Cardio Diagnostics Holdings Inc. - CDIO STOCK NEWS

Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO) has received preliminary pricing determinations from the Centers for Medicare & Medicaid Services (CMS) for its PrecisionCHD and Epi+Gen CHD tests. This marks a important step towards securing Medicare reimbursement for these AI-powered cardiovascular tests. The preliminary 'gapfill' pricing decision, if finalized, will be effective for claims starting January 1, 2025, allowing Medicare contractors to determine pricing based on actual cost data.

The tests aim to improve risk assessment, diagnosis, management, and monitoring of coronary heart disease (CHD) for Medicare patients. PrecisionCHD aids in CHD diagnosis using genetic and epigenetic markers, while Epi+Gen CHD assesses the three-year risk for a CHD event. Both tests received dedicated CPT Proprietary Laboratory Analysis (PLA) codes effective April 1, 2024.

Cardio Diagnostics Holdings Inc. (NASDAQ: CDIO) has launched a redesigned website, CDIO.AI, emphasizing its AI-driven approach to cardiovascular care. The new site highlights three core solutions: Epi+Gen CHD, PrecisionCHD, and the Actionable Clinical Intelligence (ACI) platform. These AI-powered tests assess coronary heart disease risk, detect and manage stable ischemic heart disease, and provide personalized insights for clinicians.

The website enhances user experience for investors, patients, healthcare providers, payers, and researchers. It features streamlined access to financial reports, test information, ordering processes, and collaboration opportunities. The redesign aims to clarify Cardio Diagnostics' position as a leader in precision cardiovascular medicine, showcasing its commitment to improving patient outcomes and reducing healthcare costs through AI-driven diagnostics and prevention strategies.

Cardio Diagnostics announces that its Epi+Gen CHD heart attack risk assessment test is now available at the Family Medicine Specialists' (FMS) retail clinical location within the Meijer Supercenter in McHenry, Illinois. Meijer, a retailer with over 500 locations, primarily serves middle-aged and older adults in the Midwest, a demographic with high heart disease risk. The Epi+Gen CHD test predicts the likelihood of a heart attack or sudden death from coronary heart disease within the next three years. This initiative aligns with Meijer's commitment to health and wellness, providing accessible cardiovascular care. The partnership between Cardio Diagnostics, FMS, and Meijer aims to offer timely and accurate heart health assessments, especially in rural and suburban regions with healthcare access.

Cardio Diagnostics (NASDAQ: CDIO) will showcase its advanced cardiovascular solutions at the 2024 Onsite Employee Health Clinics Forum in Chicago, IL, from June 27-28, 2024. The event focuses on enabling employers to optimize onsite clinical care facilities. Cardio Diagnostics will highlight its Epi+Gen CHD and PrecisionCHD DNA-based blood tests, which are designed for easy integration into onsite clinics, offering cost savings and reduced absenteeism for employers. The HeartRisk platform will also be featured, providing employers with real-time cardiovascular risk insights. CEO Meesha Dogan expressed enthusiasm about partnering with employers to improve workplace health and productivity.

Cardio Diagnostics Holdings, a leader in AI-driven cardiovascular medicine, has successfully completed its SOC 2 Type I audit. This certification highlights their commitment to data security and confidentiality. Achieving this compliance ensures the company meets stringent security standards set by the AICPA, providing trust for current and future partners. SOC 2 compliance is important in the healthcare sector, safeguarding sensitive patient data from breaches and ensuring adherence to HIPAA regulations. Tim Dogan, CTO, emphasized the importance of maintaining trust and the highest quality and compliance standards.

Cardio Diagnostics Holdings announced its participation in the CMS CLFS Annual Meeting on June 25, 2024. The company will recommend pricing for its Epi+Gen CHD and PrecisionCHD tests for Medicare payment under the CLFS for 2025. CMS will release proposed determinations by early September 2024 and final decisions in November 2024. The tests were recently awarded CPT PLA codes (0439U and 0440U) by the AMA, effective April 1, 2024. Additionally, Cardio Diagnostics is pursuing coverage through the MolDx program with a pre-submission meeting scheduled for Q3 2024. CEO Meesha Dogan emphasized the importance of these steps in making the tests accessible to Medicare beneficiaries. The Epi+Gen CHD test assesses the three-year risk for CHD events, while PrecisionCHD aids in diagnosing CHD. These tests aim to improve detection, prevention, and management of CHD among Medicare patients, who are at high risk for heart disease.

Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO) announced the availability of its clinical blood tests, Epi+Gen CHD and PrecisionCHD, at Family Medicine Specialists' newest location at Walmart Supercenter in Round Lake Beach, Illinois. The partnership aims to democratize access to top-tier heart disease services. These tests offer personalized insights into heart attack risk and coronary heart disease status. The evolution of retail clinics is projected to capture a significant market share by 2030. This strategic alliance is a game-changer in cardiovascular health management, providing advanced cardiac diagnostic tools directly into retail healthcare clinic locations.

Cardio Diagnostics announced the publication of a study showing that its PrecisionCHD™ test could save health insurers over $113 million annually. The study demonstrated the potential economic benefits of the test for the detection and management of coronary heart disease, offering significant cost savings compared to traditional tests. PrecisionCHD is an AI-powered multiomic DNA test that evaluates six DNA methylation and ten genetic biomarkers, with a sensitivity and specificity of 79% and 76%, respectively. The budget impact model revealed estimated savings of $113.6 million per year for a plan with one million members, highlighting the test's cost efficiency and effectiveness.