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Item 1. Business

2026-03-13 compared with 2025-03-20 · 1282 added, 1335 removed, 212 unchanged (93% of the section changed)

in this report to “Cardio,” “we,” “us” or the “Company” refer to Cardio Diagnostics Holdings,

References to our “management” or our “management team” refer to the officers and directors of Cardio Diagnostics

Holdings, Inc.

Cardio Diagnostics, Inc.

Cardio”) was founded in 2017 in Coralville, Iowa by Meeshanthini (Meesha) Dogan, PhD, and Robert (Rob) Philibert, MD PhD.

formed in January 2017 as an Iowa LLC and was subsequently incorporated as a Delaware C Corp in September 2019.

Cardio was formed to further develop and commercialize a series of products for

major types of cardiovascular disease and associated co-morbidities, including coronary heart disease (“CHD”), stroke, heart

failure and diabetes, by leveraging our Artificial Intelligence (“AI”)-driven Integrated Genetic-Epigenetic Engine™.

As a company, we aspire to give every American adult insight into their unique risk for various cardiovascular diseases.

to become one of the leading medical technology companies for enabling improved prevention, detection, treatment and management of cardiovascular

disease and associated co-morbidities.

Cardio is transforming the approach to cardiovascular medicine from reactive to proactive and

hopes to accelerate the adoption of Precision Cardiovascular Medicine for all.

We believe that incorporating our solutions into routine

clinical practice in and prevention efforts can help alter the trajectory that nearly one in two Americans is expected to develop some

form of cardiovascular disease by 2035.

Cardio believes

that it is the first company to develop and commercialize epigenetics-based clinical tests for cardiovascular disease that

have clear value propositions for multiple stakeholders including (1) patients, (2) clinicians, (3) hospitals/health systems, (4) employers

and (5) payors.

According to the CDC, epigenetics is the study of how a person’s behaviors and environment can cause changes that

affect the way a person’s genes work.

Unlike genetic changes, epigenetic changes are reversible and do not change one’s DNA

sequence, but they can change how a person’s body reads a DNA sequence.

Cardio launched its

first clinical test, Epi+Gen CHD™, a three-year symptomatic CHD risk assessment clinical blood test targeting CHD events, including

heart attacks, in 2021 during the Covid-19 pandemic.

As a result, the initial strategy for commercialization involved launching the test

via telemedicine and in smaller provider practices such as concierge medicine practices.

The volume of tests through these channels were

minimal, and as the circumstances around Covid-19 pandemic improved, management re-vamped the Company’s go-to-market strategy to

include other healthcare verticals and stakeholders beyond patients and small providers, including larger provider organizations, group

purchasing organizations, employers, payors and life insurers.

This new approach allowed Cardio to expand the reach of our solutions

beyond the initial focus areas.

Beyond the launch of Epi+Gen CHD, in March 2023, we announced the launch of our second product, PrecisionCHD™,

an integrated epigenetic-genetic clinical blood test for the detection of coronary heart disease.

The Epi+Gen CHD™ and PrecisionCHD™

tests are coupled to Actionable Clinical Intelligence (“ACI”), a platform that offers new epigenetic and genetic insights

to clinicians prescribing the to personalize patient management and help improve chronic care management.

In May 2023, we launched CardioInnovate360™,

a research-use-only (“RUO”) solution to support the discovery, development and validation of novel biopharmaceuticals for

the assessment and management of cardiovascular diseases.

In February 2024, we announced the launch of HeartRisk™, a cardiovascular

disease risk intelligence platform.

We believe that our Epi+Gen CHD™ and PrecisionCHD™ tests are categorized as laboratory-developed

tests, or “LDTs.” The new go-to-market strategy is also being implemented for these products.

As a company in the early stages

of its development, the Company continuously reevaluates its business, the market in which it operates and potential new opportunities.

The Company may seek other alternatives within the healthcare field in order to grow its business and increase revenues.

Such alternatives

may include, but not be limited to, combinations or strategic partnerships with other laboratory companies or with medical practices such

as hospitalists or behavioral health.

Key recent developments include:

· Increased revenue in 2024;

· Recommended pricing for our two Current Procedural Terminology (“CPT”)

Proprietary Laboratory Analysis (“PLA”) codes from the American Medical Association, 0440U for PrecisionCHD™ and 0439U

for Epi+Gen CHD™, at the Centers for Medicare and Medicaid Services’ (“CMS”) Clinical Laboratory Fee Schedule

(CLFS) annual meeting;

· Expanded the availability of our Epi+Gen CHD™ test to Family Medicine Specialists’

retail clinical location at Meijer Supercenter;

· Received Medicare pricing determination from Centers for Medicare and Medicaid

Services (CMS) for PrecisionCHD™ and Epi+Gen CHD™;

· We have entered into partnerships with seven new provider organizations.

partners include specialized practices in Michigan, Illinois, Texas, Florida, California, and Connecticut, representing various medical

specialties including concierge medicine, primary care, and precision medicine

expects that sales and partnership cycles will continue to be long.

Our ongoing strategy for expanding our business operations and increasing

revenue generation include the following:

· Develop additional products, including clinical tests for stroke, congestive heart

failure and diabetes;

· Expand clinical and health economics evidence portfolio to continue to demonstrate

value of products and increase reach;

· Leverage our newly-awarded CPT PLA codes;

· Expand the adoption of our products across key channels, including health systems

and self-insured employers, including for HeartRisk, Cardio’s new SaaS product;

· Scale our internal operations capabilities with a focus on improving efficiency

and reducing our cost of goods sold;

· Pursue potential strategic partnership(s) and acquisition(s) of one or more synergistic

References in this report to “Cardio,”

“we,” “us” or the “Company” refer to Cardio Diagnostics Holdings, Inc.

References to our “management”

or our “management team” refer to the officers and directors of Cardio Diagnostics Holdings, Inc.

Cardio was formed to further develop and commercialize

a series of products for major types of cardiovascular disease and associated co-morbidities, including coronary heart disease (“CHD”),

stroke, heart failure and diabetes, by leveraging our Artificial Intelligence (“AI”)-driven Multi-Omics Engine™ (formerly

known as our AI-Integrated Genetic-Epigenetic Engine TM ) .

company, we aspire to give every American adult insight into their unique risk for various cardiovascular diseases.

Cardio aims to become

one of the leading medical technology companies for enabling improved prevention, early detection and treatment of cardiovascular disease.

Cardio is transforming the approach to cardiovascular disease from reactive to proactive and hope to accelerate the adoption of Precision

Medicine for all.

We believe that incorporating Cardio’s solutions into routine practice in primary care and prevention efforts

can help alter the trajectory that nearly one in two Americans is expected to develop some form of cardiovascular disease by 2035.

Cardio believes that it is the first company to

develop and commercialize epigenetics-based clinical tests for cardiovascular disease that have clear value propositions for multiple

stakeholders including (1) patients, (2) clinicians, (3) hospitals/health systems, (4) employers and (5) payors.

According to the CDC,

epigenetics is the study of how a person’s behaviors and environment can cause changes that affect the way a person’s genes

Unlike genetic changes, epigenetic changes are reversible and do not change one’s DNA sequence, but they can change how a

person’s body reads a DNA sequence.

Cardio launched its first clinical test, Epi+Gen

CHD™, a three-year symptomatic CHD risk assessment clinical blood test targeting CHD events, including heart attacks, in 2021 during

the COVID-19 pandemic.

As a result, the initial strategy for commercialization involved launching the test via telemedicine and in smaller

provider practices such as concierge medicine practices.

The volume of tests through these channels was minimal, and as the circumstances

around COVID-19 pandemic improved, management re-vamped the Company’s go-to-market strategy to include other healthcare verticals

and stakeholders beyond patients and small providers, including larger provider organizations, group purchasing organizations, employers,

payors and life insurers.

This new approach allowed Cardio to expand the reach of our solutions beyond the initial focus areas.

the launch of Epi+Gen CHD, in March 2023, we announced the launch of our second product, PrecisionCHD™, an integrated epigenetic-genetic

clinical blood test for the detection of coronary heart disease.

The PrecisionCHD™ test is coupled to our Actionable Clinical Intelligence

(“ACI”), a platform that offers new epigenetic and genetic insights to clinicians prescribing the test to personalize patient

management and help improve chronic care management.

In May 2023, we launched CardioInnovate360™, a research-use-only (“RUO”)

solution to support the discovery, development and validation of novel biopharmaceuticals for the assessment and management of cardiovascular

In February 2024, we announced the launch of HeartRisk™, a cardiovascular disease risk intelligence platform.

that our Epi+Gen CHD™ and PrecisionCHD™ tests are categorized as laboratory-developed tests, or “LDTs.” The new

go-to-market strategy is also being implemented for these products.

Despite long partnership and sales cycles, in some instances as long

as 24 months, Cardio has been able to increase the number of provider organizations offering its tests and has continued the development

of a more robust sales and partnership pipeline.

In the fiscal year ended December 31, 2025, the focus of the Company remained on driving

adoption of our clinical solutions, predominantly among providers, channel partners and employers.

In addition, the Company made progress

in its ongoing expansion to additional markets domestically and internationally with the first international expansion to India, partnering

with channel partners such as YMCA of East Tennessee and Southdale YMCA to offer testing to its members and community, The Company also

made progress in setting up our laboratory facility as a high complexity testing laboratory in compliance with the Clinical Laboratory

Improvement Amendments (“CLIA”).

Cardio expects that sales and

partnership cycles will continue to be long, especially with the current economic uncertainty.

Our ongoing strategy for expanding our

business operations and increasing revenue generation include the following:

Leverage our CPT PLA codes and expand reimbursement efforts with

both government and commercial payors;

Develop additional products, including clinical tests for stroke,

congestive heart failure and diabetes;

Expand clinical and health economics evidence portfolio to continue to demonstrate value of products and increase reach;

Offer laboratory services via our CLIA laboratory;

Expand the adoption of our products across key channels, including health systems and self-insured employers;

Explore additional market opportunities in the US;

Explore partner-led international expansions like that in India;

Explore opportunities to grow presence in India, including with local manufacturing;

Scale our internal operations capabilities with a focus on improving efficiency and reducing our cost of goods sold;

Pursue potential strategic partnership(s) and/or acquisition(s) of one or more synergistic companies.

As of March 13, 2026, we have sold an aggregate

2,251,181 shares of our Common Stock under the Sales Agreement and may sell up to another $5,298,889 of our Common Stock through Craig-Hallum

under the Sales Agreement.

Recent Regulatory and Judicial Developments

Regarding LDTs

On May 6, 2024, the FDA published a final rule amending

the definition of an in vitro diagnostic (“IVD”) device to include tests manufactured by a clinical laboratory.

the rule, LDT, i.e., tests designed, manufactured, and used within a single CLIA-certified high complexity laboratory, would have been

medical devices subject to FDA regulation under the Federal Food, Drug, and Cosmetic Act (“FDC Act”).

The final rule also

announced FDA’s intention to apply its medical device requirements to LDTs.

Under the final rule, all LDTs, unless subject to a

specific exemption, would have been subject to premarket authorization requirements (510(k), de novo classification, or PMA) for each

LDT performed by the laboratory, and to postmarket registration and listing, medical device reporting, correction, removal, and recall,

complaint handling, labeling, investigational device, and quality system requirements.

On September 19, 2025, the FDA formally rescinded its May 2024 final

rule regulating LDTs as medical devices, following a March 31, 2025 federal court ruling.

District Court for the Eastern District

of Texas found that the FDA exceeded its authority, reverting LDT oversight to Clinical Laboratory Improvement Amendments (CLIA).

has been no further pursuit by the current administration.

Industry Background

According to the American

Heart Association (“AHA”), even though an estimated 80% of cardiovascular disease (“CVD”) is preventable, it remains

the leading cause of death in the United States and globally.

The AHA also reported that over 650,000 deaths in the United States each

year are attributable to heart disease, which amounts to one in every four deaths.

The Centers for Disease Control and Prevention (“CDC”)

estimates that in the United States, one person dies every 36 seconds from CVD.

Unfortunately, the incidence of CVD is expected to continue

to rise with the AHA projecting that by 2035, nearly half of Americans will have some form of CVD.

CVD represents conditions that

affect the heart and blood vessels such as coronary heart disease (“CHD”), stroke, and congestive heart failure (“CHF”).

According to the American Heart Association (“AHA”),

even though an estimated 80% of cardiovascular disease (“CVD”) is preventable, it remains the leading cause of death in the

United States and globally.

The AHA also reported that over 650,000 deaths in the United States each year are attributable to heart disease,

which amounts to one in every four deaths.

The Centers for Disease Control and Prevention (“CDC”) estimates that in the United

States, one person dies every 36 seconds from CVD.

Unfortunately, the incidence of CVD is expected to continue to rise with the AHA projecting

that by 2035, nearly half of Americans will have some form of CVD.

CVD represents conditions

that affect the heart and blood vessels such as coronary heart disease (“CHD”), stroke, and congestive heart failure (“CHF”).

CHD is the most common type of heart disease and according to the CDC, was responsible for nearly 370,000 deaths in 2019.

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as smoking, unhealthy diet, physical inactivity, and being overweight can also increase the risk for CVD.

to the enormous morbidity and mortality associated with CVD, the economic burden of CVD is also staggering as depicted in the figure below

from the Cardiovascular Disease:

A Costly Burden For America, Projections Through 2035 report by the AHA.

CVD is the costliest disease

in the United States and the economic burden associated with CVD is expected to continue to soar.

According to the CDC Foundation, every

year, one in six United States healthcare dollars is expended on CVD.

The AHA reports that in 2016, the

cost of CVD was $555 billion and is expected to rise to over $1 trillion by 2035.

Of the $555 billion, $318 billion was associated with

medical costs, and the remaining $237 billion with indirect costs such as lost productivity.

By 2035, the medical costs associated with

CVD are expected to increase 135% to $749 billion, while the indirect costs are expected to rise by 55% to $368 billion.

Currently, among

the various types of CVD, the medical costs of CHD are the highest at $89 billion and are expected to rise to $215 billion by 2035 as

depicted in the figure below from the Cardiovascular Disease:

In addition to the enormous morbidity and mortality

associated with CVD, the economic burden of CVD is also staggering as depicted in the figure below from the Cardiovascular Disease:

Costly Burden For America, Projections Through 2035 report by the AHA.

CVD is the costliest disease in the United States and the economic

burden associated with CVD is expected to continue to soar.

According to the CDC Foundation, every year, one in six United States healthcare

dollars is expended on CVD.

The AHA reports that in 2016, the cost of CVD was

$555 billion and is expected to rise to over $1 trillion by 2035.

Of the $555 billion, $318 billion was associated with medical costs,

and the remaining $237 billion with indirect costs such as lost productivity.

By 2035, the medical costs associated with CVD are expected

to increase 135% to $749 billion, while the indirect costs are expected to rise by 55% to $368 billion.

Currently, among the various types

of CVD, the medical costs of CHD are the highest at $89 billion and are expected to rise to $215 billion by 2035 as depicted in the figure

below from the Cardiovascular Disease:

A Costly Burden For America, Projections Through 2035 report by the AHA.

this expected significant rise in human health and economic burdens, the United States healthcare market is seeking more efficient and

effective methods to better prevent, detect, manage, and treat CVD.

This same trend is playing out across developed nations around the

globe as the burden of CVD continues to grow due to a rise in major risk factors such as obesity, poor diet and Type 2 diabetes.

To address this expected significant rise in human

health and economic burdens, the United States healthcare market is seeking more efficient and effective methods to better prevent, detect,

manage, and treat CVD.

This same trend is playing out across developed nations around the globe as the burden of CVD continues to grow

due to a rise in major risk factors such as obesity, poor diet and Type 2 diabetes.

This is consistent with the cardiovascular diagnostic

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Cardiovascular Diagnostic Testing Market is estimated to grow from $8.47 billion in 2022 to $12.41 billion by 2027, with a CAGR of 7.94%.

There are several healthcare tailwinds that are driving this

expected growth and are expected to support the large-scale adoption of our solutions:

There are several healthcare tailwinds that are

driving this expected growth and are expected to support the large-scale adoption of our solutions:

The aging population:

According to the Population

Reference Bureau, by 2060, the number of Americans aged 65 and over is projected to more than double from 46 million to over 98 million.

This demographic shift will result in increased demand for healthcare services in general and for CVD specifically because the risk for

CVD increases with age.

According to the AHA, the risk for CVD at age 24 is about 20% and more than doubles to 50% by age 45, with 90%

of those over the age of 80 having some form of CVD.

According to the Population Reference Bureau, by 2060, the number of Americans aged 65 and over is projected to more than double from 46 million to over 98 million.

This demographic shift will result in increased demand for healthcare services in general and for CVD specifically because the risk for CVD increases with age.

According to the AHA, the risk for CVD at age 24 is about 20% and more than doubles to 50% by age 45, with 90% of those over the age of 80 having some form of CVD.

The rise of chronic diseases:

Chronic diseases such as heart disease,

cancer, and diabetes are rising in the United States.

The rise of these conditions is further driven by less-than-ideal lifestyle choices

such as smoking, an unhealthy diet, and sedentary behavior.

As a result, better predictive and diagnostic tools are needed to get ahead

of these conditions alongside the need for improved treatment and management of these conditions.

Chronic diseases such as heart disease, cancer, and diabetes are rising in the United States.

The rise of these conditions is further driven by less-than-ideal lifestyle choices such as smoking, an unhealthy diet, and sedentary behavior.

As a result, better predictive and diagnostic tools are needed to get ahead of these conditions alongside the need for improved treatment and management of these conditions.

The rise of costs associated with chronic diseases:

Chronic diseases,

including heart disease and cancer continue to drive up healthcare costs, placing a growing financial burden on employers, insurers, and

the healthcare system at large.

In the United States, the direct and indirect costs associated with CVD is expected to climb as prevalence

The financial strain is particularly evident in employer-sponsored health plans, where CVD is a leading driver of high-cost

claims, absenteeism, and reduced productivity.

As healthcare costs rise, self-insured employers, benefits consultants, payers, and providers

are actively seeking cost-effective solutions to mitigate the impact of CVD.

This includes early detection strategies, precision diagnostics,

and personalized prevention programs that can identify at-risk individuals before costly acute events occur.

Chronic diseases, including heart disease and cancer continue to drive up healthcare costs, placing a growing financial burden on employers, insurers, and the healthcare system at large.

In the United States, the direct and indirect costs associated with CVD is expected to climb as prevalence increases.

The financial strain is particularly evident in employer-sponsored health plans, where CVD is a leading driver of high-cost claims, absenteeism, and reduced productivity.

As healthcare costs rise, self-insured employers, benefits consultants, payers, and providers are actively seeking cost-effective solutions to mitigate the impact of CVD.

This includes early detection strategies, precision diagnostics, and personalized prevention programs that can identify at-risk individuals before costly acute events occur.

The shift to value-based care:

The shift to value-based care drives

healthcare providers to focus on quality rather than quantity of care.

The shift to value-based care is a crucial driver of growth for

Cardio because it incentivizes health care providers to focus on providing quality care rather than simply providing more care.

believes providers can tackle the costliest and deadliest disease category with its solutions while reducing costs.

The shift to value-based care drives healthcare providers to focus on quality rather than quantity of care.

The shift to value-based care is a crucial driver of growth for Cardio because it incentivizes health care providers to focus on providing quality care rather than simply providing more care.

Cardio believes providers can tackle the costliest and deadliest disease category with its solutions while reducing costs.

The growth of telemedicine:

Driven largely by the COVID-19 pandemic,

telemedicine is a growing trend in healthcare, as it allows patients to receive care from providers remotely.

Remote, telemedicine-based

preventative programs and tests can serve those who are already undergoing routine screening, but more importantly, expand reach to most

Americans who currently are not receiving preventative healthcare, including rural and underserved populations.

our evidence-based solutions

can be deployed remotely, which is expected to further drive adoption by patients and clinicians.

Driven largely by the COVID-19 pandemic, telemedicine is a growing trend in healthcare, as it allows patients to receive care from providers remotely.

Remote, telemedicine-based preventative programs and tests can serve those who are already undergoing routine screening, but more importantly, expand reach to most Americans who currently are not receiving preventative healthcare, including rural and underserved populations.

our evidence-based solutions can be deployed remotely, which is expected to further drive adoption by patients and clinicians.

The adoption of Artificial Intelligence (AI):

AI is increasingly

incorporated into many aspects of healthcare, including administrative tasks, diagnosis and treatment.

AI has the potential to improve

the quality of care while reducing costs.

Machine learning, which is a type of AI, is instrumental to our cutting-edge solutions, powering

their clinical performance and differentiating them from other technologies for CVD.

AI is increasingly incorporated into many aspects of healthcare, including administrative tasks, diagnosis and treatment.

AI has the potential to improve the quality of care while reducing costs.

Machine learning, which is a type of AI, is instrumental to our cutting-edge solutions, powering their clinical performance and differentiating them from other technologies for CVD.

The rise of patient engagement:

Thanks to technology, patients are

becoming more engaged in their healthcare.

They use online tools to research their conditions and treatments and are more likely to participate

in their care.

This includes demanding cutting-edge clinical tests that can help them better prevent chronic diseases such as CVD while

improving the length and quality of life.

As a result, healthcare providers and organizations that offer such services including our solutions

are likely to have an edge over those who do not.

Thanks to technology, patients are becoming more engaged in their healthcare.

They use online tools to research their conditions and treatments and are more likely to participate in their care.

