Cardio Diagnostics Holdings, Inc. Announces Breakthrough in Coronary Heart Disease Detection with PrecisionCHD Test, Published in the Journal of the American Heart Association

CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), a leader in artificial intelligence-driven precision cardiovascular medicine tests, today announced the publication of its groundbreaking study in the Journal of the American Heart Association (JAHA), an official journal of the American Heart Association. This study, conducted in collaboration with Intermountain Healthcare and University of Iowa Hospitals and Clinics, describes the development and validation of PrecisionCHD, a pioneering artificial intelligence-guided integrated genetic-epigenetic test for detecting coronary heart disease (CHD).

The article entitled “The Validation of an Integrated Genetic-Epigenetic Test for the Assessment of Coronary Heart Disease,” unveils a significant leap in CHD diagnosis. Traditional diagnostic methods for CHD are often invasive, require exposure to ionizing radiation, and are not widely accessible due to the need for specialized infrastructure. Furthermore, some of the tests are not sensitive to all forms of CHD and can be very costly. As a result, millions of Americans do not receive adequate and potentially lifesaving cardiac care in a timely manner. With the introduction of PrecisionCHD, clinicians now have a powerful, scalable, non-invasive alternative, in the form of a blood-based test that uses artificial intelligence (AI) and personalized genetic and epigenetic information to sensitively detect the presence of CHD.

The study detailed in JAHA, conducted by researchers from Cardio Diagnostics, Intermountain Healthcare and the University of Iowa Hospitals and Clinics, describes the development and validation of the PrecisionCHD test in three independent cohorts totaling 2,516 individuals. PrecisionCHD is the first integrated genetic-epigenetic test for the detection of CHD that uses the input from six methylation sensitive digital PCR (MSdPCR) assessments to determine the presence or absence of CHD.

The article details the mapping of each of these MSdPCR assays to distinct modifiable drivers of CHD through which clinicians are able to gain personalized insights into each patient’s CHD presentation. In addition, the article notes that because methylation is dynamic, clinicians can consider focused re-testing to determine the effectiveness of CHD therapy. Robert Philibert MD Ph.D., lead author and Chief Medical Officer of Cardio Diagnostics, stated that “this is a game changer for Personalized Cardiovascular Care” and noted that “unlike other methods of CHD testing, there is no exposure of patients to ionizing radiation or potentially kidney damaging contrast dye.” Dr. Philibert added, “What’s truly revolutionary about this approach is its ability to provide a more comprehensive, personalized snapshot of a patient’s CHD drivers, allowing for early intervention and tailored treatment plans. This is personal for me; seeing patients who previously had limited options for early diagnosis now have access to this state-of-the-art technology is a milestone in cardiac care.”

The implications of this research are particularly relevant for rural healthcare, where access to specialized medical facilities and diagnostics is often limited. Americans in rural communities have limited access to specialized medical facilities, fewer healthcare providers, and often, travel far greater distances for medical care. Because the PrecisionCHD test requires only a simple blood draw, patients in underserved areas will now have access to state-of-the-art cardiac assessments.

PrecisionCHD’s ability to be administered in primary care or telemedicine settings significantly reduces the need for patients from rural communities to travel to distant specialized clinics. This accessibility marks a step towards mitigating healthcare disparities, especially in rural areas with limited resources and infrastructure. Meesha Dogan Ph.D., CEO and Co-Founder of Cardio Diagnostics, emphasized, “Our commitment is to democratize access to essential cardiac care, particularly in rural areas where advanced diagnostic tools are scarce and cardiovascular specialists are even more rare. PrecisionCHD’s remote accessibility and deployment capability in non-specialized settings are pivotal in achieving this goal.”

Dr. Dogan added that “this study marks a significant step forward in CHD diagnosis, leveraging the synergies of genetics, epigenetics, and AI to offer a highly sensitive, efficient, scalable and personalized approach for CHD care.” She noted that “because the test was also recently awarded an Innovation Technology contract from Vizient, the nation’s largest group purchasing organization, clinicians at 60% of hospitals and 97% of academic medical centers in the United States already have access to the test.”

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.

Contacts

Investors:

Gene Mannheimer

Investor Relations

855-226-9991

investors@cardiodiagnosticsinc.com

Media & Public Relations:

Khullani Abdullahi

pr@cardiodiagnosticsinc.com