This is the second CPT PLA code the American Medical Association
(AMA) granted for the Company’s AI-powered coronary heart disease
tests. This significant milestone enables the acceleration of
reimbursement for the Epi+Gen CHD test from federal and private
payers, while increasing access to this precision cardiovascular
medicine test.
Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven
precision cardiovascular medicine company, today announced that the
American Medical Association (AMA) has granted and assigned a
dedicated Current Procedural Terminology (CPT®) Proprietary
Laboratory Analysis (PLA) code, 0439U, for the company’s AI-driven
coronary heart disease (CHD) event risk assessment test, Epi+Gen
CHD.
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
AI-powered integrated genetic-epigenetic clinical blood test for
evaluating the likelihood of a patient experiencing a CHD event,
mainly a heart attack, within the next three years.
Primary Prevention of Heart Attacks: The Clinical and
Economic Benefits of Epi+Gen CHD
Every year, about 805,000 people in the United States have a
heart attack, with someone experiencing a heart attack every 40
seconds. Heart disease is the leading cause of death for both men
and women. In 2021, heart disease was responsible for the deaths of
more than 695,000 Americans. Of those deaths, 310,661 occurred in
women, which represents one in every five female deaths.
There are challenges in detecting women’s heart disease because,
according to Johns Hopkins Medicine, women’s heart disease symptoms
and signs can be atypical, which delays understanding of their
risks for a heart attack. Epi+Gen CHD evaluates an individual’s
unique genetic and epigenetics to predict their risk for a heart
attack or sudden cardiac death associated with CHD with unrivaled
personalized insights driven by the company’s groundbreaking
epigenetic-genetic technology. By leveraging the power of AI, the
company’s technology can provide patient-specific epigenetic and
genetic drivers of CHD to help guide preventive care and
potentially save lives.
In peer-reviewed studies, Epi+Gen CHD was more cost-effective
and more sensitive for assessing heart attack risk compared to
standard lipid-based risk calculators. Specifically, in a
validation study conducted with Intermountain Healthcare, Epi+Gen
CHD was shown to be, on average, about twice as sensitive in
detecting risk for a CHD event in women than lipid-based
calculators.
Enhancing Employer Risk Mitigation Strategies with Epi+Gen
CHD
For employers, the financial burden of heart attacks includes
direct costs related to diagnosing, managing and treating heart
disease, as well as indirect costs such as lost productivity due to
employee absenteeism and short-term disability. Employee
absenteeism and short-term disability resulting from cardiovascular
disease can cost employers about $1,119 more in the first month
following a cardiovascular event. The cardiovascular health of U.S.
employees costs $363 billion annually, including $216 billion in
direct medical costs and nearly $147 billion in indirect costs.
Uniquely, Cardio Diagnostics combines the ability to offer
employees the advanced Epi+Gen CHD heart attack risk test with
aggregated risk data for employers to help inform their benefits
offerings. Cardio Diagnostics’ Employer Risk IntelligenceTM
platform provides employers and brokers with the first-of-its-kind
cardiovascular employee population health intelligence backed by a
clinical test and layered insights in a compliant manner.
“Cardio Diagnostics is committed to driving widespread adoption
of our solutions, and obtaining a reimbursement code for Epi+Gen
CHD is a critical milestone in our commercialization strategy and
for gaining reimbursement from federal and private payers,” said
Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics.
For employers, this means potentially greater access to a
technology that enables a healthier workforce and significant
savings in healthcare costs related to heart disease. Cardio
Diagnostics continues to lead the way in precision cardiovascular
medicine, leveraging the power of AI and epigenetics to help
prevent heart attacks. The company's commitment to making heart
disease risk assessment, detection, and management more accessible,
personalized, and precise is key to winning the fight against the
leading cause of death 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.
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 management,
dilution to stockholders, lack of capital, the effects of rapid
growth upon the Company and the ability of management to
effectively respond to the growth and demand for products and
services of the Company, newly developing technologies, the
Company’s ability to compete, regulatory matters, protection of
technology, the effects of competition and the ability of the
Company to obtain future financing. An extensive list of factors
that can affect future results are discussed in the Current Report
on Form 10-K for the period ended December 31, 2022 and Form 10-Q
for the period ended March 31, 2023 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240103868723/en/
Investors: Gene Mannheimer Investor Relations
855-226-9991 investors@cardiodiagnosticsinc.com
Media & Public Relations: Khullani Abdullahi
855-226-9991 pr@cardiodiagnosticsinc.com
Cardio Diagnostics (NASDAQ:CDIO)
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