticsinc.com

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Khullani Abdullahi

855-226-9991

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CHICAGO – Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-driven precision cardiovascular medicine company, announces that the U.S. Patent and Trademark Office has issued a notice of allowance to University of Iowa Research Foundation (“UIRF”) for U.S. Application No. 17,857,723 titled Compositions and Methods for Detecting Predisposition to Cardiovascular Disease, which is exclusively licensed to the Company from UIRF, and that was co-invented by Cardio Diagnostics’ founders, Meesha Dogan, Ph.D., and Robert Philibert, MD Ph.D., the Chief Executive Officer and Chief Medical Officer of the Company, respectively. This is the second U.S. patent being issued in this patent family. Patents in this patent family have also been issued in the European Union, China, India, and Australia.

Among Escalating CVD Burden, Company Continues to Expand IP Portfolio

According to the American Heart Association, cardiovascular disease (CVD) claims 2,552 lives daily in the United States, translating to a death every 34 seconds. Heart disease, which includes heart attacks, has been the leading cause of death in the United States for 100 years. On average, a heart attack occurs every 40 seconds in the U.S., with around 605,000 new and 200,000 recurrent heart attacks reported annually.

Unfortunately, an estimated 170,000 of these heart attacks are silent, occurring without significant symptoms. This can mean that many Americans with a silent event are not being identified as at high risk early enough, nor are they being identified after the event. These figures underscore the critical health burden posed by CVD and heart disease in the U.S., highlighting the urgent need for enhanced prevention, detection, management, and treatment strategies. The Company continues to expand the IP portfolio protections associated with its Integrated Epigenetic-Genetic Engine technology, which lies at the heart of its solutions to this growing burden. The Company’s IP portfolio also encompasses its clinical blood tests, Epi+Gen CHD^TM and PrecisionCHD^TM, and software solutions, HeartRisk^TM and CardioInnovate360^TM.

Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics, stated, “The issuance of our latest patent helps us further protect our precision technology and solutions that harness the power of advanced genomics, advanced epigenomics, and artificial intelligence for the risk assessment, diagnosis, treatment, management and monitoring of cardiovascular disease. Our Precision Medicine solutions enable healthcare stakeholders, from patients, clinicians, and payors to employers, to make data-driven clinical, personal, and business decisions to get ahead of the human toll and financial burden of heart disease.”

Solutions Built on Current IP Portfolio

Epi+Gen CHD: An integrated genetic-epigenetic blood test to assess the three-year risk for coronary heart disease (CHD) events, particularly heart attacks or sudden death associated with CHD.

PrecisionCHD: An integrated genetic-epigenetic blood test to aid in diagnosing coronary heart disease.

HeartRisk: A cardiovascular disease risk intelligence platform to enable data-driven multi-stakeholder collaborations among patients, innovative providers, health plans, employers, and governmental entities to drive transformative risk stratification in heart disease and enhance earlier prevention and interventions.

CardioInnovate360: A biopharma research solution that offers three pivotal capabilities: the identification of novel biomarkers and pathways critical in CVD pathogenesis, patient stratification for enhanced clinical trial efficacy, and the development of non-invasive, scalable post-market surveillance and companion diagnostic tests.

The Company’s AI-driven integrated epigenetic-genetic technologies for cardiovascular disease are scalable, accessible, and highly sensitive. The Company’s IP strategy is designed to enhance the global protections of its one-of-a-kind technology.

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 Forms 10-Q for the period ended March 31, 2023, and September 30, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240305535830/en/

Investors:

Gene Mannheimer

Investor Relations

855-226-9991

investors@cardiodiagnosticsinc.com

Media & Public Relations:

Khullani Abdullahi

855-226-9991

pr@cardiodiagnosticsinc.com

CHICAGO – Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, announced today the nationwide rollout and a significant expansion of its groundbreaking HeartRisk™ platform. HeartRisk combines insights from HIPAA-compliant anonymized and aggregated clinical cardiovascular data obtained through Cardio Diagnostics’ Epi+Gen CHD and PrecisionCHD clinical tests, with industry and geographic data to enable real-time population-level cardiovascular disease (CVD) risk insights.

This expansion extends the reach of its proprietary data intelligence platform to correctional facilities, risk-bearing providers engaged in value-based contracts, and broker and benefits consultants. The move marks a strategic leap in addressing the financial and security challenges, such as those associated with transporting inmates in correctional facilities, of scaling access to cardiovascular testing across diverse sectors.

