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Business Wire
2 days ago
- Health
- Business Wire
Cardio Diagnostics Receives Gapfill Payment Rates for AI-Driven Cardiovascular Tests from the Centers for Medicare and Medicaid Services (CMS)
CHICAGO--(BUSINESS WIRE)-- Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-powered precision cardiovascular medicine company, today announced that the Centers for Medicare and Medicaid Services (CMS), through the MolDX program, has issued preliminary gapfill payment rates of $350 for Epi+Gen CHD™ and $684.76 for PrecisionCHD™. A 'gapfill' payment rate means that pricing is determined by each Medicare contractor, including MolDX, based on cost data from Cardio Diagnostics. These preliminary payment rates, proposed as part of the calendar year 2025 gapfill pricing process, are expected to be finalized later this year and will be effective for claims with dates of service on or after January 1, 2025. The proposed rates represent a significant positive development in the Company's efforts to expand access to its advanced cardiovascular testing for Medicare beneficiaries. 'We view this as a critical step toward expanding timely access and improving care for Medicare patients' said Meesha Dogan, PhD., CEO and Co-Founder of Cardio Diagnostics. 'Many Medicare beneficiaries, who are at elevated risk for coronary heart disease, go undetected and undertreated, often resulting in avoidable heart attacks, hospitalizations, and poor outcomes.' Cardio Diagnostics clarified during a recent meeting with MolDX that initial public documentation had inadvertently transposed the pricing between the two tests, and MolDX confirmed the correct association of the proposed payment rates to their respective tests. Addressing the Leading Cause of Death Cardiovascular disease remains the leading cause of death in the United States, particularly among Americans aged 65 and older. In 2022 alone, over 700,000 Americans died from heart disease, with coronary heart disease (CHD) accounting for more than 370,000 deaths. PrecisionCHD™ is a groundbreaking AI-powered test designed to aid in the diagnosis of CHD by analyzing both genetic and epigenetic markers. Meanwhile, Epi+Gen CHD™ provides insight into a patient's three-year risk for a CHD event, such as a heart attack. Both tests are performed from a simple blood draw, enabling scalable, accessible, and non-invasive cardiovascular assessment. Both tests received dedicated CPT Proprietary Laboratory Analysis (PLA) codes from the American Medical Association, 0439U for Epi+Gen CHD and 0440U for PrecisionCHD, that were effective on April 1, 2024. 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 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.
Business Wire
10-06-2025
- Business
- Business Wire
Cardio Diagnostics Secures Japanese Patent for AI-Driven Cardiovascular Disease Detection Technology
CHICAGO--(BUSINESS WIRE)-- Cardio Diagnostics Holdings Inc. (Nasdaq: CDIO), an artificial intelligence-powered precision cardiovascular medicine company, today announced that the Japan Patent Office has issued a patent for another set of biomarkers in the company's intellectual property portfolio. The patent, titled 'Compositions and Methods for Detecting Predisposition to Cardiovascular Disease,' (Japanese Patent No. 7672192) is exclusively licensed to Cardio Diagnostics from the University of Iowa Research Foundation (UIRF) and names Cardio Diagnostics' founders Meesha Dogan, Ph.D., Chief Executive Officer, and Robert Philibert, MD, Ph.D., Chief Medical Officer, as inventors. The Japanese patent further strengthens Cardio Diagnostics' global IP strategy and adds to its robust portfolio of issued patents in the United States, Europe, Australia, India, and China, covering core technologies that helped yield the Company's clinical solutions. 'Receiving this patent in Japan marks a critical milestone in our mission to globalize our precision cardiovascular medicine platform,' said Meesha Dogan, Ph.D., CEO of Cardio Diagnostics. 'As cardiovascular disease continues to rise in prevalence worldwide, the ability to offer AI-powered, methylation- and genetics-based diagnostics in international markets like Japan represents a major step forward in improving early detection and prevention of heart disease.' 'We are proud to support this important innovation from the University of Iowa ecosystem,' said Marie Kerbeshian, Ph.D., Executive Director of the UIRF. 'Cardio Diagnostics continues to demonstrate the global relevance of its technology, and we look forward to the impact it will have in advancing cardiovascular medicine across borders.' The Japanese patent protects Cardio Diagnostics' novel methods and compositions that enable the detection of cardiovascular disease risk and presence using epigenetic and genetic biomarkers interpreted through advanced machine learning algorithms. This issuance underscores the global applicability of the Company's pioneering approach to heart disease prevention. As part of its expanding IP footprint, Cardio Diagnostics is committed to delivering innovative, data-driven solutions that empower healthcare providers and patients with actionable insights for cardiovascular health, now on a global scale. 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 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 results are discussed in the Current Report on Form 10-K for the period ended in December 31, 2024, and Form 10-Q for the period ended in March 31, 2025, 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.