This includes demanding cutting-edge clinical tests that can help them better prevent chronic diseases such as CVD while improving the length and quality of life.

As a result, healthcare providers and organizations that offer such services including our solutions are likely to have an edge over those who do not.

Building compelling evidence.

Our AI-driven Integrated Genetic-Epigenetic

Engine™ enables rapid design, development, and launch of diagnostic solutions resulting from over

a decade of research studies.

Our solutions that result from this technology, including our Epi+Gen CHD™ test for coronary

heart disease event risk assessment and PrecisionCHD™ for the earlier detection of coronary heart disease, were developed through

rigorous studies that are peer-reviewed and published and others that are being prepared for peer-reviewed publication in collaboration

with leading healthcare and research institutions.

In addition to the superior sensitivity of the Epi+Gen CHD™ and PrecisionCHD™

tests, the evidence bases for both the PrecisionCHD™ and Epi+Gen CHD™ tests also

include an economic case to drive a more holistic and compelling argument for adoption.

Our AI-driven Multi-Omics Engine™ enables rapid design, development, and launch of diagnostic solutions resulting from over a decade of research studies.

Our solutions that result from this technology, including our Epi+Gen CHD™ test for coronary heart disease event risk assessment and PrecisionCHD™ for the earlier detection of coronary heart disease, were developed through rigorous studies that are peer-reviewed and published and others that are being prepared for peer-reviewed publication in collaboration with leading healthcare and research institutions.

In addition to the superior sensitivity of the Epi+Gen CHD™ and PrecisionCHD™ tests, the evidence bases for both the PrecisionCHD™ and Epi+Gen CHD™ tests also include an economic case to drive a more holistic and compelling argument for adoption.

product use cases.

To continue to differentiate our products and their value propositions, we continue to invest in studies to

expand their use cases.

For example, with the PrecisionCHD™ test, we presented preliminary data at the American Heart

Association and American College of Cardiology conferences on this test’s ability to detect non-obstructive form of coronary

heart disease (INOCA) and predict mortality of acute coronary syndrome patients.

Engaging experts and key stakeholders.

At Cardio, we understand

that engaging experts and key healthcare stakeholders is critical to realizing our solutions’ full potential and ensuring that these

solutions reach as many people as possible.

At Cardio, we understand that engaging experts and key healthcare stakeholders is critical to realizing our solutions’ full potential and ensuring that these solutions reach as many people as possible.

Prioritizing and executing strategic acquisitions.

Our expertise

at several intersections across biology, machine learning, lab assay development, and cardiovascular disease, provide an array of strategic

acquisition opportunities to better serve the cardiovascular disease market by horizontally and vertically integrating across the cardiac

care continuum.

Our expertise at several intersections across biology, machine learning, lab assay development, and cardiovascular disease, provide an array of strategic acquisition opportunities to better serve the cardiovascular disease market by horizontally and vertically integrating across the cardiac care continuum.

Prioritizing payor coverage.

We believe that to continue to grow

the market traction of our solutions, it would require pursuing additional payor coverage.

We are engaging the appropriate experts, building

necessary evidence, and have a roadmap in place for this.

As part of this priority, we are pursuing pilots and strategic collaborations.

We expect that it will take six to twelve months to engage additional payors and potentially longer to secure additional coverage for

our solutions.

We believe that to continue to grow the market traction of our solutions, we must secure broad payor coverage.

We have already secured CPT PLA reimbursement codes for PrecisionCHD™ (0440U) and Epi+Gen CHD™ (0439U) and final CMS gapfill payment rates of $854 for both tests.

For Medicare, we are currently pursuing coverage for these tests, which we believe is the critical first phase to accomplishing widespread reimbursement for our tests.

For commercial payors, we are partnering with a third-party company and expect to have the capability to submit claims out-of-network beginning in Q2 2026.

We are also continuing to build necessary evidence, and are pursuing pilots and strategic collaborations with payors.

We expect that the process to secure broad coverage could take years, which means that our ability to generate meaningful revenue will continue to be constrained.

Evaluating FDA pathway.

Cardio is evaluating an FDA regulatory pathway to enable broader access

to our tests.

Cardio is evaluating an FDA regulatory pathway to enable broader access to our tests.

The FDA pathway would enable Cardio’s tests to be performed broadly at many labs across the country.

We are continuing to build our evidence base for this.

Continued education.

Changes to established workflows and clinical practice take time.

However, we continue to invest in efforts to educate healthcare stakeholders, including physicians and decision makers, on our technology, tests and their value propositions.

Such efforts include conference attendance, webinars, and one-on-one educational sessions.

Targeting multiple revenue channels.

To ensure that our revenue

stream is diversified, Cardio has and will continue to target multiple revenue channels for which our solutions have compelling value

propositions.

To ensure that our revenue stream is diversified, Cardio has and will continue to target multiple revenue channels for which our solutions have compelling value propositions.

This strategy includes, but is not limited to providers, health systems, and employers.

We are also pursuing international expansions to further diversify revenue streams.

Launching synergistic products.

To more fully address cardiovascular

health, Cardio is leveraging our AI-driven Integrated Genetic-Epigenetic Engine™ to develop a series of clinical tests for major

types of cardiovascular disease and associated co-morbidities, including stroke, congestive heart failure and diabetes.

We have also started

to develop additional synergistic products other than new clinical blood tests.

Our first such product, HeartRisk™, is a cardiovascular

disease risk intelligence platform, designed to augment our clinical blood tests.

At the core of Cardio is our proprietary

AI-driven Integrated Genetic-Epigenetic Engine™, an engine invented and built by three key employees/officers for

over a decade.

Our technology enables rapid design, development and launch of new diagnostic solutions through the identification

of robust integrated genetic-epigenetic biomarkers and their translation into clinical tests for cardiovascular disease and associated

co-morbidities.

To more fully address cardiovascular health, Cardio is leveraging our AI-driven Multi-Omics Engine™ to develop a series of clinical tests for major types of cardiovascular disease and associated co-morbidities, including stroke, congestive heart failure and diabetes.

We have also started to develop additional synergistic products other than new clinical blood tests.

Our first such product, HeartRisk™, is a cardiovascular disease risk intelligence platform, designed to augment our clinical blood tests.

Our Technology

At the core of Cardio is our proprietary AI-driven

Multi-Omics Engine™, an engine invented and built by three key employees/officers for over a decade.

Our technology enables rapid

design, development and launch of new diagnostic solutions through the identification of robust integrated genetic-epigenetic biomarkers

and their translation into clinical tests for cardiovascular disease and associated co-morbidities.

This Engine consists of multiple layers.

It begins with genome-wide genetic (single nucleotide polymorphisms or SNPs),

genome-wide epigenetic (DNA methylation) and clinical data points.

Using high-performance computing, ML/AI techniques and deep domain

expertise in medicine, molecular biology and engineering, a panel of SNP-DNA methylation biomarkers and mined, modeled and translated

into standalone laboratory assays.

As a result, our products, which

are clinical tests, consist of two components.

It begins with genome-wide genetic (single nucleotide polymorphisms or SNPs), genome-wide epigenetic (DNA methylation) and clinical data

Using high-performance computing, ML/AI techniques and deep domain expertise in medicine, molecular biology and engineering, a

panel of SNP-DNA methylation biomarkers are mined, modeled and translated into standalone laboratory assays.

As a result, our products, which are clinical tests,

consist of two components.

The first is a laboratory component, which involves epigenetic DNA biomarkers.

biomarkers (“SNPs”) represent an individual’s inherited risk for the disease, have been reported to drive less than

20% of the risk for cardiovascular disease (Hou, K et al, Aug 2019, Nature Genetics) and do not change with intervention ( i.e.

Epigenetic biomarkers (DNA methylation) represent an individual’s acquired risk for the disease that is influenced by lifestyle

and environment which is a larger driver for cardiovascular risk compared to genetics, is largely confounded by genetics and has been

shown to change over time with intervention or changes in one’s lifestyle and environment ( i.e.

The second is

an analytical component, which involves applying a proprietary interpretive predictive machine learning model to predict risk and provide

personalized insights to help clinicians tailor patient management.

The combination of biomarkers and predictive machine learning model

is unique to each clinical test we develop.

Products and Services

We have and will continue

to leverage our AI-driven Integrated Genetic-Epigenetic Engine™ to develop a series of clinical tests for cardiovascular disease.

As of March 2025, we have leveraged this Engine to develop two clinical products:

Genetic biomarkers (“SNPs”)

represent an individual’s inherited risk for the disease, have been reported to drive less than 20% of the risk for cardiovascular

disease (Hou, K et al, Aug 2019, Nature Genetics) and do not change with intervention ( i.e.

Epigenetic biomarkers (DNA

methylation) represent an individual’s acquired risk for the disease that is influenced by lifestyle and environment which is a

larger driver for cardiovascular risk compared to genetics, is largely confounded by genetics and has been shown to change over time with

intervention or changes in one’s lifestyle and environment ( i.e.

The second is an analytical component, which

involves applying a proprietary interpretive predictive machine learning model to predict risk and provide personalized insights to help

clinicians tailor patient management.

The combination of biomarkers and predictive machine learning model is unique to each clinical test

Our Products and Services

We have and will continue to leverage our AI-driven

Multi-Omics Engine™ to develop a series of clinical tests for cardiovascular disease.

As of March 2026, we have leveraged this Engine

to develop two clinical products:

Epi+Gen CHD™ and PrecisionCHD™.

We believe that our first product,

Epi+Gen CHD™, is the first epigenetics-based clinical blood test capable of assessing near-term (three-year) risk for a

We believe that our first product, Epi+Gen CHD™,

is the first epigenetics-based clinical blood test capable of assessing near-term (three-year) risk for a

coronary heart disease (“CHD”) event, including heart attacks, and our

second product, PrecisionCHD™, is the first epigenetics-based clinical blood test for the detection of CHD.

Both Epi+Gen CHD and PrecisionCHD

are accompanied by our provider-facing Actionable Clinical Intelligence™ platform, which maps a patient’s unique biomarker

profile and other information onto modifiable factors such as diabetes, hypertension, hypercholesterolemia, and smoking, known to be critical

drivers of coronary heart disease.

CardioInnovate360™ is a

research use only (RUO) solution we launched to support the discovery, development and validation of novel biopharmaceuticals for the

assessment and management of cardiovascular diseases.

In 2024, we launched our first software

product, HeartRisk™.

Our PrecisionCHD test is accompanied by our provider-facing

Actionable Clinical Intelligence™ platform, which maps a patient’s unique biomarker profile and other information onto modifiable

factors such as diabetes, hypertension, hypercholesterolemia, and smoking, known to be critical drivers of coronary heart disease.

CardioInnovate360™ is a research use only

(RUO) solution we launched to support the discovery, development and validation of novel biopharmaceuticals for the assessment and management

of cardiovascular diseases.

In 2024, we launched our first software product,

HeartRisk™ is a cardiovascular disease risk intelligence platform that combines insights from HIPAA-compliant

3 unchanged sentences

Clinicians’ Current Approach to Cardiovascular Disease

Currently, a patient’s risk for CVD is generally assessed

using two common lipid-based clinical tests known as Framingham Risk Score (FRS) and ASCVD Pooled Cohort Equation (PCE).

FRS and PCE are 10-year CVD risk calculators

that aggregate common clinical variables such as cholesterol and diabetes, demographics and subjective, self-reported information such

as smoking status.

Currently, a patient’s risk for CVD is generally

assessed using two common lipid-based clinical tests known as Framingham Risk Score (FRS) and ASCVD Pooled Cohort Equation (PCE).

FRS and PCE are 10-year CVD risk calculators that

aggregate common clinical variables such as cholesterol and diabetes, demographics and subjective, self-reported information such as smoking

For the early detection of CHD, tests that are routinely used in a provider setting include stress echocardiograms.

These tests have several limitations and are less effective for several reasons:

· In a peer-reviewed published study by Cardio in collaboration with Intermountain

Healthcare (Dogan, Meeshanthini & Knight, Stacey & Dogan, Timur & Knowlton, Kirk & Philibert, Robert.

validation of integrated genetic-epigenetic biomarkers for predicting incident coronary heart disease.

10.2217/epi-2021-0123),

we found that for predicting the three-year risk for

a coronary heart disease event such as a heart attack, the average sensitivity of FRS and PCE was 44% in men and 32% in women.

This means that for every 100 men and 100 women deemed "at-risk” for a coronary heart disease event, the test only correctly

identifies 44 men and 32 women.

· In a peer-reviewed published study by Cardio in collaboration with Intermountain

Healthcare and University of Iowa Hospitals and Clinics (Philibert, Robert & Dogan, Timur & Knight, Stacey & Ahmad, Ferhaan

& Lau, Stanley & Miles, George & Knowlton, Kirk & Dogan, Meeshanthini.

Validation of integrated genetic-epigenetic

test for the assessment of coronary heart disease.

have several limitations and are less effective for several reasons:

In a peer-reviewed published study by Cardio in collaboration with Intermountain Healthcare (Dogan, Meeshanthini & Knight, Stacey & Dogan, Timur & Knowlton, Kirk & Philibert, Robert.

External validation of integrated genetic-epigenetic biomarkers for predicting incident coronary heart disease.

10.2217/epi-2021-0123), we found that for predicting the three-year risk for a coronary heart disease event such as a heart attack, the average sensitivity of FRS and PCE was 44% in men and 32% in women.

This means that for every 100 men and 100 women deemed "at-risk” for a coronary heart disease event, the test only correctly identifies 44 men and 32 women.

In a peer-reviewed published study by Cardio in collaboration with Intermountain Healthcare and University of Iowa Hospitals and Clinics (Philibert, Robert & Dogan, Timur & Knight, Stacey & Ahmad, Ferhaan & Lau, Stanley & Miles, George & Knowlton, Kirk & Dogan, Meeshanthini.

Validation of integrated genetic-epigenetic test for the assessment of coronary heart disease.

Journal of American Heart Association.

10.1161/JAHA.123.030934), we

found that the overall average area under the curve, sensitivity, and specificity in three independent test cohorts for detecting coronary

heart disease were 82%, 79%, and 76%, respectively.

· In a peer-reviewed published study by Cardio in collaboration with Intermountain

Healthcare and University of Iowa Hospitals and Clinics (Philibert, Robert & Dogan, Timur & Knight, Stacey & Ahmed, Ferhaan

& Lau, Stanley & Miles, George & Knowlton, Kirk & Dogan, Meeshanthini.

Validation of an

integrated genetic-epigenetic test for the assessment of coronary heart disease.

Jounal of American Heart Association.

10.1161/JAHA.123.030934 ),

we found that for predicting the presence of coronary heart disease, PrecisionCHD

had an 80% sensitivity for men and 76% sensitivity for women .

· The fasting requirement for current tests could be cumbersome for patients to comply, and the lack of

fasting could affect test results.

10.1161/JAHA.123.030934), we found that the overall average area under the curve, sensitivity, and specificity in three independent test cohorts for detecting coronary heart disease were 82%, 79%, and 76%, respectively.

In a peer-reviewed published study by Cardio in collaboration with Intermountain Healthcare and University of Iowa Hospitals and Clinics (Philibert, Robert & Dogan, Timur & Knight, Stacey & Ahmed, Ferhaan & Lau, Stanley & Miles, George & Knowlton, Kirk & Dogan, Meeshanthini.

Validation of an integrated genetic-epigenetic test for the assessment of coronary heart disease.

Journal of American Heart Association.

10.1161/JAHA.123.030934 ), we found that for predicting the presence of coronary heart disease, PrecisionCHD had an 80% sensitivity for men and 76% sensitivity for women .

The fasting requirement for current tests could be cumbersome for patients to comply, and the lack of fasting could affect test results.

The patient care plan that results from these tests generally lack personalization.

· Lipid-based risk assessment tests depend on self-reported, subjective

information such as smoking status from patients, and inaccurate information could affect the accuracy of test results.

· Undergoing these tests requires an in-person clinic visit to collect blood

samples and other necessary data points such as blood pressure, which may delay or prevent access to primary prevention, e.g., for those

who are unable to make time for the visit, have transportation issues or live in rural areas are likely to delay primary prevention altogether.

Similarly, to undergo a stress echocardiogram for instance, an in-person visit is required, and such a visit can take weeks to schedule

that could delay care for patients especially if they are experiencing symptoms such as chest pain.

· Commonly used risk assessment tests were also developed predominantly using data from men and therefore,

may be less effective for women.

CHD™ is the Only Epigenetics-based Clinical Test for Coronary Heart Disease Event Risk

is a scientifically backed clinical blood test that is based on an individual’s objective genetic and epigenetic DNA biomarkers

for assessing the three-year risk for a coronary heart disease event such as a heart attack.

In a peer-reviewed study done in collaboration

with Intermountain Healthcare (Dogan, Meeshanthini & Knight, Stacey & Dogan, Timur & Knowlton, Kirk & Philibert, Robert.

External validation of integrated genetic-epigenetic biomarkers for predicting incident coronary heart disease.

10.2217/epi-2021-0123), this test demonstrated a 76% and 78% sensitivity for men and women, respectively, for three-year CHD risk.

This means that for every 100 men and 100 women deemed "at-risk” for a coronary heart disease event, the test correctly identifies

76 men and 78 women.

In comparison, the average sensitivity of the Framingham Risk Score and the ASCVD Pooled Cohort Equation was found

to be 44% and 32% for men and women, respectively.

The performance of the test in this study was evaluated across two cohorts that were

independent of each other.

One cohort was used for the development of this test and the other was used to independently validate the

performance of the test, showing Epi+Gen CHD™ to be approximately 1.7 times and 2.4 times more sensitive than the current lipid-based

clinical risk estimators in men and women, respectively.

In another peer-reviewed study focusing on the cost utility of Epi+Gen CHD™

(Jung, Younsoo & Frisvold, David & Dogan, Timur & Dogan, Meeshanthini & Philibert, Robert.

Cost-utility analysis

of an integrated genetic/epigenetic test for assessing risk for coronary heart disease.

10.2217/epi-2021-0021), this

test was associated with up to $42,000 in cost savings per quality adjusted life year and improved survival compared to the ASCVD Pooled

Cohort Equation.

In another peer-reviewed study, (Philibert, Willem & Andersen, Allan & Hoffman, Eric & Philibert, Robert

& Dogan, Meeshanthini.

The reversion of DNA methylation at coronary heart disease risk loci in response to prevention therapy.

https://doi.org/10.3390/pr9040699), DNA methylation of this test was shown to change within 90 days of intervention

in the form of smoking cessation, demonstrating that this test could potentially also be leveraged to evaluate the effectiveness of interventions.

The blood-based version of this

test was introduced for market testing in 2021 The pricing of the test varies based on factors such as organization type and test volume.

The price of the test and revenue streams could change in the future depending on market forces and payor requirements, as well as on

the customer and the region in which the test is being sold.

We are continuing to build additional clinical and health economics evidence

to pursue payor coverage.

A key first step in expanding critical payor coverage is to have this test be assigned a CPT PLA code, and the

American Medical Association awarded the Epi+Gen CHD™ a CPT PLA code, 0439U.

that the Epi+Gen CHD™ test can benefit numerous healthcare stakeholders.

For instance, we believe that this test will enable clinicians

to identify patients at-risk in the near-term for CHD-related events, including a heart attack, and utilize actionable insights from

this test to provide more personalized care for their patients to help prevent the event and improve outcomes.

These actionable insights

are conveyed via our provider-facing Actionable Clinical Intelligence™ platform, which maps a patient’s unique biomarker

profile and other information onto pathways and modifiable drivers of coronary heart disease.

In addition to clinicians, we believe that

this test can enable healthcare organizations and payors to reduce the cost of care, and employers to understand and better manage business

risks including healthcare costs.

Insights for these stakeholders upon leveraging the Epi+Gen CHD™ test are provided via our new

software product, HeartRisk™, which is a cardiovascular disease risk intelligence platform.

The pricing for this platform will

be customized based on the organization type and size, and use case.

PrecisionCHD™ is the Only Epigenetics-based Clinical

Test for the Early Detection of Coronary Heart Disease

PrecisionCHD™ is a scientifically

backed clinical blood test that is based on an individual’s objective genetic and epigenetic DNA biomarkers for the detection of

coronary heart disease.

In a peer-reviewed published study by Cardio in collaboration with Intermountain Healthcare and University of

Iowa Hospitals and Clinics (Philibert, Robert & Dogan, Timur & Knight, Stacey & Ahmad, Ferhaan & Lau, Stanley & Miles,

George & Knowlton, Kirk & Dogan, Meeshanthini.

Validation of integrated genetic-epigenetic test for the assessment of

coronary heart disease.

Lipid-based risk assessment tests depend on self-reported, subjective information such as smoking status from patients, and inaccurate information could affect the accuracy of test results.

Undergoing these tests requires an in-person clinic visit to collect blood samples and other necessary data points such as blood pressure, which may delay or prevent access to primary prevention, e.g., for those who are unable to make time for the visit, have transportation issues or live in rural areas are likely to delay primary prevention altogether.

Similarly, to undergo a stress echocardiogram for instance, an in-person visit is required, and such a visit can take weeks to schedule that could delay care for patients especially if they are experiencing symptoms such as chest pain.

Commonly used risk assessment tests were also developed predominantly using data from men and therefore, may be less effective for women.

Epi+Gen CHD™ is the Only Epigenetics-based

Clinical Test for Coronary Heart Disease Event Risk Assessment

Epi+Gen CHD™ is a scientifically backed clinical

blood test that is based on an individual’s objective genetic and epigenetic DNA biomarkers for assessing the three-year risk for

a coronary heart disease event such as a heart attack.

