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Cardio Diagnostics Holdings, Inc. to Present Data Demonstrating PrecisionCHD's Ability to Detect INOCA and MINOCA at the American Heart Association Scientific Sessions

1. CDIO presents new data at AHA Scientific Sessions for PrecisionCHD test. 2. PrecisionCHD detects INOCA and MINOCA, underdiagnosed heart diseases. 3. 30-50% of invasive coronary angiography patients have INOCA. 4. DNA methylation effectively identifies coronary artery obstruction. 5. Focus on personalized care enhances accessibility in cardiology.

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Why Bullish?

The article discusses significant advancements of the PrecisionCHD test, potentially increasing CDIO’s market relevance and attracting investors due to its innovative approach. Historical precedents show similar technologies have led to stock price increases; for instance, the rise of telehealth has bolstered companies focused on remote diagnostics.

How important is it?

The focus on detecting commonly undiagnosed conditions positions CDIO as a leader in cardiovascular diagnostics, crucial for addressing unmet medical needs. This unique commercial potential makes the article highly relevant and important to CDIO's future performance.

Why Long Term?

As CDIO's PrecisionCHD test gains traction, it may solidify its market position, enhancing revenue streams over time. Long-term adoption of innovative diagnostics can lead to sustained growth, as witnessed in the biotech sector with tools that significantly improve disease detection.

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Ischemia with No Obstructive Coronary Arteries (INOCA) and Myocardial Infarction with No Obstructive Coronary Arteries (MINOCA) are two underdiagnosed, potentially fatal forms of heart disease that standard diagnostic testing routinely fails to detect

Cardio Diagnostics Holdings, Inc. (NASDAQ:CDIO), an AI-powered Precision Cardiovascular Medicine company, today announced that the Company will be presenting new data at the American Heart Association (AHA) Scientific Sessions demonstrating that the epigenetic biomarkers of the Company's PrecisionCHD test are able to detect Ischemia with No Obstructive Coronary Arteries (INOCA) and Myocardial Infarction with No Obstructive Coronary Arteries (MINOCA) presentations. PrecisionCHD is an integrated epigenetic-genetic blood test that aids in the diagnosis of coronary heart disease (CHD). The AHA Scientific Sessions will take place in New Orleans, LA, from November 7 to 10.

A Critical Gap in Cardiovascular Diagnostics

CHD is the most common type of cardiovascular disease (CVD), is the primary cause of heart attacks, and remains a leading cause of death in the United States. The diagnosis of CHD is traditionally focused on the obstructive form of the disease. However, research shows that approximately 30 to 50 percent of patients referred for invasive coronary angiography have INOCA and up to 10 percent of all myocardial infarctions are MINOCA. INOCA is more frequently observed in women. Unfortunately, without access to expensive invasive provocative testing at highly specialized testing centers, INOCA goes undiagnosed and untreated. As a result, tens of thousands of patients needlessly suffer premature mortality and nonfatal myocardial infarctions annually.

"INOCA and MINOCA continue to pose a diagnostic challenge in modern cardiology," said Robert Philibert, MD, PhD, Chief Medical Officer of Cardio Diagnostics. "When ischemia or heart attacks occur without visible blockages, clinicians are left with uncertainty. More than ever, a noninvasive and accessible tool such as our PrecisionCHD test that could help detect these conditions and provide insight into a patient's biology for personalized management will mark a pivotal step towards Precision Cardiovascular Medicine."

DNA Methylation Predicts Coronary Obstruction and Can Detect INOCA and MINOCA

At the AHA Scientific Sessions, Dr. Philibert will be presenting new data from a study titled "DNA Methylation Strongly Predicts Level of Coronary Artery Obstruction and Ischemia with No Obstructive Coronary Artery Spectrum Presentations in Those with Acute Coronary Syndrome." In collaboration with the University of Iowa, the study examined 267 patients hospitalized for acute coronary syndrome at the University of Iowa Hospitals and Clinics who underwent coronary angiography. The goal of the study was to determine if the DNA methylation markers of the PrecisionCHD test could identify those with INOCA and MINOCA. The key findings of the study include that methylation indices used in PrecisionCHD by themselves sensitively and specifically detected INOCA presentations with an overall AUC of 0.90 while providing in-depth molecular phenotyping that provided personalized, actionable insights to help inform care.

These findings build on previously published data in the Journal of the American Heart Association validating PrecisionCHD's ability to sensitively and specifically detect coronary heart disease in three independent cohorts spanning first-episode, community, and hospital settings.

Leading the Future of Precision Cardiovascular Medicine

DNA methylation can help elucidate molecular drivers of disease and through its dynamic nature, provide feedback on disease progression and intervention effectiveness. By translating DNA methylation into actionable insights, PrecisionCHD empowers clinicians to define a patient's disease presentation and underlying drivers beyond obstruction. This approach supports personalized care that can be deployed at scale in both clinical settings and via telemedicine. This is especially important for women who more often experience INOCA, for patients in rural settings, and for those facing longer in-person appointment wait times including Veterans who often lack access to specialized invasive testing.

"Cardio Diagnostics is pioneering a molecular lens into heart disease," said Tim Dogan, PhD, Chief Technology Officer of Cardio Diagnostics. "These findings validate how our advanced epigenetic technology can detect disease biology, unlocking a new paradigm of precision cardiovascular diagnostics that is both accessible and transformative."

To schedule a time to meet with Dr. Philibert at the American Heart Association Scientific Sessions or to schedule a time to learn more about how our solutions can help your patients or employees, email support@cdio.ai.

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. For more information, please visit https://cdio.ai/.

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, and dependence on results as discussed in the Annual Report on Form 10-K for the period ended December 31, 2024, 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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