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Item 1. Business

2024-04-01 compared with 2023-03-31 · 985 added, 913 removed, 480 unchanged (80% of the section changed)

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

Mana Capital Acquisition Corp.

was formed on

May 19, 2021 under the laws of the State of Delaware, as a blank check company for the purpose of engaging in a merger, share exchange,

asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination, with one or more target businesses

On October 25, 2022 (the “Closing”),

Cardio Diagnostics Holdings, Inc.

(the “Company”), f/k/a Mana Capital Acquisition Corp., our legal predecessor and a special

purpose acquisition company (“Mana”) sponsored by Mana Capital, LLC, consummated the previously announced Merger with Cardio

Diagnostics, Inc.

(“Legacy Cardio”), and Mana Merger Sub, Inc.

(“Merger Sub”), a wholly owned subsidiary of Mana

pursuant to a Merger Agreement and Plan of Reorganization dated as of May 27, 2022, as amended on September 15, 2022 (the “Business

Combination Agreement”).

Pursuant to the Merger, Merger Sub merged with and into Legacy Cardio, the separate corporate existence

of Merger Sub ceased, and Legacy Cardio continued as the surviving corporation in the Merger and as a wholly owned subsidiary of Mana.

The Merger was approved by Mana’s stockholders at a meeting held on October 25, 2022.

On the Closing, the Company changed its name

from Mana Capital Acquisition Corp.

to Cardio Diagnostics Holdings, Inc.

As of the opening of trading on October 26,

2022, the Company’s Common Stock (the “Common Stock”) and public warrants (the “Public Warrants”), formerly

those of Mana, began trading on The Nasdaq Capital Market (“Nasdaq”) under the symbols “CDIO” and “CDIOW,”

respectively.

At the Closing and subject to the conditions

of the Business Combination Agreement, all shares of Common Stock of Legacy Cardio were cancelled and converted into the right to receive

a number of shares of the Company’s Common Stock equal to 3.427259 (the “Exchange Ratio”) per Legacy Cardio share and

a pro rata portion of up to 43,334 shares of the Company’s Common Stock issuable upon conversion of certain promissory notes aggregating

$433,334 issued to Legacy Cardio in consideration of loans made to us to extend the corporate existence of Mana through October 26, 2022

(the “Extension Notes”).

In addition, each outstanding option and warrant to purchase shares of Legacy Cardio Common Stock

was converted into an option or warrant, as the case may be, to purchase shares of the Company’s Common Stock with the same terms

except for the number of shares exercisable and the exercise price, as adjusted for the Exchange Ratio.

Cardio Diagnostics, Inc.

("Legacy Cardio”)

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As a 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 hopes to accelerate

the adoption of Precision Medicine for all.

We believe that incorporating our 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 aims 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 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.

According to the CDC, epigenetics is the study

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Several reasons for this

failure include (i) the current in-person risk screening approach is incompatible with busy everyday life as demonstrated by the COVID-19

associated decrease in primary care visits for preventive screening;

(ii) even if the current risk screening tests are taken, they only

identify 44% and 32% of men and women at high risk, respectively;

and (iii) the lack of patient care plan personalization.

A highly accessible,

personalized and precise solution for CHD prevention is not currently available.

failure include (i) the current in-person risk screening approach is incompatible with busy everyday life;

(ii) even if the current risk

screening tests are taken, they only identify 44% and 32% of men and women at high risk, respectively;

and (iii) the lack of patient care

plan personalization.

We believe that a highly accessible, personalized and precise solution for CHD prevention is not currently available.

Furthermore, with the ongoing COVID-19 pandemic,

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scalable, at-home risk screening tool that can help physicians better direct care and allow patients to receive the help they need sooner.

Our first test, Epi+Gen CHD™, which was

introduced for market testing in 2021, is a three-year symptomatic CHD risk assessment test targeting CHD events, including heart attacks.

Our first test, Epi+Gen CHD™, which

was introduced for market testing in 2021, is a three-year symptomatic CHD risk assessment clinical blood test targeting CHD events,

including heart attacks.

In March 2023, we announced the launch of our second product, PrecisionCHD™, an integrated

epigenetic-genetic blood test for the early detection of coronary heart disease.

The Company earned only $901 and $950 in revenue

for the years ended December 31, 2021 and 2022, respectively, through a telemedicine platform.

Rather than using its resources to actively

pursue this sales channel, in mid to late 2022, we started focusing our efforts on establishing relationships with potential customers,

a process that can take many months and up to as much as a year or more to finalize, depending on the sales channel.

For example, hospitals

routinely take a year or longer to make purchasing decisions.

While these relationships take considerable time to establish, we believe

that they provide far greater revenue potential for our existing and future tests.

We believe that our Epi+Gen CHD™ and PrecisionCHD™

tests are categorized as laboratory-developed tests, or “LDTs.” Under current FDA policy, an LDT does not require premarket

authorization or other FDA clearance or approval.

As such, we believe that the Epi+Gen CHD™ and PrecisionCHD™ tests do not require

FDA premarket evaluation of our performance claims or marketing authorization, and such premarket review and authorization has not been

Although submissions that are pending before the FDA or that have been denied are not publicly available, to the best of our

knowledge, no epigenetic-based clinical test for cardiovascular disease has, to date, been cleared or approved by the FDA.

Industry Background

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 help improve chronic care management.

In May 2023, we launched

CardioInnovate360 TM , 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 announce the launch of

HeartRisk™, a cardiovascular risk intelligence platform.