In a peer-reviewed study done in collaboration with Intermountain Healthcare (Dogan,

Meeshanthini & Knight, Stacey & Dogan, Timur & Knowlton, Kirk & Philibert, Robert.

External validation of integrated

genetic-epigenetic biomarkers for predicting incident coronary heart disease.

10.2217/epi-2021-0123), this test demonstrated

a 76% and 78% sensitivity for men and women, respectively, for three-year CHD risk.

This means that for every 100 men and 100 women deemed

"at-risk” for a coronary heart disease event, the test correctly identifies 76 men and 78 women.

In comparison, the average

sensitivity of the Framingham Risk Score and the ASCVD Pooled Cohort Equation was found to be 44% and 32% for men and women, respectively.

The performance of the test in this study was evaluated across two cohorts that were independent of each other.

One cohort was used for

the development of this test, and the other was used to independently validate the performance of the test, showing Epi+Gen CHD™

to be approximately 1.7 times and 2.4 times more sensitive than the current lipid-based clinical risk estimators in men and women, respectively.

In another peer-reviewed study focusing on the cost utility of Epi+Gen CHD™ (Jung, Younsoo & Frisvold, David & Dogan, Timur

& Dogan, Meeshanthini & Philibert, Robert.

Cost-utility analysis of an integrated genetic/epigenetic test for assessing

risk for coronary heart disease.

10.2217/epi-2021-0021), this test was associated with up to $42,000 in cost savings

per quality adjusted life year and improved survival compared to the ASCVD Pooled Cohort Equation.

In another peer-reviewed study, (Philibert,

Willem & Andersen, Allan & Hoffman, Eric & Philibert, Robert & Dogan, Meeshanthini.

The reversion of DNA methylation

at coronary heart disease risk loci in response to prevention therapy.

https://doi.org/10.3390/pr9040699), DNA methylation

of this test was shown to change within 90 days of intervention in the form of smoking cessation, demonstrating that this test could potentially

also be leveraged to evaluate the effectiveness of interventions.

The blood-based version of this test was introduced

for market testing in 2021.

The pricing of the test varies based on factors such as organization type and test volume.

The price of the

test and revenue streams could change in the future depending on market forces and payor requirements, as well as on the customer and

the region in which the test is being sold.

We are continuing to build additional clinical and health economics evidence to pursue payor

A key first step in expanding critical payor coverage is to have this test be assigned a CPT PLA code, and the American Medical

Association awarded the Epi+Gen CHD™ a CPT PLA code, 0439U.

This test received a final CMS gapfill payment rate of $854 in 2025.

We believe that the Epi+Gen CHD™ test can

benefit numerous healthcare stakeholders.

For instance, we believe that this test will enable clinicians to identify patients at-risk

in the near-term for CHD-related events, including a heart attack, and utilize actionable insights from this test to provide more personalized

care for their patients to help prevent the event and improve outcomes.

These actionable insights are conveyed via our provider-facing

Actionable Clinical Intelligence™ platform, which maps a patient’s unique biomarker profile and other information onto pathways

and modifiable drivers of coronary heart disease.

In addition to clinicians, we believe that this test can enable healthcare organizations

and payors to reduce the cost of care, and employers to understand and better manage business risks including healthcare costs.

for these stakeholders upon leveraging the Epi+Gen CHD™ test are provided via our new software product, HeartRisk™, which

is a cardiovascular disease risk intelligence platform.

The pricing for this platform will be customized based on the organization type

and size, and use case.

PrecisionCHD™ is the Only Epigenetics-based

Clinical Test for the Early Detection of Coronary Heart Disease

PrecisionCHD™ is a scientifically backed clinical

blood test that is based on an individual’s objective genetic and epigenetic DNA biomarkers for the detection of coronary heart

In a peer-reviewed published study by Cardio in collaboration with Intermountain Healthcare and University of Iowa Hospitals

and Clinics (Philibert, Robert & Dogan, Timur & Knight, Stacey & Ahmad, Ferhaan & Lau, Stanley & Miles, George &

Knowlton, Kirk & Dogan, Meeshanthini.

Validation of integrated genetic-epigenetic test for the assessment of coronary heart

Journal of American Heart Association.

10.1161/JAHA.123.030934), this test demonstrated an overall

average area under the curve, sensitivity, and specificity in three independent test cohorts for detecting coronary heart disease of 82%,

79%, and 76%, respectively.

The average sensitivity for men and women were 80% and 76%, respectively.

This means that for every 100 men

and 100 women deemed "to have” coronary heart disease, the test correctly identifies 80 men and 76 women.

In comparison, the

most commonly used and least invasive test for detecting coronary heart disease, exercise ECG, has a sensitivity of only 58%.

10.1161/JAHA.123.030934), this test demonstrated an overall average area

under the curve, sensitivity, and specificity in three independent test cohorts for detecting coronary heart disease of 82%, 79%, and

76%, respectively.

The average sensitivity for men and women was 80% and 76%, respectively.

This means that for every 100 men and 100

women deemed “to have” coronary heart disease, the test correctly identifies 80 men and 76 women.

In comparison, the most

commonly used and least invasive test for detecting coronary heart disease, exercise ECG, has a sensitivity of only 58%.

The performance

19 unchanged sentences

90 days of intervention in the form of smoking cessation.

The blood-based version of this

test was introduced for market testing in 2023.

The blood-based version of this test was introduced

for market testing in 2023.

The pricing of the test varies based on factors such as organization type and test volume.

The American Medical Association awarded the PrecisionCHD™ a CPT PLA code, 0440U.

The price of the test and revenue streams could

change in the future depending on market forces and payor requirements, as well as on the customer and the region in which the test is

We are continuing to build additional clinical and health economics evidence to pursue payor coverage.

that the PrecisionCHD™ test can benefit numerous healthcare stakeholders.

For instance, we believe that this test will enable clinicians

to identify patients with CHD with a simple blood test and utilize actionable insights from this test to provide more personalized care

for their patients to help improve outcomes.

These actionable insights are conveyed via our provider-facing Actionable Clinical Intelligence™

platform, which maps a patient’s unique biomarker profile and other information onto modifiable factors such as diabetes, inflammation,

hypercholesterolemia, and smoking, known to be critical drivers of coronary heart disease.

In addition to clinicians, we believe that

this test can enable healthcare organizations and payors to reduce the cost of care, and employers to understand and better

manage business risks including healthcare cost.

Insights for these stakeholders upon leveraging the PrecisionCHD™ test

are provided via our new software product, HeartRisk™, which is a cardiovascular disease risk

intelligence platform.

The pricing for this platform will be customized based on the organization type and size, and use case.

Cardio intends to accelerate the

adoption of Epi+Gen CHD™ and PrecisionCHD™ by:

The American Medical

Association awarded the PrecisionCHD™ a CPT PLA code, 0440U.

This test received a final CMS gapfill payment rate of $854 in 2025.

The price of the test and revenue streams could change in the future depending on market forces and payor requirements, as well as on

the customer and the region in which the test is being sold.

We are continuing to build additional clinical and health economics evidence

to pursue payor coverage.

We believe that the PrecisionCHD™ test can

benefit numerous healthcare stakeholders.

For instance, we believe that this test will enable clinicians to identify patients with CHD

with a simple blood test and utilize actionable insights from this test to provide more personalized care for their patients to help improve

These actionable insights are conveyed via our provider-facing Actionable Clinical Intelligence™ platform, which maps

a patient’s unique biomarker profile and other information onto modifiable factors such as diabetes, inflammation, hypercholesterolemia,

and smoking, known to be critical drivers of coronary heart disease.

In addition to clinicians, we believe that this test can enable healthcare

organizations and payors to reduce the cost of care, and employers to understand and better manage

business risks including healthcare cost.

Insights for these stakeholders upon leveraging the PrecisionCHD™ test are provided via

our new software product, HeartRisk™, which is a cardiovascular disease risk intelligence platform.

The pricing for this platform

will be customized based on the organization type and size, and use case.

Cardio intends to accelerate the adoption of Epi+Gen

CHD™ and PrecisionCHD™ by:

developing strategic clinical partnerships to reach as many patients as possible;

growing the clinical and economic evidence base supporting the use of the tests;

leveraging industry organizations to engage and educate providers;

· launching a piloting program to for innovative providers and key strategic partners;

offering pilot programs to for innovative providers and key strategic partners;

developing strategic partnerships with other healthcare stakeholders such as payors and employers .

· developing a customized customer portal to reduce transaction friction.

Cardio foresees potential opportunities to increase the

gross margin of the Epi+Gen CHD™ and PrecisionCHD™ by:

· establishing a laboratory to potentially reduce cost associated with processing samples;

Cardio foresees potential opportunities to increase the gross margin

of the Epi+Gen CHD™ and PrecisionCHD™ by:

processing patient samples in the laboratory in larger batches;

1 unchanged sentence

increasing the level of automation to reduce manual processing.

We have completed

a pre-submission with the FDA pertaining to our PrecisionCHD product and have received feedback from the FDA on that submission.

complete additional pre- submissions to the FDA as we continue to evaluate FDA’s feedback and further develop our regulatory strategy.

We have engaged outside expertise for this process.

We have completed a pre-submission with the FDA

pertaining to our PrecisionCHD product and have received feedback from the FDA on that submission.

We may complete additional pre-submissions

to the FDA as we continue to evaluate FDA’s feedback and further develop our regulatory strategy.

We have engaged outside expertise

for this process.

Product Pipeline

In March 2023, we announced the

debut of the PrecisionCHD™ test, our second clinical blood test for the detection of CHD.

In May 2023, we launched CardioInnovate360™

a research-use- only (RUO) solution to support the discovery, development and validation of novel biopharmaceuticals for the assessment

and management of cardiovascular diseases.

In February 2024, we announced the launch of HeartRisk™, our first software product that

is a cardiovascular disease risk intelligence platform.

We have several other tests in our product pipeline at various stages of development

for congestive heart failure, stroke and diabetes.

However, as a company in the early stages of its development, we continuously reevaluate

our business, the market in which we operate and potential new opportunities.

We may modify our product pipeline, seek other alternatives

within the healthcare field in order to grow the Company’s business and increase revenues.

Such alternatives may include, but not

be limited to, combinations or strategic partnerships with other laboratory companies or with medical practices such as hospitalists or

behavioral health.

Market Opportunity

Cardiovascular disease (“CVD”)

is the leading cause of death in the United States, accounting for one in four deaths.

Despite being largely preventable, the American

Heart Association projects that by 2035, nearly 45% of Americans will have some form of CVD.

One of the key ways to address the prevalence

of CVD is to shift the approach for CVD from reactive treatment to proactive prevention and earlier detection.

We have several other tests in our product pipeline at various

stages of development for congestive heart failure, stroke and diabetes.

However, as a company in the early stages of its development,

we continuously reevaluate our business, the market in which we operate and potential new opportunities.

We may modify our product pipeline,

seek other alternatives within the healthcare field in order to grow the Company’s business and increase revenues.

Such alternatives

may include, but not be limited to, combinations or strategic partnerships with other laboratory companies or with medical practices such

as hospitalists or behavioral health.

Our Market Opportunity

Cardiovascular disease (“CVD”) is the

leading cause of death in the United States, accounting for one in four deaths.

Despite being largely preventable, the American Heart

Association projects that by 2035, nearly 45% of Americans will have some form of CVD.

One of the key ways to address the prevalence of

CVD is to shift the approach for CVD from reactive treatment to proactive prevention and earlier detection.

As such, technologies that

can more precisely assess the risk for and detect CVD before symptoms emerge or a catastrophic cardiac event occurs becomes even more

According to Research and

Markets in their Outlook on the Cardiovascular Diagnostic Testing Global Market to 2027 - Increasing Number of Insurance Providers Presents

Opportunities press release published on July 4, 2022, the Global Cardiovascular Diagnostic Testing Market is estimated to grow from $8.47

billion in 2022 to $12.41 billion by 2027, with a CAGR of 7.94%.

The increasing prevalence of cardiovascular diseases, technological advancements

in cardiovascular disease diagnostics, and the growing number of initiatives to promote cardiovascular disease testing are the major factors

driving the growth of this market.

Our principal

mission is to enable better detection of the presence and risk of major cardiovascular diseases through a series of clinical tests developed

by leveraging our proprietary AI-driven Integrated Genetic-Epigenetic Engine™.

Our initial product, Epi+Gen CHD™, is a highly

sensitive and accessible clinical test for three-year coronary heart disease (“CHD”) event

risk assessment, including risk for a heart attack.

Our second product, PrecisionCHD™, is a highly sensitive and accessible

clinical test for the detection of CHD.

from the US Census Bureau, Cardio estimates that 146 million adults could potentially benefit from our Epi+Gen CHD™ test, 157 million

adults for our PrecisionCHD test, 152 million adults for the congestive heart failure test, 153 million adults for the stroke test and

140 million adults for the diabetes test.

The pricing of each of our tests may vary, but the US addressable market equates to $51 billion

for Epi+Gen CHD™, assuming a pricing of $350/test, $134 billion for PrecisionCHD™, assuming a price of $850/test, $53 billion

for congestive heart failure, assuming a pricing of $350/test, $53 billion for stroke, assuming a pricing of $350/test and $49 billion

for diabetes, assuming a pricing of $350/test for a total US addressable market of $340 billion.

This total addressable market evaluation

also assumes that one patient could be tested with multiple tests, and each test is administered to each patient a single time in a year

although some patients may benefit from being re-tested in less than a year.

Strategy for Epi+Gen CHD™ and PrecisionCHD™

Our current go-to-market

(“GTM”) strategy is predominantly a product-led innovation growth strategy that emphasizes enterprise-wide adoption across

key healthcare sub-verticals with a particular emphasis on deeply centralized key opinion and health trend leaders like innovative providers,

health systems, and employers.

This strategy is augmented with a bottom-up consumer- led sales focused on directly acquiring and retaining

savvy and health-conscious consumers interested in using the latest technologies to address their cardiovascular disease concerns.

Healthcare Sub-Vertical Priorities for Epi+Gen CHD™

According to Research and Markets in their Outlook

on the Cardiovascular Diagnostic Testing Global Market to 2027 - Increasing Number of Insurance Providers Presents Opportunities press

release published on July 4, 2022, the Global Cardiovascular Diagnostic Testing Market is estimated to grow from $8.47 billion in 2022

to $12.41 billion by 2027, with a CAGR of 7.94%.

The increasing prevalence of cardiovascular diseases, technological advancements in cardiovascular

disease diagnostics, and the growing number of initiatives to promote cardiovascular disease testing are the major factors driving the

growth of this market.

Our principal mission is to enable better detection

of the presence and risk of major cardiovascular diseases through a series of clinical tests developed by leveraging our proprietary AI-driven

Multi-Omics Engine™.

Our initial product, Epi+Gen CHD™, is a highly sensitive and accessible clinical test for three-year

coronary heart disease (“CHD”) event risk assessment, including risk for a heart attack.

Our second product, PrecisionCHD™,

is a highly sensitive and accessible clinical test for the detection of CHD.

Using data from the US Census Bureau, test intended

use and disease prevalence, Cardio estimates that 146 million adults could potentially benefit from our Epi+Gen CHD™ test, and 60

million adults for our PrecisionCHD test.

Using the final CMS gapfill pricing of $854/test as a basis, the US addressable market equates

to ~$125 billion for Epi+Gen CHD™, and $51 billion for PrecisionCHD™.

This total addressable market does not account for variations

in test price, including self-pay, pilot pricing, discounts and different payment rates by different payors.

It also does not account

for re-testing for patients over time.

Go-To-Market Strategy for Epi+Gen CHD™

and PrecisionCHD™

By assessing the risk for a heart

attack early and/or detecting CHD early to potentially avert a heart attack, we believe that the clinical and economic utility of the

Epi+Gen CHD™ and PrecisionCHD™ tests will support their commercial adoption.

We believe that Epi+Gen CHD™ and PrecisionCHD™

can address a significant addressable market opportunity even before these tests are covered and reimbursed by payors.

While we believe

that such coverage and reimbursement would be necessary to gain widespread adoption, obtaining such coverage and reimbursement from federal

and private payors may take several years, if it is obtained at all.

We intend to focus on the following key channels as part of our GTM

Our current go-to-market (“GTM”) strategy

is predominantly a product-led innovation growth strategy that emphasizes enterprise-wide adoption across key healthcare sub-verticals

with a particular emphasis on deeply centralized key opinion and health trend leaders like innovative providers, health systems, and employers.

Healthcare Sub-Vertical Priorities for Epi+Gen

CHD™ and PrecisionCHD™

By assessing the risk for a heart attack early and/or

detecting CHD early to potentially avert a heart attack, we believe that the clinical and economic utility of the Epi+Gen CHD™ and

PrecisionCHD™ tests will support their commercial adoption.

We believe that Epi+Gen CHD™ and PrecisionCHD™ can address

a significant addressable market opportunity even before these tests are covered and reimbursed by payors.

While we believe that such

coverage and reimbursement would be necessary to gain widespread adoption, obtaining such coverage and reimbursement from federal and

private payors may take several years, if it is obtained at all.

We intend to focus on the following key channels as part of our GTM strategy:

Innovative Health Systems

innovative health systems diversify their business models and care delivery pathways, there is a renewed emphasis on using precision

medical technologies to better manage expensive and chronic conditions, including CHD.

By assessing the risk for a CHD event including

a heart attack before it occurs, Epi+Gen CHD™ has the potential to improve population health.

We believe that the improved performance

of our test compared to other risk calculators, coupled with evidence of cost savings and enhanced survival, will drive the adoption

of Epi+Gen CHD™ by health systems to continue improving the health of their patients.

Similarly, with PrecisionCHD™, innovative

health systems are able to help test their patients detect CHD earlier with a simple blood test, potentially leading to better patient

As innovative health systems diversify their business

models and care delivery pathways, there is a renewed emphasis on using precision medical technologies to better manage expensive and

chronic conditions, including CHD.

By assessing the risk for a CHD event including a heart attack before it occurs, Epi+Gen CHD™

has the potential to improve population health.

We believe that the improved performance of our test compared to other risk calculators,

coupled with evidence of cost savings and enhanced survival, will drive the adoption of Epi+Gen CHD™ by health systems to continue

improving the health of their patients.

Similarly, with PrecisionCHD™, innovative health systems are able to help test their patients

detect CHD earlier with a simple blood test, potentially leading to better patient outcomes.

Physician-Directed Channels, Including Concierge Practices

Early adoption is driven by practices

committed to innovation in medicine for patients who are more focused on preventive health and wellness and have the financial means to

pay out-of- pocket for concierge subscription services.

There is a convergence in innovative providers, health-conscious consumers, and

best-in-class tests and technologies in concierge medicine practices or other similar practices

to provide on-demand elite personalized and readily accessible healthcare.

With an estimated 2,000 to 5,000 concierge practices

in the United States, there is robust growth in high-end healthcare services with an equal demand for innovative diagnostic tools.

Additionally,

concierge practices are not price-sensitive, so reimbursement is not a top priority.

Early adoption in the employer space

is likely to be driven by self-insured employers and employers looking to provide employee perks relevant to health.

Self-insured employers

are consistently seeking solutions to help manage their biggest cost centers such as heart disease.

In a post-pandemic world, the health

and wellbeing of employees are also top-of-mind for many employers to ensure that their employees are healthy and productive.

view healthcare investments as another investment in the business.

Employers leveraging innovative diagnostic solutions can connect better

health for employees to drive overall business objectives and have a competitive advantage in managing business risks while attracting

and retaining talent.

Early adoption is driven by practices committed

to innovation in medicine for patients who are more focused on preventive health and wellness and have the financial means to pay out-of-

pocket for concierge subscription services.

There is a convergence in innovative providers, health-conscious consumers, and best-in-class

tests and technologies in concierge medicine practices or other similar practices to provide on-demand elite personalized and readily

accessible healthcare.

With an estimated 2,000 to 5,000 concierge practices in the United States, there is robust growth in high-end healthcare

services with an equal demand for innovative diagnostic tools.

Additionally, concierge practices are not price-sensitive, so reimbursement

is not a top priority.

Early adoption in the employer space is likely to

be driven by self-insured employers and employers looking to provide employee perks relevant to health.

Self-insured employers are consistently

seeking solutions to help manage their biggest cost centers such as heart disease.

In a post-pandemic world, the health and wellbeing

of employees are also top-of-mind for many employers to ensure that their employees are healthy and productive.

Employers view healthcare

investments as another investment in the business.

Employers leveraging innovative diagnostic solutions can connect better health for

employees to drive overall business objectives and have a competitive advantage in managing business risks while attracting and retaining

Telemedicine and Marketplaces

Many Americans

are concerned about being proactive with their health needs.

Understanding their personalized risk with tests at the forefront of medicine

is crucial for those with financial resources.

Many Americans are concerned about being proactive

with their health needs.

Understanding their personalized risk with tests at the forefront of medicine is crucial for those with financial

According to the U.S.

Census Bureau based on the 2020 census, there are nearly 44 million

households that earn $100,000 or more annually.

We expect high-earning Americans who are proactive about their health to constitute the

initial attainable market.

Sales and Marketing for Epi+Gen CHD™ and PrecisionCHD™

with a Focus on Strategic Channel Partnerships

While our overall sales and

marketing initiatives will span the gamut across traditional, print, and digital media, our primary sales and marketing strategy consists

of the branding, collaboration, co-marketing, and co-sales opportunities involved in strategic channel partnerships.

