What changed in this filing

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Item 1A. Risk Factors

2024-04-01 compared with 2023-03-31 · 801 added, 1097 removed, 909 unchanged (68% of the section changed)

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$8,376,834 for the years ended December 31, 2022 and 2023, respectively, and we have an accumulated deficit of $14,368,380 at December

expect losses to continue as a result of our ongoing activities to commercially launch our first diagnostic assessment tests, to gain market

recognition and acceptance of that initial product, to expand our marketing channels and otherwise position ourselves to grow our revenue

opportunities, all of which will require hiring additional employees as well as other significant expenses.

We are unable to predict when

we will become profitable, and it is possible that we may never become profitable.

We may encounter unforeseen expenses, difficulties,

complications, delays, and other unknown factors that may adversely affect our business.

The size of our future net losses will depend,

in part, on the rate of future growth of our expenses, which we expect to increase substantially as a public company, and on our ability

to generate revenue.

We expect losses to continue as a result of our ongoing activities to increase the adoption of our products, to gain market

recognition and acceptance of our products, to expand our marketing channels and otherwise position ourselves to grow our revenue opportunities,

all of which will require hiring additional employees as well as other significant expenses.

We are unable to predict when we will become

profitable, and it is possible that we may never become profitable.

We may encounter unforeseen expenses, difficulties, complications,

delays, and other unknown factors that may adversely affect our business.

The size of our future net losses will depend, in part, on the

rate of future growth of our expenses, which we expect to increase substantially as a public company, and on our ability to generate revenue.

Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.

If additional capital is not available when required, if at all, or is not available on acceptable terms, we could be forced to modify

or abandon our current business plan.

If additional capital

is not available when required, if at all, or is not available on acceptable terms, we could be forced to modify or abandon our current

business plan.

We believe our long-term value as a company will be greater if

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These risks and challenges include our ability to:

attract new users of our tests through patient awareness as well as through key channel participants;

gain market acceptance of our initial and future tests and services with key constituencies and maintain and expand such relationships;

attract new customers for our tests through patient awareness, sales and marketing campaigns, as well as through key channel partners;

gain market acceptance of our current and future tests and services with key constituencies and maintain and expand such relationships;

comply with existing and new laws and regulations applicable to our business and in our industry;

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future prospects and the risks and challenges we may encounter.

We were established in 2017 and we are continuing

to grow our marketing and management capabilities.

Consequently, predictions about our future success or viability may not be as accurate

as they could be if we had a longer operating history.

The evolving nature of

the medical diagnostics industry increases these uncertainties.

If our growth strategy is not successful, we may not be able to

continue to grow our revenue or operations.

Our limited operating history, evolving business and growth make it difficult to evaluate

our future prospects and the risks and challenges we may encounter.

were established in 2017 and we are continuing to grow our marketing and management capabilities.

Consequently, predictions about our

future success or viability may not be as accurate as they could be if we had a longer operating history.

evolving nature of the medical diagnostics industry increases these uncertainties.

our growth strategy is not successful, we may not be able to continue to grow our revenue or operations.

Our limited operating history,

evolving business and growth make it difficult to evaluate our future prospects and the risks and challenges we may encounter.

In addition, as a business with a limited operating

history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown challenges.

We are transitioning

to a company capable of supporting commercialization, sales and marketing.

We may not be successful in such a transition and, as a result,

our business may be adversely affected.

be successful at commercialization, sales and marketing and, as a result, our business may be adversely affected.

Our quarterly results may fluctuate significantly and may not

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Our results of operations and key metrics discussed

elsewhere in this registration statement may vary significantly in the future and period-to-period comparisons of our operating results

elsewhere in this Annual Report on Form 10-K may vary significantly in the future and period-to-period comparisons of our operating results

and key metrics may not provide a full picture of our performance.

Accordingly, the results of any one quarter or year should not be

relied upon as an indication of future performance.

Our quarterly financial results and metrics may fluctuate as a result of a variety

of factors, many of which are outside of our control, and as a result they may not fully reflect the underlying performance of our business.

These quarterly fluctuations may negatively affect the value of our securities.

Factors that may cause these fluctuations include, without

Accordingly, the results of any one quarter or year should not be relied

upon as an indication of future performance.

Our quarterly financial results and metrics may fluctuate as a result of a variety of factors,

many of which are outside of our control, and as a result they may not fully reflect the underlying performance of our business.

quarterly fluctuations may negatively affect the value of our securities.

Factors that may cause these fluctuations include, without limitation:

the level of demand for our tests and services, which may vary significantly from period to period;

our ability to attract new customers, whether patients or strategic channel partners;

our ability to attract new customers, whether patients or strategic channel partners or other customers;

the timing of recognition of revenues;

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adoption rates by participants in our key channels;

increases or decreases in the number of patients that use our tests or pricing changes upon any signing and renewals of agreements with healthcare sub-vertical channel participants;

increases or decreases in the number of patients, providers and organizations that use our tests or pricing changes upon any signing and renewals of agreements with healthcare sub-vertical channel partners;

changes in our pricing policies or those of our competitors;

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price of our Common Stock to decline.

We received less proceeds from the Business Combination than

we initially expected.

This could prevent us from executing on our business plan and may result in our results of operation and financial

condition being worse than we previously projected.

We rely on the availability of capital to grow

our business.

The projections that we prepared in June 2022 in connection with the Business Combination assumed that we would receive

at least an aggregate of $15 million in capital from the Business Combination and the Legacy Cardio private placements conducted in 2022

prior to the Business Combination.

This base amount anticipated at least $5.0 million in proceeds remaining in the Trust Account following

payment of the requested redemptions.

At Closing, we received only a nominal amount of cash from the Trust Account due to higher than

expected redemptions by Mana public stockholders and higher than expected expenses in connection with the Business Combination.

we have less cash available to pursue our anticipated growth strategies and new initiatives than we projected.

This has caused and may

continue to cause significant delays in, or limit the scope of, our planned acquisition strategy and our planned product expansion timeline.

Our actual 2022 results differ materially from

the projections that were provided for the Business Combination for several reasons, including, among other things:

(i) the actual

level of redemptions by Mana public stockholders being higher than anticipated redemption levels;

(ii) the merger transaction costs and

deferred IPO costs substantially exceeding the remainder of the funds in the Trust Account after the redemption amount was paid;

general and administrative expenses for 2022 are expected to be higher than projected as a result of higher than expected costs associated

with investing in growth initiatives and positioning Cardio to operate with a strong corporate governance structure and higher costs related

to being a public company, including those related to directors’ and officers’ liability insurance.

As a result of these and

other factors, we have earned only $950 in revenue in 2022 compared to the revenue projection of $784,250 included in the projections Legacy Cardio

provided to Mana in connection with its consideration of the Business Combination transaction.

Additionally, we currently expect our actual

2023 results to differ materially from our projections for several reasons, including, among other things:

(i) the continued and

cumulative effects of the factors described in the immediately preceding paragraph, including less than anticipated transaction proceeds

and increased costs of revenue;

(ii) higher than projected general and administrative expenses as a result of the impact of employee

and executive hires and public company expenses, including directors’ and officers’ liability insurance;

and (iii) lower

than projected revenues as a result of a having less capital to carry out the business plan on which our projections were based.

Given the dynamic nature of the markets we operate

in, and the current status of our business, although we lack the visibility to reasonably quantify, the results for the future periods

beyond 2023 may also materially differ from our projections.

Because we experienced high redemptions by Mana

public stockholders in connection with the Business Combination and high transaction costs, we have no Trust Account proceeds available

to pursue our anticipated growth strategies and new initiatives, including our acquisition strategy, which could have a material impact

on our projected estimates and assumptions and actual results of operations and financial condition.

The estimates and assumptions used

in building our projections required the exercise of judgment and were and continue to be subject to various economic, business, competitive,

regulatory, legislative, political and other factors.

There can be no assurance that the projected results will be realized even after

accounting for the differences discussed herein, or that actual results will not be significantly higher or lower than estimated.

failure to achieve our projected results could harm the trading price of our securities and our financial position, and adversely affect

our future profitability and cash flows.

We expect to need to raise additional capital to fund our existing

operations or develop and commercialize new services or expand our operations.

Due to the extremely high percentage of redemptions

requested in connection with the Business Combination, substantially all of the funds in the Trust Account that was established as the

depository of the IPO net proceeds and proceeds from the private placement sale of the Sponsor Warrants, we expect that we will need additional

capital sooner than we previously anticipated.

We incurred approximately $2.6 million in transaction costs relating to the Business Combination,

consisting of banking, legal and other professional fees, including deferred IPO expenses.

After redemptions by public stockholders and

payment of such expenses, all funds in the Trust Account at the time of the Business Combination were expended.

We expect to spend significant amounts to expand

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and to develop new tests and services.

Based upon our current operating plan, we believe that our existing cash, cash equivalents and

restricted cash will be sufficient to fund our operating and capital needs for at least the next 12 months, although we may need to delay

the timing of, or scale back, certain aspects of our business plan.

This estimate and our expectation regarding the sufficiency of funds

are based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.

Until such time, if ever, as we can generate sufficient revenues, we may finance our cash needs through a combination of equity offerings

and debt financings or other sources.

In addition, we may seek additional capital due to favorable market conditions or strategic considerations,

even if we believe that we have sufficient funds for our current or future operating plans.

If we are unable to raise additional capital, we may need to delay the timing of, or scale back,

certain aspects of our business plan and operations.

The estimate and our expectation regarding the sufficiency of funds to continue our

business plan and operations are based on assumptions that may prove to be wrong, and we could use our available capital resources sooner

than we currently expect.

Until such time, if ever, as we can generate sufficient revenues, we may finance our cash needs through a combination

of equity offerings and debt financings or other sources.

In addition, we may seek additional capital due to favorable market conditions

or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans.

Our present and future funding requirements

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our ability to achieve revenue growth;

our ability to effectively manage medical expense amounts;

our ability to effectively manage our expenses and burn;

the cost of expanding our operations, including our geographic scope, and our offerings, including our marketing efforts;

our rate of progress in launching, commercializing and establishing adoption of our services;

our rate of progress in launching, commercializing and establishing adoption of our tests and services;

the effect of competing technological and market developments.

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strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable

rights to our technologies, intellectual property, or future revenue streams or grant licenses on terms that may not be favorable to us.

Furthermore, any capital raising efforts may divert our management from their day-to-day activities, which may adversely affect our ability

to advance development activities.

If we need additional capital and cannot raise it on acceptable terms, or at all, we may not be able

to, among other things:

rights to our technologies, intellectual property, or future revenue streams or grant licenses on terms that may not be favorable to

Furthermore, any capital raising efforts may divert our management from their day-to-day activities, which may adversely affect our

ability to advance development activities.

If we need additional capital and cannot raise it on acceptable terms, or at all, we may not

be able to, among other things:

invest in our business and continue to grow our brand and expand our customer and patient bases;

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The potential loss of key employees of the acquired businesses.

In the case of an investment, alliance, joint venture, or

other partnership:

In the case of an investment, alliance, joint

venture, or other partnership:

Our ability to cooperate with our co-venturer;

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current business model is unproven and the profit potential, if any, is unknown at this time.

We are subject to all of

the risks inherent in the creation of a new business.

Our ability to achieve profitability is dependent, among other things, on our initial

marketing and accompanying product acceptance to generate sufficient operating cash flow to fund future expansion.

There can be no assurance

that our results of operations or business strategy will achieve significant revenue or profitability.

We are subject to all

of the risks inherent in the creation of a new business.

Our ability to

achieve profitability is dependent, among other things, on our initial marketing and accompanying product acceptance to generate sufficient

operating cash flow to fund current operations and future expansion.

There can be no assurance that our results of operations or business

strategy will achieve significant revenue or profitability.

The market for epigenetic tests is fairly new and unproven, and

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Our ability to attract new customers and increase

revenue from existing customers depends in part on our ability to enhance and improve its solutions, increase adoption and usage of its

revenue from existing customers depends in part on our ability to enhance and improve our solutions, increase adoption and usage of our

products and introduce new products and features.

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may have interoperability difficulties with our solutions, or may not achieve the market acceptance necessary to generate significant

If we are unable to successfully enhance our existing solutions and capabilities to meet evolving customer requirements, increase

adoption and usage of our solutions, develop new products, or if our efforts to increase the usage of our products are more expensive

than we expects, then our business, results of operations and financial condition could be harmed.

or any revenue.

If we are unable to successfully enhance our existing solutions and capabilities to meet evolving customer requirements,

increase adoption and usage of our solutions, develop new products, or if our efforts to increase the usage of our products are more expensive

than we expect, then our business, results of operations and financial condition could be harmed.

The success of our business depends on our ability to expand

into new vertical markets and attract new customers in a cost-effective manner.

order to grow our business, we plan to drive greater awareness and adoption of our tests and services from enterprises across new

vertical markets.

We intend to increase our investment in sales and marketing, as well as in technological development, to meet evolving

customer needs in these and other markets.