The Company earned only $950 and $17,065 in revenue for the

years ended December 31, 2022 and 2023, respectively.

We are continuing to focus our efforts on establishing relationships with

larger organizations and channel partners to increase adoption of our solutions.

However, this process can take many months and up

to as much as a year or more to finalize, depending on the sales channel.

For example, hospitals routinely take a year or longer to

make purchasing decisions.

While these relationships take considerable time to establish, we believe that our strategy to pursue

larger organizations can provide far greater revenue potential for our existing and future products.

We have begun to see results

from this recent shift in marketing focus:

In October 2023, we announced that we have secured an Innovative Technology Contract from

Vizient, Inc., the nation’s largest provider-driven healthcare performance improvement company, with a customer base

encompassing over 60% of hospitals and 97% of academic medical centers in the United States.

In November 2023, we announced that

Family Medicine Specialists (FMS), a leading Illinois primary care provider with eight locations, is implementing our heart attack

risk assessment test, Epi+Gen CHD™, covering at least 1,200 BlueCross BlueShield Medicare, Medicaid, HMO and PPO health plan

and other health plan patients with CHD risk factors.

We believe that our Epi+Gen CHD™ and

PrecisionCHD™ tests are categorized as laboratory-developed tests, or “LDTs.” Under current FDA enforcement discretion

policy, an LDT does not require FDA premarket authorization, or other FDA clearance or approval.

As such, we believe that the Epi+Gen

CHD™ and PrecisionCHD™ tests do not require FDA premarket evaluation of our performance claims or marketing authorization,

and such premarket authorization has not been obtained.

Although submissions that are pending before the FDA or that have been denied

are not publicly available, to the best of our knowledge, no epigenetic-based clinical test for cardiovascular disease has, to date, been

cleared or approved by the FDA.

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 seek other alternatives

within the healthcare field in order to grow our 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.

According to the American Heart Association

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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”).

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

The National Center

for Health Statistics reported that the prevalence of CHD is approximately 6.7%, and according to the AHA, over 20 million adults aged

20 or older in the United States have CHD.

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.

Center for Health Statistics reported that the prevalence of CHD is approximately 6.7%, and according to the AHA, over 20 million adults

aged 20 or older in the United States have CHD.

CHD is also the major cause of heart attacks.

According to the AHA, every 40 seconds, someone

in the United States has a heart attack, with over 800,000 Americans having a heart attack each year.

The CDC reported that in 2020, stroke

was responsible for one in six CVD-related deaths.

The AHA estimates that every year, nearly 800,000 Americans have a stroke which is

the leading cause of major long-term disability, with a stroke-related death occurring every 3.5 minutes.

According to the AHA, over six

million adults have heart failure and nearly 380,000 deaths in 2018 were attributable to heart failure.

There are numerous risk factors

that could increase an individual’s risk for CVD.

Several key risk factors include diabetes, high blood cholesterol, and high blood

For example, according to the CDC, over 34 million adults have diabetes and according to Johns Hopkins Medicine, those with

diabetes are two to four times more likely to develop CVD.

Alongside genetics, age, sex, and ethnicity, lifestyle factors such as smoking,

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

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.

According to the AHA, every 40 seconds,

someone in the United States has a heart attack, with over 800,000 Americans having a heart attack each year.

The CDC reported that in

2020, stroke was responsible for one in six CVD-related deaths.

The AHA estimates that every year, nearly 800,000 Americans have a stroke

which is the leading cause of major long-term disability, with a stroke-related death occurring every 3.5 minutes.

According to the AHA,

over six million adults have heart failure and nearly 380,000 deaths in 2018 were attributable to heart failure.

There are numerous risk

factors that could increase an individual’s risk for CVD.

Several key risk factors include diabetes, high blood cholesterol, and

high blood pressure.

For example, according to the CDC, over 34 million adults have diabetes and according to Johns Hopkins Medicine,

those with diabetes are two to four times more likely to develop CVD.

Alongside genetics, age, sex, and ethnicity, lifestyle factors such

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

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:

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:

A Costly Burden For America,

Projections Through 2035 report by the AHA.

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 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 testing market trends

reported by 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.

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.

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

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 testing market

trends reported by 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.

They estimate that 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%.

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 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.

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

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.

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.

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:

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Building compelling evidence.

Our AI-driven Integrated Genetic-Epigenetic

Engine™ enables rapid design, development, and launch of diagnostic solutions resulting from a decade of research studies.

solutions that result from this technology, including our Epi+Gen CHD™ test for coronary heart disease risk assessment and

PrecisionCHD™ for the early 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 the Epi+Gen CHD™ test also include an economic case to drive a more holistic and compelling

argument for adoption.

Our AI-driven Integrated Genetic-Epigenetic Engine™ enables rapid design, development, and launch of diagnostic solutions resulting from a decade of research studies.

Our solutions that result from this technology, including our Epi+Gen CHD™ test for coronary heart disease risk assessment and PrecisionCHD™ for the early 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 the Epi+Gen CHD™ test also include an economic case to drive a more holistic and compelling argument for adoption.

We plan to continue such studies including similar health economic studies for the PrecisionCHD™ test.

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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 coronary heart disease, stroke and congestive heart failure.

Our Technology

At the core of Cardio is our proprietary AI-driven

Integrated Genetic-Epigenetic Engine™, an engine invented and built by three key employees/officers over the past decade.

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

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.

At the core of Cardio is our proprietary

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

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.

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.

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 and mined, modeled and translated into standalone laboratory assays.

a result, our products, which are clinical tests, consist of two components.