By prioritizing strategic

channel partnerships, we believe we can accelerate our market penetration into the key healthcare sub-verticals we intend to prioritize

for our growth.

The key to our efforts is a well-defined and executed channel partnership integration strategy that will serve to accelerate

the sales cycles for each of our distribution channels.

The sales cycles are generally defined as the period in which such distribution

channel will turn over its inventory of our tests, which may vary for each distribution channel.

Utilizing and developing such strategic

channel partnerships, we believe, will generate revenue in a myriad of ways including larger contracts for our Epi+Gen CHD™ and

PrecisionCHD™ clinical blood tests, and bundling our solutions alongside other synergistic technologies, services, and products.

channel partnerships are key for the growth of our solutions.

There are several key revenue and strategy benefits to developing a robust

channel partnership strategy, including:

Census Bureau based on the 2020 census, there are nearly 44 million households that earn $100,000 or

more annually.

We expect high-earning Americans who are proactive about their health to constitute the initial attainable market.

Sales and Marketing for Epi+Gen CHD™ and

PrecisionCHD™ with a Focus on Strategic Channel Partnerships

While our overall sales and marketing initiatives

will span the gamut across traditional, print, and digital media, our primary sales and marketing strategy consists of the branding, collaboration,

co-marketing, and co-sales opportunities involved in strategic channel partnerships.

By prioritizing strategic channel partnerships, we

believe we can accelerate our market penetration into the key healthcare sub-verticals we intend to prioritize for our growth.

to our efforts is a well-defined and executed channel partnership integration strategy that will serve to accelerate the sales cycles

for each of our distribution channels.

The sales cycles are generally defined as the period in which such distribution channel will turn

over its inventory of our tests, which may vary for each distribution channel.

Utilizing and developing such strategic channel partnerships,

we believe, will generate revenue in a myriad of ways including larger contracts for our Epi+Gen CHD™ and PrecisionCHD™ clinical

blood tests, and bundling our solutions alongside other synergistic technologies, services, and products.

Strategic channel partnerships are key for the growth

of our solutions.

There are several key revenue and strategy benefits to developing a robust channel partnership strategy, including:

Defensibility and Displacement

Strategic channel partners may have exclusivity agreements for

Epi+Gen CHD™ and PrecisionCHD™, which forecloses distribution channels to potential competitors.

Strategic channel partners may have exclusivity

agreements for Epi+Gen CHD™ and PrecisionCHD™, which forecloses distribution channels to potential competitors.

Distribution and Network Effects

Channel partners under consideration

for Epi+Gen CHD™ and PrecisionCHD™ strategic partnerships have large, related healthcare and life science networks that we

expect to leverage as part of the relationship.

Channel partners under consideration for Epi+Gen

CHD™ and PrecisionCHD™ strategic partnerships have large, related healthcare and life science networks that we expect to leverage

as part of the relationship.

Bi-Directional Value

The cardiovascular disease space is

of paramount concern to stakeholders across the healthcare continuum;

the scale of the disease across the population and the associated

costs ensures that addressing cardiovascular disease from a payment, cost, patient outcome, and prevention standpoint for stakeholders

across the spectrum.

The cardiovascular disease space is of paramount

concern to stakeholders across the healthcare continuum;

the scale of the disease across the population and the associated costs ensures

that addressing cardiovascular disease from a payment, cost, patient outcome, and prevention standpoint for stakeholders across the spectrum

will continue to be a priority.

Pricing Differentiation

The economics of each channel partnership can be crafted independently

to offer each strategic partner a per-unit cost relevant to the size of their network.

The economics of each channel partnership can be

crafted independently to offer each strategic partner a per-unit cost relevant to the size of their network.

Complementary Goods

Bundling Epi+Gen CHD™, PrecisionCHD™,

HeartRisk™ and future Cardio solutions alongside complementary clinical, analytics, treatment pathways, and services-consulting

for primary prevention optimization with key partners expands the ROI of the investment in our solutions.

Bundling Epi+Gen CHD™,

PrecisionCHD™, HeartRisk™ and future Cardio solutions alongside complementary clinical, analytics, treatment pathways, and

services-consulting for primary prevention optimization with key partners expands the ROI of the investment in our solutions.

Hiring and Talent to Accelerate Growth

Our growth strategy will require

investment in internal and external healthcare enterprise sales, marketing and deep customer insights.

By combining best-in-class revenue

operations technologies with seasoned healthcare sales and marketing experts, we believe we can quickly scale the selling approaches we

have outlined and validated to transform the cardiovascular healthcare experience, driving revenue and increased margins.

New hires will

be targeting the entire continuum of revenue needs, including opportunity identification, campaign design, and execution.

Manufacture/Supply

The content of the sample collections

kits for both Epi+Gen CHD™ and PrecisionCHD™ are identical, and we rely on third-party suppliers for kit contents required

to collect and transport a blood sample to the lab for processing.

These are commonly used supplies that are and can be sourced from multiple

distributors.

Upon sourcing these contents, they are assembled into lancet- based and vacutainer-based sample collection kits internally

and fulfilled.

Our growth strategy will require investment in internal

and external healthcare enterprise sales, marketing and deep customer insights.

By combining best-in-class revenue operations technologies

with seasoned healthcare sales and marketing experts, we believe we can quickly scale the selling approaches we have outlined and validated

to transform the cardiovascular healthcare experience, driving revenue and increased margins.

New hires will be targeting the entire continuum

of revenue needs, including opportunity identification, campaign design, and execution.

Manufacture/Supply Chain

The content of the sample collections kits for both

Epi+Gen CHD™ and PrecisionCHD™ are identical, and we rely on third-party suppliers for kit contents required to collect and

transport a blood sample to the lab for processing.

These are commonly used supplies that are and can be sourced from multiple distributors.

Upon sourcing these contents, they are assembled into lancet- based and vacutainer-based sample collection kits internally and fulfilled.

We intend to maintain an inventory of fully assembled kits to meet expected demand for at least six months.

However, since

there are no particular or unique assembly protocols and assembly is handled internally, the lead time to assemble additional sample collection

kits would be minimal after the contents are sourced.

Proprietary genetic and DNA methylation

components are sourced from large manufacturers and manufactured under good manufacturing practices (“cGMP”).

There are alternative

manufacturers for each of these components, and no additional lead time is expected.

Laboratory assays that are manufactured under cGMP

to specifications are expected to be available to meet anticipated demand for at least six months.

However, since there are no

particular or unique assembly protocols and assembly is handled internally, the lead time to assemble additional sample collection kits

would be minimal after the contents are sourced.

Proprietary genetic and DNA methylation components

are sourced from large manufacturers and manufactured under good manufacturing practices (“cGMP”).

There are alternative manufacturers

for each of these components, and no additional lead time is expected.

Laboratory assays that are manufactured under cGMP to specifications

are expected to be available to meet anticipated demand for at least six months.

Both the Epi+Gen CHD™ and PrecisionCHD™

clinical blood tests currently are offered as LDTs through an experienced laboratory with the appropriate Clinical Laboratory Improvement

clinical blood tests currently are offered as LDTs through our newly established laboratory with the appropriate Clinical Laboratory Improvement

Amendments of 1988 (“CLIA”) certification and state licensure.

However, we are currently setting up an internal operational

hub that includes a CLIA laboratory.

We anticipate completing this process in 2025.

However, we are moving at a measured pace in order

to preserve resources, so the timing of completion of the internal CLIA laboratory could be delayed.

We will continue to use the services

of our outside laboratory without interruption until our laboratory is operational.

Competitive Strengths

The initial CLIA survey was conducted by a CLIA compliance

manager, which found no deficiencies.

Our Competitive Strengths

Innovation is the key to success.

In the rapidly moving cardiac diagnostics space, we believe that we have the team, differentiated technology, and deep technical and business

expertise to deliver a market differentiating suite of products for our customers to address unmet clinical needs in the cardiovascular

space and help us dominate our market.

The pillar of our strategy has

been innovation, from the onset with our technology development and intellectual property that account for future growth, to our commercialization

and partnership efforts that bring together key healthcare stakeholders.

We believe that, among other reasons, the future belongs

to Cardio based on the following competitive strengths:

In the rapidly

moving cardiac diagnostics space, we believe that we have the team, differentiated technology, and deep technical and business expertise

to deliver a market differentiating suite of products for our customers to address unmet clinical needs in the cardiovascular space and

help us dominate our market.

The pillar of our strategy has been innovation,

from the onset with our technology development and intellectual property that account for future growth, to our commercialization and

partnership efforts that bring together key healthcare stakeholders.

We believe that, among other reasons, the future

belongs to Cardio based on the following competitive strengths:

Technology and products are strongly backed by science.

Our technology and products stem

from over a decade of rigorous scientific research by the founding team in collaboration with other clinical and research experts from

leading organizations.

Our founding team consist of experts in machine learning approaches in healthcare and in epigenetics with highly-cited

peer-reviewed publications.

Our technology and products stem from over a decade

of rigorous scientific research by the founding team in collaboration with other clinical and research experts from leading organizations.

Our founding team consist of experts in machine learning approaches in healthcare and in epigenetics with highly-cited peer-reviewed publications.

The technology and products are developed and validated with extensive clinical data.

The key findings have

been published after undergoing stringent independent third-party peer review.

The key findings have been published after undergoing

stringent independent third-party peer review.

Broad intellectual property portfolio protects our current and future products and their applications.

As of March 2025,

our patent portfolio includes six patent families, which encompasses two issued patents in the U.S., as well as issued patents in United

Kingdom, France, Germany, Italy, Switzerland, Ireland, Hong Kong, Australia, China, and India, four pending U.S.

patent applications,

two pending PCT International applications, and almost forty patent applications pending worldwide, and which are generally directed to

methods and compositions for detecting biomarkers associated with cardiovascular disease and diabetes for diagnosis and other applications.

In addition, we have extensive trade secrets and know-how, including algorithms and assay designs, that are critical for the continued

development and improvement of our current and future products.

As of March 2026, our patent portfolio includes

seven patent families, which encompasses two issued patents in the U.S., as well as issued patents in United Kingdom, France, Germany,

Italy, Switzerland, Ireland, Hong Kong, Australia, China, India, and Japan, five pending U.S.

patent applications, one pending PCT International

application, and forty-five patent applications pending worldwide, which are generally directed to methods and compositions for detecting

biomarkers associated with cardiovascular disease and diabetes for diagnosis and other applications.

In addition, we have extensive trade

secrets and know-how, including algorithms and assay designs, that are critical for the continued development and improvement of our current

and future products.

Big data and artificial intelligence (machine learning) expertise drive future product development.

Our expertise in processing billions of clinical genotypic,

epigenetic and phenotypic data points to generate critical insights allows us to continue to develop innovative products.

· Proprietary cutting-edge AI-driven Integrated Genetic-Epigenetic Engine™ accelerates product

We have built a proprietary

AI-driven Integrated Genetic-Epigenetic Engine™ that is made up of layers of big data, our algorithms informed by biology and its

expert domain knowledge that was designed and built over the past decade and can be leveraged to enable rapid design, development and

launch of new diagnostic solutions.

Our expertise in processing

billions of clinical genotypic, epigenetic and phenotypic data points to generate critical insights allows us to continue to develop innovative

Proprietary cutting-edge AI-driven Multi-Omics Engine™ accelerates product development.

We have built a proprietary AI-driven Multi-Omics Engine™ that is made up of layers

of big data, our algorithms informed by biology and its expert domain knowledge that was designed and built over more than a decade and

can be leveraged to enable rapid design, development and launch of new diagnostic solutions.

Multiple potential product offerings with strong value propositions for key healthcare stakeholders.

We have built a robust product

pipeline for various types of cardiovascular disease and other indications that leverage our AI-driven Integrated Genetic-Epigenetic Engine™

to continue to build market traction.

We believe that our current and future products have strong value propositions for various key stakeholders

in healthcare.

As a result, we believe that our customers will adopt and champion our products.

We have built a robust product pipeline for various

types of cardiovascular disease and other indications that leverage our AI-driven Multi-Omics Engine™ to continue to build market

We believe that our current and future products have strong value propositions for various key stakeholders in healthcare.

a result, we believe that our customers will adopt and champion our products.

Products that can potentially drive value in multiple ways.

We believe that our tests are

the first epigenetics-based clinical tests for heart disease.

Unlike genetic biomarkers that are static, the DNA methylation (epigenetic)

biomarkers included in our products are generally dynamic.

Therefore, DNA methylation biomarkers can change over time and as a result,

in addition to initial assessment, our products could potentially be used to personalize interventions and help monitor the effectiveness

of these interventions.

We believe that our tests are the first epigenetics-based

clinical tests for heart disease.

Unlike genetic biomarkers that are static, the DNA methylation (epigenetic) biomarkers included in our

products are generally dynamic.

Therefore, DNA methylation biomarkers can change over time and as a result, in addition to initial assessment,

our products could potentially be used to personalize interventions and help monitor the effectiveness of these interventions.

Commercial processes that are inherently scalable to meet demand.

Our commercial pipeline is inherently

Laboratory testing kits consist of easy to synthesize oligonucleotide products, readily available PCR reagents, and can be kitted

months in advance.

Our lancet and vacutainer-based sampling kits incorporate readily available components that can be sourced from several

Our commercial pipeline is inherently scalable.

Laboratory testing kits consist of easy to synthesize oligonucleotide products, readily available PCR reagents, and can be kitted months

Our lancet and vacutainer-based sampling kits incorporate readily available components that can be sourced from several vendors.

Our propriety algorithms can be scaled and automated to process data from thousands of samples.

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can be automated and scaled by adding existing commercial equipment.

· A leadership team of seasoned healthcare professionals and executives that is led by a visionary

Cardio is led by a management team with experience in inventing

innovative technologies, developing and commercializing clinical products, and building high growth companies.

Even though we believe that our

solutions provide significant advantages over solutions that are currently available from other sources, we expect continued intense competition.

This includes companies that are entering the cardiovascular diagnostics market or existing companies that are looking to capitalize on

the same or similar opportunities as Cardio is in the clinical and non-clinical spaces.

Some of our potential and current competitors

have longer operating histories and have, or will have, substantially greater financial, technical, research, and other resources than

we do, along with larger, more established marketing, sales, distribution, and service organizations.

This could enable our competitors

to respond more quickly or efficiently than it can to capture a larger market share, respond to changes in the regulatory landscape or

adapt to meet new trends in the market.

Having access to more resources, these competitors may undertake more extensive research and development

efforts, substantially reduce the time to introducing new technologies, accelerate key hires to drive adoption of their technologies,

deploy more far-reaching marketing campaigns and implement a more aggressive pricing policy to build larger customer bases than we have.

In some cases, we are competing for the same resources our customers allocate for purchasing cardiovascular diagnostics products or for

establishing strategic partnerships.

A leadership team of seasoned healthcare professionals and executives that is led by a visionary founder.

Cardio is led by a management team with experience

in inventing innovative technologies, developing and commercializing clinical products, and building high growth companies.

Even though we believe that our solutions provide

significant advantages over solutions that are currently available from other sources, we expect continued intense competition.

This includes

companies that are entering the cardiovascular diagnostics market or existing companies that are looking to capitalize on the same or

similar opportunities as Cardio is in the clinical and non-clinical spaces.

Some of our potential and current competitors have longer

operating histories and have, or will have, substantially greater financial, technical, research, and other resources than we do, along

with larger, more established marketing, sales, distribution, and service organizations.

This could enable our competitors to respond

more quickly or efficiently than it can to capture a larger market share, respond to changes in the regulatory landscape or adapt to meet

new trends in the market.

Having access to more resources, these competitors may undertake more extensive research and development efforts,

substantially reduce the time to introducing new technologies, accelerate key hires to drive adoption of their technologies, deploy more

far-reaching marketing campaigns and implement a more aggressive pricing policy to build larger customer bases than we have.

In some cases,

we are competing for the same resources our customers allocate for purchasing cardiovascular diagnostics products or for establishing

strategic partnerships.

We expect new competitors to emerge and the intensity of competition to increase.

There is a likelihood

that our competitors may develop solutions that are similar ours and ones that could achieve greater market acceptance than ours.

could attract customers away from our solutions and reduce our market share.

To compete effectively, we must scale our organization and

infrastructure appropriately and demonstrate that our products have superior value propositions, cost savings, and clinical performance.

The clinical cardiovascular diagnostic

space is perhaps the most intensely competitive market space in clinical medicine.

Even though we believe our solutions offer significant

advantages to existing methods, we expect alternative biomarker assessment approaches to continue to exist and to be developed.

to coronary heart disease (CHD) risk assessment and early detection, our competitors use a variety of technologies including genetic,

serum lipid-based, imaging, proteomic and "people tracking” approaches.

Genetic testing, both whole genome

and more focused panel modalities, is the first type of biomarker assessment and is used by many clinicians to assess lifetime risk for

However, whereas the scientific tenets for this approach are generally accepted, it does not identify when CHD might develop, and

we believe that the relative power of this method for predicting CHD as compared to its Epi+Gen CHD™ test is limited.

whereas the use of this test may divert revenues for testing, this approach is in some respects complementary, and it is conceivable that

some clinicians may elect to get both forms of testing to have a more holistic assessment of both short term and lifetime risk.

The best-known biomarker approach

is that embodied by the American Heart Association/American College of Cardiology Atherosclerotic Cardiovascular Risk Calculator (referred

to ASCVD risk calculator or Pooled Cohort Equation).

This method integrates laboratory assessment of serum lipids, blood pressure and

self-reported health variables to impute 10-year risk for all forms of atherosclerotic cardiovascular disease (mainly CHD, but also stroke

and peripheral artery disease) using a standard algebraic equation.

This is the most commonly used method of assessing CHD risk and enjoys

general acceptance by the medical community.

There is a likelihood that our

competitors may develop solutions that are similar ours and ones that could achieve greater market acceptance than ours.

This could attract

customers away from our solutions and reduce our market share.

To compete effectively, we must scale our organization and infrastructure

appropriately and demonstrate that our products have superior value propositions, cost savings, and clinical performance.

The clinical cardiovascular

diagnostic space is perhaps the most intensely competitive market space in clinical medicine.

Even though we believe our solutions offer

significant advantages to existing methods, we expect alternative biomarker assessment approaches to continue to exist and to be developed.

With respect to coronary heart disease (CHD) risk assessment and early detection, our competitors use a variety of technologies including

genetic, serum lipid-based, imaging, proteomic and “people tracking” approaches.

Genetic testing, both whole genome and more focused

panel modalities, is the first type of biomarker assessment and is used by many clinicians to assess lifetime risk for CHD.

However, whereas

the scientific tenets for this approach are generally accepted, it does not identify when CHD might develop, and we believe that the relative

power of this method for predicting CHD as compared to its Epi+Gen CHD™ test is limited.

In addition, whereas the use of this test

may divert revenues for testing, this approach is in some respects complementary, and it is conceivable that some clinicians may elect

to get both forms of testing to have a more holistic assessment of both short term and lifetime risk.

The best-known biomarker approach is that embodied

by the American Heart Association/American College of Cardiology Atherosclerotic Cardiovascular Risk Calculator (referred to ASCVD risk

calculator or Pooled Cohort Equation).

This method integrates laboratory assessment of serum lipids, blood pressure and self-reported

health variables to impute 10-year risk for all forms of atherosclerotic cardiovascular disease (mainly CHD, but also stroke and peripheral

artery disease) using a standard algebraic equation.

This is the most commonly used method of assessing CHD risk and enjoys general acceptance

by the medical community.

It is perhaps the most direct competitor for our Epi+Gen CHD™ test.

We believe that

our test has superior performance, does not require overnight fasting and will eventually provide greater information to the clinician

than this current market standard.

In addition, we note that our test assesses risk over a three-year window rather than a 10-year window

which it believes is a more relevant period of time for patient management.

Imaging modalities are also used

to assess risk for and detect CHD.

Perhaps the most commonly used imaging method for predicting risk for CHD is Coronary Artery Calcium

(“CAC”) screening.

We believe that our test has superior

performance, does not require overnight fasting and will eventually provide greater information to the clinician than this current market

In addition, we note that our test assesses risk over a three-year window rather than a 10-year window which it believes is

a more relevant period of time for patient management.

Imaging modalities are also used to assess risk

for and detect CHD.

Perhaps the most commonly used imaging method for predicting risk for CHD is Coronary Artery Calcium (“CAC”)

In this method, a low intensity computed tomography (“CT”) scan is taken of the heart.

using this data, the amount of calcium laden plaque is determined and the result used to assess 10-year risk for CHD.

Strengths of this

approach include the general acceptance of the medical community.

Weaknesses include the necessity of exposing patients to x-ray radiation

and the inability of the CAC test to monitor patient response.

Then using this data, the

amount of calcium laden plaque is determined and the result used to assess 10-year risk for CHD.

Strengths of this approach include the

general acceptance of the medical community.

Weaknesses include the necessity of exposing patients to x-ray radiation and the inability

of the CAC test to monitor patient response.

In many ways, this test competes with our test.

At the same time, we note

that this test is not yet recommended as a primary method for screening low risk individuals, uses a longer risk assessment window, and

could actually be used as secondary testing to evaluate patients who are not found to be at low risk using Epi+Gen CHD™ or who are

flagged for CHD by the PrecisionCHD™ test.

Proteomic methods, as exemplified by

serologic assessments of individual proteins such as c-reactive protein or of entire protein panels, such as that for the HART CADhs or

CVE tests from Prevencio are another risk assessment tool.

