Cardio Diagnostics Holdings Stock Price, News & Analysis
Company Description
Cardio Diagnostics Holdings Inc. (NASDAQ: CDIO) is an artificial intelligence-powered precision cardiovascular medicine company operating in the professional, scientific, and technical services sector, with a focus on research and development in biotechnology. According to the company’s public disclosures and press releases, Cardio Diagnostics was formed to further develop and commercialize clinical tests for cardiovascular disease by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine, referred to as its “Core Technology.” The company’s work centers on making cardiovascular disease prevention, detection, and management more accessible, personalized, and precise.
Cardio Diagnostics positions itself at the intersection of epigenetics, genetics, and AI to address coronary heart disease (CHD), which is described in its communications as a leading cause of death in the United States and a major global health concern. Its clinical offerings are based on blood tests that analyze molecular biomarkers and apply machine learning algorithms to generate insights into coronary heart disease risk, presence, and potential drivers of disease biology.
Core Technology and Business Focus
The company’s Core Technology is an AI-driven Integrated Genetic-Epigenetic Engine for cardiovascular disease. Public materials explain that this engine interprets epigenetic and genetic biomarkers using advanced algorithms to support precision cardiovascular medicine. The company states that this platform underpins its clinical tests and is intended to improve prevention, detection, and treatment of cardiovascular disease by providing personalized, data-driven insights.
Cardio Diagnostics describes itself as a precision cardiovascular medicine company that focuses on:
- Prevention of cardiovascular disease through early risk assessment.
- Detection of coronary heart disease using integrated genetic and epigenetic markers.
- Management and monitoring of disease by tracking molecular changes over time.
Clinical Tests and Solutions
According to company press releases and descriptions, Cardio Diagnostics has developed epigenetics- and AI-based clinical blood tests for coronary heart disease:
- Epi+Gen CHD™: A clinically validated test described as providing a three-year risk assessment for a coronary heart disease event, including heart attack risk. It is performed from a simple blood draw and uses epigenetic and genetic information interpreted by AI to estimate future CHD event risk.
- PrecisionCHD™: An integrated epigenetic-genetic clinical blood test that aids in the diagnosis and management of coronary heart disease. Company communications state that PrecisionCHD can detect CHD at a molecular level by combining epigenetics, genetics, and AI technology, and that it provides personalized insights into key molecular drivers of disease.
Publicly shared data indicate that PrecisionCHD’s epigenetic biomarkers have been studied for their ability to detect Ischemia with No Obstructive Coronary Arteries (INOCA) and Myocardial Infarction with No Obstructive Coronary Arteries (MINOCA), two forms of non-obstructive disease that standard diagnostic testing can fail to detect. The company has highlighted research showing that DNA methylation markers used in PrecisionCHD can sensitively and specifically detect INOCA presentations and provide molecular phenotyping that may inform personalized care.
Applications in Diagnosis, Risk Assessment, and Management
Based on the company’s descriptions, Cardio Diagnostics’ tests are designed for several key clinical applications:
- Risk assessment: Epi+Gen CHD is used to evaluate an individual’s three-year risk of a CHD event, such as a heart attack.
- Diagnosis and disease characterization: PrecisionCHD aids in diagnosing CHD, including obstructive and non-obstructive forms, and can provide insight into disease presentations like INOCA and MINOCA.
- Management and monitoring: The company states that the dynamic nature of DNA methylation and the test’s mapping to modifiable drivers of CHD make PrecisionCHD suitable for non-invasive, repeatable monitoring of disease biology, including inflammation-driven CHD.
Cardio Diagnostics has also described a platform called Actionable Clinical Intelligence, which is coupled to its Epi+Gen CHD and PrecisionCHD tests. This platform is said to provide personalized insights by linking evaluated epigenetic and genetic biomarkers to drivers of coronary heart disease, supporting more tailored clinical decision-making.