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DNA biomarkers.

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

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 assist physicians in

tailoring a prevention and care plan.

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

test we develop.

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 assist physicians in tailoring a prevention and care plan.

The combination of biomarkers and

predictive machine learning model is unique to each clinical test we develop.

Our 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 2023, we have

leveraged this Engine to develop two products:

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 2024,

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 test capable of assessing near-term (three-year) risk for coronary heart disease (“CHD”) and our

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

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 coronary heart disease

(“CHD”) and our second product, PrecisionCHD™, is the first epigenetics-based clinical blood test for the detection

Both Epi+Gen CHD and PrecisionCHD are accompanied

by our provider-only 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.

Recently, we launched our first software

product, HeartRisk™.

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

anonymized and aggregated clinical cardiovascular data obtained through our Epi+Gen CHD™ and PrecisionCHD™ clinical

blood tests, with industry and geographic data to enable real-time population-level cardiovascular disease (“CVD”) risk insights.

These insights are customized for the stakeholder implementing our clinical solutions.

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

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.

For the early detection of CHD, tests that are routinely used in a provider

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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.

(2021), External validation of integrated genetic-epigenetic biomarkers for predicting incident coronary heart

10.2217/epi-2021-0123), we found that for three-year coronary heart disease risk assessment, 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.

A similar study was

performed for PrecisionCHD™ that demonstrates its high sensitivity and is undergoing the process to be peer-reviewed and

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 three-year coronary heart disease risk assessment, 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.

Similar study was performed for PrecisionCHD that demonstrates its high sensitivity and is undergoing the process to be peer-reviewed and published.

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.

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

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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 Risk Assessment

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

In a peer-reviewed study done in collaboration with Intermountain Healthcare (Dogan, Meeshanthini & Knight, Stacey & Dogan, Timur

& Knowlton, Kirk & Philibert, Robert, 2021;

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

Epi+Gen CHD™ is the Only Epigenetics-based Clinical

Test for Coronary Heart Disease 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 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.

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, 2021, Cost-utility analysis of an integrated genetic/epigenetic test for assessing risk for coronary heart

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.

The blood-based version of this test was introduced

for market testing in 2021 and the saliva-based version is anticipated to be launching in 2023.

The current charge to perform the test

is $350, which can be paid for either out-of-pocket or via HSA/FSA.

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 building

additional clinical and health economics evidence to pursue payor coverage.

To date, we have sold our Epi+Gen CHD™ test to multiple

customers who are patients through a telemedicine provider platform.

We believe that the Epi+Gen CHD™ test empowers

patients to prevent CHD with actionable information about their near-term risk for CHD-related events, including a heart attack.

that our Company’s initial product will enable clinicians to identify patients in need of clinical attention and gaps in cardiovascular

care for their patients so they can bridge the gap in care and proactively manage them.

In addition, we believe that our products can

enable healthcare organizations and payors to reduce the cost of care.

We have a worldwide exclusive license agreement

with the University of Iowa Research Foundation (“UIRF”) relating to our patent and patent-pending technology.

Under the terms of that license

agreement, Cardio is required to pay each of:

(i) 2% of annual net sales, and (ii) 15% of non-royalty fees paid to the Company if it enters

into one or more sublicensing agreements.

In addition to that licensed technology, we have

other patent applications pending relating to improvements to and bolstering our technology, which are potentially valuable and of possible

strategic importance to the Company.

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

from their inventions.

Consequently, Meeshanthini Dogan and Robert Philibert, our Chief Executive Officer and Chief Medical Officer, who

are co-inventors of the technology along with UIRF, will benefit from this policy.

PrecisionCHD™ is the Only Epigenetics-based Clinical Test

for the Early Detection of Coronary Heart Disease

PrecisionCHD™

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

early detection of coronary heart disease.

PrecisionCHD™ aids in the early detection of coronary heart disease to better

enable the management of this condition to prevent a symptomatic event such as a heart attack.

Using epigenetic (DNA methylation) and

genetic (single nucleotide polymorphism) biomarkers along with a proprietary machine-learning model developed by analyzing billions of

genomic and epigenomic data points, PrecisionCHD™ detects coronary heart disease with better than 75% sensitivity in both men and

A key defining characteristic of PrecisionCHD™ is its accompanying provider-only Actionable Clinical Intelligence ™

platform, which maps a patient’s unique biomarker profile onto modifiable risk factors such as diabetes, hypertension, hypercholesterolemia,

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

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

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.

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 building 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 recently, the American Medical

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

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-only

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.

to clinicians, we believe that this test can enable healthcare organizations and payors to reduce the cost of care, and employers to understand

and 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 risk intelligence platform.

The pricing for this platform

will be customized based on the organization type and size.

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

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%.

The performance

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

One cohort was used for the development

of this test and the other two were used to independently validate the performance of the test, showing PrecisionCHD™ to be approximately

1.4 times and 1.3 times more sensitive than an exercise ECG in men and women, respectively, for detecting coronary heart disease.

another peer-reviewed study, (Broyles, Damon & Philibert, Robert.

Precision epigenetics provides a scalable pathway for improving

coronary heart disease care globally.

10.2217/epi-2023-0233), the global scalability of PrecisionCHD was outlined in comparison

to commonly used coronary heart disease tests such as exercise ECG and CCTA.

Similar to the Epi+Gen CHD™ test, a peer-reviewed

study was conducted to evaluate if the DNA methylation biomarkers of PrecisionCHD could be potentially leveraged to evaluate the effectiveness

of interventions.