The CADhs test is a good example of a proteomic competitor and predicts the

one-year risk for having ≥70% stenosis in a major coronary artery while another Prevencio test HART CVE, predicts one year risk for

individuals at risk for developing a major adverse cardiovascular event.

Important differences between our tests and their offerings include

the window of prediction (three-year vs one-year), the type of technology employed (AI-guided interpretation of genotype and methylation

sensitive digital PCR results compared to algorithm interpretation of results from Luminex bead immunoassays).

Because we believe that

digital PCR based methods are more scalable testing solutions than Luminex bead platforms, we believe that our approach has an advantage.

Finally, researchers have described

methods to use wearable devices, such as the Huami wrist device, to predict risk for cardiovascular disease.

Although people doubtlessly

use these and similar methods derived from wearable devices to assess risk, their exact clinical market penetrance is currently low, and

whether they would pose as a direct competitor for our test remains uncertain.

However, the aforementioned is

only a snapshot of the current market space in which we currently compete and which we intend to compete in the future.

Our intellectual

property claims include methods to develop tests for coronary heart disease, as well as incident and prevalent heart failure, stroke and

The test for prevalent coronary heart disease, whose basis was published in 2018, is well underway, and we expect this test

to become a strong competitor for other methods of establishing current CHD, such as exercise treadmill testing, and for monitoring response

to CHD treatment.

At the same time, we note that this test

is not yet recommended as a primary method for screening low risk individuals, uses a longer risk assessment window, and could actually

be used as secondary testing to evaluate patients who are not found to be at low risk using Epi+Gen CHD™ or who are flagged for

CHD by the PrecisionCHD™ test.

Proteomic methods, as exemplified by serologic assessments

of individual proteins such as c-reactive protein or of entire protein panels, such as that for the HART CADhs or CVE tests from Prevencio

are another risk assessment tool.

The CADhs test is a good example of a proteomic competitor and predicts the one-year risk for having

≥70% stenosis in a major coronary artery while another Prevencio test HART CVE, predicts one year risk for individuals at risk for

developing a major adverse cardiovascular event.

Important differences between our tests and their offerings include the window of prediction

(three-year vs one-year), the type of technology employed (AI-guided interpretation of genotype and methylation sensitive digital PCR

results compared to algorithm interpretation of results from Luminex bead immunoassays).

Because we believe that digital PCR-based methods

are more scalable testing solutions than Luminex bead platforms, we believe that our approach has an advantage.

Finally, researchers have described methods to use

wearable devices, such as the Huami wrist device, to predict risk for cardiovascular disease.

Although people doubtlessly use these and

similar methods derived from wearable devices to assess risk, their exact clinical market penetrance is currently low, and whether they

would pose as a direct competitor for our test remains uncertain.

However, the aforementioned is only a snapshot of

the current market space in which we currently compete and which we intend to compete in the future.

Our intellectual property claims

include methods to develop tests for coronary heart disease, as well as incident and prevalent heart failure, stroke and diabetes.

test for prevalent coronary heart disease, whose basis was published in 2018, is well underway, and we expect this test to become a strong

competitor for other methods of establishing current CHD, such as exercise treadmill testing, and for monitoring response to CHD treatment.

In summary, the cardiovascular

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orient our organization appropriately and demonstrate that our products provide better value for our customers.

We have made broad

pending intellectual property (“IP”) claims with respect to the use of epigenetic and gene-methylation interactions for the

assessment and monitoring of cardiovascular disease, specifically coronary heart disease, congestive heart failure and stroke, as well

Our portfolio falls into six patent families.

The members of these patent families have been filed in the United States and

a number of foreign jurisdictions including Europe Union, Japan, India, Australia, United Arab Emirates, Saudi Arabia, Canada and China.

Intellectual Property

We have made broad pending intellectual property

(“IP”) claims with respect to the use of epigenetic and gene-methylation interactions for the assessment and monitoring of

cardiovascular disease, specifically coronary heart disease, congestive heart failure and stroke, as well as diabetes.

Our portfolio falls

into seven patent families.

The members of these patent families have been filed in the United States and a number of foreign jurisdictions

including Europe Union, Japan, India, Australia, United Arab Emirates, Saudi Arabia, Canada and China.

U.S., Patent Nos.

11,414,704 and 12,043,869, titled Compositions and Methods for Detecting Predisposition to Cardiovascular Disease, were

issued in 2022 and 2024, respectively, to the University of Iowa Research Foundation (“UIRF”), the co-inventors of which are

11,414,704 and

12,043,869, titled Compositions and Methods for Detecting Predisposition to Cardiovascular Disease, were issued in 2022 and 2024, respectively,

to the University of Iowa Research Foundation (“UIRF”), the co-inventors of which are Dr.

Dogan and Dr.

Philibert, our Chief Executive Officer and Chief Medical Officer, respectively.

The original patent family also includes

issued patents in Europe, China, Australia, India, and a number of other pending applications.

We have a worldwide exclusive license agreement

Under UIRF’s Inventions Policy, inventors are generally entitled to 25% of income from earnings from their inventions.

Philibert, our Chief

Executive Officer and Chief Medical Officer, respectively.

The original patent family also includes issued patents in Europe, China, Australia,

India, and a number of other pending applications.

We have a worldwide exclusive license agreement with UIRF.

Under UIRF’s Inventions

Policy, inventors are generally entitled to 25% of income from earnings from their inventions.

Consequently, Dr.

Dogan and Dr.

Philibert will benefit from this policy.

Our issued and

pending patents cover general methods as well as key technological steps that enable these core approaches while facilitating the continued

patenting of material included in the patent applications.

In addition to the technology licensed from UIRF, we have other patent applications

pending relating to improvements to our technology, which are potentially valuable and of possible strategic importance to the Company.

We expect to continue to file new patent applications to protect additional products and methodologies as they emerge.

The initial work

on our AI-driven Integrated Genetic-Epigenetic Engine™ is derived from work done by our founders while at the University of Iowa.

Follow-on work on our core technology also is derived from work done by our founders while at the University of Iowa but was furthered

by our founders and Cardio’s Chief Technology Officer independent of the University of Iowa.

The follow-on work is described in

our second, third, fourth, fifth and sixth families of patent applications.

The initial work

is described in the first family of patents and patent applications and is generally directed to a number of single nucleotide polymorphism

(“SNP”) biomarkers and a number of methylation site biomarkers that are associated with the presence or the early onset of

a number of cardiovascular diseases.

The first family of patents and patent applications is owned solely by UIRF and is exclusively licensed

As of March 2025, this family includes twelve granted patents and eight pending patent applications.

Any and all patents issuing

in this family will be solely owned by UIRF and, barring any changes to the UIRF exclusive license agreement, will fall under the exclusive

license to Cardio.

The first family

is generally directed to biomarkers associated with cardiovascular disease.

This family includes two issued patents in the US as well

as issued patents in the United Kingdom, France, Germany, Italy, Switzerland, Ireland, Hong Kong, Australia, China and India, and pending

applications in Australia, Canada, China, Europe, Hong Kong, Japan, and the US.

The issued claims in the original US patent and in Australia,

China and India are directed to methods and/or compositions (e.g., kits) for determining the methylation status of at least one CpG dinucleotide

and the genotype of at least one single-nucleotide polymorphism (SNP) that use or include at least one primer for detecting the presence

or absence of methylation in a particular region of the genome (referred to as cg12586707) and at least one primer for detecting the presence

or absence of a SNP in a particular region of the genome (referred to as rs11597065).

The issued claims in the EP patent are similarly

directed to compositions (e.g., a kit) for determining the methylation status of at least one CpG dinucleotide and a genotype of at least

one SNP that includes at least one primer that detects the presence or absence of methylation in a particular region of the genome (referred

to as cg26910465) and at least one primer that detects a SNP in a particular region of the genome (referred to as rs10275666) or another

SNP in linkage disequilibrium with the first SNP.

will benefit from this policy.

Our issued and pending patents cover general methods

as well as key technological steps that enable these core approaches while facilitating the continued patenting of material included in

the patent applications.

In addition to the technology licensed from UIRF, we have other patent applications pending relating to improvements

to our technology, which are potentially valuable and of possible strategic importance to the Company.

We expect to continue to file new

patent applications to protect additional products and methodologies as they emerge.

The initial work on our AI-driven Multi-Omics Engine™

is derived from work done by our founders while at the University of Iowa.

Follow-on work on our core technology also is derived from

work done by our founders while at the University of Iowa but was furthered by our founders and Cardio’s Chief Technology Officer

independent of the University of Iowa.

The follow-on work is described in our second, third, fourth, fifth and sixth families of patent

applications.

The initial work is described in the first family

of patents and patent applications and is generally directed to a number of single nucleotide polymorphism (“SNP”) biomarkers

and a number of methylation site biomarkers that are associated with the presence or the early onset of a number of cardiovascular diseases.

The first family of patents and patent applications is owned solely by UIRF and is exclusively licensed by Cardio.

As of March 2025, this

family includes thirteen granted patents and seven pending patent applications.

Any and all patents issuing in this family will be solely

owned by UIRF and, barring any changes to the UIRF exclusive license agreement, will fall under the exclusive license to Cardio.

The first family is generally directed to biomarkers

associated with cardiovascular disease.

This family includes two issued patents in the US as well as issued patents in the United Kingdom,

France, Germany, Italy, Switzerland, Ireland, Hong Kong, Australia, China, Japan, and India, and pending applications in Australia, Canada,

China, Europe, Hong Kong, Japan, and the US.

The issued claims in the original US patent and in Australia, China and India are directed

to methods and/or compositions (e.g., kits) for determining the methylation status of at least one CpG dinucleotide and the genotype of

at least one single-nucleotide polymorphism (SNP) that use or include at least one primer for detecting the presence or absence of methylation

in a particular region of the genome (referred to as cg12586707) and at least one primer for detecting the presence or absence of a SNP

in a particular region of the genome (referred to as rs11597065).

The issued claims in the EP patent are similarly directed to compositions

(e.g., a kit) for determining the methylation status of at least one CpG dinucleotide and a genotype of at least one SNP that includes

at least one primer that detects the presence or absence of methylation in a particular region of the genome (referred to as cg26910465)

and at least one primer that detects a SNP in a particular region of the genome (referred to as rs10275666) or another SNP in linkage

disequilibrium with the first SNP.

The claims that issued in the second U.S.

patent are directed to methods for determining

the methylation status of at least one CpG dinucleotide and the genotype of at least one SNP that includes at least one primer that detects

the presence or absence of methylation in a particular region of the genome (referred to as cg11964099) and at least one primer that detects

a SNP in a particular region of the genome (referred to as rs9988960).

This family of patents is in-licensed under an exclusive license

agreement with UIRF, and is expected to expire in 2037, absent any applicable patent term adjustments or extensions.

patent are directed to methods for determining the methylation

status of at least one CpG dinucleotide and the genotype of at least one SNP that includes at least one primer that detects the presence

or absence of methylation in a particular region of the genome (referred to as cg11964099) and at least one primer that detects a SNP

in a particular region of the genome (referred to as rs9988960).

This family of patents is in-licensed under an exclusive license agreement

with UIRF, and is expected to expire in 2037, absent any applicable patent term adjustments or extensions.

The second family

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This family includes pending applications in the U.S., Australia, United

Arab Emirates, Canada, China, Europe, Hong Kong, India, Japan, Saudi Arabia, and Singapore, with original claims directed to compositions

Arab Emirates, Canada, China, Europe, Hong Kong, India, Japan, and Singapore, with original claims directed to compositions

(e.g., a kit) that include at least one primer for determining the methylation status of at least one CpG dinucleotide from a group of

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this second family are expected to expire in 2041, absent any applicable patent term adjustments or extensions.

The second family

of patent applications is co-owned by UIRF and Cardio, since Cardio expanded on and further refined the original research that was done

at the University of Iowa.

The ownership of any and all patents that ultimately issue in this family will depend on the specific subject

matter that is claimed in each issued patent.

For example, depending upon the specific biomarkers claimed and when those biomarkers were

identified ( e.g ., during the initial work at the University of Iowa or during the follow-on work at Cardio), ownership could lie

solely with UIRF or Cardio, or ownership could be shared between UIRF and Cardio ( e.g ., if a claimed biomarker was initially identified

at the University of Iowa and its significance with respect to diabetes was further refined by Cardio;

or if one of the claimed biomarkers

was identified at the University of Iowa and another one of the claimed biomarkers was identified at Cardio).

The third family

is generally directed to biomarkers associated with predicting a three-year incidence of cardiovascular disease.

This family includes

applications pending in the U.S., Australia, United Arab Emirates, Canada, China, Europe, Hong Kong, India, Japan, Saudi Arabia, and Singapore,

with original claims directed to compositions (e.g., a kit) that include at least one primer for determining the methylation status of

at least one CpG dinucleotide from a group of three different methylation sites, or a different CpG dinucleotide in linkage disequilibrium

with one of the listed CpG dinucleotides, and at least one primer for determining the genotype of at least one SNP from a group of five

different SNPs, or a different SNP in linkage disequilibrium with one of the listed SNPs.

The pending applications also included original

claims to methods of determining the presence of biomarkers associated with three-year incidence of cardiovascular disease, claims to

a computer-readable medium for performing such methods, and claims to a system for determining the methylation status of at least one

CpG dinucleotide and the genotype of a SNP.

This family of patents is owned exclusively by Cardio Diagnostics.

Patents issuing from this

third family are expected to expire in 2041, absent any applicable patent term adjustments or extensions.

The fourth family

is generally directed to computer resources (e.g., a dashboard) designed by Cardio Diagnostics for use by their stakeholders (e.g., patients,

physicians, researchers, insurance companies, etc.).

The computer resources are designed to provide results as well as information and

context related to Cardio Diagnostics tests and the specific biomarkers that are used.

The pending claims are directed to methods of displaying

relevant information including genetic marker test results as well as probability analysis (based on, e.g., the population, age, and/or

gender of patients), and hyperlinks to relevant literature.

The pending application also includes claims to computer-readable media containing

instructions for performing such methods and computer systems for executing such instructions.

This family currently includes an International

PCT application and is solely owned by Cardio.

Patents issuing from this fourth family are expected to expire in 2044, absent any applicable

patent term adjustments or extensions.

The fifth family

is generally directed to biomarkers associated with detecting cardiovascular disease.

The pending claims are directed to compositions

The second family of patent applications is co-owned

by UIRF and Cardio, since Cardio expanded on and further refined the original research that was done at the University of Iowa.

The ownership

of any and all patents that ultimately issue in this family will depend on the specific subject matter that is claimed in each issued

For example, depending upon the specific biomarkers claimed and when those biomarkers were identified ( e.g ., during the

initial work at the University of Iowa or during the follow-on work at Cardio), ownership could lie solely with UIRF or Cardio, or ownership

could be shared between UIRF and Cardio ( e.g ., if a claimed biomarker was initially identified at the University of Iowa and its

significance with respect to diabetes was further refined by Cardio;

or if one of the claimed biomarkers was identified at the University

of Iowa and another one of the claimed biomarkers was identified at Cardio).

The third family is generally directed to biomarkers

associated with predicting a three-year incidence of cardiovascular disease.

This family includes applications pending in the U.S., Australia,

United Arab Emirates, Canada, China, Europe, Hong Kong, India, Japan, Saudi Arabia, and Singapore, with original claims directed to compositions

(e.g., a kit) that include at least one primer for determining the methylation status of at least one CpG dinucleotide from a group of

six different methylation sites, or a different CpG dinucleotide in linkage disequilibrium with one of the listed CpG dinucleotides, and

at least one primer for determining the genotype of at least one SNP from a group of ten different SNPs, or a different SNP in linkage

three different methylation sites, or a different CpG dinucleotide in linkage disequilibrium with one of the listed CpG dinucleotides,

and at least one primer for determining the genotype of at least one SNP from a group of five different SNPs, or a different SNP in linkage

disequilibrium with one of the listed SNPs.

The pending application also includes claims to methods of determining the presence of biomarkers

associated with detecting cardiovascular disease, claims to a computer- readable medium for performing such methods, and claims to a system

for determining the methylation status of at least one CpG dinucleotide and the genotype of a SNP.

This family currently includes an International

PCT application, a U.S.

utility application, and an Indian application and is solely owned by Cardio.

Patents issuing from this fifth

The pending applications also included original claims to methods of determining the presence

of biomarkers associated with three-year incidence of cardiovascular disease, claims to a computer-readable medium for performing such

methods, and claims to a system for determining the methylation status of at least one CpG dinucleotide and the genotype of a SNP.

family of patents is owned exclusively by Cardio Diagnostics.

Patents issuing from this third family are expected to expire in 2041, absent

any applicable patent term adjustments or extensions.

The fourth family is generally directed to computer

resources (e.g., a dashboard) designed by Cardio Diagnostics for use by their stakeholders (e.g., patients, physicians, researchers, insurance

companies, etc.).

The computer resources are designed to provide results as well as information and context related to Cardio Diagnostics

tests and the specific biomarkers that are used.

The pending claims are directed to methods of displaying relevant information including

genetic marker test results as well as probability analysis (based on, e.g., the population, age, and/or gender of patients), and hyperlinks

to relevant literature.

The pending applications also include claims to computer-readable media containing instructions for performing

such methods and computer systems for executing such instructions.

This family currently includes applications pending in Australia, United

Arab Emirates, Canada, China, Europe, India, Japan, Singapore, and the U.S.

and is solely owned by Cardio.

Patents issuing from this fourth

family are expected to expire in 2044, absent any applicable patent term adjustments or extensions.

The sixth family

is generally directed to an algorithm that can be used to predict mortality based on the methylation status of at least one CpG dinucleotide

and/or information obtained from cardio-imaging.

The pending claims are directed to methods for predicting mortality based on the presence

of cardiovascular disease that include obtaining epigenetic data and/or image data and generating an output that includes a mortality

risk assessment for the subject.

This family currently includes a pending US provisional application, which is owned solely by Cardio.

Patents issuing from the sixth family are expected to expire in 2045, absent any applicable patent term adjustments or extensions.

The Exclusive License

Agreement entered into with UIRF and those licenses granted under that license agreement terminate on the expiration of the patent rights

licensed under the license agreement, unless certain proprietary, non-patented technical information is still being used by Cardio, in

which case the license agreement will not terminate until the date of termination of such use.

The licenses under the license agreement

could terminate prior to the expiration of the licensed patent rights if we materially breach our obligations under the license agreement,

including failing to pay the applicable license fees and any interest on such fees, and failing to fully remedy such breach within the

period specified in the license agreement, or if we enter liquidation, have a receiver or administrator appointed over any assets related

to the license agreement, or if we cease to carry on business, file for bankruptcy or if an involuntary bankruptcy petition is filed against

Additionally, we have considerable

IP in the form of trade secrets, including bioinformatics and high-performance computing techniques and artificial intelligence and machine

learning algorithms used to identify genetic and epigenetic biomarkers for various products and to interpret genetic and epigenetic data

from patient samples to generate clinically actionable information, as well as the methods to develop new methylation sensitive assays.

We protect our proprietary information, which includes, but is not limited to, trade secrets, know-how, and copyrights.

Our future success

depends on protecting that knowledge, obtaining trademarks on our products, copyright on key materials, and avoiding infringing on the

IP rights of others.

Where appropriate, we will assess the operating space and acquire licenses for critical technologies that we do not

possess or cannot create.

We continue to invest in technological innovation and will seek mutualistic and symbiotic licensing opportunities

to promote and maintain our competitive position.

In order to provide our products,

we currently use a variety of third party technologies including, for example, genotyping, digital methylation assessment and data processing

technologies.

The terms of these agreements for the non-exclusive use of these technologies are subject to change without notice and could

affect our ability to deliver our solutions.

In addition, from time to time, we may face claims from third parties asserting ownership

of, or demanding release of, the open-source software or derivative works that we developed using such software (which could include our

proprietary source code), or otherwise seeking to enforce the terms of the applicable open-source license.

These claims could result in

litigation that could be costly to defend, have a negative effect on our operating results and financial condition or require us to devote

additional research and development resources to change our existing or future solutions.

Responding to any infringement or noncompliance

claim by an open-source vendor, regardless of its validity, discovering certain open-source software code in our products, or a finding

that we have breached the terms of an open-source software license, could harm our business, results of operations and financial condition.

In each case, we would be required to either seek licenses to software or services from other parties and redesign our products to function

with such other parties’ software or services or develop these components internally, which would result in increased costs and

could result in delays to product launches.

The fifth family is generally directed to biomarkers

associated with detecting cardiovascular disease.

The pending claims are directed to compositions (e.g., a kit) that include at least

one primer for determining the methylation status of at least one CpG dinucleotide from a group of six different methylation sites, or

a different CpG dinucleotide in linkage disequilibrium with one of the listed CpG dinucleotides, and at least one primer for determining

the genotype of at least one SNP from a group of ten different SNPs, or a different SNP in linkage disequilibrium with one of the listed

The pending application also includes claims to methods of determining the presence of biomarkers associated with detecting cardiovascular

disease, claims to a computer- readable medium for performing such methods, and claims to a system for determining the methylation status

of at least one CpG dinucleotide and the genotype of a SNP.

This family currently includes applications, pending in Australia, United

Arab Emirates, Canada, China, Europe, India, Japan, Saudi Arabia, Singapore, and the U.S.

and is solely owned by Cardio.

Patents issuing

from this fifth family are expected to expire in 2044, absent any applicable patent term adjustments or extensions.

