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American Medical Association (AMA) Grants Cardio Diagnostics Holdings, Inc.’s AI-Powered Coronary Heart Disease Detection Test, PrecisionCHD, a Dedicated CPT PLA Reimbursement Code

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Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO) has achieved a milestone by obtaining a dedicated Current Procedural Terminology (CPT) Proprietary Laboratory Analysis (PLA) code, 0440U, from the American Medical Association (AMA) for its AI-driven coronary heart disease (CHD) detection test, PrecisionCHD. This will facilitate reimbursement from federal and private payers and expand access to the innovative test. The CPT PLA code will be effective on April 1, 2024, and is a significant step toward broader adoption of the first and only integrated genetic-epigenetic diagnostic blood test for CHD.
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The assignment of a CPT PLA code to Cardio Diagnostics Holdings' PrecisionCHD test has significant financial implications. This proprietary code enables more streamlined billing processes, which can lead to quicker reimbursement from payers. For investors, this development is a positive indicator of potential revenue growth, as it may increase the adoption rate of the PrecisionCHD test. The ability to bill payers effectively is crucial for the company's cash flow and profitability. Given that cardiovascular diseases remain a leading cause of death globally, the demand for such diagnostic tests is likely to remain robust, which could translate into sustained revenue streams for Cardio Diagnostics Holdings.

From a market perspective, the adoption of AI-driven diagnostic tools reflects a broader trend in healthcare towards personalized medicine. Companies that successfully integrate cutting-edge technologies such as AI and epigenetics into their product offerings may gain a competitive advantage. This, in turn, could lead to a positive reevaluation of the company's stock as it demonstrates an ability to navigate complex reimbursement landscapes and capitalize on emerging healthcare trends.

The new CPT PLA code for the PrecisionCHD test is a pivotal regulatory milestone that can have a transformative impact on patient care and healthcare economics. By facilitating reimbursement, it encourages broader clinical adoption, which means more patients could benefit from early detection of coronary heart disease. For healthcare providers, the integration of such AI-driven tests into practice could improve patient outcomes and potentially reduce long-term healthcare costs associated with CHD by enabling earlier and more personalized treatment strategies.

For payers, the decision to reimburse for innovative tests like PrecisionCHD is often based on the test's clinical utility and cost-effectiveness. The assignment of a CPT code is an acknowledgment of the test's potential value in the healthcare system. Over time, as data accumulates on the effectiveness of the PrecisionCHD test, payers will be better positioned to assess its impact on healthcare costs and patient outcomes, which could influence coverage decisions and the level of reimbursement.

The integration of AI and epigenetics represents a cutting-edge approach in the field of cardiovascular diagnostics. The PrecisionCHD test's ability to predict coronary heart disease could be a game-changer in terms of early intervention and personalized treatment plans. The clinical relevance of such a diagnostic tool is underscored by the high mortality rates associated with CHD and the significant healthcare costs it incurs. A test that can accurately identify individuals at risk could lead to more effective management of the disease, ultimately improving patient outcomes and reducing the burden on the healthcare system.

It is important to monitor post-market studies and real-world data that will emerge following the broader adoption of the test. Such data will be critical in validating the test's clinical efficacy and utility. The medical community will be particularly interested in how the test compares to existing diagnostic methods in terms of sensitivity, specificity and overall impact on patient management. These factors will influence the long-term success of the product and its acceptance in clinical practice.

Obtaining a CPT PLA code marks a key milestone in securing reimbursement from federal and private payers for, and expanding access to the innovative PrecisionCHD test powered by AI and epigenetics

CHICAGO--(BUSINESS WIRE)-- Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the American Medical Association (AMA) has assigned a dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analysis (PLA), 0440U, for the company’s AI-driven coronary heart disease (CHD) detection test, PrecisionCHD. Receipt of this new CPT PLA code, which will be effective on April 1, 2024, is a significant step toward payer billing and payment, facilitating broader adoption of the first and only integrated genetic-epigenetic diagnostic blood test for CHD.