Regulatory and Reimbursement Milestones
In its public announcements, Cardio Diagnostics reports that both Epi+Gen CHD and PrecisionCHD received CPT Proprietary Laboratory Analysis (PLA) codes from the American Medical Association (0439U for Epi+Gen CHD and 0440U for PrecisionCHD). The company has also disclosed that the Centers for Medicare and Medicaid Services (CMS), through the MolDX program, issued preliminary and then final gapfill payment rates for these tests, with a final rate effective for certain Medicare claims on or after a specified date. The company characterizes these reimbursement developments as important steps toward expanding access to its cardiovascular testing for Medicare beneficiaries.
Research, Clinical Studies, and Intellectual Property
Cardio Diagnostics emphasizes research and clinical validation of its technology. Company communications reference:
- Data presented at the American Heart Association Scientific Sessions demonstrating that DNA methylation markers used in PrecisionCHD can predict levels of coronary artery obstruction and detect INOCA and MINOCA in patients with acute coronary syndrome.
- Previously published data in the Journal of the American Heart Association validating PrecisionCHD’s ability to detect coronary heart disease in multiple independent cohorts.
- A planned Cardio Diagnostics-sponsored clinical study, in collaboration with AGEPHA Pharma, to explore using PrecisionCHD to identify patients with inflammation-driven CHD and assess their response to LODOCO (low-dose colchicine), an FDA-approved anti-inflammatory medication.
The company also highlights its intellectual property portfolio. It has announced that the Japan Patent Office issued a patent titled “Compositions and Methods for Detecting Predisposition to Cardiovascular Disease,” which is exclusively licensed to Cardio Diagnostics from the University of Iowa Research Foundation. This patent covers biomarkers and methods for detecting cardiovascular disease risk and presence using epigenetic and genetic biomarkers interpreted through machine learning algorithms. The company notes that this Japanese patent adds to issued patents in the United States, Europe, Australia, India, and China, supporting its global IP strategy around its core technologies.
Partnerships and Market Reach
Cardio Diagnostics has disclosed several collaborations that illustrate how its tests are being used in practice:
- Provider network expansion in the United States: The company reports partnerships with multiple provider organizations across regions of the U.S., including concierge medicine, functional medicine, primary care, integrative cardiology, longevity-focused practices, and direct primary care. These organizations integrate Epi+Gen CHD and PrecisionCHD into their clinical workflows to obtain insights into coronary heart disease, heart attack risk, and potential drivers of disease.
- Community health collaborations: Cardio Diagnostics has announced partnerships with YMCA organizations, such as YMCA of East Tennessee and Southdale YMCA in Minnesota. These programs combine heart health education with access to the company’s physician-ordered tests, sometimes at discounted rates, and may include events such as educational sessions and heart health fairs with onsite blood sample collection.
- International expansion: The company has entered into an agreement with Aimil Ltd. and Dr. Lal PathLabs Limited to launch the PrecisionCHD test in India. This partnership is described as Cardio Diagnostics’ first expansion outside the United States and its official entry into the Indian market, focusing initially on integrating and promoting the test within Dr. Lal PathLabs’ laboratory and clinical network.
Stock Listing and Corporate Status
According to its SEC filings, Cardio Diagnostics Holdings, Inc. is incorporated in Delaware and its common stock (CDIO) and redeemable warrants (CDIOW) are listed on The Nasdaq Stock Market LLC. The company has identified itself as an emerging growth company in SEC filings. In a disclosed Form 8-K, Cardio Diagnostics reported that it regained compliance with Nasdaq’s minimum bid price requirement for continued listing on The Nasdaq Capital Market after a period during which it had been below the required threshold.
The company’s proxy materials indicate that it holds annual meetings of stockholders, at which shareholders vote on matters such as the election of directors, approval of potential future share issuances under Nasdaq rules, and ratification of the appointment of its independent registered public accounting firm.
Role Within Biotechnology and Precision Medicine
Within the broader biotechnology and professional, scientific, and technical services landscape, Cardio Diagnostics focuses specifically on precision cardiovascular medicine. Its work centers on using epigenetic and genetic biomarkers, interpreted through AI, to improve how coronary heart disease is assessed and managed. By concentrating on molecular-level detection and risk stratification via blood-based tests, the company seeks to address diagnostic gaps in conditions such as non-obstructive coronary disease and inflammation-driven CHD, as described in its public communications.