The study represents a significant breakthrough in understanding the potential for reversing and measuring epigenetic changes associated with coronary heart disease after therapeutic intervention

Cardio Diagnostics Holdings, Inc (Nasdaq: CDIO), a pioneer of artificial intelligence-driven precision cardiovascular medicine tests, announced the publication of groundbreaking research in the journal Genes. The study titled "The Reversion of the Epigenetic Signature of Coronary Heart Disease in Response to Smoking Cessation" sheds light on the potential of reversing epigenetic changes associated with coronary heart disease (CHD) through smoking cessation.

Coronary heart disease, a leading cause of death worldwide, has long been linked to smoking. However, until now, the possibility of reversing its adverse effects at the epigenetic level through smoking cessation has remained unexplored. This new study represents a breakthrough in understanding the potential for reversing epigenetic changes associated with coronary heart disease.

The study examined the impact of smoking cessation on the six DNA methylation sites assessed by Cardio Diagnostics’ PrecisionCHD test. Data from 39 research participants who enrolled in a 90-day program of monitored smoking cessation were leveraged. PrecisionCHD, an AI-driven integrated epigenetic-genetic test for diagnosing CHD, utilizes a machine learning model to interpret the signals of six methylation-sensitive digital PCR (MSdPCR) assays and ten single nucleotide polymorphisms (SNPs) to determine CHD status. This novel approach offers two significant advantages. Firstly, it provides personalized insights into potentially modifiable lifestyle or physiological factors. Secondly, as DNA methylation is dynamic, the test serves as a mechanism to evaluate the success and efficacy of CHD therapy, enabling real-time monitoring of therapeutic interventions.

Robert Philibert, M.D., Ph.D., Chief Medical Officer of Cardio Diagnostics and the study's lead author, explained the study’s methodology and significance: “We meticulously examined a cohort of individuals who quit smoking. Using proprietary methylation sensitive digital PCR techniques, we observed an interesting phenomenon—the epigenetic signatures associated with CHD began to revert after only three months of smoking cessation.”

Notably, the study found that participants who quit smoking had increased methylation at five of the six PrecisionCHD methylation sites as compared to those who continued to smoke over a 90-day period. Increased methylation at these five sites is associated with more normal regulation of these disease-related genes. The changes in methylation occurred in genes involved in immune response, lipid metabolism, and diabetes, indicating that reversing smoking-related DNA methylation changes has a beneficial effect in a number of CHD-related processes. This discovery further suggests that methylation-based approaches could become a scalable method for evaluating the clinical effectiveness of this and other CHD interventions.

Meesha Dogan, Ph.D., CEO and co-founder of Cardio Diagnostics and one of the study's authors, remarked, "Our research represents a substantial advancement in the field of coronary heart disease management. By establishing a link between alterations in the epigenetic signatures of CHD and smoking cessation, we're forging a path towards a more personalized, effective, and adaptable method for treating CHD." She also mentioned that "Given that one of the six loci we included in our test has been demonstrated to respond to statin therapy, it's plausible that PrecisionCHD could assess the efficacy of a wide range of CHD treatments without the risk of side effects like ionizing radiation or kidney damage typically associated with other CHD evaluation methods."

The authors highlight the need for scalable methods to assess CHD therapy outcomes, similar to the transformative impact of the hemoglobin A1c (HbA1c) metric for diabetes. The results suggest that PrecisionCHD could be a game-changer in providing a direct and more precise assessment of CHD status and treatment effectiveness. This groundbreaking research marks a significant advancement in understanding and managing coronary heart disease and showcases the potential of integrating AI-driven diagnostics in precision cardiovascular medicine.

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

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230613313286/en/