“By expanding our HeartRisk™ platform, we’re not just innovating within traditional healthcare sectors but breaking new ground in diverse markets. From correctional facilities to value-based care providers and workplace wellness programs to brokerage and benefits consultants, our precision cardiovascular solutions provide actionable insights. By coupling data intelligence to evidence-based and scalable clinical tests, we’re enabling these healthcare stakeholders and their organizations to make data-driven decisions to address rising healthcare costs and implement more effective chronic disease management. We’re not just advancing precision medicine; we’re ensuring those insights can be leveraged at the population level for multiple sectors,” shared Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics.

Risk-Bearing Providers and Value-Based Care

Risk-bearing providers, such as Family Medicine Specialists that receive monthly HeartRisk population data, can better manage their shared-risk and value-based contracts by identifying and stratifying at-risk populations, and understanding the drivers of heart disease, ensuring quality measures and ratings are met. This leads to benefiting from shared risk contracts while better-managing patient health.

Family Medicine Specialists’ implementation of Cardio Diagnostics’ tests in their patient population with CHD risk factors demonstrates the first time a risk-bearing provider is leveraging precision epigenetics-based heart disease technologies with a population health intelligence tool to optimize risk-sharing contracts. HeartRisk’s ability to aggregate population-level heart attack risk, the presence of heart disease detection, and intervention monitoring and management aligns with the financial incentives of shared-risk contracts.

Empowering Workplace Wellness & Financial Health

The expanded offering equips employers with unparalleled insights into workforce health trends related not just to cardiovascular risks but also encapsulating broader wellness indicators crucial for business resilience and productivity. By integrating predictive analytics around CVD within comprehensive workplace wellness initiatives, employers can reduce healthcare costs significantly while fostering an invigorated workplace culture centered on health mindfulness.

Enabling Precision-Driven Decision-Making for Employer Clients

Brokerage and benefits entities play a pivotal role in aligning coverage plans that articulate both value and efficacy against chronic conditions like CVD, which are substantial cost centers for their clientele. The enhanced functionalities within the HeartRisk™ platform allow these entities to offer meticulous plan designs optimized by granular cumulative data insights, thus ensuring impactful investments in healthcare portfolios. This includes being able to guide employer clients on stop-loss insurance decisions, benefits allocations, and premium and escrow limits using more real-time aggregated employer CVD risk intelligence data based on clinical tests for a prospective analysis rather than a retrospective analysis.

Tackling Healthcare Challenges Behind Bars: A Constitutional Requirement

Cardiovascular disease is a leading cause of death among incarcerated individuals. The incarcerated population exhibits higher rates of cardiovascular risk factors, such as smoking and hypertension, compared to the general population. Correctional facilities have a constitutional obligation to care for the health of incarcerated individuals. This includes the provision of medical and mental health care, which is complicated by the high prevalence of chronic diseases, mental health issues, and substance use disorders among the incarcerated population.

The complexity of providing care in correctional facilities is exacerbated by resource constraints and the difficulty of providing specialized care for heart disease without transportation. The costs and security risks associated with transporting inmates into healthcare settings and facilities are staggering. Annually, more than $90 million is spent on transporting inmates to U.S Hospitals annually. HeartRisk, driven by the adoption of Epi+Gen CHD and PrecisionCHD via telehealth, is a highly scalable approach for correctional facilities to obtain heart attack and heart disease insights.

Impact on Healthcare Costs and Chronic Disease Management

The expansion of the HeartRisk™ platform is aligned with the broader trend in healthcare towards prevention and value-based care. Preventive measures are not only lifesaving but also economically beneficial, with an estimated return of $6.30 in savings for every $1 invested. Active strategies for risk factor reduction, prevention, and treatment of CVD, powered by precision population analytics, are key to addressing these growing cardiovascular cost challenges.

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 Forms 10-Q for the periods ended March 31, 2023, and September 30, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240215818293/en/

Investors:

Gene Mannheimer

Investor Relations

855-226-9991

investors@cardiodiagnosticsinc.com

Media & Public Relations:

Khullani Abdullahi

855-226-9991

pr@cardiodiagnosticsinc.com

CHICAGO – Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the Company’s AI-driven epigenetic-genetic blood tests, Epi+Gen CHD and PrecisionCHD, will be available beginning Q2 2024 in a retail healthcare setting inside the Walmart Supercenter in Round Lake Beach, Illinois.