In this peer-reviewed study, (Philibert, Robert & Moody, Joanna & Philibert, Willem & Dogan, Meeshanthini

& Hoffman, Eric.

The reversion of epigenetic signature of coronary heart disease in response to smoking cessation.

https://doi.org/10.3390/genes14061233), DNA methylation of this test was shown to change within 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 pricing of the test

varies based on factors such as organization type and test volume.

Recently, 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 being sold.

We are continuing to build 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 outcomes.

These actionable insights are conveyed via our provider-only 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.

Cardio intends to accelerate the adoption of

Epi+Gen CHD™ and PrecisionCHD™ by:

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 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 risk intelligence platform.

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

type and size.

Cardio intends to accelerate the adoption of Epi+Gen CHD™ and PrecisionCHD™ by:

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

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launching a piloting program 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:

acquiring 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:

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

processing patient samples in the laboratory in larger batches;

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increasing the level of automation to reduce manual processing.

are evaluating an FDA regulatory pathway to enable broader access to the Epi+Gen CHD™ and PrecisionCHD ™ tests.

We are currently determining the appropriate FDA pathway and are assembling the necessary FDA pre-submission materials to obtain feedback

from the FDA.

We have engaged regulatory experts and attorneys 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 test for the early detection of CHD.

addition to this test, we have several other tests in our product pipeline at various stages for congestive heart failure (expected

launch in 2023), stroke (expected launch in 2023) and diabetes (expected launch in 2024).

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.

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

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

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 early detection.

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 critical.

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.

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”) risk assessment.

Our second product, PrecisionCHD™,

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

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”) risk assessment.

Our second product, PrecisionCHD™, is a highly sensitive

and accessible clinical test for the detection of CHD.

Using data from the US Census Bureau, Cardio

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diabetes test.

The pricing of each of our tests may vary, but assuming $350 per test, the US addressable market

equates to $51 billion for Epi+Gen CHD™, $55 billion for PrecisionCHD™, $53 billion for congestive heart failure, $53 billion for stroke

and $49 billion for diabetes for a total US addressable market of $261 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.

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.

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

Since the launch of Epi+Gen CHD™ in 2021

via telemedicine, the predominant initial go-to-market (“GTM”) strategy was 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 risk

Our sales and marketing efforts were largely limited due to constraints in resources and predominantly leveraged digital marketing

Sales were handled through our telemedicine partner to multiple customers.

Moving forward, with additional resources and a growing

team, in addition to this bottom-up GTM motion, we have adopted 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™

assessing the risk for CHD 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 TM tests will support their commercial adoption.

We believe that Epi+Gen

CHD™ and PrecisionCHD TM can address a significant addressable market opportunity even before these tests are covered

by insurance and eligible for approval for reimbursement.

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 is expected to take several years,

if it is obtained at all.

We intend to focus on the following key channels:

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 risk concerns.

Healthcare Sub-Vertical Priorities for Epi+Gen CHD™

and PrecisionCHD™

By assessing the risk for CHD 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

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 CHD before a cardiac event, 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 early with a simple blood test, potentially leading to better

patient outcomes.

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 CHD before a cardiac event, 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

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 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 will be

driven by remote-first companies looking to provide employee perks relevant to health.

We believe the two reasons for this are replacing

in-office amenities and acknowledging that health is top of mind for most employees in a post-pandemic world.

Health equity is 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 attracting and retaining

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 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.

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

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.

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.

Because the Epi+Gen CHD™ test is currently out-of-pocket, we expect high-earning Americans who are proactive about

their health to constitute the initial attainable market.

Additionally, many have discretionary flexible spending account ("FSA”)

or health savings account ("HSA”) funds.

A strategic partner will be health and wellness marketplaces that aggregate FSA and

HSA-eligible items for those who wish to tackle their health using their pre-tax dollars.

According to the Global Wellness Institute,

Americans spend more than $275 billion annually on out-of-pocket wellness and health initiatives.

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

a Focus on Strategic Channel Partnerships

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

Recent GTM Progress and Announcements

Since our last 10Q filing for the period

ending in September 30, 2023, we have announced several key milestones, initiatives and progress.

Some of those include:

· Planned launch of a new lab and fulfillment center to expand testing capacity, reduce costs, reduce

turnaround time and improved margins.

· Entering into a Supply and Distribution Agreement with one of India’s premier organizations, Aimil

Ltd, to lay the pre-marketing groundwork via Aimil’s extensive healthcare network.

· Receiving an Innovative Technology Contract from Vizient, the largest group purchasing organization

with a customer base encompassing 60% of hospitals and 97% of academic medical centers in the US.

· Publication of a key peer-reviewed study on PrecisionCHD development and validation for the detection

of coronary heart disease in the Journal of American Heart Association.

· An agreement with Family Medicine Specialists to test at least 1,200 of their BlueCross BlueShield

and other health plan patients across four locations.

· Obtained two Current Procedural Terminology (CPT) Proprietary Laboratory Analysis (PLA) codes from the

American Medical Association, 0440U for PrecisionCHD and 0439U for Epi+Gen CHD.

· The launch of HeartRisk, a cardiovascular risk intelligence platform, initially for employers

to provide insights that combine HIPAA-compliant anonymized and aggregated clinical cardiovascular risk data with industry and geographic

data, with the aim of helping employers understand the cardiovascular risks in their workforce compared to population and industry benchmarks.