There is no guarantee, however, that we will be successful in gaining new customers from existing

and new markets.

We have limited experience in marketing and selling our products and services generally, and in particular in new markets,

which may present unique and unexpected challenges and difficulties.

Furthermore, we may incur additional costs to modify our current

solutions to conform to the customer’s requirements, and we may not be able to generate sufficient revenue to offset these costs.

We may also be required to comply with certain regulations required by government customers, which will require us to incur costs, devote

management time and modify our current solutions and operations.

If we are unable to comply with those regulations effectively and in

a cost-effective manner, our financial results could be adversely affected.

the costs of the new marketing channels we use or plan to pursue increase dramatically, then we may choose to use alternative and

less expensive channels, which may not be as effective as the channels we currently use or have plans to use.

As we add to or change the

mix of our marketing strategies, we may need to expand into more expensive channels than those we are currently in, which could adversely

affect our business, results of operations and financial condition.

In addition, we have limited experience marketing our products and

services and we may not be successful in selecting the marketing channels that will provide us with exposure to customers in a cost-effective

As part of our strategy to penetrate the new vertical markets, we expect to incur marketing expenses before we are able to recognize

any revenue in such markets, and these expenses may not result in increased revenue or brand awareness.

We expect to make significant

expenditures and investments in new marketing activities, and these investments may not lead to the cost-effective acquisition of additional

If we are unable to maintain effective marketing programs, then our ability to attract new customers or enter into new vertical

markets could be adversely affected.

order to grow our business, we plan to drive greater awareness and adoption

of our tests and services from customers across new vertical markets.

We intend to increase our investment in sales and marketing, as

well as in technological development, to meet evolving customer needs in these and other markets.

There is no guarantee, however, that

we will be successful in gaining new customers from existing and new markets.

We have limited experience in marketing and selling our

products and services generally, and in particular in new markets, which may present unique and unexpected challenges and difficulties.

Furthermore, we may incur additional costs to modify our current solutions to conform to the customer’s requirements, and we may

not be able to generate sufficient revenue to offset these costs.

We may also be required to comply with certain regulations required

by government customers, which will require us to incur costs, devote management time and modify our current solutions and operations.

If we are unable to comply with those regulations effectively and in a cost-effective manner, our financial results could be adversely

the costs of the new marketing channels we use or plan to pursue increase

dramatically, then we may choose to use alternative and less expensive channels, which may not be as effective as the channels we currently

use or have plans to use.

As we add to or change the mix of our marketing strategies, we may need to expand into more expensive channels

than those we are currently in, which could adversely affect our business, results of operations and financial condition.

we have limited experience marketing our products and services and we may not be successful in selecting the marketing channels that will

provide us with exposure to customers in a cost-effective manner.

As part of our strategy to penetrate the new vertical markets, we expect

to incur marketing expenses before we are able to recognize any revenue in such markets, and these expenses may not result in increased

revenue or brand awareness.

We expect to make significant expenditures and investments in new marketing activities, and these investments

may not lead to the cost-effective acquisition of additional customers.

If we are unable to maintain effective sales and marketing programs,

then our ability to attract new customers or enter into new vertical markets could be adversely affected.

Consolidation in the health care industry could have a material

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as health care providers consolidate to create larger and more integrated health care delivery systems with greater market power, these

providers may try to use their market power to negotiate fee reductions for our products and services.

providers may try to use their market power to negotiate price reductions for our products and services.

Finally, consolidation may also

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the clinical epigenetics market is still fairly new, we face competition from various sources, including large, well-capitalized technology

companies such as Exact Sciences and Prevencio.

These competitors may have better brand name recognition, greater financial and engineering

resources and larger sales teams than we have.

As a result, our competitors may be able to develop and introduce competing solutions and

technologies that may have greater capabilities than our solutions or that are able to achieve greater customer acceptance, and they may

be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, standards or customer requirements.

In addition, we may also compete with smaller companies, who may develop their own platforms that perform similar services as our platform.

companies such as Cleerly and Prevencio.

These competitors may have better brand name recognition, greater financial and engineering resources

and larger sales teams than we have.

As a result, our competitors may be able to develop and introduce competing solutions and technologies

that may have greater capabilities than our solutions or that are able to achieve greater customer acceptance, and they may be able to

respond more quickly and effectively than we can to new or changing opportunities, technologies, standards or customer requirements.

addition, we may also compete with smaller companies, who may develop their own platforms that perform similar services as our platform.

We expect that competition will increase and intensify as we continue to expand our serviceable markets and improve our tests and services.

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than ours, then our revenue could be adversely affected.

In addition , increased

competition may result in pricing pressures and require us to incur additional sales and marketing expenses, which could negatively impact

our sales, profitability and market share.

In addition ,

increased competition may result in pricing pressures and require us to

incur additional sales and marketing expenses, which could negatively impact our sales, profitability and market share.

Our business depends on customers increasing their use of our

solutions, and we may experience loss of customers or decline in their use of our solutions.

ability to grow and generate revenue depends, in part, on our ability to maintain and grow our relationships with existing customers and

convince them to increase their usage of our tests and services.

ability to grow and generate revenue depends, in part, on our ability to maintain and grow our relationships with existing customers

and convince them to increase their usage of our tests and services.

If our customers do not increase their use of our tests and services,

then our revenue may not grow, and our results of operations may be harmed.

It is difficult to accurately predict customers’ usage levels and the loss of customers or reductions in their usage levels may

have a negative impact on our business, results of operations and financial condition.

If a significant number of customers cease using,

or reduce their usage of, our tests and services, then we may be required to expend significantly more on sales and marketing than we

currently plan to expend in order to maintain or increase revenue from customers.

These additional expenditures could adversely affect

our business, results of operations and financial condition.

then our revenue may not grow, and our results

of operations may be harmed.

It is difficult to accurately predict customers’ usage levels and the loss of customers or reductions

in their usage levels may have a negative impact on our business, results of operations and financial condition.

If a significant number

of customers cease using, or reduce their usage of our tests and services, then we may be required to expend significantly more on sales

and marketing than we currently plan to expend in order to maintain or increase revenue from customers.

These additional expenditures

could adversely affect our business, results of operations and financial condition.

Our technologies and products leverage and incorporate

AI and machine learning, and their development, maintenance, and operational success are subject to various risks and uncertainties,

some of which are beyond our control and may adversely affect our business, results of operations and financial condition, and may

also result in reputational harm and liability.

One of the key components of our technology

and solutions is the use of machine learning/artificial intelligence (“ML/AI”).

While we have made, and expect to continue

to make, investments in the continued development of AI capabilities, adoption of fast changing AI technology presents risks, challenges

and potential unintended consequences.

Also, the markets for our solutions and services are rapidly evolving and are highly competitive,

and many of our competitors are also seeking to incorporate AI into their products.

Competing firms may be able to develop and embed AI

in their products more quickly than we can.

If our competitors are better able to incorporate AI in their products and we are unable to

compete effectively with them, our business, results of operations and financial condition could be adversely affected.

Our ML/AI powering our technology and products,

there are known risks of with the use of ML/AI including accuracy, bias, toxicity, privacy, security and data provenance.

testing and deploying ML/AI systems may also increase the cost of our offerings.

Our failure to adequately address potential risks relating

to the use of ML/AI in our technology and solutions could result in litigation regarding, among other things, intellectual property, privacy

and other claims that could result in liability for our company.

It may also result in new or increased governmental or regulatory scrutiny,

which could result in regulatory action, legal liabilities, regulatory penalties, and damage to our reputation, potentially harming our

business and financial condition.

The use of our AI capabilities could raise ethical or social concerns and our failure to adequately

address these concerns or the failure of our competitors, clients or other end users to do so could negatively impact our brand and reputation.

Our success in ML/AI technologies depends significantly on the continued service of our key technical personnel

especially our Chief Technology Officer and our Chief Executive Officer, and our ability to attract and retain skilled professionals

in a competitive market.

The loss of key personnel or the inability to hire and retain the necessary talent could adversely affect our

technological competitiveness and operational capabilities.

Interruptions or performance problems associated with our technology

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continued growth depends in part on the ability of customers to access its tests and services at any time and within an acceptable amount

Cardio may in the future experience, disruptions, outages and other performance problems due to a variety of factors, including

infrastructure changes, introductions of new applications and functionality, software errors and defects, capacity constraints due to

an increasing number of customers or security related incidents.

In addition, from time-to-time, Cardio or its vendors may experience

limited periods of equipment downtime, server downtime due to server failure or other technical difficulties (as well as maintenance requirements).

It may become increasingly difficult to maintain and improve our performance, especially during high volume times

and as its solution becomes more complex and its customer traffic increases.

If our solution is unavailable or if our customers are unable

to access our solutions within a reasonable amount of time or at all, our business would be adversely affected, and its brand could be

In the event of any of the factors described above, or certain other failures of our infrastructure, customer or patient data

may be permanently lost.

To the extent that Cardio does not effectively address capacity constraints, upgrade its systems, as needed,

and continually develop our technology and network architecture to accommodate actual and anticipated changes in technology, customers

may cease to use our solutions and our business and operating results may be adversely affected.

We may in the future experience disruptions, outages and other performance problems due to a variety of factors, including challenges

with suppliers, infrastructure changes, introductions of new applications and functionality, software errors and defects, capacity constraints

due to an increasing number of customers or security related incidents.

In addition, from time-to-time, we or our vendors may experience

limited periods of equipment downtime, server downtime due to server failure or other technical difficulties (as well as maintenance

requirements).

It may become increasingly difficult to maintain and improve our performance, especially during high volume

times and as our solution becomes more complex and our customer demand

and traffic increases.

If our solution is unavailable or if our customers are unable to access our solutions within a reasonable amount

of time or at all, our business would be adversely affected, and its brand could be harmed.

In the event of any of the factors described

above, or certain other failures of our infrastructure, customer or patient data may be permanently lost.

To the extent that we do not

effectively address capacity constraints, upgrade our systems, as needed, and continually develop our technology and network architecture

to accommodate actual and anticipated changes in technology, customers may cease to use our solutions and our business and operating

results may be adversely affected.

We rely on a limited number of suppliers, contract manufacturers,

and logistics providers, and our test is performed by a single contract high complexity Clinical Laboratory Improvement Amendments (CLIA)

our Epi+Gen CHD™ test, we and our vendors rely on a limited number of suppliers for laboratory reagents and sampling kit supplies,

contract manufacturers, and logistics providers.

For example, certain proprietary reagents are manufactured under Good Manufacturing Practice

(GMP) by a single contract manufacturer located in Michigan;

the sample collection kits are assembled and fulfilled by one fulfillment

center located in Iowa;

and the Epi+Gen CHD™ test is performed in one high complexity CLIA laboratory located in Missouri.

on a limited number of suppliers and a sole contract manufacturer, fulfillment

center and laboratory present various risks.

These include the risk that in the event of an interruption from any part of our supply chain

for any reason, such as a natural catastrophe, labor dispute, or system interruption.

We may not be able to develop an alternate source

without incurring material additional costs and substantial delays.

For example, during 2021, the Coronavirus pandemic impacted the ability

to conduct in-person training of personnel at the laboratory, which delayed launch of Epi+Gen CHD™ by approximately two and a half

As a public company, the delay of a product launch by a nearly a fiscal quarter could cause our reported results of operations

to fail to meet market expectations, which, in turn, and could negatively impact our stock price.

our Epi+Gen CHD™ and PrecisionCHD™ tests, we and our vendors rely on a limited number of suppliers for laboratory reagents

and sampling kit supplies, contract manufacturers, and logistics providers.

For example, certain proprietary reagents are manufactured

under Good Manufacturing Practice (GMP) by a single contract manufacturer located in Michigan;

the blood collection tubes included in

the sample collection kits are manufactured by a single manufacturer;

and the tests are performed in one high complexity CLIA laboratory

located in Missouri.

The reliance on a limited number of suppliers

and a sole contract manufacturer and laboratory present various risks.

These include the risk that in the event of an interruption from

any part of our supply chain for any reason, such as a natural catastrophe, labor dispute, or system interruption.

We may not be able

to develop an alternate source without incurring material additional costs and substantial delays.

For example, during 2021, the Coronavirus

pandemic impacted the ability to conduct in-person training of personnel at the laboratory, which delayed the launch of Epi+Gen CHD™

by approximately two and a half months.

As a public company, the delay of a product launch by a nearly a fiscal quarter could cause our

reported results of operations to fail to meet market expectations, which, in turn, and could negatively impact our stock price.

The security of our solutions, networks or computer systems may

be breached, and any unauthorized access to our customer data will have an adverse effect on its business and reputation.

be breached, and any unauthorized access to our customer data will have an adverse effect on our business and reputation.

The use of our solutions involves the storage,

transmission and processing of our customers’ private data, and this data may contain confidential and proprietary information of

our customers or their customers’ patients, employees, business partners or other persons (“customer personnel”) or

other personal or identifying information regarding our customers and customer personnel.