Round Lake Beach, a northern suburb of Chicago in Lake County, has been chosen as the strategic starting point for this retail healthcare initiative. This initiative is an expansion of the ongoing Heart Attack Prevention Initiative with Family Medicine Specialists (FMS) to increase the accessibility of clinical cardiovascular diagnostic solutions, moving them beyond traditional provider settings and into the more accessible realm of retail healthcare for hundreds of additional patients in Lake County, Illinois. The retail healthcare footprint and market share continues to grow as more Americans embrace the convenience and accessibility to high quality healthcare services. In a recent report, AMN Healthcare reported that 30.3 percent (79.6 million) Americans received care at a retail clinic, and expect 32.8 percent of Americans to do so in 2024.

“Our partnership with FMS to bring our tests to their Walmart locations is a game-changer in the field of cardiovascular health management. By integrating Cardio Diagnostics’ state-of-the-art clinical tests within FMS’s expansive retail network, we are shifting the paradigm from a model that relies on specialty care infrastructure to one that meets American communities in their backyard. This strategic alliance not only democratizes access to top-tier heart disease services but also propels Cardio Diagnostics as a leader in cardiovascular retail healthcare innovation. Our ultimate goal is to meet patients where they are, weaving advanced medical services seamlessly into the fabric of their everyday lives,” shared Meesha Dogan, Ph.D., Co-Founder and CEO of Cardio Diagnostics.

Employees and customers in the Round Lake Beach Walmart location of FMS will have access to both of Cardio Diagnostics’ clinical blood tests on a walk-in basis. The Company’s epigenetic-genetic cardiovascular clinical blood tests, Epi+Gen CHD™ and PrecisionCHD™, detect heart attack risk and coronary heart disease status, respectively. These tests are easy to administer in the retail healthcare setting because they only require a simple blood draw, bringing this vital service closer to patients.

“At Family Medicine Specialists, we have multiple retail healthcare partnerships and are particularly excited about our unique and innovative partnership with Cardio Diagnostics, a leader in clinical cardiovascular diagnostic solutions. This collaboration will enable us to bring advanced cardiac diagnostic tools directly into our retail healthcare clinic locations, enhancing our ability to provide more advanced patient care without the need for additional infrastructure. We believe that this partnership will empower our clinicians with additional resources to better serve our patients’ needs,” stated Jason Bellucci, MBA, President of Family Medicine Specialists.

Bringing Precision Cardiovascular Testing to Each Neighborhood

Heart attacks and coronary heart disease pose significant health risks, and earlier detection and intervention remain crucial for prevention. In the current healthcare paradigm, accessing specialized tests for assessing one’s heart attack risk or for the diagnosis of coronary heart disease means having to navigate complex schedules and significant waiting periods. While primary care and family medicine practices have managed to maintain relatively shorter wait times, specialty areas like cardiology have seen a significant rise, with the average wait time now extending to about 26.6 days. This delay particularly impacts cardiology patients, where timely intervention can be crucial.

With 45% of Americans projected to have some form of cardiovascular disease by 2035, the key question is, how can Americans and their providers quickly gain clarity about a patient’s heart disease without weeks of waiting for a specialist appointment? The short answer is, cardiology specialty tests must be routinely and readily available in community settings, such as in retail healthcare stores.

With the deployment of Cardio Diagnostics’ advanced blood tests across select Walmart locations in partnership with FMS, the Company aims to help alleviate the critical issue of increasing wait times for specialty care. Cardio Diagnostics’ expanded collaboration with FMS at select Walmart locations, beginning with the Round Lake Beach location, is a key opportunity to reduce wait times for cardiac assessments and care, and expand community-based access to heart disease solutions.

The company intends to continue to identify and partner with provider organizations with a strong retail healthcare presence who are keen to enhance their existing heart disease-related services with precision cardiovascular diagnostic and risk assessment technologies.