The sixth family is generally directed to an algorithm

that can be used to predict mortality based on the methylation status of at least one CpG dinucleotide and/or information obtained from

cardio-imaging.

The pending claims are directed to methods for predicting mortality based on the presence of cardiovascular disease that

include obtaining epigenetic data and/or image data and generating an output that includes a mortality risk assessment for the subject.

This family currently includes an International PCT application, which is owned solely by Cardio.

Patents issuing from the sixth family

are expected to expire in 2045, absent any applicable patent term adjustments or extensions.

The seventh family is generally directed to using

methylation sites and levels to predict the level of coronary artery obstruction and ischemia in those with acute coronary syndrome.

family currently includes a pending U.S.

provisional application, which is owned solely by Cardio.

Patents issuing from the seventh family

are expected to expire in 2046, absent any applicable patent term adjustments or extensions.

The Exclusive License Agreement entered into with

UIRF and those licenses granted under that license agreement terminate on the expiration of the patent rights licensed under the license

agreement, unless certain proprietary, non-patented technical information is still being used by Cardio, in which case the license agreement

will not terminate until the date of termination of such use.

The licenses under the license agreement could terminate prior to the expiration

of the licensed patent rights if we materially breach our obligations under the license agreement, including failing to pay the applicable

license fees and any interest on such fees, and failing to fully remedy such breach within the period specified in the license agreement,

or if we enter liquidation, have a receiver or administrator appointed over any assets related to the license agreement, or if we cease

to carry on business, file for bankruptcy or if an involuntary bankruptcy petition is filed against Cardio.

Additionally, we

have considerable IP in the form of trade secrets, including bioinformatics and high-performance computing techniques and artificial

intelligence and machine learning algorithms used to identify genetic and epigenetic biomarkers for various products and to interpret

genetic and epigenetic data from patient samples to generate clinically actionable information, as well as the methods to develop new

methylation sensitive assays.

We protect our proprietary information, which includes, but is not limited to, trade secrets, know-how,

and copyrights.

Our future success depends on protecting that knowledge, obtaining trademarks on our products, copyright on key materials,

and avoiding infringing on the IP rights of others.

Where appropriate, we will assess the operating space and acquire licenses for critical

technologies that we do not possess or cannot create.

We continue to invest in technological innovation and will seek mutualistic and

symbiotic licensing opportunities to promote and maintain our competitive position.

In order to provide our products, we currently use

a variety of third party technologies including, for example, genotyping, digital methylation assessment and data processing technologies.

The terms of these agreements for the non-exclusive use of these technologies are subject to change without notice and could affect our

ability to deliver our solutions.

In addition, from time to time, we may face claims from third parties asserting ownership of, or demanding

release of, the open-source software or derivative works that we developed using such software (which could include our proprietary source

code), or otherwise seeking to enforce the terms of the applicable open-source license.

These claims could result in litigation that could

be costly to defend, have a negative effect on our operating results and financial condition or require us to devote additional research

and development resources to change our existing or future solutions.

Responding to any infringement or noncompliance claim by an open-source

vendor, regardless of its validity, discovering certain open-source software code in our products, or a finding that we have breached

the terms of an open-source software license, could harm our business, results of operations and financial condition.

In each case, we

would be required to either seek licenses to software or services from other parties and redesign our products to function with such other

parties’ software or services or develop these components internally, which would result in increased costs and could result in

delays to product launches.

Furthermore, we might be forced to limit the features available in our current or future solutions.

The laboratory testing and

healthcare industry and the practice of medicine are extensively regulated at both the state and federal levels, and additionally, the

practice of medicine is similarly extensively regulated by the various states.

Our ability to operate profitably will depend in part upon

its ability, and that of its vendor partners, to maintain all necessary licenses and to operate in compliance with applicable laws and

Those laws and rules continue to evolve, and therefore we devote significant resources to monitoring relevant developments in FDA,

CLIA, healthcare and medical practice regulation.

Those laws and rules include, but are not limited to, ones that govern the regulation

of clinical laboratories in general and the regulation of LDTs in particular.

As discussed below, legislation has been introduced in Congress

that, if enacted, would substantially alter federal regulation of diagnostic tests, including LDTs.

As the applicable laws and rules change,

we are likely to make conforming modifications in our business processes from time to time.

In many jurisdictions where we operate, neither

our current nor our anticipated business model has been the subject of judicial or administrative interpretation.

We cannot be assured

that a review of our business by courts or regulatory authorities will not result in determinations that could adversely affect our operations

or that the laboratory and healthcare regulatory environment will not change in a way that restricts our operations.

and Federal Regulatory Issues

Clinical Laboratory Improvement Amendments of 1988 and State

Clinical laboratories are required

to hold certain federal and state licenses, certifications and permits to conduct our business.

As to federal certifications, in 1988,

Congress passed the Clinical Laboratory Improvement Amendments of 1988, or (“CLIA”), establishing more rigorous quality standards

for all commercial laboratories that perform testing on human specimens for the purpose of providing information for the diagnosis, prevention,

Government Regulation

The laboratory testing and healthcare industry and

the practice of medicine are extensively regulated at both the state and federal levels, and additionally, the practice of medicine is

similarly extensively regulated by the various states.

Our ability to operate profitably will depend in part upon its ability, and that

of its vendor partners, to maintain all necessary licenses and to operate in compliance with applicable laws and rules.

Those laws and

rules continue to evolve, and therefore we devote significant resources to monitoring relevant developments in FDA, CLIA, healthcare and

medical practice regulation.

Those laws and rules include, but are not limited to, ones that govern the regulation of clinical laboratories

in general and the regulation of LDTs in particular.

As discussed below, legislation has been introduced in Congress that, if enacted,

would substantially alter federal regulation of diagnostic tests, including LDTs.

As the applicable laws and rules change, we are likely

to make conforming modifications in our business processes from time to time.

In many jurisdictions where we operate, neither our current

nor our anticipated business model has been the subject of judicial or administrative interpretation.

We cannot be assured that a review

of our business by courts or regulatory authorities will not result in determinations that could adversely affect our operations or that

the laboratory and healthcare regulatory environment will not change in a way that restricts our operations.

State and Federal Regulatory Issues

Clinical Laboratory Improvement Amendments of 1988 and

State Regulation

Clinical laboratories are required to hold certain

federal and state licenses, certifications and permits to conduct our business.

As to federal certifications, in 1988, Congress passed

the Clinical Laboratory Improvement Amendments of 1988, or (“CLIA”), establishing more rigorous quality standards for all

commercial laboratories that perform testing on human specimens for the purpose of providing information for the diagnosis, prevention,

or treatment of disease or the assessment of the health of human beings.

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through CLIA.

Laboratories must comply with

all applicable CLIA requirements.

If a clinical laboratory is found not to comply with CLIA standards, the government may impose sanctions,

limit or revoke the laboratory’s CLIA certificate (and prohibit the owner, operator or laboratory director from owning, operating,

or directing a laboratory for two years following license revocation), subject the laboratory to a directed plan of correction, on-site

monitoring, civil monetary penalties, civil actions for injunctive relief, criminal penalties, or suspension or exclusion from the Medicare

and Medicaid programs.

CLIA provides that a state

may adopt laboratory licensure requirements and regulations that are more stringent than those under federal law and requires compliance

with such laws and regulations.

New York State in particular, has implemented its own more stringent laboratory regulatory requirements.

State laws may require the laboratory to obtain state licensure and/or laboratory personnel to meet certain qualifications, specify certain

quality control procedures or facility requirements, or prescribe record maintenance requirements.

Moreover, several states impose the

same or similar state requirements on out-of-state laboratory testing specimens collected or received from, or test results reported back

to, residents within that state.

Therefore, the laboratory is required to meet certain laboratory licensing requirements for those states

in which we offer services or from which we accept specimens and that have adopted regulations beyond CLIA.

For more information on state

licensing requirements, see "— California Laboratory Licensing,” "— New York Laboratory Licensing” and

"— Other State Laboratory Licensing Laws.”

Laboratories must comply with all applicable CLIA

requirements.

If a clinical laboratory is found not to comply with CLIA standards, the government may impose sanctions, limit or revoke

the laboratory’s CLIA certificate (and prohibit the owner, operator or laboratory director from owning, operating, or directing

a laboratory for two years following license revocation), subject the laboratory to a directed plan of correction, on-site monitoring,

civil monetary penalties, civil actions for injunctive relief, criminal penalties, or suspension or exclusion from the Medicare and Medicaid

CLIA provides that

a state may adopt laboratory licensure requirements and regulations that are more stringent than those under federal law and requires

compliance with such laws and regulations.

New York State in particular, has implemented its own more stringent laboratory regulatory

requirements.

State laws may require the laboratory to obtain state licensure and/or laboratory personnel to meet certain qualifications,

specify certain quality control procedures or facility requirements, or prescribe record maintenance requirements.

Moreover, several states

impose the same or similar state requirements on out-of-state laboratory testing specimens collected or received from, or test results

reported back to, residents within that state.

Therefore, the laboratory is required to meet certain laboratory licensing requirements

for those states in which we offer services or from which we accept specimens and that have adopted regulations beyond CLIA.

information on state licensing requirements, see “California Laboratory Licensing,” “New York Laboratory Licensing”

and “Other State Laboratory Licensing Laws.”

California Laboratory Licensing

to federal certification requirements for laboratories under CLIA, the laboratory is required under California law to maintain a California

state license and comply with California state laboratory laws and regulations.

Similar to the federal CLIA regulations, the California

state laboratory laws and regulations establish standards for the operation of a clinical laboratory and performance of test services,

including the education and experience requirements of the laboratory director and personnel (including requirements for documentation

of competency), equipment validations, and quality Management practices.

All testing personnel must maintain a California state license

or be supervised by licensed personnel.

Clinical laboratories are subject

to both routine and complaint-initiated on-site inspections by the state.

If a clinical laboratory is found to be out of compliance with

California laboratory standards, the California Department of Public Health (“CDPH”), may suspend, restrict or revoke the

California state laboratory license to operate the clinical laboratory (and exclude persons or entities from owning, operating, or directing

a laboratory for two years following license revocation), assess civil money penalties, and/or impose specific corrective action plans,

among other sanctions.

Clinical laboratories must also provide notice to CDPH of any changes in the ownership, directorship, name or location

of the laboratory.

In addition to federal certification requirements

for laboratories under CLIA, the laboratory is required under California law to maintain a California state license and comply with California

state laboratory laws and regulations.

Similar to the federal CLIA regulations, the California state laboratory laws and regulations establish

standards for the operation of a clinical laboratory and performance of test services, including the education and experience requirements

of the laboratory director and personnel (including requirements for documentation of competency), equipment validations, and quality

Management practices.

All testing personnel must maintain a California state license or be supervised by licensed personnel.

Clinical laboratories are subject to both routine

and complaint-initiated on-site inspections by the state.

If a clinical laboratory is found to be out of compliance with California laboratory

standards, the California Department of Public Health (“CDPH”) may suspend, restrict or revoke the California state laboratory

license to operate the clinical laboratory (and exclude persons or entities from owning, operating, or directing a laboratory for two

years following license revocation), assess civil money penalties, and/or impose specific corrective action plans, among other sanctions.

Clinical laboratories must also provide notice to CDPH of any changes in the ownership, directorship, name or location of the laboratory.

Failure to provide such notification may result in revocation of the state license and sanctions under the CLIA program.

Any revocation of a CLIA certificate or exclusion from participation in Medicare or Medicaid programs may result in suspension of the

California state laboratory license.

Any revocation

of a CLIA certificate or exclusion from participation in Medicare or Medicaid programs may result in suspension of the California state

laboratory license.

New York Laboratory Licensing

do not conduct tests on specimens originating from New York State.

In order to test specimens originating from, and return results to

New York State, a clinical laboratory is required to obtain a New York state laboratory permit and comply with New York state laboratory

laws and regulations.

The New York state laboratory laws, regulations and rules are equal to or more stringent than the CLIA regulations

and establish standards for the operation of a clinical laboratory and performance of test services, including education and experience

requirements of a laboratory director and personnel, physical requirements of a laboratory facility, equipment validations, and quality

Management practices.

The laboratory director(s) must maintain a Certificate of Qualification issued by the New York State Department

of Health (“NYS DOH”) in the permitted test categories.

laboratory conducting tests on specimens originating in New York is subject to proficiency testing and on-site survey inspections conducted

by the Clinical Laboratory Evaluation Program (“CLEP”) under the NYS DOH.

If a laboratory is found to be out of compliance

with New York’s CLEP standards, the NYS DOH, may suspend, limit, revoke or annul the New York laboratory permit, censure the holder

of the license or assess civil money penalties.

Statutory or regulatory noncompliance may result in a laboratory’s operator, owners

and/or laboratory director being found guilty of a misdemeanor under New York law.

Clinical laboratories must also provide notice to

CLEP of any changes in ownership, directorship, name or location of the laboratory.

Failure to provide such notification may result in

revocation of the state license and sanctions under the CLIA program.

Any revocation of a CLIA certificate or exclusion from participation

in the Medicare or Medicaid programs may result in suspension of the New York laboratory permit.

The NYS DOH also must approve each LDT before that test

is offered to patients located in New York.

State Laboratory Licensing Laws

In addition to New York and California,

certain other states require licensing of out-of-state laboratories under certain circumstances.

We have obtained licenses in the states

that we believe require us to do so and believe we are in compliance with applicable state laboratory licensing laws, including Maryland

and Pennsylvania.

We currently do not conduct tests on specimens originating from Rhode Island.

Potential sanctions for violation

of state statutes and regulations can include significant monetary fines, the rejection of license applications, the suspension or loss

of various licenses, certificates and authorizations, and in some cases criminal penalties, which could harm our business.

CLIA does not

preempt state laws that have established laboratory quality standards that are more stringent than federal law.

Laboratory-Developed

The FDA generally considers an

LDT to be a test that is designed, manufactured, and used within a single laboratory that is certified under CLIA and meets the regulatory

requirements under CLIA to perform high complexity testing.

LDTs are performed using a variety of laboratory instruments and reagents

and may also incorporate FDA-authorized in vitro diagnostics (“IVDs”) that the laboratory modifies in some way and validates

for its new use.

The FDA has historically taken the position that it has the authority to regulate LDTs as medical devices under the Federal

Food, Drug and Cosmetic Act (“FDC Act”), but it has generally exercised enforcement discretion with regard to LDTs.

that even though the FDA believes it can impose regulatory requirements on LDTs, such as requirements to obtain premarket approval, de

novo authorization, or 510(k) clearance of LDTs, it has generally chosen not to enforce those requirements to date.

Although FDA has generally

exercised enforcement discretion for LDTs, the FDA has stated it retains discretion to require compliance with premarket when FDA deems

it appropriate to address significant public health concerns.

2024, FDA published a final rule amending the definition of an in vitro diagnostic (“IVD”) device to include tests manufactured

by a clinical laboratory.

Pursuant to the rule, laboratory developed tests (“LDTs”), i.e., tests designed, manufactured,

and used within a single CLIA-certified high complexity laboratory, are medical devices subject to FDA regulation under the Federal Food,

Drug, and Cosmetic Act.

The final rule also announced FDA’s intention to apply its medical device requirements to LDTs.

final rule, all LDTs, unless subject to a specific exemption, will be subject to premarket authorization requirements (510(k), de novo

classification, or PMA) for each LDT performed by the laboratory, and to postmarket registration and listing, medical device reporting,

correction, removal, and recall, complaint handling, labeling, investigational device, and quality system requirements.

FDA intends to

phase in these requirements beginning May 6, 2025.

The final rule states that certain categories of LDTs will be subject to enforcement

discretion with respect to some or all of these requirements.

For example, FDA will apply enforcement discretion to currently marketed

LDTs that were first offered prior to May 6, 2024, with respect to most quality system requirements and the requirement for premarket

authorization if they are not modified or modified in only limited ways.

Laboratories performing these tests are subject to other requirements,

including the requirement to submit the labeling for the LDT to FDA for review.

FDA will similarly exercise enforcement discretion with

respect to premarket authorization for LDTs approved by the New York State Clinical Laboratory Evaluation Program (“NYS-CLEP”).

Unless overturned

by a court or Congress, or stayed or withdrawn by the new Administration, the final rule will substantially increase costs and regulatory

burdens for many clinical laboratories in ways that may adversely affect their ability to develop, perform, and offer LDTs.

challenging FDA’s authority to regulate LDTs have been filed in federal court:

the American Clinical Laboratory Association filed

a lawsuit against FDA on May 29, 2024 in the Eastern District of Texas, while the Association for Molecular Pathology filed a lawsuit

on August 19, 2024 in the Southern District of Texas.

The ultimate success of these lawsuits, which were subsequently consolidated, or

any future lawsuits that may be brought against the FDA challenging the LDT rule, is uncertain.

It is also unclear whether a court would

delay the implementation of the final rule while the litigation is ongoing, which means we may need to initiate steps to comply with

the final rule even if it is ultimately overturned.

proposals addressing the FDA’s oversight of LDTs have been previously introduced.

In June 2021, Congress introduced the VALID Act,

which would have established a new risk-based regulatory framework for in vitro clinical tests (“IVCTs”), a category which

would have included IVDs, LDTs, collection devices and instruments used with such tests.

FDA’s new LDT final rule may renew attention

to the VALID Act or other legislation and may lead to the introduction of new proposals to limit the FDA’s regulatory authority.

On July 12, 2024, the House Appropriations Committee issued a Report accompanying a FY 2025 appropriations bill in which it directed

the FDA to suspend efforts to implement the LDT final rule and to continue working with Congress to modernize the regulatory approach

This directive is not binding on the FDA.

in Administration and in Congress could significantly affect FDA’s ability to implement the final rule or to otherwise regulate

For example, the Department of Health and Human Services, which oversees FDA, could stay enforcement of the rule or seek to rescind

the final rule, or could direct FDA to not regulate LDTs as medical devices.

Separately, Congress could enact legislation aimed at preventing

FDA from regulating LDTs and/or assigning oversight of LDTs to a different agency.

above, separately, CMS oversees clinical laboratory operations through the CLIA program.

Regulation by the U.S.

We currently do not conduct tests on specimens originating

from New York State.

In order to test specimens originating from, and return results to New York State, a clinical laboratory is required

to obtain a New York state laboratory permit and comply with New York state laboratory laws and regulations.

The New York state laboratory

laws, regulations and rules are equal to or more stringent than the CLIA regulations and establish standards for the operation of a clinical

laboratory and performance of test services, including education and experience requirements of a laboratory director and personnel, physical

requirements of a laboratory facility, equipment validations, and quality Management practices.

The laboratory director(s) must maintain

a Certificate of Qualification issued by the New York State Department of Health (“NYS DOH”) in the permitted test categories.

A clinical laboratory conducting tests on specimens

originating in New York is subject to proficiency testing and on-site survey inspections conducted by the Clinical Laboratory Evaluation

Program (“CLEP”) under the NYS DOH.

If a laboratory is found to be out of compliance with New York’s CLEP standards,

the NYS DOH, may suspend, limit, revoke or annul the New York laboratory permit, censure the holder of the license or assess civil money

Statutory or regulatory noncompliance may result in a laboratory’s operator, owners and/or laboratory director being

found guilty of a misdemeanor under New York law.

Clinical laboratories must also provide notice to CLEP of any changes in ownership,

directorship, name or location of the laboratory.

Failure to provide such notification may result in revocation of the state license and

sanctions under the CLIA program.

Any revocation of a CLIA certificate or exclusion from participation in the Medicare or Medicaid programs

may result in suspension of the New York laboratory permit.

The NYS DOH also must approve each LDT before that

test is offered to patients located in New York.

Other State Laboratory Licensing Laws

In addition to New York and California, certain

other states require licensing of out-of-state laboratories under certain circumstances.

We have obtained or are in the process of obtaining

licenses in the states that we believe require us to do so, including Maryland, Pennsylvania and Rhode Island, and believe we are in compliance

with applicable state laboratory licensing laws.

Potential sanctions

for violation of state statutes and regulations can include significant monetary fines, the rejection of license applications, the suspension

or loss of various licenses, certificates and authorizations, and in some cases criminal penalties, which could harm our business.

does not preempt state laws that have established laboratory quality standards that are more stringent than federal law.

Laboratory-Developed Tests

The FDA generally considers an LDT to be a test

that is designed, manufactured, and used within a single laboratory that is certified under CLIA and meets the regulatory requirements

under CLIA to perform high complexity testing.

LDTs are performed using a variety of laboratory instruments and reagents and may also

incorporate FDA-authorized in vitro diagnostics (“IVDs”) that the laboratory modifies in some way and validates for its new

The FDA historically took the position that it had the authority to regulate LDTs as medical devices under the Federal Food, Drug,

and Cosmetic Act (“FDC Act”) but generally exercised enforcement discretion with regard to LDTs.

This meant that even though

the FDA believed it could impose regulatory requirements on LDTs, such as requirements to obtain premarket approval, de novo authorization,

or 510(k) clearance of LDTs, it generally chose not to enforce those requirements.

On May 6, 2024, FDA published a final rule amending

the definition of an in vitro diagnostic (“IVD”) device to include tests manufactured by a clinical laboratory.

the rule, LDTs would have been subject to regulation as medical devices under the FDC Act, including, unless exempt, premarket authorization

requirements (510(k), de novo classification, or PMA) for each LDT performed by the laboratory, and to postmarket registration and listing,

medical device reporting, correction, removal, and recall, complaint handling, labeling, investigational device, and quality system requirements.