Individuals or entities may attempt to penetrate

our network or platform security, or that of our third-party hosting and storage providers, and could gain access to our customer and

customer personnel private data, which could result in the destruction, disclosure or misappropriation of proprietary or confidential

information of our customers and customer personnel.

If any of our customers’ or customer personnel’s private data is leaked,

obtained by others or destroyed without authorization, it could harm our reputation, we could be exposed to civil and criminal liability,

and we may lose our ability to access private data, which will adversely affect the quality and performance of our solutions.

In addition, our services may be subject to

computer malware, viruses and computer hacking, fraudulent use attempts and phishing attacks, all of which have become more prevalent

in our industry.

Though it is difficult to determine what, if any, harm may directly result from any specific interruption or attack,

they may include the theft or destruction of data owned by Cardio or our customers or customer personnel, and/or damage to our platform.

our customers or their customers, patients, employees, business partners or other persons (“customer personnel”) or other

personal or identifying information regarding our customers and customer personnel.

Individuals or entities may attempt to penetrate our

network or platform security, or that of our third-party hosting and storage providers, and could gain access to our customer and customer

personnel private data, which could result in the destruction, disclosure or misappropriation of proprietary or confidential information

of our customers and customer personnel.

If any of our customers’ or customer personnel’s private data is leaked, obtained

by others or destroyed without authorization, it could harm our reputation, we could be exposed to civil and criminal liability, and we

may lose our ability to access private data, which will adversely affect the quality and performance of our solutions.

In addition, our platform and services may be

subject to computer malware, viruses and computer hacking, fraudulent use attempts and phishing attacks, all of which have become more

prevalent in our industry.

Though it is difficult to determine what, if any, harm may directly result from any specific interruption or

attack, they may include the theft or destruction of data owned by us or our customers or customer personnel, and/or damage to our platform.

Any failure to maintain the performance, reliability, security and availability of our products and technical infrastructure to the satisfaction

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any such security breach.

Unauthorized access to or security breaches of its platform, network or computer systems, or those of our technology

Unauthorized access to or security breaches of our platform, network or computer systems, or those of our technology

service providers, could result in the loss of business, reputational damage, regulatory investigations and orders, litigation, indemnity

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If customers believe that our platform does not provide adequate

security for the storage of sensitive information or its transmission over the

Internet, our business will be harmed.

Customers’ concerns about security or privacy may deter them from using our solutions for

activities that involve personal or other sensitive information.

security for the storage of sensitive information or its transmission over

the Internet, our business will be harmed.

Customers’ concerns about

security or privacy may deter them from using our solutions for activities that involve personal or other sensitive information.

We maintain cybersecurity coverage;

this coverage may not continue to be available on acceptable terms, may not be available in sufficient amounts to cover one or more large

claims against us, and may include larger self-insured retentions or certain exclusions.

In addition, the insurer might disclaim coverage

as to any future claim.

A successful claim not fully covered by our insurance could have a material adverse impact on our liquidity, financial

condition, and results of operations.

Any failure to offer high-quality customer support may adversely

affect our relationships with our customers.

ability to retain existing customers and attract new customers depends in part on its ability to maintain a consistently high level of

ability to retain existing customers and attract new customers depends in part on our ability to maintain a consistently high level of

customer service and technical support.

Our current and future customers depend on its customer support team

to assist them in utilizing our tests and services effectively and to help them to resolve issues quickly and to provide ongoing support.

If we are unable to hire and train sufficient support resources or are otherwise unsuccessful in assisting our customers effectively,

it could adversely affect our ability to retain existing customers and could prevent prospective customers from adopting our solutions.

We may be unable to respond quickly enough to accommodate short-term increases in demand for customer support.

We also may be unable to

modify the nature, scope and delivery of our customer support to compete with changes in the support services provided by our competitors.

Increased demand for customer support, without corresponding revenue, could increase our costs and adversely affect our business, results

Our current and future customers depend on our customer support

team to assist them in utilizing our tests and services effectively and

to help them to resolve issues quickly and to provide ongoing support.

If we are unable to hire and train sufficient support resources or

are otherwise unsuccessful in assisting our customers effectively, it could adversely affect our ability to retain existing customers

and could prevent prospective customers from adopting our solutions.

We may be unable to respond quickly enough to accommodate short-term

increases in demand for customer support.

We also may be unable to modify the nature, scope and delivery of our customer support to compete

with changes in the support services provided by our competitors.

Increased demand for customer support, without corresponding revenue,

could increase our costs and adversely affect our business, results of operations and financial condition.

Our sales are and will be highly

dependent on our business reputation and on positive recommendations from customers.

Any failure to maintain high-quality customer support,

or a market perception that we do not maintain high-quality customer support, could adversely affect our reputation, business, results

of operations and financial condition.

Our sales are and will be highly dependent on its business reputation and on positive recommendations

from customers.

Any failure to maintain high-quality customer support, or a market perception that we do not maintain high-quality customer

support, could adversely affect our reputation, business, results of operations and financial condition.

The information that we provide to our customers could be inaccurate

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data in the healthcare industry is fragmented in origin, inconsistent in format, and often incomplete, the overall quality of data received

or accessed in the healthcare industry is often poor, the degree or amount of data which is

knowingly or unknowingly absent or omitted can be material.

If the test results that we provide to our customers are based on incorrect

or incomplete data or if we make mistakes in the capture, input, or analysis of these data, our reputation may suffer, and our ability

to attract and retain customers may be materially harmed.

or accessed in the healthcare industry is often poor, the degree or amount of data which

is knowingly or unknowingly absent or omitted can be material.

results that we provide to our customers are based on incorrect or incomplete data or if we make mistakes in the capture, input, or analysis

of these data, our reputation may suffer, and our ability to attract and retain customers may be materially harmed.

addition, in the future, we may assist our customers with the management and submission of data to governmental entities, including CMS.

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If we fail to abide by

such policies or submits incorrect or incomplete data, we may be exposed to liability to a client, court, or government agency

that concludes that its storage, handling, submission, delivery, or display of health information or other data was wrongful or erroneous.

such policies or submits incorrect or incomplete data, we may be exposed

to liability to a client, court, or government agency that concludes that its storage, handling, submission, delivery, or display of health

information or other data was wrongful or erroneous.

Our proprietary applications may not operate properly, which

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may become less competitive, and our business may suffer.

The clinical epigenetic testing and cardiovascular

diagnostics markets are undergoing rapid technological change, frequent product and service innovation and evolving industry standards.

If we are unable to provide enhancements and new features for our existing tests and services or additional tests and services that achieve

market acceptance or that keep pace with these technological developments, our business could be adversely affected.

The success of enhancements,

new tests and services depends on several factors, including the timely completion, introduction and market acceptance of the innovations.

The clinical epigenetic testing, artificial intelligence/machine

learning-based solutions and the cardiovascular diagnostics markets are undergoing rapid technological change, frequent product and service

innovation and evolving industry standards.

If we are unable to provide enhancements and new features for our existing tests and services

or additional tests and services that achieve market acceptance or that keep pace with these technological developments, our business

could be adversely affected.

The success of enhancements, new tests and services depends on several factors, including the timely completion,

introduction and market acceptance of the innovations.

Failure in this regard may significantly impair our revenue growth.

In addition, because our solutions are designed to operate on existing

cloud software and technologies, we will need to continuously modify and enhance our solutions to keep pace with changes in internet-related

hardware, software, communication, browser and database technologies, alongside changes in laboratory technologies.

We may not be successful

in either developing these modifications and enhancements or in bringing them to market in a timely fashion.

Furthermore, uncertainties

about the timing and nature of new diagnostic tests, network platforms or technologies, including laboratory technologies, or modifications

to existing tests, platforms or technologies, could increase our research and development expenses.

Any failure of our solutions to keep

pace with technological changes or operate effectively with future network platforms and technologies, including laboratory technologies,

could reduce the demand for our solutions, result in customer dissatisfaction and adversely affect our business.

because our solutions are designed to operate on existing cloud software and technologies, we will need to continuously modify and enhance

our solutions to keep pace with changes in internet-related hardware, software, communication, browser and database technologies, alongside

changes in laboratory technologies.

We may not be successful in either developing these modifications and enhancements or in bringing

them to market in a timely fashion.

Furthermore, uncertainties about the timing and nature of new diagnostic tests, network platforms

or technologies, including laboratory technologies, or modifications to existing tests, platforms or technologies, could increase our

research and development expenses.

Any failure of our solutions to keep pace with technological changes or operate effectively with future

network platforms and technologies, including laboratory technologies, could reduce the demand for our solutions, result in customer dissatisfaction

and adversely affect our business.

Our growth strategy may not prove viable and expected growth

and value may not be realized.

While our overall sales and marketing initiatives

will span the gamut across traditional, print and digital mediums, our primary sales

and marketing strategy consists of the branding, collaboration, co-marketing, and co-sales opportunities involved in strategic

channel partnerships.

By prioritizing strategic channel partnerships, we believe we can accelerate our market penetration into the key

healthcare sub-verticals we intend to prioritize for our growth.

The key to our efforts is a well-defined and executed channel partnership

integration strategy that we believe will serve to accelerate the sales cycle.

Although there is no assurance, we believe such strategic

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

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

There can be no assurance that we will be successful

in acquiring customers through these and other strategies.

Insiders will continue to have substantial influence over the

Company after the Business Combination, which could limit investors’ ability to affect the outcome of key transactions, including

a change of control.

Following the Business Combination, our executive

officers and directors beneficially own approximately 36.7% of our outstanding Common Stock.

As a result, these stockholders, if they

act together, will be able to influence our management and affairs and most matters requiring stockholder approval, including the election

of directors and approval of significant corporate transactions.

They may also have interests that differ from other investors and may

vote in a way with which other investors disagree and which may be adverse to other investors’ interests.

This concentration of

ownership may have the effect of delaying, preventing or deterring a change in control of our Company and might affect the market price

of our Common Stock.

our overall sales and marketing initiatives will span the gamut across traditional, print and digital mediums, our primary sales

and marketing strategy consists of the branding, collaboration, co-marketing,

and co-sales opportunities involved in strategic channel partnerships.

By prioritizing strategic channel partnerships, we believe we can

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

The key to our efforts

is a well-defined and executed channel partnership integration strategy that we believe will serve to accelerate the sales cycle.

there is no assurance, we believe such strategic channel partnerships will generate revenue in a myriad of ways, including larger contracts

for our Epi+Gen CHD™ and PrecisionCHD™ tests, our HeartRisk platform, and bundling our solutions alongside other

synergistic technologies, services, and products.

There can be no assurance that we will be successful in acquiring customers through

these and other strategies.

Market and economic conditions may negatively impact our business,

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adopted by the SEC, are creating uncertainty for public companies.

Our new management following the Business Combination will need to

invest significant time and financial resources to comply with both existing and evolving requirements for public companies, which will

lead, among other things, to significantly increased general and administrative expenses and a certain diversion of management time and

attention from revenue generating activities to compliance activities.

Our management will need to invest significant time and financial resources

to comply with both existing and evolving requirements for public companies, which will lead, among other things, to significantly increased

general and administrative expenses and a certain diversion of management time and attention from revenue generating activities to compliance

Risks Related to our Business Operations

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against us, any ensuing litigation, regardless of outcome, could result in a substantial cost to the Company, divert management’s

attention from operations, and decrease market acceptance of our toolsets.

attention from operations, and decrease market acceptance of our solutions.

The limitations of liability set forth in any contracts we

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Additionally, we

may be subject to claims that are not explicitly covered by contract.

may be subject to claims that are not explicitly covered by a contract.

We also maintain general liability coverage;

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our business will suffer.

Our future success depends, in part, on our

ability to continue to attract and retain highly skilled personnel.

we believe that there is, and will continue to be, intense competition

for highly skilled management, medical, engineering, data science, sales and other personnel with experience in our industry.

provide competitive compensation packages and a high-quality work environment to hire, retain and motivate employees.

are unable to retain and motivate our existing employees and attract qualified personnel to fill key positions, we may be unable

to manage our business effectively, including the development, marketing and sale of our products, which could adversely affect our business,

results of operations and financial condition.

To the extent we hire personnel from competitors, we also may be subject to allegations

that they have been improperly solicited or that they have divulged proprietary or other confidential information.

If we are unable to

retain our employees, our business, results of operations and financial condition could be adversely affected.

future success depends, in part, on our ability to continue to attract and retain highly skilled personnel.

we believe that there is,

and will continue to be, intense competition for highly skilled management, medical, engineering, data science, sales and other personnel

with experience in our industry.

We must provide competitive compensation packages and a high-quality work environment to hire, retain

and motivate employees.

If we are unable

to retain and motivate our existing employees and attract qualified personnel to fill key positions, we may be unable to manage our business

effectively, including the development, marketing and sale of our products, which could adversely affect our business, results of operations

and financial condition.