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 Forms 10-Q for the period ended March 31, 2023 and September 30, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240207106347/en/

Investors:

Gene Mannheimer

Investor Relations

855-226-9991

investors@cardiodiagnosticsinc.com

Media & Public Relations:

Khullani Abdullahi

855-226-9991

pr@cardiodiagnosticsinc.com

CHICAGO – Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-driven precision cardiovascular medicine company, announces that Houston-based resTOR Longevity Clinic will integrate Cardio Diagnostics’ solutions into its battery of tests for new patients in its longevity-focused concierge clinic. This collaboration marks a significant milestone for Cardio Diagnostics, as resTOR will be the first longevity clinic in America to incorporate Cardio Diagnostics’ innovative blood-based epigenetic tests for cardiovascular disease, Epi+Gen CHD and PrecisionCHD, into its testing regime for new patients.

“Our partnership with resTOR Longevity Clinic bridges the emerging innovative approach to medicine with a concrete application of the epigenetics of aging by using DNA methylation technologies to tackle and manage heart disease. By integrating Cardio Diagnostics’ clinical tests for heart disease with a longevity-focused clinic, we are making longevity-based medicine a reality by addressing one of the leading causes of aging and death. Our ultimate goal is to partner with the most innovative provider organizations in the country and push the boundaries of modern medicine to transform innovation in cardiovascular medicine with an emphasis on living a longer and healthier life,” stated Meesha Dogan, Ph.D., Co-Founder and CEO of Cardio Diagnostics.

Both organizations are focused on expanding their influence within the longevity and precision medicine fields. Cardio Diagnostics aims to continue identifying and partnering with forward-thinking clinics like resTOR Longevity to disseminate its cutting-edge technologies further. The goal is to establish a new standard in cardiovascular care that prioritizes prevention and personalized treatment plans, thereby contributing to increased patient health span and lifespan. This partnership is a stepping stone towards a broader vision where longevity-based medicine becomes the norm, and Cardio Diagnostics is at the forefront of this transformative shift.

“resTOR Longevity Clinic is thrilled to announce its official launch, offering a transformative approach to enhancing healthspan and lifespan,” shared Dr. Gregory Burzynski, MD, the founder of the clinic. “In our clinic, we integrate state-of-the-art technologies with a deep understanding of each patient’s unique health challenges. Cardio Diagnostics’ solutions offer us the ability to craft precise and personalized intervention strategies that are tailored to a patient’s specific biology.”

Longevity, Aging and Epigenetics

The longevity clinic market is part of the broader anti-aging industry, which is experiencing significant growth due to demographic shifts and a rising emphasis on proactive health management. The global longevity and anti-senescence therapy market was valued at $25.1 billion in 2020 and is projected to reach $44.2 billion by 2030. The integration of advanced diagnostics and therapies in clinics like resTOR Longevity is a reflection of this growing market and the potential for substantial economic impact within the healthcare industry.

Across the world, 75% of all premature cardiovascular deaths can be prevented. Partnerships between leading clinics like resTOR Longevity and innovative diagnostic companies like Cardio Diagnostics can help prevent premature deaths from cardiovascular disease. As Professor David Sinclair, co-director of Harvard’s Sinclair Lab, shared in the Financial Times, “DNA is no longer destiny. Twenty percent of our future health is prewritten, determined by our genes, but the other 80 percent is within our control.”

Practices like resTOR Longevity Clinic avoid a one-size-fits-all approach. By embracing a holistic view of wellness, they make the latest evidence-based technologies accessible to patients. Additionally, such clinics combine these technologies with a hyper-focus on precision medicine approaches to develop bespoke wellness strategies that are based on each patient’s unique biological makeup.

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.

About resTOR Longevity Clinic

resTOR Longevity Clinic is a pioneering healthcare provider that focuses on enhancing health span and lifespan. Led by Dr. Gregory Burzynski, the clinic offers a holistic approach to wellness, integrating state-of-the-art technology with a deep understanding of each patient’s unique biological narrative. The clinic provides bespoke wellness strategies, comprehensive health evaluations, and personalized insights and recommendations. For more information, please visit https://restorlongevityclinic.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 Forms 10-Q for the period ended March 31, 2023, and September 30, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240205124482/en/

Investors:

Gene Mannheimer

Investor Relations

855-226-9991

investors@cardiodiagnosticsinc.com

Media & Public Relations:

Khullani Abdullahi

855-226-9991

pr@cardiodiagnosticsinc.com

CHICAGO – Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), a pioneering AI-driven precision cardiovascular medicine company, today announced that India’s Patent Office has granted a patent to the University of Iowa Research Foundation (“UIRF”) under patent number 484488, titled “A Kit for Determining Methylation Status of a CpG Dinucleotide and a Genotype of a Single Nucleotide Polymorphism.”