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

with a Focus on Strategic Channel Partnerships

While our overall sales and marketing initiatives

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

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

We are targeting accelerating the

sales cycles for distribution channels for telemedicine, concierge practices, innovative health systems and employers to cycles of four

to six weeks, one to nine months, nine to twelve months and six to nine months, respectively.

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:

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,

Defensibility and Displacement

Strategic channel partners would have exclusivity

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

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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™,

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.

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

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Manufacture/Supply Chain

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.

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.

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

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.

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.

Both the Epi+Gen CHD™ and PrecisionCHD™

tests will be offered as Laboratory Developed Tests (“LDTs”) through an experienced laboratory with the appropriate Clinical

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

However, we intend to acquire a laboratory

and are currently evaluating potential lab candidates for acquisition.

clinical blood tests currently are offered as LDTs through an experienced 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 2024.

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 until 2025.

We will continue to use

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

Our Competitive Strengths

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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.

partnership efforts that bring together key healthcare stakeholders.

We believe that,

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Technology and products are strongly backed by science.

technology and products stem from over a decade of rigorous scientific research by the Founders in collaboration with other clinical

and research experts from leading organizations.

technology and products stem from over a decade of rigorous scientific research by the Founders in collaboration with other clinical and

research experts from leading organizations.

Our founders are experts in machine learning approaches in healthcare and in epigenetics

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

March 2023, our patent portfolio includes four patent families, one issued U.S.

patent, six patent applications pending worldwide, one

issued EU patent, one notice of allowance for China, two pending PCT International applications, and one provisional application generally

directed to 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 that are

critical for the continued development and improvement of our current and future products.

of March 2024, our patent portfolio includes five patent families, which encompasses issued patents in the U.S., United Kingdom, France,

Germany, Italy, Switzerland, Ireland, Hong Kong, Australia, China, and India, one allowed U.S.

patent application, two pending PCT International

applications, and more than thirty 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 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.

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 development.

built a proprietary AI-driven Integrated Genetic-Epigenetic Engine™ that is made up of layers of big data, our algorithms

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

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

built a robust product pipeline for various types of cardiovascular disease and other indications that leverage our AI-driven Integrated

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.

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Products that can potentially drive value in multiple ways.

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.

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 scalable.

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 vendors.

commercial pipeline is inherently scalable.

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 vendors.

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

In addition, the

laboratory processes can be automated and scaled by adding existing commercial equipment.

In addition, the laboratory processes 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 founder.

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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.

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.

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

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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,

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.

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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, but no competitors of which we are aware use epigenetics.

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.

whereas the scientific tenets for this approach are generally accepted, it does not identify when the 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).

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 CHD.

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

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a more relevant period of time for patient management.

Imaging modalities coupled to machine

learning 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.

In this method, a low intensity computed tomography (“CT”)

scan is taken of the heart.

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.

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.

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

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

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

Our intellectual property claims include methods to develop tests for coronary heart

disease, as well as incident and prevalent heart failure, stroke and diabetes.

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.

In summary, the cardiovascular diagnostic space

is extremely competitive and fast moving.

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 diagnostic

space is extremely competitive and fast moving.

We believe that the serum lipid, proteomic and to a certain extent, imaging-based modalities

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capacity for assisting with interventions and response monitoring.

other technologies are not static, and we expect refinements and/or combination of existing approaches to vigorously compete for customers

in our business space.

We will need to scale our efforts, orient our organization appropriately and demonstrate that our products provide

better value for our customers.

However, the other technologies are not static, and we expect refinements

and/or combination of existing approaches to vigorously compete for customers in our business space.

We will need to scale our efforts,

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

Intellectual Property

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 three patent families.

These patent applications have been filed in the United States and

foreign jurisdictions, including the European Union, Japan, Canada and China.

In the European Union a patent has already been granted.

Recently, a new provisional patent application was filed.

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 five patent families.

These patent applications have been filed in the United States and a number of foreign jurisdictions including

the European Union, Japan, India, Canada and China.

In the U.S., Patent No.

11,414,704, titled Compositions and Methods for Detecting

Predisposition to Cardiovascular Disease, was issued in 2022 to the University of Iowa Research Foundation (“UIRF”),

the co-inventors of which are Dr.

Predisposition to Cardiovascular Disease, was issued in 2022 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.

is exclusively licensed to Cardio under our license agreement with UIRF.

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.

We expect to continue to file new patent applications to protect additional products and methodologies as they emerge.

This patent family also

includes issued patents in Europe, China, Australia, India, a notice of allowance in the US, 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, around which there is currently

a family of patent and patent applications.

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

The follow-on work is described in the second and third 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 highly associated, at a statistically significant level, 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 2023, this family includes seven granted patents, one soon-to-be issued patent (received notice

of allowance), and six 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 includes a granted patent in

Europe and the U.S., an allowed application in China and pending applications in Australia, Canada, Europe, India, Japan and the U.S.

The issued claims in the EP patent are 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

first SNP in a particular region of the genome (referred to as rs10275666) or another SNP in linkage disequilibrium with the first SNP.

The European patent is validated in six European countries including France, Germany, Italy, Ireland, Switzerland, and United Kingdom.

The allowed claims in the U.S.

are directed to methods for determining the presence of a biomarker associated with coronary heart disease

(CHD) that includes performing a genotyping assay on a nucleic acid sample to detect the presence of a SNP in a particular region of the

genome (referred to as rs11597065), bisulfite converting a nucleic acid sample and performing a methylation assay to detect the presence

or absence of methylation in a particular region of the genome (referred to as cg12586707), and inputting the data from the genotyping

assay and the methylation assay into a basic, non-specific algorithm.