Associated Press
26-03-2025
- Business
- Associated Press
Cardio Diagnostics Holdings, Inc. to Showcase Enhanced PrecisionCHD™, Actionable Clinical Intelligence™ and New Clinical Advancements at the American College of Cardiology's 74th Annual Scientific Session
Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-powered precision cardiovascular medicine company, today announced its participation in the American College of Cardiology's 74th Annual Scientific Session & Expo (ACC.25), taking place March 29-31, 2025, at McCormick Place in Chicago, IL. Cardio Diagnostics will be exhibiting at Booth #2033, showcasing its growing portfolio of advanced cardiovascular solutions, focusing on the Company's PrecisionCHD™ test and its enhanced Actionable Clinical Intelligence (ACI™) report designed to transform how coronary heart disease (CHD) is diagnosed and managed. Cardio Diagnostics' mission is to redefine cardiovascular care by combining epigenetics, genetics, and artificial intelligence to enable earlier detection of heart disease and more personalized patient management. Through our commitment to data-driven innovation, Cardio Diagnostics aims to prevent heart disease, improve diagnostic accuracy, and enable clinicians with actionable insights to deliver targeted, effective care. Spotlight on PrecisionCHD™ and Actionable Clinical Intelligence (ACI™) PrecisionCHD™, Cardio Diagnostics' flagship solution, is a clinical blood test available by prescription to aid in the diagnosis and management of coronary heart disease (CHD). Unlike traditional diagnostic tools, PrecisionCHD™ is radiation-free, requires no fasting, and is performed through a simple blood draw, either via standard phlebotomy or lancet-based sampling. By evaluating a unique panel of 10 genetic and 6 epigenetic (DNA methylation) markers, PrecisionCHD™ provides clinicians with deep insights into the unique underlying molecular drivers of CHD for each patient. Importantly, the test results map epigenetic biomarkers to modifiable risk factors, allowing clinicians to personalize patient management. For cardiologists, PrecisionCHD™ serves as a critical tool in the fight against CHD, offering a non-invasive, radiation-free method to assess molecular drivers of CHD that traditional diagnostics may overlook. With the ability to track changes over time, PrecisionCHD™ empowers cardiologists to refine treatment plans based on a patient's unique epigenetic profile, ultimately driving more effective interventions and better long-term cardiovascular outcomes. This year at ACC.25, Cardio Diagnostics will specifically highlight the updated Actionable Clinical Intelligence (ACI™) report for PrecisionCHD™, now enhanced to provide clearer, easier-to-interpret and more actionable clinical insights. The updated ACI™ leverages PrecisionCHD™'s six key methylation markers, giving prescribing clinicians sharper visibility into their patients' modifiable drivers of disease, including inflammation-related risk - a critical advancement for personalized care. 'PrecisionCHD™ and our enhanced Actionable Clinical Intelligence™ deliver a level of insight that no other solution offers cardiologists today,' said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics. 'By integrating epigenetics, genetics, and AI, we provide a clearer, more actionable understanding of a patient's modifiable drivers of coronary heart disease. This empowers cardiologists to deliver truly personalized care and improve patient outcomes.' Poster Presentation - Methylation Biomarkers as Predictors of Mortality in ACS Patients: A Critical Advancement for Clinical Cardiology At ACC.25, Cardio Diagnostics will present compelling new data on the power of the methylation biomarkers of the PrecisionCHD™ test to predict mortality in patients with Acute Coronary Syndrome (ACS), offering cardiologists a novel, actionable tool to guide patient management to help improve survival outcomes. The poster, titled 'Synergistic Effects of Combining Methylation Data with Imaging Data in Predicting Mortality of Acute Coronary Syndrome (ACS) Patients,' highlights findings from a recent study by Cardio Diagnostics demonstrating the superiority of PrecisionCHD methylation indices to angiographic methods for predicting mortality risk in ACS patients. In addition, the study delineates a machine learning-based method that could be integrated within existing electronic health records systems to synergistically combine angiographic and methylation information for predicting mortality risk. By interrogating key methylation pathways linked to inflammation and coronary heart disease, PrecisionCHD™ can enable clinicians to more effectively stratify mortality risk and personalize treatment plans for ACS patients, potentially improving outcomes. 'These findings underscore the power of methylation-based biomarkers in cardiovascular medicine,' said Rob Philibert, M.D., Ph.D., Chief Medical Officer of Cardio Diagnostics. 'Traditional imaging tools provide valuable anatomical insights, but they fall short in predicting long-term mortality risk and providing mechanistic insights. Our study shows that methylation biomarkers not only fill this gap but also offer a more precise, biologically driven assessment of mortality risk, allowing cardiologists to intervene earlier and more effectively.' Visit Cardio Diagnostics at Booth #2033 Attendees are invited to visit Booth #2033 to learn more about the Company's PrecisionCHD™, Epi+Gen CHD™ and Actionable Clinical Intelligence™ solutions, and its broader vision for AI-driven, epigenetic-guided precision cardiovascular medicine. The Company's executive team will also be onsite to engage with cardiologists, potential partners and attendees on how these innovations are transforming cardiovascular care. 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 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 results are discussed in the Current Report on Form 10-K for the period ended in 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. Investor Relations 855-226-9991 [email protected] & Public Relations Public Relations 855-226-9991 SOURCE: Cardio Diagnostics Holdings, Inc. Copyright Business Wire 2025. PUB: 03/26/2025 08:31 AM/DISC: 03/26/2025 08:32 AM