Transforming CHD Diagnosis: The Clinical and Economic Benefits of PrecisionCHD

CHD, which is the most common type of heart disease and the major cause of heart attacks, was responsible for over 375,000 deaths in 2021 and the medical costs associated with CHD are projected to reach about $215 billion by 2035. The PrecisionCHD test, which evaluates a patient’s unique genetic and epigenetic biomarkers and interprets them using AI, aims to aid in the diagnosis of CHD and provide personalized insights to help prevent a costly heart attack and improve outcomes.

Identifying those with CHD and intervening prior to a heart attack occurring are essential to reducing the unprecedented economic and health burden associated with CHD. However, the lack of readily accessible, scalable and cost-effective diagnostic solutions for CHD poses a significant challenge, and could lead to delayed diagnosis and care, particularly among underserved and minority populations. The PrecisionCHD test only requires a simple blood draw, can be deployed remotely, and be scaled without the need for specialized infrastructure to enable more timely intervention and management.

“Cardio Diagnostics is committed to ensuring that our solutions are widely accessible and receiving a dedicated CPT PLA code for PrecisionCHD is a critical milestone in our commercialization strategy,” said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics. “With PrecisionCHD, we believe that expanding equitable access to CHD diagnostics and improving patient health outcomes while reducing healthcare expenditure is possible.”

Transforming Care Delivery with PrecisionCHD

With the potential to prevent costly heart attacks and improve patient outcomes, PrecisionCHD is poised to play a significant role in reducing healthcare expenditures. By focusing on personalized insights and care along with earlier intervention even in locations that lack specialty cardiology resources, such as those in rural settings, PrecisionCHD supports the value-based care objective of delivering high-quality, timely care at a lower cost, benefiting patients, providers, and the healthcare system.

A Health Plan’s Population Health Initiative Can be Accelerated by PrecisionCHD

PrecisionCHD introduces a groundbreaking approach to CHD detection, which creates a new category of scalable and personalized cardiovascular diagnostic tools. This blood test offers innovative opportunities for health plans that need to implement, alongside their provider partners, widespread and actionable CHD detection and member risk stratification programs, leading to better care management and patient outcomes along with improved cost management. This potential impact on population health can be as significant as the technology itself.

PrecisionCHD Recognized for Innovation

The study outlining the development and validation of the PrecisionCHD test in collaboration with Intermountain Healthcare and University of Iowa Hospitals and Clinics, was recently published in the Journal of the American Heart Association, an official journal of the American Heart Association. PrecisionCHD was also included in the recent Innovative Technology contract awarded to Cardio Diagnostics by Vizient, Inc., the nation’s largest provider-driven healthcare performance improvement company whose customer base encompasses over 60% of hospitals and 97% of academic medical centers in the United States.

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 www.cardiodiagnosticsinc.com.

Investors:

Gene Mannheimer

Investor Relations

855-226-9991

investors@cardiodiagnosticsinc.com



Media & Public Relations:

Khullani Abdullahi

Source: Cardio Diagnostics Holdings, Inc.

FAQ

What is the significance of obtaining the CPT PLA code 0440U for Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO) and its PrecisionCHD test?

Obtaining the CPT PLA code 0440U is a key milestone for Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO) as it enables reimbursement from federal and private payers and expands access to the innovative PrecisionCHD test. This will facilitate broader adoption of the first and only integrated genetic-epigenetic diagnostic blood test for coronary heart disease (CHD).

What is the expected effective date of the CPT PLA code 0440U for Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO) and its PrecisionCHD test?

The CPT PLA code 0440U will be effective on April 1, 2024, for Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO) and its PrecisionCHD test.

What are the benefits of the PrecisionCHD test for Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO) and patients?

The PrecisionCHD test is the first and only integrated genetic-epigenetic diagnostic blood test for coronary heart disease (CHD), providing clinical and economic benefits. It is expected to facilitate broader adoption and improve access to innovative CHD diagnosis.

Cardio Diagnostics Holdings Inc.

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