The patent was exclusively licensed to the Company from the University of Iowa Research Foundation (UIRF). It was co-invented by Cardio Diagnostics’ founders, Meesha Dogan, Ph.D., and Robert Philibert, MD, Ph.D., the Chief Executive Officer and Chief Medical Officer of the Company, respectively.

Heart Disease in India Begins Earlier in Adults

The burden of heart disease in India is substantial and growing, driven by high prevalence rates, significant risk factors, high mortality, and lack of access to specialty cardiology settings. Particularly concerning is the early onset of cardiovascular disease in Indians compared to their western counterparts; Indians are found to develop cardiovascular disease 10-years earlier and during their prime work years. Based on the age at which many Indians are struck with heart disease, the World Economic Forum and Harvard School of Public Health estimate that India’s economic losses related to cardiovascular disease will exceed $2.5 trillion.

By partnering with Indian business leaders to introduce innovative precision-based cardiovascular diagnostic methods and advanced management insights, the Company can help accelerate preventive health initiatives and improve cardiovascular health outcomes in India. This presents a significant opportunity for Cardio Diagnostics to expand its footprint in the world’s fastest growing nation by population.

Expanding Access to Scalable Heart Disease Solutions in India

Cardio Diagnostics recently entered into a Supply and Distribution Agreement with Aimil Ltd., a company at the forefront of the instrumentation industry in India since 1932 with 14 sales and services offices across India. Aimil is a leader in introducing innovative, best-in-class technologies from around the world to their extensive healthcare network throughout India.

“Securing this patent in India is a significant milestone for the company, especially with our ongoing collaboration with Aimil to introduce our solutions in India through Aimil’s extensive healthcare network,” said Meesha Dogan Ph.D., CEO and Co-founder of Cardio Diagnostics. “We’re committed to leading the fight against heart disease globally and are excited for the synergies that lie ahead.”

Marie Kerbeshian, Ph.D., Executive Director of UIRF, said, “University of Iowa remains steadfast in partnering with companies like Cardio Diagnostics that are dedicated to tackling global healthcare challenges such as heart disease. Cardio Diagnostics exemplifies the transformation of cutting-edge research into Precision Medicine solutions with the potential to impact and save lives worldwide.”

The Company’s robust intellectual property portfolio includes granted patents in the United States, Europe, India, China, Australia and Hong Kong, numerous pending patents worldwide, proprietary laboratory assays, proprietary AI-driven Integrated Genetic-Epigenetic Engine, proprietary Risk Intelligence platform (HeartRisk), proprietary AI algorithms of the Epi+Gen CHD and PrecisionCHD clinical tests, and a multitude of other trade secrets. The company remains committed to developing and protecting its innovative technologies that can improve cardiovascular health outcomes for patients globally.

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 Forms 10-Q for the periods ended March 31, 2023 and September 30, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240108888659/en/

Investors:

Gene Mannheimer

Investor Relations

855-226-9991

investors@cardiodiagnosticsinc.com

Media & Public Relations:

Khullani Abdullahi

855-226-9991

pr@cardiodiagnosticsinc.com

CHICAGO – Please replace the release with the following corrected version due to multiple revisions.

The updated release reads:

CARDIO DIAGNOSTICS HOLDINGS, INC. UNVEILS GROUNDBREAKING EMPLOYER CARDIOVASCULAR DISEASE RISK INTELLIGENCE PLATFORM, HEARTRISK™

HeartRisk™ Empowers Employers Who Adopt Cardio Diagnostics’ Solutions to Proactively Combat Cardiovascular Disease in Their Workforce and Mitigate Business Risks

Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the Company’s new HeartRisk proprietary data intelligence platform will be available to employers who offer the Company’s innovative cardiovascular disease clinical tests as a health benefit to their employees. HeartRisk, a leading platform that combines insights from HIPAA-compliant anonymized and aggregated clinical cardiovascular risk data with industry and geographic data, aims to help employers understand the cardiovascular risks in their workforce compared to population and industry benchmarks.