To the extent we hire personnel from competitors, we also may be subject to allegations that they have been improperly

solicited or that they have divulged proprietary or other confidential information.

If we are unable to retain our employees, our business,

results of operations and financial condition could be adversely affected.

If we cannot maintain our corporate culture as it grows, we could

lose the innovation, teamwork, passion and focus on execution that it believes contribute to its success, and its business may be harmed.

We believe that our corporate culture is a critical

component to our success.

We have and will continue to invest substantial time

and resources in building our team.

believe that our corporate culture is a critical component to our success.

We have and will continue to invest substantial

time and resources in building our team.

As we grow and develop the infrastructure of a public company, we may find it difficult to maintain

our corporate culture.

Any failure to preserve our culture could negatively affect our future success, including our ability to

retain and recruit personnel and effectively focus on and pursue our corporate objectives.

Any failure to preserve our culture could negatively

affect our future success, including our ability to retain and recruit personnel and effectively focus on and pursue our corporate objectives.

We may be unable to manage our growth.

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costs, manage our marketing programs in conjunction with an emerging market, and attract, train, motivate and manage our employees effectively.

Our growth strategy will place significant demands on our management team and our financial, administrative and other resources.

Operating results will depend substantially on the ability of our officers and key employees to manage changing business

conditions and to implement and improve its financial, administrative and other resources.

Our growth strategy will place significant demands on our management team

and our financial, administrative and other resources.

Operating results will depend substantially on the ability of our officers and

key employees to manage changing business conditions

and to implement and improve its financial, administrative and other resources.

management fails to manage the expected growth, our results of operations, financial condition, business and prospects could be adversely

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the managers and employees of the respective business entities.

If we are unable to respond to and manage changing business conditions,

or the scale of our operations, then the quality of our products and services, our ability to retain key personnel, and our business could

be harmed, which in turn, could adversely affect our results of operations, financial

condition, business and prospects.

are unable to respond to and manage changing business conditions, or the scale of our operations, then the quality of our products and

services, our ability to retain key personnel, and our business could be harmed, which in turn, could adversely affect our results

of operations, financial condition, business and prospects.

Our Board of Directors may change its strategies, policies, and

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or future obligations.

Our investment, financing, leverage, and dividend

policies, and our policies with respect to all other activities, including growth, capitalization, and operations, are determined exclusively

by our board of directors, and may be amended or revised at any time by

our board of directors without notice to or a vote of our stockholders.

This could result in the Company conducting operational matters,

making investments, or pursuing different business or growth strategies than those contemplated in this Annual Report on Form 10-K.

our charter and bylaws do not limit the amount or percentage of indebtedness, funded or otherwise, that we may incur.

High leverage also

increases the risk of default on our obligations.

In addition, a change in our investment policies, including the manner in which we allocate

our resources across our portfolio or the types of assets in which we seek to invest, may increase our exposure to interest rate risk

and liquidity risk.

Changes to our policies with regards to the foregoing could materially adversely affect our financial condition, results

of operations, and cash flow.

investment, financing, leverage, and dividend policies, and our policies with respect to all other activities, including growth, capitalization,

and operations, are determined exclusively by our board of directors, and may be

amended or revised at any time by our board of directors without notice to or

a vote of our stockholders.

This could result in the Company conducting operational matters, making investments, or pursuing different

business or growth strategies than those contemplated in this Annual Report on Form 10-K.

Further, our charter and bylaws do not limit

the amount or percentage of indebtedness, funded or otherwise, that we may incur.

High leverage also increases the risk of default on

our obligations.

In addition, a change in our investment policies, including the manner in which we allocate our resources across our

portfolio or the types of assets in which we seek to invest, may increase our exposure to interest rate risk and liquidity risk.

to our policies with regards to the foregoing could materially adversely affect our financial condition, results of operations, and cash

Our business is subject to the risks of earthquakes, fire, floods,

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Further, if a natural disaster or man-made problem were to affect our network service

providers or Internet service providers, this could adversely affect the ability of our customers to use its products and platform.

addition, natural disasters and acts of terrorism could cause disruptions in our business, or the businesses of our customers or service

We also rely, and will continue to rely, on our network and third-party infrastructure and enterprise applications and internal

technology systems for our engineering, sales and marketing and operations activities.

Further, if a natural disaster, health epidemics

or pandemic, or man-made problem were to affect our network service providers or Internet service providers, this could adversely affect

the ability of our customers to use our products and platform.

In addition, health epidemics or pandemics, natural disasters and acts

of terrorism could cause disruptions in our business, or the businesses of its customers or service providers.

providers or Internet service providers, this could adversely affect the ability of our customers to use our products and platform.

addition, health epidemics or pandemics, natural disasters and acts of terrorism could cause disruptions in our business, or the businesses

of our customers or service providers.

We also rely, and will continue to rely, on our network and third-party infrastructure and enterprise

applications and internal technology systems for our engineering, sales and marketing and operations activities.

In the event of a major

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time-consuming to defend and could harm our reputation regardless of the outcome.

We may in the future become subject to legal

proceedings and claims that arise in the ordinary course of business, including intellectual property, collaboration, licensing agreement,

product liability, employment, class action, whistleblower and other litigation claims, and governmental and other regulatory investigations

and proceedings.

Such matters can be time- consuming , divert management’s

attention and resources, cause us to incur significant expenses or liability, or require us to change our business practices.

the expense of litigation and the timing of this expense from period to period are difficult to estimate, subject to change, and could

adversely affect our financial condition and results of operations.

Because of the potential risks, expenses, and uncertainties of litigation,

we may, from time to time, settle disputes, even where we have meritorious claims or defenses, by agreeing to settlement agreements.

of the foregoing could adversely affect our business, financial condition, and results of operations.

may in the future become subject to legal proceedings and claims that arise in the ordinary course of business, including intellectual

property, collaboration, licensing agreement, product liability, employment, class action, whistleblower and other litigation claims,

and governmental and other regulatory investigations and proceedings.

Such matters can be time- consuming ,

divert management’s attention and resources, cause us to incur significant expenses or liability, or require us to change our business

In addition, the expense of litigation and the timing of this expense from period to period are difficult to estimate, subject

to change, and could adversely affect our financial condition and results of operations.

Because of the potential risks, expenses, and

uncertainties of litigation, we may, from time to time, settle disputes, even where we have meritorious claims or defenses, by agreeing

to settlement agreements.

Any of the foregoing could adversely affect our business, financial condition, and results of operations.

Risks Related to our Intellectual Property

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to this broad definition of Technical Information raises the possibility that unaffiliated third parties could use such Technical Information,

including Technical Information developed by the Company, to make, use, sell, offer to sell and import products and/or processes that

including Technical Information used by the Company, to make, use, sell, offer to sell and import products and/or processes that

compete with the Company’s exclusively-licensed products and/or processes or are positioned in markets that the Company may enter

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by us of its intellectual property rights could result in significant costs and harm our business and operating results.

success depends upon our ability to refrain from infringing upon the intellectual property rights of others.

Some companies, including

some of our competitors, own large numbers of patents, copyrights and trademarks, which they may use to assert claims against us.

grow and enter new markets, we will face a growing number of competitors.

As the number of competitors in our industry grows and the functionality

of products in different industry segments overlaps, we expect that software and other solutions in our industry may be subject to such

claims by third parties.

Third parties may in the future assert claims of infringement, misappropriation or other violations of intellectual

property rights against us.

We cannot assure investors that infringement claims will not be asserted against us in the future, or that,

if asserted, any infringement claim will be successfully defended.

A successful claim against us could require that we pay substantial

damages or ongoing royalty payments, prevent us from offering our products and services, or require that we comply with other unfavorable

We may also be obligated to indemnify our customers or business partners or pay substantial settlement costs, including royalty

payments, in connection with any such claim or litigation and to obtain licenses, modify applications or refund fees, which could be costly.

Even if we were to prevail in such a dispute, any litigation regarding our intellectual property could be costly and time-consuming and

divert the attention of our management and key personnel from our business operations.

success depends upon our ability to refrain from infringing upon the intellectual

property rights of others.

Some companies, including some of our competitors, own large numbers of patents, copyrights and trademarks,

which they may use to assert claims against us.

As we grow and enter new markets, we will face a growing number of competitors.

number of competitors in our industry grows and the functionality of products in different industry segments overlaps, we expect that

software and other solutions in our industry may be subject to such claims by third parties.

Third parties may in the future assert claims

of infringement, misappropriation or other violations of intellectual property rights against us.

We cannot assure investors that infringement

claims will not be asserted against us in the future, or that, if asserted, any infringement claim will be successfully defended.

claim against us could require that we pay substantial damages or ongoing royalty payments, prevent us from offering our products and

services, or require that we comply with other unfavorable terms.

We may also be obligated to indemnify our customers or business partners

or pay substantial settlement costs, including royalty payments, in connection with any such claim or litigation and to obtain licenses,

modify applications or refund fees, which could be costly.

Even if we were to prevail in such a dispute, any litigation regarding our

intellectual property could be costly and time-consuming and divert the attention of our management and key personnel from our business

Certain of our core technology is licensed, and that license

may be terminated if we were to breach our obligations under the license.

The initial work on our core technology is derived

from work done by our founders while at the University of Iowa, around which there is currently a family of patent applications, the rights

of which are owned by the University of Iowa Research Foundation (UIRF) and exclusively licensed to us.

In addition, 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.

Therefore, the follow-on work is co-owned by UIRF and us, and exclusively licensed to us under the license agreement with UIRF.

agreement and those licenses granted under the 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 if we fail 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 us.

The license agreement can also be terminated by UIRF as a result of our failure to timely achieve certain performance

goals, including minimum requirements for commercial sales of our cardiac test, provided that URIF first provides written notice to us

of such failure and if such failure is not remedied within 90 days following any such notice.

work on our core technology is derived from work done by our founders while at the University of Iowa, around which there is currently

a family of patent applications, the rights of which are owned by the University of Iowa Research Foundation (UIRF) and exclusively licensed

In addition, certain 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.

Therefore, certain follow-on work is co-owned by UIRF and us, and exclusively licensed to us

under the license agreement with UIRF.

That license agreement and those licenses granted under the 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.

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 if we fail 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 us.

The license agreement can also be terminated by UIRF

as a result of our failure to timely achieve certain performance goals, including minimum requirements for commercial sales of our cardiac

test, provided that UIRF first provides written notice to us of such failure and if such failure is not remedied within 90 days following

any such notice.

Some of our technologies incorporate “open-source”

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or assessment or litigation.

In order to provide our products, we currently

use a variety of technologies including, for example, genotyping, digital methylation assessment and data processing technologies owned

by third parties.

The terms of these agreements , and any other “open

source” software agreements we may rely upon in the future, are subject to change without notice and may increase our costs.

our failure to comply with the terms of one or more of these agreements could expose us to business disruption because the license may

be terminated automatically due to non-compliance.

The use and distribution of open-source software

may also entail greater risks than the use of third-party commercial software,

order to provide our products, we currently use a variety of technologies including, for example, genotyping, digital methylation assessment

and data processing technologies owned by third parties.

The terms of these agreements ,

and any other “open source” software agreements we may rely upon in the future, are subject to change without notice and may

increase our costs.

Moreover, our failure to comply with the terms of one or more of these agreements could expose us to business disruption

because the license may be terminated automatically due to non-compliance.

use and distribution of open-source software may also entail greater risks than the use of third-party commercial software,

as open-source licensors generally do not provide warranties or other contractual protections regarding infringement claims or the quality

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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 proprietary source code.

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

Furthermore, we might be forced to limit the features available in our current or future solutions.

If these delays and feature

limitations occur, our business, results of operations and financial condition could be adversely affected.

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 proprietary source code.

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

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.

If these delays and feature limitations occur, our business, results of operations and financial condition could

be adversely affected.

Intellectual property

that is in-licensed may have been made using government funding and, thus, may be subject to federal regulations under the Bayh-Dole Act.

The intellectual property Cardio has licensed

from UIRF is indicated as having been discovered through government funded programs and thus, may be subject to federal regulations under

the Bayh-Dole Act.

In general, the Bayh-Dole Act provides the U.S.

government certain rights in inventions developed using government

funding, such as a right to a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.

In addition, intellectual property generated with government funding is also subject to certain reporting requirements, and the Bayh-Dole

Act requires that any products subject to the Bayh-Dole Act be manufactured substantially in the United States, although this manufacturing

requirement can be waived if the owner of the patents and applications can show that reasonable efforts to manufacture the product substantially

in the United States were unsuccessful, or that under the circumstances, domestic manufacture is not commercially feasible.

Under the Bayh-Dole Act, the U.S.

has the right to take title to inventions developed using a U.S.

government funded program, referred to as “march-in rights,”

for a number of reasons including, for example, failure to disclose the invention to the government or failure to file an application

within specified time limits.

In addition, under the Bayh-Dole Act, the U.S.

government has the right to require any invention developed

government funding to be granted exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a

third party if it determines that (i) adequate steps have not been taken to commercialize the invention (ii) government action is necessary

to meet public health or safety needs or (iii) government action is necessary to meet requirements for public use under federal regulations.