The original algorithm developed during the initial work is not

disclosed in the first family of patents and patent applications.

This family of patents is in-licensed under our exclusive license agreement

with UIRF and is expected to expire in 2037, absent any applicable patent term adjustments or extensions.

second family, which is follow-on work conducted by Cardio, is generally directed to a number of SNP biomarkers and a number of methylation

site biomarkers that are highly associated, at a statistically significant level, with diabetes.

This family includes a pending

PCT International application, with 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 five 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 PCT application

also includes claims to methods of determining the presence of biomarkers associated with diabetes, 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 at least one SNP.

The specific algorithm developed for the association of biomarkers with diabetes, which includes an Artificial Intelligence

(AI) component, is not a part of the disclosure of the second family of patent applications, and Cardio presently intends to maintain

this aspect as a trade secret.

Patents issuing from the second family are expected to expire in 2041, absent any applicable patent term

adjustments or extensions.

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 and fifth

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

The first family of patents and patent applications is owned solely by UIRF and is exclusively licensed by Cardio.

2024, this family includes eleven granted patents, one soon-to-be issued patent (received notice of allowance), 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 issued patents in the US, United Kingdom, France, Germany, Italy, Switzerland,

Ireland, Hong Kong, Australia, China and India, an allowed application in the U.S., and pending applications in Australia, Canada, China,

Europe, Hong Kong, and Japan.

The issued claims in the US, 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.

allowed claims in the U.S.

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 is generally directed to

biomarkers associated with diabetes.

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 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 five 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

The pending applications also include claims to methods of determining the presence of biomarkers associated with diabetes, 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 at least one SNP.

This family is co-owned by Cardio Diagnostics and UIRF, and the UIRF-owned portion

is in-licensed under the same exclusive license agreement as the first family.

Patents issuing from 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 some of the original research that was done at the University

As of December 2022, this family includes one International PCT application.

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;

ownership with UIRF or Cardio, or ownership could be shared between UIRF and us.

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

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 of patent applications, also

considered follow-on work of Cardio, is generally directed to a number of SNP biomarkers and a number of methylation site biomarkers that

are highly associated, at a statistically significant level, with the three-year incidence of cardiovascular disease.

This family includes

one pending PCT International application and a pending U.S.

application, with 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 PCT application also includes 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.

The specific algorithm developed for the association

of biomarkers with three-year incidence of cardiovascular disease, which includes an Artificial Intelligence (AI) component, is not a

part of the disclosure of the third family of patent applications, and Cardio presently intends to maintain this aspect as a trade secret.

This family of patents is owned exclusively by Cardio.

As of December 2022, this family includes one International PCT application as

well as a one U.S.

utility application.

Any and all patents issuing in this family

will be solely owned by Cardio.

Patents issuing from the third family are expected to expire in 2041, absent any applicable patent term

adjustments or extensions.

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 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 include 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 Diagnostics.

Patents issuing from this fourth family are expected to expire in 2044, absent

any applicable patent term adjustments or extensions.

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 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 .

Patents issuing from this fifth family are expected to expire in 2044, absent any applicable patent term adjustments or extensions.

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 us, 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 cease to carry on business, or file for

bankruptcy or if an involuntary bankruptcy petition is filed against the Cardio.

Additionally,

we have considerable IP in the form of trade secrets, including bioinformatics and high-performance computing techniques 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, trademarks and copyrights.

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 the 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.

future success depends on protecting that knowledge, obtaining trademarks on our products, copyright on key materials, and avoiding infringing

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opportunities to promote and maintain our competitive position.

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

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.

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.

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.

Government Regulation

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 laboratory-developed tests ("LDTs”)

in particular.

As discussed below, legislation has been introduced in Congress that 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.

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.

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

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of 1988 and State Regulation

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.

CLIA requires such laboratories to

be certified by the federal government and mandates compliance with various operational, personnel, facilities administration, validation,

quality and proficiency testing requirements intended to ensure the accuracy, reliability and timeliness of patient test results.

certification is also a prerequisite to be eligible to bill state and federal healthcare programs, as well as many commercial third-party

payers, for laboratory testing services.

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.

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.

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.”

The laboratory running the

test has also been accredited by the College of American Pathologists, or CAP, which means that it has been certified as following CAP

standards and guidelines in operating the laboratory facility and in performing tests that ensure the quality of the test results.

is a deemed accrediting body for CMS, meaning that successful inspection by CAP satisfies a laboratory’s CLIA requirements, and

results in the issuance of a Certificate of Accreditation by CMS.

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.

CLIA requires such laboratories to be certified by the federal

government and mandates compliance with various operational, personnel, facilities administration, validation, quality and proficiency

testing requirements intended to ensure the accuracy, reliability and timeliness of patient test results.

CLIA certification is also a

prerequisite to be eligible to bill state and federal healthcare programs, as well as many commercial third-party payers, for laboratory

testing services.

The Centers for Medicare & Medicaid Services (“CMS”) regulates laboratories that perform testing on

individuals in the U.S.

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

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

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.”

California Laboratory Licensing

addition to federal certification requirements for laboratories under CLIA, the laboratory is required under California law to maintai n

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.

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

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If a clinical laboratory is found to be out of compliance with California laboratory

standards, the California Department of Public Health, or 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.

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.

New York Laboratory Licensing

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, or NYS DOH, in the permitted test categories.

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.

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, or 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.

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

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.

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

CLIA does not preempt state laws that have established laboratory quality standards that are more stringent than federal law.

