AGEPHA Pharma will supply LODOCO® (low-dose colchicine) for a Cardio Diagnostics-sponsored clinical study to explore the use of Cardio Diagnostics’ PrecisionCHD™ test to identify patients with inflammation-driven coronary heart disease (CHD)

Cardio Diagnostics Holdings Inc. (NASDAQ: CDIO), a precision cardiovascular medicine company with a pioneering technology at the intersection of epigenetics and AI, today announced an agreement with AGEPHA Pharma that will enable the validation of a precision-guided approach to treating inflammation-driven coronary heart disease (CHD). Specifically, AGEPHA Pharma will supply LODOCO® (low-dose colchicine), its FDA-approved anti-inflammatory medication, for a Cardio Diagnostics-sponsored clinical study to explore the use of Cardio Diagnostics’ PrecisionCHD™ blood test to identify patients with inflammation-driven coronary heart disease (CHD) and assess their response to LODOCO® over time.

Inflammation is increasingly recognized as a key driver to atherosclerosis and adverse cardiac events. Therefore, the clinical community is increasingly seeking more informative tools to guide targeted treatment approaches, especially for conditions like INOCA (Ischemia with No Obstructive Coronary Arteries), which is gaining attention for its inflammatory underpinnings and diagnostic complexity.

Cardio Diagnostics’ PrecisionCHD™ test is an AI-powered integrated genetic-epigenetic test to aid in the diagnosis and management of CHD. The six DNA methylation markers evaluated by the PrecisionCHD™ test map to modifiable drivers of CHD, including inflammation. For each patient, the PrecisionCHD™ test provides personalized insights into their specific molecular drivers that could help inform more targeted treatment and clinical decision making. This and the dynamic nature of DNA methylation make the PrecisionCHD™ test uniquely suited for non-invasive, repeatable monitoring of inflammation, offering a significant advantage over traditional imaging-based approaches.

Cardio Diagnostics is currently evaluating potential clinical sites for this study. The sponsored study will use PrecisionCHD™ to identify patients with inflammation-driven CHD who will be prescribed LODOCO® by a physician if clinically warranted. The patient will then be re-tested to examine changes in inflammation via DNA methylation signatures. The final study design will be outlined in partnership with the Principal Investigator of the clinical site(s) and registered as a clinical trial.

“This study reflects a precision medicine model where diagnosis and treatment are both guided by the patient’s unique molecular insights,” said Robert Philibert MD PhD, Chief Medical Officer at Cardio Diagnostics. “All interventions have potential adverse events. Fortunately, through the use of PrecisionCHD™, forward leaning clinicians can maximize the therapeutic index of cardiovascular treatment plans for their patients.”

This initiative follows broader scientific momentum, including the American Heart Association’s recent $15 million commitment to studying inflammation’s impact on cardiovascular and brain health, a sign of growing recognition of the need for precision tools in inflammation 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250708766264/en/

“This study reflects a precision medicine model where diagnosis and treatment are both guided by the patient’s unique molecular insights."