Compliance with such regulations may limit Cardio’s

exclusive rights, subject Cardio to expenditure of resources with respect to reporting requirements and limit Cardio’s ability to

contract with non-U.S.

manufacturers.

In addition, any exercise by the government of any of the foregoing rights under the Bayh-Dole Act

may affect Cardio’s competitive position, business, financial condition, results of operations, and prospects.

Risks Related to Government Regulation

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Comprehensive statutes and regulations govern the manner in which we

provide and bill for services and collect reimbursement from governmental programs and private payors, our contractual relationships with

our providers, vendors and customers, our marketing activities and other aspects of our operations.

provide and bill for our products services and collect reimbursement from governmental programs and private payors, our contractual relationships

with providers, vendors and customers, our marketing activities and other aspects of our operations.

Of particular importance are:

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Any action against us for violation of these laws or regulations, even if we successfully defend against it, could cause us to incur significant

legal expenses, divert management’s attention from the operation of our business and result in adverse publicity.

legal expenses, divert management’s attention from the operation of our business and result in loss of customers and adverse publicity.

To enforce compliance with the federal laws,

14 unchanged sentences

healthcare providers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.

laws, regulations and standards governing the provision of healthcare services may change significantly in the future.

We cannot assure

investors that any new or changed healthcare laws, regulations or standards will not materially adversely affect our business.

assure investors that a review of our business by judicial, law enforcement, regulatory or accreditation authorities will not result in

a determination that could adversely affect our operations.

The laws, regulations and standards

governing the provision of healthcare services may change significantly in the future.

We cannot assure investors that any new or changed

healthcare laws, regulations or standards will not materially adversely affect our business.

We cannot assure investors that a review

of our business by judicial, law enforcement, regulatory or accreditation authorities will not result in a determination that could adversely

affect our operations.

Food and Drug Administration (the “FDA”)

1 unchanged sentence

or approval and incur costs associated with complying with post-market controls.

We believe the test that we currently offers

is a laboratory-developed test, or “LDT.” The FDA generally considers

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

The FDA sometimes determines that a test that

is being offered by a laboratory as an LDT is not an LDT under the FDA’s interpretation of that term but is an in vitro diagnostic

(“IVD”) medical device in commercial distribution, and therefore must

comply with the regulations that apply to IVDs, including the need for successfully completing the FDA review process.

If the FDA were

to conclude that our test is not an LDT, we would be subject to extensive regulation as a medical device.

Moreover, even for tests that are deemed to be

LDTs, the FDA has historically taken the position that it has the authority to regulate such tests as IVDs under the Federal Food, Drug,

and Cosmetic Act, or FDC Act, although 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 clearance of LDTs, it has generally chosen not to enforce those requirements.

The regulatory environment for LDTs has changed over

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 revamp the regulation of both LDTs and IVDs.

For example, the VALID Act, introduced

in June 2021, would clarify and enhance the FDA’s authority to regulate LDTs, while the VITAL Act, introduced in May 2021, would

assign oversight of LDTs exclusively to the Centers for Medicare and Medicaid Services, or CMS.

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 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.

In the meantime, the regulation by the FDA of

LDTs remains uncertain.

The FDA may, if Congress does not enact new legislation, seek to establish new requirements for LDTs.

premarket clearance, approval or authorization is required by FDA for any of our existing or future tests, or for any components or materials

we use in our tests, such as the component used to collect samples from patients, we may be forced to stop selling our tests or we may

be required to modify claims for or make other changes to our tests while we work to obtain FDA clearance, approval or de novo authorization.

Our business would be adversely affected while such review is ongoing and if we are ultimately unable to obtain premarket clearance, approval

or de novo authorization.

For example, the regulatory premarket clearance, approval or de novo authorization process may involve, among

other things, successfully completing analytical, pre-clinical and/or clinical studies beyond the studies we have already performed or

plans to perform for our LDT.

These studies may be extensive and costly and may take a substantial period of time to complete.

studies may fail to generate data that meets the FDA’s requirements .

The studies may also not be conducted in a manner that meets the FDA’s requirements, and therefore could not be used in support

of the marketing application.

We would also need to submit a premarket notification, or 510(k), a request for de novo authorization, or

a PMA application to the FDA and to include information ( e.g.

, clinical and other data) supporting our LDT.

Completing such studies

requires the expenditure of time, attention and financial and other resources, and may not yield the desired results, which may delay,

limit or prevent regulatory clearances, approvals or de novo authorizations.

There can be no assurance that the submission of such an

application will result in a timely response by the FDA or a favorable outcome that will allow the test to be marketed.

Certain types of standalone diagnostics software

are subject to FDA regulation as a medical device (specifically, software as a medical device or “ SaMD ”).

of SaMD are subject to premarket authorization requirements.

If the FDA were to conclude that Cardio or our licensee is required to obtain

premarket authorization for the software used in Epi+Gen CHD™ or PrecisionCHD™, our ability to offer the tests as an LDT could

be delayed or prevented, which would adversely affect our business.

In addition, we may require cooperation in our

filings for FDA clearance, approval or de novo authorization from third-party manufacturers of the components of our tests.

cannot assure investors that any of our tests for which we decide to pursue or are required to obtain premarket clearance, approval or

de novo authorization by the FDA will be cleared, approved or authorized on a timely basis, if at all.

In addition, if a test has been

cleared, approved or authorized, certain kinds of changes that we may make, e.g.

, to improve the test, or because of issues with

suppliers of the components of the test or modification by a supplier to a component upon which our test approval relies, may result in

the need for the test to obtain new clearance, approval or authorization from the FDA before we can implement them, which could

increase the time and expense involved in implementing such changes commercially.

Ongoing compliance with FDA regulations, such as the

Quality System Regulation, labeling requirements, Medical Device Reports, and recall reporting, would increase the cost of conducting

our business and subject us to heightened regulation by the FDA.

We will be subject to periodic inspection by the FDA to ascertain whether

our facility does comply with applicable requirements.

The penalties for failure to comply with these and other requirements may include

Warning Letters, product seizure, injunctions, civil penalties, criminal penalties, mandatory customer notification, and recalls, any

of which may adversely impact our business and results of operations.

Furthermore, the FDA or the Federal Trade Commission

(“FTC”), as well as state consumer protection agencies and competitors, may object to the materials and methods we use to

promote the use of our current tests or other LDTs we may develop in the

future, including with respect to the product claims in our promotional materials, and may initiate enforcement actions against us.

actions by these agencies may include, among others, injunctions, civil penalties, and equitable monetary relief.

our Epi+Gen CHD™ and PrecisionCHD™ tests are 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.

FDA sometimes determines that a test that is being offered by a laboratory as an LDT is not an LDT under the FDA’s interpretation

of that term but is an in IVD product in commercial distribution, and

therefore must comply with the regulations that apply to IVDs, including the need for successfully completing the FDA review process.

If the FDA were to conclude that our test is not an LDT, we would be subject to extensive regulation as a medical device.

For tests that

are deemed to be LDTs, the FDA has historically taken the position that it has the authority to regulate such tests as IVDs under the

Federal Food, Drug, and Cosmetic Act (“FDC Act”), although it has generally exercised enforcement discretion with regard

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 clearance of LDTs, it has generally chosen not to enforce those requirements.

Various bills have been

introduced in Congress seeking to substantially revamp the regulation of both LDTs and IVDs.

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 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.

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

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.

In the meantime,

the regulation by the FDA of LDTs remains uncertain.

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, QSR, and post-market

surveillance obligations.

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

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.

the FDA premarket clearance, approval or authorization is required by FDA for any of our existing or future tests, or for any components

or materials we use in our tests, such as the component used to collect samples from patients, we would need to submit a premarket notification,

PMA application or request for de novo authorization to the FDA and to include information supporting our LDT.

For example, the regulatory

premarket clearance, approval or de novo authorization process may involve, among other things, successfully completing analytical, pre-clinical

and/or clinical studies beyond the studies we have already performed or plan to perform for our LDT.

These studies may be extensive and

costly and may take a substantial period of time to complete.

Any such studies may fail to generate data that meets the FDA’s requirements .

The studies may also not be conducted in a manner that meets the FDA’s requirements, and therefore could not support the marketing

There can be no assurance that the submission of such an application will result in a timely response by the FDA or a favorable

outcome that will allow the test to be marketed.

In addition, we may be forced to stop selling our tests or we may be required to modify

claims for or make other changes to our tests while we work to obtain FDA clearance, approval or de novo authorization.

Our business may

be adversely affected while such review is ongoing and if we are ultimately unable to obtain premarket clearance, approval or de novo

authorization.

Certain types of standalone diagnostics device

software functions are subject to FDA regulation as a medical device.

Some types of device software functions are subject to premarket

requirements.

If the FDA were to conclude that Cardio or our licensee is required to obtain premarket authorization for the software

used in Epi+Gen CHD™ or PrecisionCHD™, our ability to offer the tests as an LDT could be delayed or prevented, which would

adversely affect our business.

In addition, we may require cooperation in our filings for FDA clearance, approval or de novo authorization

from third-party manufacturers of the components of our tests.

We cannot be certain that we will receive the support we need from third-party

vendors in a timely fashion, or that the information they provide will meet FDA’s requirements.

We cannot assure

investors that any of our tests for which we decide to pursue or are required to obtain premarket clearance, approval or de novo authorization

by the FDA will be cleared, approved or authorized on a timely basis, if at all.

In addition, if a test has been cleared, approved or

authorized, certain kinds of changes that we may make, e.g.

, to improve the test, or because of issues with suppliers of the components

of the test or modification by a supplier to a component upon which our test approval relies, may result in the need for the test to obtain

new clearance, approval or authorization from the FDA before we can implement

Ongoing compliance with FDA regulations, such as the QSR, labeling requirements, Medical Device Reports, and recall reporting, would

increase the cost of conducting our business.

We will be subject to periodic inspection by the FDA to ascertain whether our facility does

comply with applicable requirements.

The penalties for failure to comply with these FDA requirements may include Warning Letters, product

seizure, injunctions, civil penalties, criminal penalties, mandatory customer notification, and recalls, any of which may adversely impact

our business and results of operations.

the FDA or the Federal Trade Commission (“FTC”), as well as state consumer protection agencies, may object to the materials

and methods we use to promote the use of our current tests or other tests we

may develop in the future, including with respect to the product claims in our

promotional materials, and may initiate enforcement actions against us.

Enforcement actions by these agencies may include, among others,

injunctions, civil penalties, fines, and equitable monetary relief.

If our products do not receive adequate coverage and reimbursement

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success will be limited.

We currently do not have broad-based coverage

and reimbursement for the Epi+Gen CHD™ and PrecisionCHD™ tests.

However, our strategy is to expand access to our tests by

pursuing coverage and reimbursement by third-party payors, including government payors.

Coverage and reimbursement by third-party payors,

including managed care organizations, private health insurers, and government healthcare programs, such as Medicare and Medicaid in the

United States and similar programs in other countries, for the types of early detection tests we perform can be limited and uncertain .

currently do not have broad-based coverage and reimbursement for the Epi+Gen CHD™ and PrecisionCHD™ tests.

However, our strategy

is to expand access to our tests by pursuing coverage and reimbursement by third-party payors, including government payors.

reimbursement by third-party payors, including managed care organizations, private health insurers, and government healthcare programs,

such as Medicare and Medicaid in the United States and similar programs in other countries, for the types of risk assessment and detection

tests we perform can be limited and uncertain .

Healthcare providers may not order our products unless third-party payors cover and provide adequate reimbursement for a substantial portion

11 unchanged sentences

unsuccessful or may take several years to achieve.

If eligible for reimbursement, laboratory tests

such as ours generally are classified for reimbursement purposes under CMS’s Healthcare Common Procedure Coding System (“HCPCS”)

and the American Medical Association’s (“AMA”) Current Procedural Terminology (“CPT”) coding systems.

and payors must use those coding systems to bill and pay for our diagnostic

tests, respectively.

These HCPCS and CPT codes are associated with the particular product or service that is provided to the individual.

Accordingly, without a HCPCS or CPT code applicable to our products, the submission of claims could be a significant challenge.

creates an HCPCS code or the AMA establishes a CPT code, CMS establishes payment rates and coverage rules under traditional Medicare,

and private payors establish rates and coverage rules independently.

Under Medicare, payment for laboratory tests is generally made under

the Clinical Laboratory Fee Schedule (“CLFS”) with payment amounts assigned to specific HCPCS and CPT codes.

effective January 1, 2018, a new Medicare payment methodology went into effect for clinical laboratory tests, under which laboratory-reported

private payor rates are used to establish Medicare payment rates for tests reimbursed via the CLFS.

The new methodology implements Section

216 of the Protecting Access to Medicare Act of 2014 (“PAMA”) and requires laboratories that meet certain requirements related

to volume and type of Medicare revenues to report to CMS their private payor payment rates for each test they perform, the volume of tests

paid at each rate, and the HCPCS code associated with the test.