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 Tests

The FDA generally considers a laboratory-developed

test, or LDT, to be a test that is developed, validated, used and performed within a single laboratory.

The FDA has historically taken the position

that it has the authority to regulate LDTs as in vitro diagnostic, or IVD medical devices under the Federal Food, Drug and Cosmetic Act,

or FDC Act, but it has generally exercised enforcement discretion with regard to LDTs.

This means 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.

However, there have been situations in which FDA, because

of safety, public health, or other concerns, has required companies offering LDTs to comply with FDA regulations applicable to other IVDs,

including the requirement for premarket review and authorization.

Separately, the Centers for Medicare and Medicaid

Services, or CMS, oversees clinical laboratory operations through the CLIA program.

The regulatory environment for LDTs has changed

For example, in 2020, the Department of Health and Human Services, or HHS, directed the FDA to stop regulating LDTs, but in

2021, HHS reversed its policy.

Thereafter, the FDA resumed requiring submission of emergency use authorization, or EUA, requests, for

COVID-19 LDTs, but has not indicated an intent to change its policy of enforcement discretion with respect to other, non-COVID, LDTs.

Various bills have been

introduced in Congress seeking to substantially change the regulation of both LDTs and IVDs:

The VALID Act

In March 2020, the Verifying

Accurate Leading-edge IVCT Development, or VALID, Act was introduced in the Senate, and proposed a common regulatory framework

for in vitro clinical tests, or IVCTs, which would comprise both IVDs and LDTs, and would require premarket approval for some tests currently

offered as LDTs.

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 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.

This means 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.

In September 2023, the FDA announced a

proposed regulation that would, if adopted, alter the FDA’s historical exercise of enforcement discretion for LDTs by classifying

LDTs as medical devices.

The proposed regulation would subject LDTs to a more stringent regulatory framework, including premarket

clearance or approval requirements, quality system regulations (“QSR”), and post-market surveillance obligations.

to comply with these and other FDA regulations could result in legal actions, including fines and penalties.

The FDA has indicated

it plans to finalize the proposed rule in the second quarter of 2024, though it is uncertain whether the FDA will finalize the proposed

rule on this timeline or at all or whether there would be litigation challenging the final rule.

proposals addressing the FDA’s oversight of LDTs have been previously introduced.

In March 2020, the Verifying Accurate, Leading-edge

IVCT Development (“VALID”) Act of 2020 was introduced in the Senate, which proposed a risk-based regulatory framework

for IVDs and LDTs and required premarket approval for some in vitro clinical tests.

The VALID Act was reintroduced in

June 2021 and would similarly clarify and enhance the FDA’s authority to regulate LDTs.

The VALID Act was included in the

FDA Safety and Landmark Advancements, or FDASLA, legislation, which was favorably voted upon by the Senate Health, Education, Labor and

Pensions (HELP) Committee in June 2022.

The FDASLA will now be considered by the full Senate.

In May 2022, the House Energy and Commerce

Committee approved a version of the FDASLA that does not include the VALID Act, and which will now be considered by the full House.

the Senate and the House pass their respective versions of the FDASLA, a Senate-House conference committee will be convened to reconcile

the differences in the legislation, including any differences relating to the VALID Act.

If enacted, VALID will foreseeably have a significant

impact on the clinical laboratory sector, and many LDTs will be required to undergo FDA premarket review and authorization at some point.

The particular impact on our LDTs is difficult to predict at this time.

Depending on the final version of the legislation, some tests

already on the market as of the date of enactment may be "grandfathered” and may not require premarket authorization, at least

Other LDTs may not be required to obtain premarket authorization at all.

Additionally, the FDA will need to undertake rulemaking

or develop guidance to implement the new law, a process that would likely take months or years.

It is therefore not possible to predict

the specific impact of VALID on our operations.

If premarket authorization is required, it could lead to a substantial increase in the

time and cost to bring the tests to market or require significant resources to obtain FDA authorization to allow continued marketing of

VALID may also result in ongoing FDA regulatory obligations even for tests that do not need to undergo FDA review.

The VITAL Act

In March 2020, the Verified

Innovative Testing in American Laboratories, or VITAL, Act was introduced in the Senate, and would expressly shift the regulation

of LDTs from the FDA to CMS.

The VITAL Act was reintroduced in May 2021.

Unlike the VALID Act, the VITAL Act has not been referred to

the HELP Committee and has not been incorporated into FDASLA, making its prospects of enactment in this session of Congress unlikely.

In addition to potential legislation affecting

LDTs, the FDA or the Federal Trade Commission, or FTC, as well as state consumer protection agencies and competitors, regulate the materials

and methods used in the promotion of LDTs, including with respect to the product claims in promotional materials.

Enforcement actions

by the FDA, FTC and/or state consumer protection agencies for objectionable claims may include, among others, injunctions, civil penalties,

and equitable monetary relief.

Neither the VALID Act nor the VITAL Act has been

enacted into law as of the date of this Annual Report on Form 10-K.

Although, as mentioned above, the VALID Act was favorably voted upon

in June 2022 by the Senate Health, Education, Labor and Pensions Committee as part of the FDA Safety and Landmark Advancements bill, it

was not included in the version of that legislation that was enacted by Congress and signed into law.

Congress may, through the enactment

of other legislation during the current session of Congress or the subsequent Congress, enact VALID or establish new regulatory requirements

for LDTs through other legislation.

June 2021 and again most recently in March 2023;

the prospects for enactment are uncertain.