On March 31, 2025, a federal district court

vacated the FDA final rule, thereby cancelling the rulemaking’s associated requirements.

The court held that LDTs do not meet the

definition of a medical device under the FDC Act and the FDA therefore lacks jurisdiction to regulate them.

The court directed FDA to

rescind the final rule, which occurred on September 19, 2025.

The FDA has not indicated how it will interpret the court ruling or whether

it will seek a different regulatory approach with respect to LDTs or components thereof.

Over the years, various legislative proposals addressing

the FDA’s oversight of LDTs have been introduced in Congress.

In June 2021, Congress introduced the Verifying Accurate, Leading-edge

IVCT Development Act (“VALID Act”) to establish a new risk-based regulatory framework for in vitro clinical tests (“IVCTs”),

including IVDs, LDTs, collection devices and instruments used with such tests.

This legislation was re-introduced in 2023 but was not

The VALID Act was again re-introduced in 2025, indicating that there remains debate about whether and how LDTs should be regulated

Over the years, various legislative proposals addressing

the FDA’s oversight of LDTs have been introduced in Congress.

In June 2021, Congress introduced the Verifying Accurate, Leading-edge

IVCT Development Act (“VALID Act”), which would have established a new risk-based regulatory framework for in vitro clinical

tests (“IVCTs”), a category which would have included IVDs, LDTs, collection devices and instruments used with such tests.

This legislation was re-introduced in 2023 but was not enacted.

The VALID Act was again re-introduced in 2025, indicating that there remains

debate about whether and how LDTs should be regulated in the U.S.

As mentioned above,

separately, CMS oversees clinical laboratory operations through the CLIA program

Regulation of Medical Devices by the U.S.

Food and Drug Administration

Should the FDA decide to no longer

exercise enforcement discretion for LDTs, LDTs would be subject to extensive regulation as medical devices under the FDC Act and its implementing

regulations, which govern, among other things, medical device development, testing, labeling, storage, premarket clearance or approval,

advertising and promotion and product sales and distribution.

To be commercially distributed in the United States, medical devices, including

some collection devices used to collect samples for testing, and certain types of software, must receive from the FDA prior to marketing,

unless subject to an exemption, clearance of a premarket notification (“510(k) clearance”), premarket approval (“PMA”),

or a de novo authorization.

IVDs are a type of medical device

that are intended to be used in the diagnosis or detection of diseases or conditions, including a determination of the state of health,

through collection, preparation and examination of specimens taken from the human body.

IVDs may be used to detect the presence of certain

chemicals, genetic information or other biomarkers related to diagnosis or detection of diseases or conditions.

IVDs may include tests

for disease prediction, prognosis, diagnosis, and screening.

The FDC Act classifies medical

devices into one of three categories based on the risks associated with the device and the level of control necessary to provide reasonable

assurance of safety and effectiveness.

To be commercially distributed in the United States,

medical devices, including some collection devices used to collect samples for testing, and certain types of software, must receive from

the FDA prior to marketing, unless subject to an exemption, clearance of a premarket notification (“510(k) clearance”), premarket

approval (“PMA”), or a de novo authorization.

IVDs are a type of medical device that are intended

to be used in the diagnosis or detection of diseases or conditions, including a determination of the state of health, through collection,

preparation and examination of specimens taken from the human body.

IVDs may be used to detect the presence of certain chemicals, genetic

information or other biomarkers related to diagnosis or detection of diseases or conditions.

IVDs may include tests for disease prediction,

prognosis, diagnosis, and screening.

The FDC Act classifies medical devices into one

of three categories based on the risks associated with the device and the level of control necessary to provide reasonable assurance of

safety and effectiveness.

Class I devices are deemed to be low risk and are subject to the fewest regulatory controls.

Class I devices are exempt from FDA premarket review requirements.

Class II devices, including some software products to the extent that

they qualify as a device, are deemed to be moderate risk, and generally require clearance through the premarket notification, or 510(k)

clearance, process.

Class III devices are generally the highest risk devices and are subject to the highest level of regulatory control

to provide reasonable assurance of the device's safety and effectiveness.

Class III devices typically require a PMA by the FDA before

they are marketed.

A clinical trial is almost always required to support a PMA application or de novo authorization and is sometimes required

for 510(k) clearance.

All clinical studies of investigational devices must be conducted in compliance with any applicable FDA and Institutional

Review Board requirements.

Devices that are exempt from FDA premarket review requirements must nonetheless comply with post-market general

controls as described below, unless the FDA has indicated otherwise.

Many Class I devices

are exempt from FDA premarket review requirements.

Class II devices, including some software products to the extent that they qualify

as a device, are deemed to be moderate risk, and generally require clearance through the premarket notification, or 510(k) clearance,

Class III devices are generally the highest risk devices and are subject to the highest level of regulatory control to provide

reasonable assurance of the device's safety and effectiveness.

Class III devices typically require a PMA by the FDA before they are marketed.

A clinical trial is almost always required to support a PMA application or de novo authorization and is sometimes required for 510(k)

All clinical studies of investigational devices must be conducted in compliance with any applicable FDA and Institutional Review

Board requirements.

Devices that are exempt from FDA premarket review requirements must nonetheless comply with post-market general controls

as described below, unless the FDA has indicated otherwise.

510(k) clearance pathway.

To obtain 510(k) clearance, a manufacturer must submit a premarket notification demonstrating to the FDA’s satisfaction that

the new device is substantially equivalent to a “predicate device.” A predicate device is a legally marketed device to which

a new device may be compared to for a determination regarding substantial equivalence.

A legally marketed device is a device that was

previously 510(k)-cleared, a device that received de novo authorization, or a device that was in commercial distribution before May 28,

1976 for which the FDA has not called for submission of a PMA application.

The FDA’s 510(k) clearance pathway usually takes from

three to 12 months from submission, but it can take longer, particularly for a novel type of product.

The PMA pathway

requires proof of the safety and effectiveness of the device to the FDA’s satisfaction.

The PMA pathway is costly, lengthy, and

A PMA application must provide extensive preclinical and clinical trial data as well as information about the device and its

components regarding, among other things, device design, manufacturing, and labeling.

As part of its PMA review process, the FDA will

typically inspect the manufacturer’s facilities for compliance with QSR requirements, which impose extensive testing, control, documentation,

and other quality assurance procedures.

The PMA review process typically takes one to three years from submission but can take longer.

If no predicate device can be identified, a device is automatically classified as Class III, requiring a PMA application.

the FDA can reclassify, either on its own initiative or in response to a request for de novo classification, for a device for which there

was no predicate device if the device is low- or moderate-risk.

If the device is reclassified as Class II, the FDA will identify special

controls that the manufacturer must implement, which may include labeling, testing, performance standards, or other requirements.

applicants can rely upon the de novo device as a predicate for a 510(k) clearance, unless the FDA exempts subsequent devices from the

need for a 510(k).

The de novo route is intended to be less burdensome than the PMA process.

To obtain 510(k)

clearance, a manufacturer must submit a premarket notification demonstrating to the FDA’s satisfaction that the new device is substantially

equivalent to a “predicate device.” A predicate device is a legally marketed device to which a new device may be compared

to for a determination regarding substantial equivalence.

A legally marketed device is a device that was previously 510(k)-cleared, a

device that received de novo authorization, or a device that was in commercial distribution before May 28, 1976 for which the FDA has

not called for submission of a PMA application.

The FDA’s 510(k) clearance pathway usually takes from three to 12 months from submission,

but it can take longer, particularly for a novel type of product.

The PMA pathway requires proof

of the safety and effectiveness of the device to the FDA’s satisfaction.

The PMA pathway is costly, lengthy, and uncertain.

application must provide extensive preclinical and clinical trial data as well as information about the device and its components regarding,

among other things, device design, manufacturing, and labeling.

As part of its PMA review process, the FDA will typically inspect the

manufacturer’s facilities for compliance with the Quality Management System Regulation (“QMSR”) requirements, which

impose extensive testing, control, documentation, and other quality assurance procedures.

The PMA review process typically takes one to

three years from submission but can take longer.

De novo pathway.

If no predicate device can be identified,

a device is automatically classified as Class III, requiring a PMA application.

However, the FDA can reclassify, either on its own initiative

or in response to a request for de novo classification, for a device for which there was no predicate device if the device is low- or

moderate-risk.

If the device is reclassified as Class II, the FDA will identify special controls that the manufacturer must implement,

which may include labeling, testing, performance standards, or other requirements.

Subsequent applicants can rely upon the de novo device

as a predicate for a 510(k) clearance, unless the FDA exempts subsequent devices from the need for a 510(k).

The de novo route is intended

to be less burdensome than the PMA process.

Post-market general controls.

After a device, including a device exempt from FDA premarket review, is placed on the market, numerous regulatory requirements apply.

After a device,

including a device exempt from FDA premarket review, is placed on the market, numerous regulatory requirements apply.

These include:

the QSR, labeling regulations, registration and listing, the Medical Device Reporting regulation (which requires that manufacturers

report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely

cause or contribute to a death or serious injury if it were to recur), and the Reports of Corrections and Removals regulation (which requires

QMSR, labeling regulations, registration and listing, the Medical Device Reporting regulation (which requires that manufacturers report

to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause

or contribute to a death or serious injury if it were to recur), and the Reports of Corrections and Removals regulation (which requires

manufacturers to report to the FDA corrective actions made to, or removal of, products in the field, if such actions were initiated to

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severity of the legal violation that led to correction or removal, the FDA may classify the manufacturer’s action as a recall.

The FDA enforces compliance with

its requirements through inspection and market surveillance.

The FDA enforces compliance

with its requirements through inspection and market surveillance.

If the FDA finds a violation, it can institute a wide variety of actions,

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and criminal prosecution.

The FDA has become increasingly

active in addressing the regulation of software used to support clinical decision making.

In 2016, the 21st Century Cures Act, (the “Cures

Act”), among other things, amended the medical device definition in the FDC Act to exclude certain software from FDA regulation,

including clinical decision support (“CDS software”) that meets certain criteria.

CDS software is exempt from the medical

device definition if it:

(a) displays, analyzes or prints medical information about a patient or other medical information;

(b) is intended

for the purpose of supporting or providing recommendations about a patient’s care to a health care professional, (“HCP”),

and (c) provides sufficient information about the basis for the recommendations to the HCP user, so that the HCP user does not rely

primarily on any of the recommendations to make a clinical decision about an individual patient;

unless (d) the software function acquires,

processes, or analyzes a medical image, a signal from an in vitro diagnostic device, or a pattern or signal from a signal acquisition

On September 28, 2022, the

FDA issued a final guidance document interpreting the Cures Act as it pertains to CDS software.

Software that is intended for use in diagnosis,

treatment, cure mitigation or prevention of disease meets the definition of a medical device and is subject to FDA regulation.

that is included in a hardware device (Software as a Medical Device or “SiMD”) is regulated as part of the hardware device.

Freestanding software (Software as a Medical Device or “SaMD”) may be subject to regulation by FDA but may be exempt from

regulation if it meets certain criteria.

The FDA has become increasingly active in addressing the regulation of software used to support

clinical decision making.

In 2016, the 21st Century Cures Act, (the “Cures Act”), among other things, amended the medical

device definition in the FDC Act to exclude certain software from FDA regulation, including clinical decision support (“CDS software”)

that meets certain criteria.

CDS software is exempt from the medical device definition if it:

(a) displays, analyzes or prints medical

information about a patient or other medical information;

(b) is intended for the purpose of supporting or providing recommendations

about a patient’s care to a health care professional, (“HCP”), user;

and (c) provides sufficient information about

the basis for the recommendations to the HCP user, so that the HCP user does not rely primarily on any of the recommendations to make

a clinical decision about an individual patient;

unless (d) the software function acquires, processes, or analyzes a medical image, a

signal from an in vitro diagnostic device, or a pattern or signal from a signal acquisition system.

FDA issued a final guidance document addressing

CDS software on September 28, 2022, and issued a revised guidance document on January 29, 2026.

Among other views expressed, the final

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test result, are not exempt from medical device regulation.

The final guidance also stated that software functions that generate risk

probabilities or risk scores are not exempt because they provide a specific diagnostic, preventive, or treatment output.

Practice of Medicine;

Corporate Practice of Medicine;

Fee-Splitting

We contract with various healthcare

companies to deliver services to patients.

This contractual relationship is subject to various state laws, including those of New York,

Texas and California, that prohibit fee-splitting or the practice of medicine by lay entities or persons and are intended to prevent unlicensed

persons from interfering with or influencing the physician’s professional judgment.

In addition, various state laws also generally

prohibit the sharing of professional services income with nonprofessional or business interests.

Activities other than those directly

related to the delivery of healthcare may be considered an element of the practice of medicine in many states.

Under the corporate practice

of medicine restrictions of certain states, decisions and activities such as scheduling, contracting, setting rates and the hiring and

management of non-clinical personnel may implicate the restrictions on the corporate practice of medicine.

State corporate practice of medicine

and fee-splitting laws vary from state to state and are not always consistent among states.

In addition, these requirements are subject

to broad powers of interpretation and enforcement by state regulators.

Some of these requirements may apply to any telemedicine company

or provider organization we contract with.

Failure to comply with regulations could lead to adverse judicial or administrative action

against us and/or the providers we work with, civil or criminal penalties, receipt of cease-and-desist orders from state regulators, loss

of provider licenses, the need to make changes to the terms of engagement with any telemedicine company or provider organization we contract

with that interfere with our business and other materially adverse consequences.

and State Fraud and Abuse Laws

We contract with various healthcare companies to

deliver services to patients.

This contractual relationship is subject to various state laws, including those of New York, Texas and California,

that prohibit fee-splitting or the practice of medicine by lay entities or persons and are intended to prevent unlicensed persons from

interfering with or influencing the physician’s professional judgment.

In addition, various state laws also generally prohibit the

sharing of professional services income with nonprofessional or business interests.

Activities other than those directly related to the

delivery of healthcare may be considered an element of the practice of medicine in many states.

Under the corporate practice of medicine

restrictions of certain states, decisions and activities such as scheduling, contracting, setting rates and the hiring and management

of non-clinical personnel may implicate the restrictions on the corporate practice of medicine.

State corporate practice of medicine and fee-splitting

laws vary from state to state and are not always consistent among states.

In addition, these requirements are subject to broad powers

of interpretation and enforcement by state regulators.

Some of these requirements may apply to any telemedicine company or provider organization

we contract with.

Failure to comply with regulations could lead to adverse judicial or administrative action against us and/or the providers

we work with, civil or criminal penalties, receipt of cease-and-desist orders from state regulators, loss of provider licenses, the need

to make changes to the terms of engagement with any telemedicine company or provider organization we contract with that interfere with

our business and other materially adverse consequences.

Federal and State Fraud and Abuse Laws

Healthcare Laws Generally

The federal Health Insurance Portability

and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their

implementing regulations, which is collectively referred to as HIPAA, established several separate criminal penalties for making false

or fraudulent claims to insurance companies and other non- governmental payors of healthcare services.

Under HIPAA, these two additional

federal crimes are:

"Healthcare Fraud” and "False Statements Relating to Healthcare Matters.” The Healthcare Fraud

statute prohibits knowingly and recklessly executing a scheme or artifice to defraud any healthcare benefit program, including private

A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government-sponsored programs.

The False Statements Relating to Healthcare Matters statute prohibits knowingly and willfully falsifying, concealing or covering up a

material fact by any trick, scheme or device or making any materially false, fictitious or fraudulent statement in connection with the

delivery of or payment for healthcare benefits, items or services.

A violation of this statute is a felony and may result in fines or

imprisonment.

This statute could be used by the government to assert criminal liability if a healthcare provider knowingly fails to refund

an overpayment.

These provisions are intended to punish some of the same conduct in the submission of claims to private payors as the

federal False Claims Act covers in connection with governmental health programs.

In addition, the Civil Monetary

Penalties Law imposes civil administrative sanctions for, among other violations, inappropriate billing of services to federally funded

healthcare programs and employing or contracting with individuals or entities who are excluded from participation in federally funded

healthcare programs.

Moreover, a person who offers or transfers to a Medicare or Medicaid beneficiary any remuneration, including waivers

of co-payments and deductible amounts (or any part thereof), that the person knows or should know is likely to influence the beneficiary’s

The federal Health Insurance Portability and Accountability

Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their implementing regulations,

which is collectively referred to as HIPAA, established several separate criminal penalties for making false or fraudulent claims to insurance

companies and other non- governmental payors of healthcare services.

Under HIPAA, these two additional federal crimes are:

Fraud” and "False Statements Relating to Healthcare Matters.” The Healthcare Fraud statute prohibits knowingly and recklessly

executing a scheme or artifice to defraud any healthcare benefit program, including private payors.

A violation of this statute is a felony

and may result in fines, imprisonment or exclusion from government-sponsored programs.

The False Statements Relating to Healthcare Matters

statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact by any trick, scheme or device or making

any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items

A violation of this statute is a felony and may result in fines or imprisonment.

This statute could be used by the government

to assert criminal liability if a healthcare provider knowingly fails to refund an overpayment.

These provisions are intended to punish

some of the same conduct in the submission of claims to private payors as the federal False Claims Act covers in connection with governmental

health programs.

In addition, the Civil

Monetary Penalties Law imposes civil administrative sanctions for, among other violations, inappropriate billing of services to federally

funded healthcare programs and employing or contracting with individuals or entities who are excluded from participation in federally

funded healthcare programs.

Moreover, a person who offers or transfers to a Medicare or Medicaid beneficiary any remuneration, including

waivers of co-payments and deductible amounts (or any part thereof), that the person knows or should know is likely to influence the beneficiary’s

selection of a particular provider, practitioner or supplier of Medicare or Medicaid payable items or services may be liable for civil

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Federal Stark Law

We are subject to the federal

self-referral prohibitions, commonly known as the Stark Law.

Where applicable, this law prohibits a physician from referring Medicare

patients to an entity providing "designated health services” if the physician or a member of such physician’s immediate

family has a "financial relationship” with the entity, unless an exception applies.

The penalties for violating the Stark Law

include the denial of payment for services ordered in violation of the statute, mandatory refunds of any sums paid for such services,

civil penalties of up to $15,000 for each violation and twice the dollar value of each such service and possible exclusion from future

participation in the federally-funded healthcare programs.

A person who engages in a scheme to circumvent the Stark Law’s prohibitions

may be fined up to $100,000 for each applicable arrangement or scheme.

The Stark Law is a strict liability statute, which means proof

of specific intent to violate the law is not required.

In addition, the government and some courts have taken the position that claims

presented in violation of the various statutes, including the Stark Law can be considered a violation of the federal False Claims Act

(described below) based on the contention that a provider impliedly certifies compliance with all applicable laws, regulations and other

rules when submitting claims for reimbursement.

A determination of liability under the Stark Law could have a material adverse effect

on our business, financial condition and results of operations.

We are subject to the federal self-referral prohibitions,

commonly known as the Stark Law.

Where applicable, this law prohibits a physician from referring Medicare patients to an entity providing

"designated health services” if the physician or a member of such physician’s immediate family has a "financial

relationship” with the entity, unless an exception applies.

The penalties for violating the Stark Law include the denial of payment

for services ordered in violation of the statute, mandatory refunds of any sums paid for such services, civil penalties of up to $15,000

for each violation and twice the dollar value of each such service and possible exclusion from future participation in the federally-funded

healthcare programs.

A person who engages in a scheme to circumvent the Stark Law’s prohibitions may be fined up to $100,000 for

each applicable arrangement or scheme.

The Stark Law is a strict liability statute, which means proof of specific intent to violate the

law is not required.

In addition, the government and some courts have taken the position that claims presented in violation of the various

statutes, including the Stark Law can be considered a violation of the federal False Claims Act (described below) based on the contention

that a provider impliedly certifies compliance with all applicable laws, regulations and other rules when submitting claims for reimbursement.

A determination of liability under the Stark Law could have a material adverse effect on our business, financial condition and results

of operations.

Federal Anti-Kickback Statute

We are also subject to the federal

Anti-Kickback Statute.

The Anti-Kickback Statute is broadly worded and prohibits the knowing and willful offer, payment, solicitation

or receipt of any form of remuneration in return for, or to induce, (i) the referral of a person covered by Medicare, Medicaid or other

governmental programs, (ii) the furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid

or other governmental programs or (iii) the purchasing, leasing or ordering or arranging or recommending purchasing, leasing or ordering

of any item or service reimbursable under Medicare, Medicaid or other governmental programs.

Certain federal courts have held that the

Anti-Kickback Statute can be violated if "one purpose” of a payment is to induce referrals.

In addition, a person or entity

does not need to have actual knowledge of this statute or specific intent to violate it to have committed a violation, making it easier

for the government to prove that a defendant had the requisite state of mind or "scienter” required for a violation.

the government may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes

a false or fraudulent claim for purposes of the False Claims Act, as discussed below.

Violations of the Anti- Kickback Statute can result

in exclusion from Medicare, Medicaid or other governmental programs as well as civil and criminal penalties, including fines of $50,000

per violation and three times the amount of the unlawful remuneration.

Imposition of any of these remedies could have a material adverse

effect on our business, financial condition and results of operations.

We are also subject to the federal Anti-Kickback

The Anti-Kickback Statute is broadly worded and prohibits the knowing and willful offer, payment, solicitation or receipt of

any form of remuneration in return for, or to induce, (i) the referral of a person covered by Medicare, Medicaid or other governmental

programs, (ii) the furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid or other governmental

programs or (iii) the purchasing, leasing or ordering or arranging or recommending purchasing, leasing or ordering of any item or service

reimbursable under Medicare, Medicaid or other governmental programs.