CMS uses the reported information to set the Medicare payment rate for

each test at the weighted median private payor rate.

The full impact of the PAMA rate-setting methodology and its applicability to our

products remains uncertain at this time.

Coverage and reimbursement by a third-party

payor may depend on a number of factors, including a payor’s determination that a product is appropriate, medically necessary, and

cost-effective.

Each payor will make its own decision as to whether to establish

a policy or enter into a contract to cover our products and the amount it will reimburse for such products.

Obtaining approvals from third-party

payors to cover our products and establishing adequate coding recognition and reimbursement levels is an unpredictable, challenging, time-consuming,

and costly process, and we may never be successful.

If third-party payors do not provide adequate coverage and reimbursement for our products,

our ability to succeed commercially will be limited.

if we establish relationships with payors to provide its products at negotiated rates, such agreements would not obligate any healthcare

eligible for reimbursement, laboratory tests such as ours generally are classified for reimbursement purposes under CMS’s Healthcare

Common Procedure Coding System (“HCPCS”) and the American Medical Association’s (“AMA”) Current Procedural

Terminology (“CPT”) coding systems.

We and payors must use those coding systems to bill and

pay for our diagnostic tests, respectively.

These HCPCS and CPT codes are associated

with the particular product or service that is provided to the individual.

Accordingly, without a HCPCS or CPT code applicable to our

products, the submission of claims could be a significant challenge.

Once CMS creates an HCPCS code or the AMA establishes a CPT code,

CMS establishes payment rates and coverage rules under traditional Medicare, and private payors establish rates and coverage rules independently.

Under Medicare, payment for laboratory tests is generally made under the Clinical Laboratory Fee Schedule (“CLFS”) with payment

amounts assigned to specific HCPCS and CPT codes.

In addition, effective January 1, 2018, a new Medicare payment methodology went into

effect for clinical laboratory tests, under which laboratory-reported private payor rates are used to establish Medicare payment rates

for tests reimbursed via the CLFS.

The new methodology implements Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”)

and requires laboratories that meet certain requirements related to volume and type of Medicare revenues to report to CMS their private

payor payment rates for each test they perform, the volume of tests paid at each rate, and the HCPCS code associated with the test.

uses the reported information to set the Medicare payment rate for each test at the weighted median private payor rate.

The full impact

of the PAMA rate-setting methodology and its applicability to our products remains uncertain at this time.

and reimbursement by a third-party payor may depend on a number of factors, including a payor’s determination that a product is

appropriate, medically necessary, and cost-effective.

Each payor will make its own decision as to whether

to establish a policy or enter into a contract to cover our products and the amount it will reimburse for such products.

Obtaining approvals

from third-party payors to cover our products and establishing adequate coding recognition and reimbursement levels is an unpredictable,

challenging, time-consuming, and costly process, and we may never be successful.

If third-party payors do not provide adequate coverage

and reimbursement for our products, our ability to succeed commercially will be limited.

if we establish relationships with payors to provide our products at negotiated rates, such agreements would not obligate any healthcare

providers to order our products or guarantee that we would receive reimbursement for our products from these or any other payors at adequate

Thus, these payor relationships, or any similar relationships, may not result in acceptable levels of coverage and reimbursement

for our products or meaningful increases in the number of billable tests we sell to healthcare providers.

We believe it may take at least

several years to achieve coverage and adequate reimbursement with a majority of third-party payors, including with those payors offering

negotiated rates.

In addition, we cannot predict whether, under what circumstances, or at what payment levels payors will cover and reimburse

for our products.

We do not expect Epi+Gen CHD™ or PrecisionCHD™ to have Medicare or other third-party coverage or reimbursement

in the near term.

However, if we fail to establish and maintain broad-based coverage and reimbursement for our products, our ability to

expand access to our products, generate increased revenue, and grow our test volume and customer base will be limited, and our overall

commercial success will be limited.

Thus, these payor relationships, or any similar relationships,

may not result in acceptable levels of coverage and reimbursement for our products or meaningful increases in the number of billable tests

we sell to healthcare providers.

We believe it may take at least several years to achieve coverage and adequate reimbursement with a majority

of third-party payors, including with those payors offering negotiated rates.

In addition, we cannot predict whether, under what circumstances,

or at what payment levels payors will cover and reimburse for our products.

We do not expect Epi+Gen CHD™ or PrecisionCHD™

to have Medicare or other third-party coverage or reimbursement in the near term.

However, if we fail to establish and maintain broad-based

coverage and reimbursement for our products, our ability to expand access to our products, generate increased revenue, and grow our test

volume and customer base will be limited, and our overall commercial success will be limited.

Our products may fail to achieve the degree of market acceptance

necessary for commercial success.

The failure of our products, once introduced,

to be listed in physician guidelines or of our studies to produce favorable results or to be published in peer-reviewed journals could

limit the adoption of our products.

In addition, healthcare providers and third-party payors, including Medicare, may rely on physician

guidelines issued by industry groups, medical societies, and other key organizations, before utilizing or reimbursing the cost of any

diagnostic or screening test.

Although we have published a study showing

the Epi+Gen CHD™ test is associated with cost saving, it is not yet, and may never be, listed in any such guidelines.

Further, if our products or the technology underlying

them do not receive sufficient favorable exposure in peer-reviewed publications, the rate of physician and market acceptance of our products

and positive reimbursement coverage decisions for our products could be negatively affected.

The publication of clinical data in peer-reviewed

journals is an important step in commercializing and obtaining reimbursement

for products, such as Epi+Gen CHD™ and PrecisionCHD™, and our inability to control when, if ever, results are published

may delay or limit our ability to derive sufficient revenues from any product that is developed using data from a clinical study.

Failure to achieve broad market acceptance of

our products, including Epi+Gen CHD™ and PrecisionCHD™, would materially harm our business ,

failure of our products, once introduced, to be listed in physician guidelines or of our studies to produce favorable results or to be

published in peer-reviewed journals could limit the adoption of our products.

In addition, healthcare providers and third-party payors,

including Medicare, may rely on physician guidelines issued by industry groups, medical societies, and other key organizations, before

utilizing or reimbursing the cost of any diagnostic or screening

Although we have published a study showing the Epi+Gen CHD™ and PrecisionCHD™

tests are associated with cost saving, it is not yet, and may never be, listed in any such guidelines.

if our products or the technology underlying them do not receive sufficient favorable exposure in peer-reviewed publications, the rate

of physician and market acceptance of our products and positive reimbursement coverage decisions for our products could be negatively

The publication of clinical data in peer-reviewed journals

is an important step in commercializing and obtaining reimbursement for products,

such as Epi+Gen CHD™ and PrecisionCHD™, and our inability to control when, if ever, results are published may delay or

limit our ability to derive sufficient revenues from any product that is developed using data from a clinical study.

to achieve broad market acceptance of our products, including Epi+Gen CHD™ and PrecisionCHD™, would materially harm our business ,

financial condition, and results of operations.

50 unchanged sentences

health information standards, whether implemented pursuant to HIPAA, congressional action or otherwise, could have a significant effect

on the manner in which we must handle healthcare related data, and the cost of comply ing with standards could be significant.

we do not comply with existing or new laws and regulations related to PHI, it could be subject to criminal or civil sanctions.

Because of the extreme sensitivity of the PII

that we store and transmit, the security features of our technology platform are very important.

If our security measures, some of which

are managed by third parties, are breached or fail, unauthorized persons may be able to obtain access to sensitive client and patient

data, including HIPAA-regulated PHI.

As a result, our reputation could be severely damaged, adversely affecting client and patient confidence.

Members may curtail their use of or stop using our services or our customer base could decrease, which would cause our business to suffer.

In addition, we could face litigation, damages for contract breach, penalties and regulatory actions for violation of HIPAA and other

applicable laws or regulations and significant costs for remediation, notification to individuals and for measures to prevent future occurrences.

Any potential security breach could also result in increased costs associated with liability for stolen assets or information, repairing

system damage that may have been caused by such breaches, incentives offered to

customers or other business partners in an effort to maintain our business relationships after a breach and implementing measures to prevent

future occurrences, including organizational changes, deploying additional personnel and protection technologies, training employees and

engaging third-party experts and consultants.

While we maintain insurance covering certain security and privacy damages and claims expenses

in the amount of at least $2.0 million, we may not carry insurance or maintain coverage sufficient to compensate for all liability

and in any event, insurance coverage would not address the reputational damage that could result from a security incident.

outsource important aspects of the storage and transmission of customer and customer personnel information, a nd thus rely on third

parties to manage functions that have material cyber-security risks.

We attempt to address these risks by requiring outsourcing subcontractors

who handle customer and customer personnel information to sign business associate agreements contractually requiring those subcontractors

to adequately safeguard personal health data to the same extent that applies to us and in some cases by requiring such outsourcing subcontractors

to undergo third-party security examinations.

In addition, we periodically hire third-party security experts to assess and test our security

However, we cannot assure investors that these contractual measures and other safeguards will adequately protect us from the

risks associated with the storage and transmission of client and patient’s proprietary and protected health information.

on the manner in which we must handle healthcare related data, and the cost of comply ing

with standards could be significant.

If we do not comply with existing or new laws and regulations related to PHI, it could be subject

to criminal or civil sanctions.

of the extreme sensitivity of the PII that we store and transmit, the security features of our technology platform are very important.

If our security measures, some of which are managed by third parties, are breached or fail, unauthorized persons may be able to obtain

access to sensitive customer and patient data, including HIPAA-regulated PHI.

As a result, our reputation could be severely damaged, adversely

affecting customer and patient confidence.

Customers may curtail their use of or stop using our services or our customer base could decrease,

which would cause our business to suffer.

In addition, we could face litigation, damages for contract breach, penalties and regulatory

actions for violation of HIPAA and other applicable laws or regulations and significant costs for remediation, notification to individuals

and for measures to prevent future occurrences.

Any potential security breach could also result in increased costs associated with liability

for stolen assets or information, repairing system damage that may have

been caused by such breaches, incentives offered to customers or other business partners in an effort to maintain our business relationships

after a breach and implementing measures to prevent future occurrences, including organizational changes, deploying additional personnel

and protection technologies, training employees and engaging third-party experts and consultants.

While we maintain insurance covering

certain security and privacy damages and claims expenses, we may not carry insurance or maintain coverage sufficient to compensate for

all liability and in any event, insurance coverage would not address the reputational damage that could result from a security incident.

outsource important aspects of the storage and transmission of customer and customer personnel information, a nd

thus rely on third parties to manage functions that have material cyber-security risks.

We attempt to address these risks by requiring

outsourcing subcontractors who handle customer and customer personnel information to sign business associate agreements contractually

requiring those subcontractors to adequately safeguard personal health data to the same extent that applies to us and in some cases by

requiring such outsourcing subcontractors to undergo third-party security examinations.

In addition, we periodically hire third-party

security experts to assess and test our security posture.

However, we cannot assure investors that these contractual measures and other

safeguards will adequately protect us from the risks associated with the storage and transmission of client and patient’s proprietary

and protected health information.

In addition, U.S.

26 unchanged sentences

Privacy and data security laws and regulations could require

we to make changes to our business, impose additional costs on us and reduce the demand for our tests and services.

Our business model contemplates that we will

store, process and transmit both public data and our customers’ and customer personnel’s private data.

Our customers may store

and/or transmit a significant amount of personal or identifying information through our platform.

Privacy and data security have become

significant issues in the United States and in other jurisdictions where

we may offer our software solutions.

The regulatory framework relating to privacy and data security issues worldwide is evolving rapidly

and is likely to remain uncertain for the foreseeable future.

Federal, state and foreign government bodies and agencies have in the past

adopted, or may in the future adopt, laws and regulations regarding the collection, use, processing, storage and disclosure of personal

or identifying information obtained from customers and other individuals.

In addition to government regulation, privacy advocates and

industry groups may propose various self-regulatory standards that may legally or contractually apply to our business.

Because the interpretation

and application of many privacy and data security laws, regulations and applicable industry standards are uncertain, it is possible that

these laws, regulations and standards may be interpreted and applied in

a manner inconsistent with our existing privacy and data management practices.

As we expand into new jurisdictions or verticals, we will

need to understand and comply with various new requirements applicable in those jurisdictions or verticals.

To the extent applicable to our business or

the businesses of our customers, these laws, regulations and industry standards could have negative effects on our business, including

by increasing our costs and operating expenses, and delaying or impeding our deployment of new core functionality and products.

with these laws, regulations and industry standards requires significant management time and attention, and failure to comply could result

in negative publicity, subject us to fines or penalties or result in demands that we modify or cease existing

business practices.

In addition, the costs of compliance with, and other burdens imposed by, such laws, regulations and industry standards

may adversely affect our customers’ ability or desire to collect, use, process and store personal information using our software

solutions, which could reduce overall demand for them.