HeartRisk, which will be available beginning February 15, 2024, involves a tiered SaaS pricing model starting at $2,500 a month. The tiered model will accommodate the diverse needs of different size employers, benefits brokers, and third-party associations who adopt the technology. This approach ensures that companies only pay for the features and services that are most relevant to their organization, thereby offering a cost-effective solution to combat cardiovascular disease in their workforce.

Via, HeartRisk, employers, benefits brokers, as well as potentially third-party administrators and health plan care managers in the future can access actionable insights related to risks associated with cardiovascular disease, such as the amount of stop-loss insurance to carry based on the degree of CVD risk in the relevant population or selections of appropriate chronic care management partners. Ultimately, stakeholders will leverage the insights from HeartRisk to make more data-driven decisions on the right suite of benefits, the proper allocation of resources, enhance employee retention rates, and take proactive measures to mitigate the profound impact of cardiovascular disease on productivity and healthcare expenditures.

Employer Healthcare Costs Are Soaring

Chronic conditions, including cardiovascular disease, significantly impact healthcare costs for employers. According to United Healthcare, heart disease and stroke alone cost employers $363 billion annually. In addition to the direct healthcare costs, chronic conditions also lead to increased workforce absenteeism and decreased productivity. According to the CDC, five chronic diseases or risk factors for cardiovascular disease-high blood pressure, diabetes, smoking, physical inactivity, and obesity-cost US employers $36.4 billion a year due to employee absenteeism. Innovative employers and their broker partners interested in managing the implications of these growing costs related to cardiovascular disease are already looking for ways to adapt to this new reality.

Cardio Diagnostics’ Epi+Gen CHD and PrecisionCHD tests address coronary heart disease, which is the most common type of heart disease, in a way that realizes value for employers on a shorter time horizon and with the goal of realizing such value prior to the manifestation of the acute impact of coronary heart disease on workforce productivity and employer healthcare costs. Epi+Gen CHD and PrecisionCHD evaluate objective epigenetic and genetic biomarkers from a patient’s blood sample and utilize a proprietary AI algorithm to assess the risk for a heart attack and aid in the diagnosis of coronary heart disease, respectively. These highly sensitive tests, which only require a simple blood draw, can be deployed remotely for offsite employees, in a provider setting or onsite via a mobile clinic; this creates the flexibility to reach more eligible employees and drives a higher benefits utilization rate. The Company’s most recent heart disease fair for an employer organization gained participation from 75% of eligible employees and their spouses.

Enhanced Risk Mitigation for Innovative Employers

Employers manage workforce health risks through a combination of preventive care, physical and mental health initiatives, and comprehensive insurance coverage. These strategies not only contribute to the well-being of employees but also help mitigate the financial risks associated with workplace injuries, chronic health conditions, and absenteeism.

Employers that fail to mitigate such risks experience significant costs, both direct and indirect. Direct costs can include increased insurance premiums and workers’ compensation claims. Indirect costs often include lost productivity due to employee absenteeism, decreased morale, and the costs associated with hiring and training replacement workers. These challenges are only expected to increase for employers. The 2022 Best Practices in Healthcare Survey found that seven in ten employers anticipate moderate to significant increases in healthcare costs over the next three years.

“As we serve providers, health plans, and employer organizations, we know that the human toll and financial costs of cardiovascular disease are integrated. According to the US Census Bureau, a majority of Americans obtain their health benefits through their employers, so innovative employers are key to winning the fight against heart disease. We built HeartRisk, a platform that combines insights from our clinical tests with other meaningful data to empower forward-thinking employers who invest in their workforce’s health,” said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics. “This isn’t just about predicting business risks that arise from workforce health outcomes; it’s about preventing them with actionable insights that help inform risk-reduction strategies to help employers reduce healthcare costs, bolster employee retention, and ultimately, build a healthier, more resilient future for their employees and company.”

Employers can get ahead of rising healthcare costs with enhanced visibility into the health of their workforce and make data-driven decisions to invest in advanced medical technologies and wellness solutions that target their biggest cost centers, such as heart disease.

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 Forms 10-Q for the periods ended March 31, 2023 and September 30, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240104446348/en/

Investors:

Gene Mannheimer

Investor Relations

855-226-9991

investors@cardiodiagnosticsinc.com

Media & Public Relations:

Khullani Abdullahi

855-226-9991

pr@cardiodiagnosticsinc.com