Cardio Diagnostics Holdings Inc Launches Revolutionary Blood Test for Early Detection of Coronary Heart Disease

PrecisionCHD^™ is the First Integrated Epigenetic-Genetic-Based Blood Test for the Early Detection of Coronary Heart Disease

CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings Inc (Nasdaq: CDIO), an artificial intelligence-powered precision cardiovascular medicine company, today announced the launch of PrecisionCHD^™, an integrated epigenetic-genetic blood test for the early detection of coronary heart disease.

PrecisionCHD is the second clinical test built using Cardio Diagnostics’ proprietary AI-driven Integrated Epigenetic-Genetic Engine. The company’s initial product, Epi+Gen CHD^™, a three-year coronary heart disease risk assessment test, also leveraged the Engine and was launched in 2021. The two tests address the most common form of cardiovascular disease – coronary heart disease – across the entire spectrum, from assessing risk for prevention to early detection. Over the next two years, Cardio Diagnostics expects to continue to leverage its Engine to develop a series of integrated epigenetic-genetic clinical tests for other cardiovascular diseases and associated conditions.

Cardiovascular disease (CVD) continues to be the leading cause of death in the United States, with coronary heart disease (CHD) being the most common type of CVD and the primary cause of heart attacks. According to the American Heart Association, nearly 400,000 deaths in 2020 are attributable to CHD, and over 800,000 Americans have a heart attack yearly. Cardio Diagnostics’ new patent-pending test, PrecisionCHD, aids in the early detection of coronary heart disease to better enable the management of this condition to prevent a symptomatic event such as a heart attack.

Using epigenetic (DNA methylation) and genetic (single nucleotide polymorphism) biomarkers along with a proprietary machine-learning model developed by analyzing billions of genomic and epigenomic data points, PrecisionCHD detects coronary heart disease with better than 75% sensitivity in both men and women. A key defining characteristic of PrecisionCHD is its accompanying provider-only Actionable Clinical Intelligence^™ platform, which maps a patient’s unique biomarker profile onto modifiable risk factors such as diabetes, hypertension, hypercholesterolemia, and smoking, known to be critical drivers of coronary heart disease.

As many healthcare organizations struggle with accessibility challenges, Cardio Diagnostics’ solutions are designed to democratize access to better care. Cardio Diagnostics’ tests, including PrecisionCHD, can be administered in provider settings or remotely through a combination of at-home sampling and telehealth solutions.

“The launch of PrecisionCHD represents a leap forward in cardiovascular medicine. I’m beyond thrilled that we’re able to make the promise of precision cardiovascular medicine a reality,” said Robert Philibert, MD Ph.D., the company’s Chief Medical Officer and Co-Founder. “Clinicians seeking to assess coronary heart disease status in their patients no longer have to worry about their ability to obtain an exercise stress test or angiogram. Now, clinicians can have a blood sample drawn in their office or a kit sent to their patient’s home for this highly sensitive test.”

PrecisionCHD gives providers a complement to traditional CHD diagnostic solutions. The test is non-invasive, simple, and provides an informative, personalized patient report of CHD status.

“While we are incredibly proud of the work we’ve done to bring PrecisionCHD to the market and the impact this test can have in improving the lives of millions around the world, we understand how timely it was that we were building in an era of Artificial Intelligence, high-performance computing, and high-throughput epigenetics,” said Meesha Dogan, Ph.D., the CEO and Co-Founder of Cardio Diagnostics. “PrecisionCHD would not have been possible without Cardio Diagnostics being at the forefront of pioneering technology at the intersection of epigenetics, genetics, and Artificial Intelligence focused on reducing the burden of the number one killer. PrecisionCHD and Epi+Gen CHD are tools to get ahead of coronary heart disease for healthcare providers, employers, and payers in this era because this is the age of AI-enabled precision medicine.”

With the U.S. launch of PrecisionCHD, this technology will first be available exclusively for existing customers, with a nationwide roll-out expected shortly thereafter. PrecisionCHD will debut at the American College of Cardiology’s 72nd Annual Scientific Session (ACC.23), taking place in New Orleans, LA, from March 4-6, 2023 at Booth #1008. The company’s executive team will be onsite to meet with industry partners and investors. Please email Khullani@cardiodiagnosticsinc.com to schedule a meeting.

About Cardio Diagnostics

Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention and early detection 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 enabling improved prevention, early detection, and assists in the treatment of cardiovascular disease. For more information, please visit www.cardiodiagnosticsinc.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “should,” “believe,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements include, without limitation, the Company’s expectations with respect to future performance, development and commercialization of products and services, the potential benefits and impact of the Company’s products and services, potential regulatory approvals, and the size and potential growth of current or future markets for the Company’s products and services. Forward-looking statements are statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties that could cause the actual results to differ materially from the expected results. These statements are based on various assumptions, whether or not identified in this press release, and are not intended to serve as, and they must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that Epi+Gen CHD™ and PrecisionCHD™ tests are accepted and adopted by patients, healthcare professionals and participants in other key channels; the impact of COVID-19 on the Company’s business; economic conditions, dependence on management, dilution to stockholders, lack of capital, changes in laws or regulations, the effects of rapid growth upon the Company and the ability of management to execute our growth strategy and ability 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, lack of industry standards, the effects of competition and the ability of the Company to obtain future financing. 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