Even the perception of privacy and data security concerns, whether or not valid,

may inhibit market acceptance of our software solutions in certain verticals.

Furthermore, privacy and data security concerns may cause

our customers’ customers, vendors, employees and other industry participants to resist providing the personal information necessary

to allow our customers to use our applications effectively.

us to make changes to our business, impose additional costs on us and reduce the demand for our tests and services.

business model contemplates that we will store, process and transmit both public data and our customers’ and customer personnel’s

private data.

Our customers may store and/or transmit a significant amount of personal or identifying information through our platform.

Privacy and data security have become significant issues

in the United States and in other jurisdictions where we may offer our solutions.

The regulatory framework relating to privacy and data

security issues worldwide is evolving rapidly and is likely to remain uncertain for the foreseeable future.

Federal, state and foreign

government bodies and agencies have in the past adopted, or may in the future adopt, laws and regulations regarding the collection, use,

processing, storage and disclosure of personal or identifying information obtained from customers and other individuals.

In addition to

government regulation, privacy advocates and industry groups may propose various self-regulatory standards that may legally or contractually

apply to our business.

Because the interpretation and application of many privacy and data security laws, regulations and applicable industry

standards are uncertain, it is possible that these laws,

regulations and standards may be interpreted and applied in a manner inconsistent with our existing privacy and data management practices.

As we expand into new jurisdictions or verticals, we will need to understand and comply with various new requirements applicable in those

jurisdictions or verticals.

the extent applicable to our business or the businesses of our customers, these laws, regulations and industry standards could have negative

effects on our business, including by increasing our costs and operating expenses, and delaying or impeding our deployment of new core

functionality and products.

Compliance with these laws, regulations and industry standards requires significant management time and attention,

and failure to comply could result in negative publicity, subject us to fines or penalties or result in demands that we modify or cease

existing business

In addition, the costs of compliance with, and other burdens imposed by, such laws, regulations and industry standards may

adversely affect our customers’ ability or desire to collect, use, process and store personal information using our solutions, which

could reduce overall demand for them.

Even the perception of privacy and data security concerns, whether or not valid, may inhibit market

acceptance of our solutions in certain verticals.

Furthermore, privacy and data security concerns may cause our customers’ customers,

vendors, employees and other industry participants to resist providing the personal information necessary to allow our customers to use

our applications effectively.

Any of these outcomes could adversely affect our business and operating results.

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disease occurs in the United States or worldwide, our business may be adversely affected.

The severity, magnitude and duration of

the current COVID-19 pandemic is uncertain and rapidly changing.

As of the date of this Annual Report on Form 10-K, the extent to which

the COVID-19 pandemic may impact our business, results of operations and financial condition remains uncertain.

Numerous state and local jurisdictions, have

imposed, and others in the future may impose, “shelter-in-place” orders, quarantines, executive orders and similar government

orders and restrictions for their residents to control the spread of COVID-19.

Such orders or restrictions have resulted in largely remote

operations at our place of business, work stoppages among some vendors and suppliers, slowdowns and delays, travel restrictions and cancellation

of events, among other effects, thereby significantly and negatively impacting its operations.

Other disruptions or potential disruptions

include restrictions on the ability of our personnel to travel;

inability of its suppliers to manufacture goods and to deliver these to

us on a timely basis, or at all;

inventory shortages or obsolescence;

delays in actions of regulatory bodies;

diversion of or limitations

on employee resources that would otherwise be focused on the operations of its business, including because of sickness of employees or

their families or the desire of employees to avoid contact with groups of people;

business adjustments or disruptions of certain third

and additional government requirements or other incremental mitigation efforts.

The extent to which the COVID-19 pandemic impacts

our business will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may

emerge concerning the severity and spread of COVID-19 and the actions to contain COVID-19 or treat its impact, among others.

It is not currently possible to reliably project

the direct impact of COVID-19 on our operating revenues and expenses.

Key factors include the duration and extent of the outbreak in our

service areas as well as societal and governmental responses.

If the COVID-19 pandemic worsens, especially in regions where we have offices

or operations, our business activities originating from affected areas could be adversely affected.

Disruptive activities could include

business closures in impacted areas, further restrictions on our employees’ and service providers’ ability to travel, impacts

to productivity if our employees or their family members experience health issues, and potential delays in hiring and onboarding of new

We may take further actions that alter our business operations as may be required by local, state, or federal authorities or

that we determine are in the best interests of our employees.

Such measures could negatively affect our sales and marketing efforts, sales

cycles, employee productivity, or customer retention, any of which could harm our financial condition and business operations.

The extent and continued impact of the COVID-19

pandemic on our business will depend on certain developments, including:

the duration and spread of the outbreak;

government responses

to the pandemic;

the impact on our customers and its sales cycles;

the impact on customer, industry, or employee events;

and the effect

on our partners and supply chains, all of which are uncertain and cannot be predicted.

Because of our business model, the full impact

of the COVID-19 pandemic may not be fully reflected in our results of operations and overall financial condition until future periods.

To the extent the COVID-19 pandemic adversely affects our business and financial results, it may also have the effect of heightening many

of the other risks described in this “Risk Factors” section, including but not limited to those relating to cyber-attacks

and security vulnerabilities, interruptions or delays due to third-parties, or our ability to raise additional capital or generate sufficient

cash flows necessary to expand our operations.

If the COVID-19 virus and its potentially

more contagious variants cause an additional resurgence of infection of COVID-19, or if new variants continue to develop resistance to

government approved COVID-19 vaccinations, or if an influenza or other pandemic were to occur, our business, results of operations, financial

condition and liquidity could be negatively impacted.

As a result of public health emergencies, we

experienced, and in the future could experience, supply chain disruptions, including shortages, delays and work stoppages among some vendors

and suppliers, travel restrictions and cancellation of events, among other effects, thereby significantly and negatively impacting our

In addition, our results and financial condition may be adversely affected by future federal or state laws, regulations, orders,

or other governmental or regulatory actions addressing public health emergencies such as a COVID-19 or the U.S.

health care system, which,

if adopted, could result in direct or indirect restrictions to its business, financial condition, results of operations and cash flow.

Changes in accounting standards and subjective assumptions, estimates

and judgments by management related to complex accounting matters could significantly affect our financial results or financial condition.

Generally accepted accounting principles and

related accounting pronouncements, implementation guidelines and interpretations with regard to a wide range of matters that are relevant

to our business, including but not limited to revenue recognition , allowance

for doubtful accounts, content asset amortization policy, valuation of our Common Stock, stock-based compensation expense and income taxes,

are highly complex and involve many subjective assumptions, estimates and judgments.

Changes in these rules or their interpretation or

changes in underlying assumptions, estimates or judgments could significantly change or increase volatility of our reported or expected

accepted accounting principles and related accounting pronouncements, implementation guidelines and interpretations with regard to a wide

range of matters that are relevant to our business, including but not limited to revenue recognition,

allowance for doubtful accounts, content asset amortization policy, valuation of our Common Stock, stock-based compensation expense and

income taxes, are highly complex and involve many subjective assumptions, estimates and judgments.

Changes in these rules or their interpretation

or changes in underlying assumptions, estimates or judgments could significantly change or increase volatility of our reported or expected

financial performance or financial condition.

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our share price to decline significantly, even if our business is doing well.

The market price of our Common Stock could decline

as a result of sales of a large number of shares of Common Stock in the market, or the perception that these sales could occur.

are a total of 9,614,743 shares of Common Stock outstanding as of March 27, 2023.

In November 2022, we filed a registration statement

on Form S-1 under the Securities Act to register securities, including a primary offering of 3,486,686 shares issuable upon exercise of

outstanding warrants and 11,883,256 shares registered for resale by selling stockholders.

The SEC declared the registration statement

effective on January 24, 2023, and as such, those securities are freely tradeable at any time.

In addition, we registered the resale of

an additional 236,686 warrants, which if exercised, will also result in freely-tradeable Common Stock.

In addition, on March 22, 2023,

we filed, and the SEC declared effective, a Form S-8 registration statement covering the Common Stock issuable upon exercise or conversion

of stock-based grants and awards issued or issuable under the Company’s 2022 Equity Incentive Plan.

Upon filing, the shares of Common

Stock covered by the Form S-8 the registration statement became eligible for sale in the public market, subject to Rule 144 limitations

applicable to affiliates.

In addition, we have agreed, at our expense,

to prepare and file registration statements with the SEC providing for the resale of shares of Common Stock issuable upon conversion of

convertible debentures (the “YA Convertible Debentures”) issued and to be issued to YA II PN, Ltd.

(“Yorkville”),

a fund managed by Yorkville Advisors Global, LP.

We expect to file the first registration statement covering the resale of Yorkville conversion

shares soon after filing this Annual Report on Form 10-K.

We expect to register for resale up to 20,363,637 shares of Common Stock that

are potentially issuable upon conversion of the YA Convertible Debentures.

That number assumes conversion at the lowest possible conversion

price of $0.55 per share, which we believe is an unlikely outcome but is contractually possible.

Yorkville is required to use its commercially

reasonable efforts to convert a minimum of at least $1,000,000 of principal amount in the aggregate of its Convertible Debentures per

calendar month.

In any event, we anticipate that the shares of Common Stock issuable upon conversion of the YA Convertible Debentures

will result in a substantial number of shares being held by a single investor who will be free to sell significant blocks of stock, if

and when it elects to do so.

Together with our earlier registration statement

that was declared effective in January 2023, the S-8 registration statement and the availability of Rule 144 for resales of other securities,

virtually all of the shares of Common Stock we have issued in non-public transactions will be eligible to be freely traded in the public

market, subject to certain limitations applicable to our affiliates.

The resale, or expected or potential resale, of a substantial number

of our shares of Common Stock in the public market could adversely affect the market price for our shares of Common Stock and make it

more difficult for investors to sell their shares of Common Stock at times and prices that they feel are appropriate.

In particular, we

expect that, because there will be a substantial number of shares registered pursuant to various registration statements, the applicable

selling securityholders will continue to offer such covered securities for a significant period of time, the precise duration of which

cannot be predicted.

Accordingly, the adverse market and price pressures resulting from an offering pursuant to a registration statement

may continue for an extended period of time.

We have filed, and the SEC has declared effective,

registration statements covering (i) the resale of Common Stock underlying Public Warrants issued in the Company’s initial public

offering and a substantial number of shares of Common Stock and shares underlying warrants issued in private placements we completed prior

to our Business Combination;

(ii) up to $17 million in securities on a shelf registration statement that we are currently using for an

at-the-market offering of up to $17 million;

and (iii) a registration statement on Form S-8 covering our 2022 Equity Incentive Plan.

sales of securities can continue to be made under these registration statements.

We also plan to file a registration statement covering

the resale of Common Stock and shares underlying warrants that we recently sold in a private placement.

In addition, all of the shares

we issued in the Business Combination to holders of Legacy Cardio securities are available for resale under Rule 144 without restriction,

subject to certain limitations that apply to our affiliates.

The total number of shares available for resale

under these registration statements and/or under Rule 144 represents a significant percentage of our outstanding shares.

The resale, or

expected or potential resale, of a substantial number of our shares of Common Stock in the public market could adversely affect the market

price for our shares of Common Stock and make it more difficult for investors to sell their shares of Common Stock at times and prices

that they feel are appropriate.

In particular, we expect that, because there are a substantial number of shares registered pursuant to

various registration statements, the applicable selling securityholders can continue to offer such covered securities for a significant

period of time, the precise duration of which cannot be predicted.

Accordingly, the adverse market and price pressures resulting from

an offering pursuant to a registration statement or Rule 144 may continue for an extended period of time.

Sales of Common Stock pursuant to these registration

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securities without your approval, which would dilute your ownership interests and may depress the market price of our Common Stock.

As of March 27, 2023, we have Warrants outstanding to purchase 7,854,627

shares of our Common Stock.

We will also have the ability to initially issue an aggregate of 3,216,516 shares of our Common Stock under

the Cardio Equity Incentive Plan, of which 1,759,599 options have been granted and are currently exercisable.

We also have issued $5.0

million of YA Convertible Debentures and expect to issue an additional $6.2 million of YA Convertible Debentures in the second quarter

The YA Convertible Debentures are convertible at the option of the holder at varying rates depending on the trading price of

our Common Stock.

The maximum number of shares into which the Debentures could convert is 20,363,637 shares, if the YA Convertible Debentures

were converted at the “floor price” of $0.55 per share.

We do not expect the conversions to take place at the “floor

price” (as defined in the YA Convertible Debentures) of $0.55, although cannot guarantee that our stock price will not, in the future,

fall to a level that will result in conversions at the floor price.

Upon filing of this Annual Report on Form 10-K, the holder of the

First YA Convertible Debenture will be able, but is not required, to convert that debenture into Common Stock, which, if so converted,

will result in immediate dilution to existing stockholders.

As of April 1, 2024, we have Warrants outstanding

to purchase 8,528,766 shares of our Common Stock.