Certain federal courts have held that the Anti-Kickback Statute

can be violated if "one purpose” of a payment is to induce referrals.

In addition, a person or entity does not need to have

actual knowledge of this statute or specific intent to violate it to have committed a violation, making it easier for the government to

prove that a defendant had the requisite state of mind or "scienter” required for a violation.

Moreover, the government may

assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent

claim for purposes of the False Claims Act, as discussed below.

Violations of the Anti- Kickback Statute can result in exclusion from

Medicare, Medicaid or other governmental programs as well as civil and criminal penalties, including fines of $50,000 per violation and

three times the amount of the unlawful remuneration.

Imposition of any of these remedies could have a material adverse effect on our business,

financial condition and results of operations.

In addition to a few statutory exceptions, the U.S.

of Health and Human Services Office of Inspector General, or OIG, has published safe-harbor regulations that outline categories of activities

that are deemed protected from prosecution under the Anti-Kickback Statute provided all applicable criteria are met.

The failure of a

financial relationship to meet all of the applicable safe harbor criteria does not necessarily mean that the particular arrangement violates

the Anti-Kickback Statute.

However, conduct and business arrangements that do not fully satisfy each applicable safe harbor may result

in increased scrutiny by government enforcement authorities, such as the OIG.

Department of Health and Human Services

Office of Inspector General, or OIG, has published safe-harbor regulations that outline categories of activities that are deemed protected

from prosecution under the Anti-Kickback Statute provided all applicable criteria are met.

The failure of a financial relationship to

meet all of the applicable safe harbor criteria does not necessarily mean that the particular arrangement violates the Anti-Kickback Statute.

However, conduct and business arrangements that do not fully satisfy each applicable safe harbor may result in increased scrutiny by government

enforcement authorities, such as the OIG.

False Claims Act

Both federal and state government

agencies have continued civil and criminal enforcement efforts as part of numerous ongoing investigations of healthcare companies and

their executives and managers.

Although there are a number of civil and criminal statutes that can be applied to healthcare providers,

a significant number of these investigations involve the federal False Claims Act.

These investigations can be initiated not only by the

government but also by a private party asserting direct knowledge of fraud.

These "qui tam” whistleblower lawsuits may be initiated

against any person or entity alleging such person or entity has knowingly or recklessly presented, or caused to be presented, a false

or fraudulent request for payment from the federal government or has made a false statement or used a false record to get a claim approved.

In addition, the improper retention of an overpayment for 60 days or more is also a basis for a False Claim Act action, even if the claim

was originally submitted appropriately.

Penalties for False Claims Act violations include fines ranging from $5,500 to $11,000 for each

false claim, plus up to three times the amount of damages sustained by the federal government.

A False Claims Act violation may provide

the basis for exclusion from the federally-funded healthcare programs.

In addition, some states have adopted similar fraud, whistleblower

and false claims provisions.

Fraud and Abuse Laws

Several states in which we

operate have also adopted similar fraud and abuse laws as described above.

The scope of these laws and the interpretations of them vary

from state to state and are enforced by state courts and regulatory authorities, each with broad discretion.

Some state fraud and abuse

laws apply to items or services reimbursed by any third-party payor, including commercial insurers, not just those reimbursed by a federally-funded

healthcare program.

A determination of liability under such state fraud and abuse laws could result in fines and penalties and restrictions

on our ability to operate in these jurisdictions.

and Federal Health Information Privacy and Security Laws

Both federal and state government agencies have

continued civil and criminal enforcement efforts as part of numerous ongoing investigations of healthcare companies and their executives

and managers.

Although there are a number of civil and criminal statutes that can be applied to healthcare providers, a significant number

of these investigations involve the federal False Claims Act.

These investigations can be initiated not only by the government but also

by a private party asserting direct knowledge of fraud.

These "qui tam” whistleblower lawsuits may be initiated against any

person or entity alleging such person or entity has knowingly or recklessly presented, or caused to be presented, a false or fraudulent

request for payment from the federal government or has made a false statement or used a false record to get a claim approved.

the improper retention of an overpayment for 60 days or more is also a basis for a False Claim Act action, even if the claim was originally

submitted appropriately.

Penalties for False Claims Act violations include fines ranging from $5,500 to $11,000 for each false claim,

plus up to three times the amount of damages sustained by the federal government.

A False Claims Act violation may provide the basis for

exclusion from the federally-funded healthcare programs.

In addition, some states have adopted similar fraud, whistleblower and false

claims provisions.

State Fraud and Abuse Laws

Several states in

which we operate have also adopted similar fraud and abuse laws as described above.

The scope of these laws and the interpretations of

them vary from state to state and are enforced by state courts and regulatory authorities, each with broad discretion.

Some state fraud

and abuse laws apply to items or services reimbursed by any third-party payor, including commercial insurers, not just those reimbursed

by a federally-funded healthcare program.

A determination of liability under such state fraud and abuse laws could result in fines and

penalties and restrictions on our ability to operate in these jurisdictions.

State and Federal Health Information Privacy

and Security Laws

There are numerous U.S.

and state laws and regulations related to the privacy and security of personally identifiable information, or PII, including health information.

In particular, HIPAA establishes privacy and security standards that limit the use and disclosure of protected health information, or

PHI, and require the implementation of administrative, physical, and technical safeguards to ensure the confidentiality, integrity and

availability of individually identifiable health information in electronic form.

Since the effective date of the HIPAA Omnibus Final Rule

on September 23, 2013, HIPAA’s requirements are also directly applicable to the independent contractors, agents and other "business

associates” of covered entities that create, receive, maintain or transmit PHI in connection with providing services to covered

Although Cardio is a covered entity under HIPAA, Cardio is also a business associate of other covered entities when Cardio is

working on behalf of our affiliated medical groups.

Violations of HIPAA may result in civil

and criminal penalties.

The civil penalties range from $100 to $50,000 per violation, with a cap of $1.5 million per year for violations

of the same standard during the same calendar year.

federal and state laws and

regulations related to the privacy and security of personally identifiable information, or PII, including health information.

In particular,

HIPAA establishes privacy and security standards that limit the use and disclosure of protected health information, or PHI, and require

the implementation of administrative, physical, and technical safeguards to ensure the confidentiality, integrity and availability of

individually identifiable health information in electronic form.

Since the effective date of the HIPAA Omnibus Final Rule on September

23, 2013, HIPAA’s requirements are also directly applicable to the independent contractors, agents and other "business associates”

of covered entities that create, receive, maintain or transmit PHI in connection with providing services to covered entities.

Cardio is a covered entity under HIPAA, Cardio is also a business associate of other covered entities when Cardio is working on behalf

of our affiliated medical groups.

Violations of HIPAA may result in civil and criminal

The civil penalties range from $100 to $50,000 per violation, with a cap of $1.5 million per year for violations of the same

standard during the same calendar year.

However, a single breach incident can result in violations of multiple standards.

Cardio must also comply with HIPAA’s breach notification rule.

Under the breach notification rule, covered entities must notify

affected individuals without unreasonable delay in the case of a breach of unsecured PHI, which may compromise the privacy, security or

integrity of the PHI.

In addition, notification must be provided to the HHS and the local media in cases where a breach affects more than

500 individuals.

Breaches affecting fewer than 500 individuals must be reported to HHS on an annual basis.

The regulations also require

business associates of covered entities to notify the covered entity of breaches by the business associate.

State attorneys general also

have the right to prosecute HIPAA violations committed against residents of their states.

While HIPAA does not create a private right

of action that would allow individuals to sue in civil court for a HIPAA violation, its standards have been used as the basis for the

duty of care in state civil suits, such as those for negligence or recklessness in misusing personal information.

In addition, HIPAA mandates

that HHS conduct periodic compliance audits of HIPAA covered entities and their business associates for compliance.

It also tasks HHS

with establishing a methodology whereby harmed individuals who were the victims of breaches of unsecured PHI may receive a percentage

of the Civil Monetary Penalty fine paid by the violator.

In light of the HIPAA Omnibus Final Rule, recent enforcement activity, and statements

from HHS, we expect increased federal and state HIPAA privacy and security enforcement efforts.

HIPAA also required HHS to adopt

national standards establishing electronic transaction standards that all healthcare providers must use when submitting or receiving certain

healthcare transactions electronically.

On January 16, 2009, HHS released the final rule mandating that everyone covered by HIPAA must

implement ICD-10 for medical coding on October 1, 2013, which was subsequently extended to October 1, 2015 and is now in effect.

Many states in which we operate

and in which patients reside also have laws that protect the privacy and security of sensitive and personal information, including health

These laws may be similar to or even more protective than HIPAA and other federal privacy laws.

For example, the laws of

the State of California, in which we operate, are more restrictive than HIPAA.

Where state laws are more protective than HIPAA, we must

comply with the state laws we are subject to, in addition to HIPAA.

In certain cases, it may be necessary to modify our planned operations

and procedures to comply with these more stringent state laws.

Not only may some of these state laws impose fines and penalties upon violators,

but also some, unlike HIPAA, may afford private rights of action to individuals who believe their personal information has been misused.

In addition, state laws are changing rapidly, and there is discussion of a new federal privacy law or federal breach notification law,

to which we may be subject.

In addition to HIPAA, state

health information privacy and state health information privacy laws, we may be subject to other state and federal privacy laws, including

laws that prohibit unfair privacy and security practices and deceptive statements about privacy and security and laws that place specific

requirements on certain types of activities, such as data security and texting.

In recent years, there have been

a number of well-publicized data breaches involving the improper use and disclosure of PII and PHI.

Many states have responded to these

incidents by enacting laws requiring holders of personal information to maintain safeguards and to take certain actions in response to

a data breach, such as providing prompt notification of the breach to affected individuals and state officials.

In addition, under HIPAA

and pursuant to the related contracts that we enter into with our business associates, we must report breaches of unsecured PHI to our

contractual partners following discovery of the breach.

Notification must also be made in certain circumstances to affected individuals,

federal authorities and others.

Various states have enacted laws

governing the privacy of personal information collected and used by businesses online.

For example, California adopted the California

Consumer Privacy Act of 2018 ("CCPA”), which went into effect on January 1, 2020 and was recently amended by the California

Privacy Rights Act of 2020 which significantly modified the CCPA in ways that affect businesses.

This law, in part, requires that companies

make certain disclosures to consumers via their privacy policies, or otherwise at the time the personal data is collected.

to determine what personal data it is collecting from individuals and for what purposes, and to update its privacy policy every 12 months

to make the required disclosures, among other things.

and Human Capital Resources

As of March 20,

2025 we had 13 full-time employees and two part-time employees.

also comply with HIPAA’s breach notification rule.

Under the breach notification rule, covered entities must notify affected individuals

without unreasonable delay in the case of a breach of unsecured PHI, which may compromise the privacy, security or integrity of the PHI.

In addition, notification must be provided to the HHS and the local media in cases where a breach affects more than 500 individuals.

affecting fewer than 500 individuals must be reported to HHS on an annual basis.

The regulations also require business associates of covered

entities to notify the covered entity of breaches by the business associate.

State attorneys general also have the right to prosecute

HIPAA violations committed against residents of their states.

While HIPAA does not create a private right of action that would allow individuals

to sue in civil court for a HIPAA violation, its standards have been used as the basis for the duty of care in state civil suits, such

as those for negligence or recklessness in misusing personal information.

In addition, HIPAA mandates that HHS conduct periodic compliance

audits of HIPAA covered entities and their business associates for compliance.

It also tasks HHS with establishing a methodology whereby

harmed individuals who were the victims of breaches of unsecured PHI may receive a percentage of the Civil Monetary Penalty fine paid

by the violator.

In light of the HIPAA Omnibus Final Rule, recent enforcement activity, and statements from HHS, we expect increased federal

and state HIPAA privacy and security enforcement efforts.

HIPAA also required HHS to adopt national standards

establishing electronic transaction standards that all healthcare providers must use when submitting or receiving certain healthcare transactions

electronically.

On January 16, 2009, HHS released the final rule mandating that everyone covered by HIPAA must implement ICD-10 for medical

coding on October 1, 2013, which was subsequently extended to October 1, 2015 and is now in effect.

Many states in which we operate and in which patients

reside also have laws that protect the privacy and security of sensitive and personal information, including health information.

laws may be similar to or even more protective than HIPAA and other federal privacy laws.

For example, the laws of the State of California,

in which we operate, are more restrictive than HIPAA.

Where state laws are more protective than HIPAA, we must comply with the state laws

we are subject to, in addition to HIPAA.

In certain cases, it may be necessary to modify our planned operations and procedures to comply

with these more stringent state laws.

Not only may some of these state laws impose fines and penalties upon violators, but also some,

unlike HIPAA, may afford private rights of action to individuals who believe their personal information has been misused.

state laws are changing rapidly, and there is discussion of a new federal privacy law or federal breach notification law, to which we

may be subject.

In addition to HIPAA, state health information privacy

and state health information privacy laws, we may be subject to other state and federal privacy laws, including laws that prohibit unfair

privacy and security practices and deceptive statements about privacy and security and laws that place specific requirements on certain

types of activities, such as data security and texting.

In recent years,

there have been a number of well-publicized data breaches involving the improper use and disclosure of PII and PHI.

Many states have

responded to these incidents by enacting laws requiring holders of personal information to maintain safeguards and to take certain actions

in response to a data breach, such as providing prompt notification of the breach to affected individuals and state officials.

under HIPAA and pursuant to the related contracts that we enter into with our business associates, we must report breaches of unsecured

PHI to our contractual partners following discovery of the breach.

Notification must also be made in certain circumstances to affected

individuals, federal authorities and others.

State Privacy Laws

Various states have enacted laws governing the privacy

of personal information collected and used by businesses online.

For example, California adopted the California Consumer Privacy Act of

2018 ("CCPA”), which went into effect on January 1, 2020 and was recently amended by the California Privacy Rights Act of 2020

which significantly modified the CCPA in ways that affect businesses.

This law, in part, requires that companies make certain disclosures

to consumers via their privacy policies, or otherwise at the time the personal data is collected.

We will have to determine what personal

data it is collecting from individuals and for what purposes, and to update its privacy policy every 12 months to make the required disclosures,

among other things.

Employees and Human Capital Resources

As of March 13, 2026, we had 15 full-time employees

and two part-time employees.

Three of our employees hold Ph.D.

We also engage contractors

and consultants from time to time.

We also engage contractors and consultants from time

None of our employees are represented by a labor union or covered under a collective bargaining agreement.

Our human capital

resources objectives include, identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees

into our collaborative culture.

Our compensation program is designed to retain, motivate and attract highly qualified executives and talented

employees and consultants.

We are committed to fostering a culture that supports diversity and an environment of mutual respect, equity

and collaboration that helps drive our business and our mission to become one of the leading medical technology companies for enabling

improved prevention, detection, treatment and management of cardiovascular disease.

Our human capital resources objectives include,

identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees into our collaborative culture.

Our compensation program is designed to retain, motivate and attract highly qualified executives and talented employees and consultants.

We are committed to fostering a culture that supports diversity and an environment of mutual respect, equity and collaboration that helps

drive our business and our mission to become one of the leading medical technology companies for enabling improved prevention, detection,

treatment and management of cardiovascular disease.

Corporation Information

Our corporate headquarters

is located at 311 W.

Our corporate headquarters is located at 311 W.

Suite 444, Chicago IL.

Our telephone number is (855) 226-9991 and our website address is cdio.ai.

information contained on, or that can be accessed through, our website is not incorporated by reference in this Annual Report on Form

10-K and does not form a part of this Annual Report on Form 10-K.

The reference to our website address does not constitute incorporation

by reference of the information contained at or available through our website, and you should not consider it to be a part of this registration

Growth Status

We are an “emerging

growth company , ” as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act

of 2012 (the “JOBS Act”), and we may take advantage of certain exemptions from various reporting requirements that are applicable

to other public companies that are not emerging growth companies, including, but not limited to, not being required to comply with the

auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”),

reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the

requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments

not previously approved.

Further, Section 102(b)(1)

of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until

private companies (that is, those that have not had a registration statement under the Securities Act declared effective or do not have

a class of securities registered under the Securities Exchange Act of 1934, as amended the “Exchange Act”), are required to

comply with the new or revised financial accounting standards.

The JOBS Act provides that a company can elect to opt out of the extended

transition period and comply with the requirements that apply to non-emerging growth companies but any such an election to opt out is

We have elected not to opt out of such extended transition period which means that when a standard is issued or revised and

it has different application dates for public or private companies, we, as an emerging growth company, can adopt the new or revised standard

at the time private companies adopt the new or revised standard.

This may make comparison of our financial statements with another public

company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition

period difficult or impossible because of the potential differences in accounting standards used.

remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the

completion of the IPO, (b) in which we have total annual gross revenue of at least $1.07 billion, or (c) in which we are deemed to be

a large accelerated filer, which means the market value of our Common Stock held by non-affiliates equaled or exceeded $700 million as

of the prior June 30, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior

three-year period.

Additionally, we are a “smaller

reporting company” as defined in Item 10(f)(1) of Regulation S-K.

Smaller reporting companies may take advantage of certain reduced

disclosure obligations, including, among other things, providing only two years of audited financial statements.

We will remain a smaller

reporting company until the last day of the fiscal year in which (1) the market value of our Common Stock held by non-affiliates equaled

or exceeded $250 million as of the end of the prior June 30th, or (2) our annual revenues equaled or exceeded $100 million during such

completed fiscal year and the market value of our Common Stock held by non-affiliates equaled or exceeded $700 million as of the prior

We are required

to file Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q with the SEC on a regular basis, and are required to disclose

certain material events in a Current Report on Form 8-K.

The SEC maintains an Internet website that contains reports, proxy and information

statements and other information regarding issuers that file electronically with the SEC.

The SEC’s Internet website is located

at www.sec.gov.

In addition, the Company will provide copies of these documents without charge upon request from us in writing at 311

West Superior Street, Suite 444, Chicago IL 60654.

The information contained

on, or that can be accessed through, our website is not incorporated by reference in this Annual Report on Form 10-K and does not form

a part of this Annual Report on Form 10-K.

The reference to our website address does not constitute incorporation by reference of the

information contained at or available through our website, and you should not consider it to be a part of this registration statement.

Emerging Growth Company, Smaller Reporting

Company and Non-Accelerated Filer Status

We are an emerging growth company (“EGC”),

as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”),

and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that

are not EGCs, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of

the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”), reduced disclosure obligations regarding executive

compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote

on executive compensation and stockholder approval of any golden parachute payments not previously approved.

Further, Section 102(b)(1) of the JOBS Act exempts

EGCs from being required to comply with new or revised financial accounting standards until private companies (that is, those that have

not had a registration statement under the Securities Act declared effective or do not have a class of securities registered under the

Securities Exchange Act of 1934, as amended the “Exchange Act”), are required to comply with the new or revised financial

accounting standards.

The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the

requirements that apply to non-emerging growth companies but any such an election to opt out is irrevocable.

We have elected not to opt

out of such extended transition period which means that when a standard is issued or revised and it has different application dates for

public or private companies, we, as an EGC, can adopt the new or revised standard at the time private companies adopt the new or revised

This may make comparison of our financial statements with another public company which is neither an emerging growth company

nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential

differences in accounting standards used.

Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of

Regulation S-K.

Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things,

providing only two years of audited financial statements, as well as continued reduced executive compensation disclosure.

We will remain

a smaller reporting company until the last day of the fiscal year in which (1) the market value of our Common Stock held by non-affiliates

equaled or exceeded $250 million as of the end of the prior June 30th, or (2) our annual revenues equaled or exceeded $100 million during

such completed fiscal year and the market value of our Common Stock held by non-affiliates equaled or exceeded $700 million as of the

prior June 30th.

We will remain an emerging growth company until

December 31, 2026, after which we will be subject to certain requirements from which we have previously been exempt.

However, we will

continue to be a smaller reporting company, as well as a non-accelerated filer.

As a result of losing EGC status, beginning in 2027, we

will no longer be able to take advantage of the extended transition period for new or revised accounting standards, and instead, will

need to adopt any new standards according to the timelines applicable to non- EGCs.

We also will be required to hold nonbinding stockholder

advisory votes on executive compensation and seek stockholder approval of any golden parachute payments not previously approved.

as a smaller reporting company, we will be allowed to continue including only two years of audited financial statements in our securities

filings and can elect to continue providing scaled down executive compensation disclosure.

Most significantly in terms of expenditure

of resources, because we will continue to be both a smaller reporting company and a non-accelerated filer, we will continue to be exempt

from the requirement to obtain an auditor’s attestation on management’s assessment of the effectiveness of our internal control

over financial reporting.

We expect that we will continue to take advantage of the smaller reporting company and non-accelerated filer

benefits for the foreseeable future.

Available Information

We are required to file Annual Reports on Form 10-K

and Quarterly Reports on Form 10-Q with the SEC on a regular basis, and are required to disclose certain material events in a Current

Report on Form 8-K.

The SEC maintains an Internet website that contains reports, proxy and information statements and other information

regarding issuers that file electronically with the SEC.

The SEC’s Internet website is located at www.sec.gov.

In addition, the

Company will provide copies of these documents without charge upon request from us in writing at 311 West Superior Street, Suite 444,

Chicago IL 60654.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business