In March 2020, the Verified Innovative Testing

in American Laboratories (“VITAL”) Act of 2020 was introduced in the Senate, which would expressly shift the regulation of

LDTs from FDA to CMS.

The VITAL Act was reintroduced in May 2021, and has not since been reintroduced.

Neither statute has been enacted.

As mentioned above, separately, CMS oversees clinical laboratory operations through the CLIA program.

Regulation by the U.S.

Food and Drug Administration

Should the FDA decide not to 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 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, or 510(k), premarket approval,

or a PMA, or a de novo authorization.

In vitro diagnostics, or IVDs, are a type of

medical device that can be used in the diagnosis or detection of diseases or conditions, including assessment of state of health, through

collection, preparation and examination of specimens from the human body.

IVDs can be used to detect the presence of certain chemicals,

genetic information or other biomarkers related to health or disease.

IVDs include tests for disease prediction, prognosis, diagnosis,

and screening.

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

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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.

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 chosen otherwise.

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 proposed device

is substantially equivalent to a previously 510(k)-cleared device or to 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 previously cleared device is known as a predicate .

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.

In addition, the COVID-19 pandemic has resulted in significant workload increases within the Center for Devices

and Radiological Health that could affect 510(k) review timelines.

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

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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, including,

as noted above, due to delays resulting from the COVID-19 pandemic.

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.

De novo pathway.

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If the device is reclassified as Class II, the FDA will identify special controls that the manufacturer

must implement, which may include labeling, performance standards, or other requirements.

Subsequent applicants can rely upon the de novo

product 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.

In October 2021, the FDA issued final regulations codifying FDA’s expectations

for de novo requests, which went into effect in January 2022.

In October 2021, the FDA also issued updated and final guidance on the de

novo request and classification process, for the purpose of providing clarity and transparency regarding the de novo classification process.

The de novo route has historically been used for many IVD products.

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).

novo route is intended to be less burdensome than the PMA process.

Post-market general controls.

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

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 manufacturers to report to the FDA corrective actions made to products in the field, or removal of products

once in the field if such actions were initiated to reduce a risk to health posed by the device or to remedy a violation of the FDC Act).

Depending on the severity of the legal violation that led to correction or removal, the FDA may classify the manufacturer’s action

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

reduce a risk to health posed by the device or to remedy a violation of the FDC Act which may present a health risk).

Depending on the

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

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If the FDA finds a violation, it can institute a wide variety of actions, ranging from an

untitled or public warning letter to enforcement actions such as fines, injunctions, and civil penalties;

recall or seizure of products;

untitled or warning letter sent to manufacturers to enforcement actions such as fines, injunctions, and civil penalties;

recall or seizure

operating restrictions, partial suspension or total shutdown of production;

refusing requests for 510(k) clearance or PMA approval of

new products;

refusing requests for 510(k) clearance or PMA

approval of new products;

withdrawal of PMAs already granted;

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”), 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.

On September 28, 2022, the FDA issued a final guidance document interpreting the Cures Act as it pertains

to CDS software.

Among other views expressed, the final guidance stated that software functions that assess or interpret the clinical

implications or clinical relevance of a signal or pattern, such as those that process or analyze an electrochemical or photometric response

generated by an assay and instrument to generate a clinical test result, are not exempt from medical device regulation.

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.

Corporate Practice of Medicine;

Fee-Splitting

We contract with a healthcare telemedicine company

to deliver services to our 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

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.

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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 we contract with.

Failure to comply with regulations could lead to adverse judicial or administrative action against us and/or the telemedicine 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 we contract with that interfere with our business and other materially

adverse consequences.

Federal and State Fraud and Abuse Laws

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

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.

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

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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

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

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 monetary

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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

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.

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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.

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

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State Fraud and Abuse Laws

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

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

There are numerous U.S.

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 penalties.

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

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

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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

our patients reside also have laws that protect the privacy and security of sensitive and personal information, including health information.

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.

These laws may be similar to or even more protective than HIPAA and other federal privacy laws.

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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.

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

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State Privacy Laws

Various states have enacted laws governing the

privacy of personal information collected and used by businesses online.

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

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Employees and Human Capital Resources

As of March 27, 2023, we had seven

full-time employees and one part-time employee.

As of April 1, 2024, we had seven

full-time employees and two part-time employees.

Three of our employees hold Ph.D.

We also engage consultants from

time to time.

None of our employees are represented by a labor union or covered under a collective bargaining agreement.

We also engage contractors and

consultants from time to time.

None of our employees are represented by a labor union or covered under a collective bargaining

Our human capital resources objectives include,

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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, early detection

and treatment of cardiovascular disease.

Corporate Information

Acquisition Corp.

was formed on May 19, 2021 under the laws of the State of Delaware as a blank check company for the purpose of engaging

in a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination,

with one or more target businesses or entities.

Legacy Cardio was formed in January 2017 as an Iowa limited liability company (Cardio

Diagnostics, LLC) and was subsequently incorporated as a Delaware C-Corp (Cardio Diagnostics, Inc.) on September 6, 2019.

Upon completion

of the Business Combination on October 25, 2022, we changed our name to Cardio Diagnostics Holdings, Inc.

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

Aberdeen St., Suite 900, Chicago IL 60642.

West Superior Street, Suite 444, Chicago IL 60654.

Our telephone number is (855) 226-9991 and our website address is cardiodiagnosticsinc.com.

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In addition, the

Company will provide copies of these documents without charge upon request from us in writing at 400 N.

Aberdeen St., Suite 900, Chicago

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