We will also have the ability to initially issue an aggregate of 4,336,941 shares of

our Common Stock under the Cardio Equity Incentive Plan, of which 3,772,425 options have been granted and are currently exercisable and

305,381 RSUs have been granted.

To the extent Warrants and options are exercised, and RSUs vest, additional shares of Common Stock could

be issued, which will result in dilution to our then existing stockholders and increase the number of shares eligible for resale in the

public market.

Sales of substantial numbers of such shares in the public market could depress the market price of our Common Stock.

At a special meeting of stockholders held on

December 18, 2023, our stockholders approved the future issuance of shares of Common Stock and/or securities convertible into or exercisable

for Common Stock equal to 20% or more of the Common Stock outstanding in one or more non-public transactions as required by Nasdaq Marketplace

Listing Rule 5635(d) (the "Share Issuance Proposal”).

Any non-public financing transaction undertaken in connection with this

approval will be conducted within the parameters set forth in the Share Issuance Proposal described in the proxy statement for the Annual

We may issue additional shares of our Common

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repayment of outstanding indebtedness, without stockholder approval, in a number of circumstances.

Our issuance of additional shares of Common

The issuance of additional shares of Common

Stock or other equity securities of equal or senior rank would have the following effects:

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third trading day prior to the date on which we give proper notice of such redemption and provided certain other conditions are met.

Trading prices of our Common Stock have not historically exceeded the $18.00 per share redemption threshold.

If and when the Public Warrants

and Sponsor Warrants become redeemable, we may not exercise our redemption right unless there is a current registration statement in

effect with respect to the shares of Common Stock underlying the Warrants.

While we have registered the Common Stock issuable upon the

exercise of the Public Warrants and Sponsor Warrants on a registration statement on Form S-1 that was declared effective by the SEC on

January 24, 2023, it must remain current and effective by future filings.

There can be no assurance that the registration statement will

still be effective at the time that we would like to exercise our redemption rights.

prices of our Common Stock have not historically exceeded the $18.00 per share redemption threshold.

If and when the Public Warrants and

Sponsor Warrants become redeemable, we may not exercise our redemption right unless there is a current registration statement in effect

with respect to the shares of Common Stock underlying the Warrants.

While we have registered the Common Stock issuable upon the exercise

of the Public Warrants and Sponsor Warrants on a registration statement on Form S-1 that was declared effective by the SEC on January

24, 2023, it must remain current and effective by future filings.

There can be no assurance that the registration statement will still

be effective at the time that we would like to exercise our redemption rights.

In the event we have determined to redeem the

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None of the Private Placement Warrants will be redeemable.

Warrants to purchase our Common Stock recently became exercisable,

which could increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders.

As of the Closing of the Business Combination,

there were 7,854,627 Warrants outstanding, all of which are currently exercisable.

To the extent Warrants are exercised, additional shares

of Common Stock could be issued, which will result in dilution to our then existing stockholders and increase the number of shares eligible

for resale in the public market.

Sales of substantial numbers of such shares in the public market could depress the market price of our

Common Stock.

Exercise of our Warrants is dependent upon the trading price

of our Common Stock.

Because of the disparity between the current stock price and the respective Warrant exercise prices, the Warrants

may never be in the money and may expire worthless.

The exercise prices of our currently outstanding

Warrants range from a high of $11.50 to a low of $1.78 per share.

We believe the likelihood that warrant holders will exercise the Warrants,

and therefore, the amount of cash proceeds that we would receive, is dependent upon the trading price of our Common Stock, the last reported

sales price for which was $1.42 per share on March 28, 2024.

If the trading price for our Common Stock is less than the applicable exercise

price of our Warrants, we believe holders of those Warrants will be unlikely to exercise their Warrants.

There is no guarantee that the

Warrants will be in the money prior to their expiration, and, as such, the Warrants may expire worthless, and we may receive no proceeds

from the exercise of the Warrants.

The Warrant Agreement designates the courts of the State of New

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in a diversion of the time and resources of our management and board of directors.

Our management will be required to devote substantial time to

maintaining and improving its internal controls over financial reporting and the requirements of being a public company which may, among

other things, strain our resources, divert management’s attention and affect our ability to accurately report our financial results

and prevent fraud.

As a privately held company, Legacy Cardio was

not required to comply with certain corporate governance and financial reporting practices and policies required of a publicly traded

As a publicly traded company, we will incur significant legal, accounting and other expenses that we were not required to incur

in the recent past, particularly after we are no longer an “emerging growth company” as defined under the JOBS Act.

are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules of the Nasdaq Stock Market.

The Sarbanes-Oxley

Act requires, among other things, that a company maintain effective disclosure controls and procedures (“DCP”) and internal

controls over financial reporting (“ICFR”).

Our management and other personnel have limited experience operating as a public

company, which may result in operational inefficiencies or errors, or a failure to improve or maintain effective ICFR and DCP necessary

to ensure timely and accurate reporting of operational and financial results.

Our existing management team will need to devote a substantial

amount of time to these compliance initiatives and may need to add personnel in areas such as accounting, financial reporting, investor

relations and legal in connection with operations as a public company.

Ensuring that we have adequate internal financial and accounting

controls and procedures in place is a costly and time-consuming effort that needs to be re-evaluated frequently.

Our compliance with existing

and evolving regulatory requirements will result in increased administrative expenses and a diversion of management’s time and attention.

to Sections 302 and 404 of the Sarbanes-Oxley Act (“Section 404”), we are required to furnish certain certifications

and reports by management on our ICFR, which, after we are no longer an emerging growth company and if we become an accelerated or large

accelerated filer under SEC rules, must be accompanied by an attestation report on ICFR issued by our independent registered public accounting

To achieve compliance with Section 404 within the prescribed

period, we will be required to document and evaluate our ICFR, which is both costly and challenging.

Implementing any appropriate changes

to our internal controls may require specific compliance training for our directors, officers and employees, entail substantial costs

to modify our existing accounting systems, and take a significant period of time to complete.

Such changes may not, however, be effective

in maintaining the adequacy of our ICFR, and any failure to maintain that adequacy, or consequent inability to produce accurate financial

statements on a timely basis, could increase our operating costs and could materially impair our ability to operate our business.

effective internal controls are necessary for us to produce reliable and timely financial reports and are important to help prevent fraud.

Any failure by us to file our periodic reports in a timely manner may cause investors to lose confidence in our reported financial information

and may lead to a decline in the price of our Common Stock.

In accordance with The Nasdaq Stock Market rules,

the majority of the directors of a company that has securities quoted on Nasdaq must be directors that are “independent” under

The various rules and regulations applicable to public companies make it more difficult and more expensive to maintain directors’

and officers’ liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to maintain

If we are unable to maintain adequate directors’ and officers’ insurance, our ability to recruit and retain qualified

officers and directors will be significantly curtailed.

Financial reporting obligations of being a public company in

the United States are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters.

As a publicly traded company, we will incur

significant additional legal, accounting and other expenses that we did not incur as a privately company.

The obligations of being a public

company in the United States require significant expenditures and will place significant demands on our management and other personnel,

including costs resulting from public company reporting obligations under the Exchange Act and the rules and regulations regarding corporate

governance practices, including those under the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley”) the Dodd-Frank Wall Street Reform

and Consumer Protection Act, and the listing requirements of the stock exchange on which our securities are listed.

These rules require

the establishment and maintenance of effective disclosure and financial controls and procedures, internal control over financial reporting

and changes in corporate governance practices, among many other complex rules that are often difficult to implement, monitor and maintain

compliance with.

Moreover, despite recent reforms made possible by the JOBS Act, the reporting requirements, rules, and regulations will

make some activities more time-consuming and costly, particularly after we are no longer an “emerging growth company.” In

addition, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability

Our management and other personnel will need to devote a substantial amount of time to ensure that we comply with all of these

requirements and to keep pace with new regulations, otherwise we may fall out of compliance and risk becoming subject to litigation or

being delisted, among other potential problems.

If we fail to comply with the rules under Sarbanes-Oxley related

to accounting controls and procedures in the future, or, if we discover material weaknesses and other deficiencies in our internal control

and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.

Section 404 of Sarbanes-Oxley requires annual

management assessments of the effectiveness of our internal control over financial reporting.

If we fail to comply with the rules under

Sarbanes-Oxley related to disclosure controls and procedures in the future, or, if we discover material weaknesses and other deficiencies

in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.

If material weaknesses or significant deficiencies are discovered or if we otherwise fail to achieve and maintain the adequacy of our

internal control, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal controls over

financial reporting in accordance with Section 404 of Sarbanes-Oxley.

Moreover, effective internal controls are necessary for us to produce

reliable financial reports and are important to helping prevent financial fraud.

If we cannot provide reliable financial reports or prevent

fraud, our business and operating results could be harmed, investors could lose confidence in our reported financial information, and

the trading price of our Common Stock could drop significantly.

incurred and will continue to incur additional costs to remediate material weaknesses in our internal control over financial reporting,

as described in Item 9A.

“Controls and Procedures.” The additional reporting and other obligations imposed by these rules

and regulations will increase legal and financial compliance costs and the costs of related legal, accounting and administrative activities.

These increased costs will require us to divert a significant amount of money that could otherwise be used to expand the business and

achieve strategic objectives.

We will need to grow the size of our organization and may experience

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As our expansion plans and strategies develop,

and as it transitions into operating as part of a public company, it expects it will need additional managerial, operational, sales, marketing,

financial and other personnel.

and as we continue to operate as a public company, we expects needing additional managerial, operational, sales, marketing, financial

and other personnel.

Future growth would impose significant added responsibilities on members of management, including:

• identifying,

recruiting, compensating, integrating, maintaining and motivating additional employees;

with demands on Management related to the increased size of its business;

• assimilating

different corporate cultures and business practices;

other entities’ books and records and conforming their practices to ours;

• integrating

operating, accounting and information technology systems of other entities with ours and in maintaining uniform procedures, policies and

standards, such as internal accounting controls;

our operational, financial and management controls, reporting systems and procedures.

· identifying, recruiting, compensating, integrating, maintaining and motivating additional

· coping with demands on Management related to the increased size of its business;

· assimilating different corporate cultures and business practices;

· converting other entities’ books and records and conforming their practices to ours;

· integrating operating, accounting and information technology systems of other entities with

ours and in maintaining uniform procedures, policies and standards, such as internal accounting controls;

· improving our operational, financial and management controls, reporting systems and procedures.

Our future financial performance and our ability

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we will be able to comply with the continued listing standards of Nasdaq.

If Nasdaq delists our shares or Public Warrants

from trading on its exchange for failure to meet the listing standards, we and our securityholders

could face significant material adverse consequences including:

common stock is listed on The Nasdaq Capital Market ("Nasdaq”).

In order to maintain that listing, we must satisfy minimum

financial and other requirements or be subject to delisting.

In the second half of 2023, we received deficiency notices from Nasdaq with

respect to our failure to meet the minimum bid price and the minimum stockholders’ equity requirement necessary for continued listing

In both instances, we were able to cure the deficiencies within the applicable cure period, and our securities continued to

trade on Nasdaq without interruption.

However, there can be no assurance that we will be able to comply with the continued listing standards

of Nasdaq at all times in the future.

If Nasdaq delists our shares of Common Stock or Public Warrants for failure to meet the listing

standards, we and our securityholders could

face significant material adverse consequences including:

a limited availability of market quotations for our securities;

reduced liquidity for our securities;

• a determination that our common stock is a “penny stock,”

which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading

activity in the secondary trading market for shares of our common stock;

a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for shares of our common stock;

a limited amount of analyst coverage;

• a decreased ability to issue additional securities or obtain

additional financing in the future.

Risks Related to Our Common Stock

The price of our Common Stock likely will be volatile like the

stocks of other early-stage companies.

The stock markets in general and the markets

for early-stage stocks have experienced extreme volatility.

The market for the Common Stock of smaller companies such as ours is characterized

by significant price volatility when compared to the shares of larger, more established companies that trade on a national securities

exchange and have large public floats, and we expect that our share price will be more volatile than the shares of such larger, more established

companies for the indefinite future.

In addition to the factors discussed in this

“Risk Factors” section, price declines in our Common Stock could also result from general market and economic conditions and

a variety of other factors, including:

• adverse actions taken by regulatory agencies with respect to our products;

• announcements of technological innovations, patents or new products by our competitors;

• regulatory developments in the United States and foreign countries;

• any lawsuit involving us or our product candidates;

• announcements concerning our competitors, or the industry in which we compete in general;

• developments concerning any strategic alliances or acquisitions we may enter into;

• actual or anticipated variations in our operating results;

• changes in recommendations by securities analysts or lack of analyst coverage;

• deviations in our operating results from the estimates of analysts;

• our inability, or the perception by investors that we will be unable, to continue to meet

all applicable requirements for continued listing of our Common Stock on the Nasdaq Capital Market, and the possible delisting of our

Common Stock;

• sales of our Common Stock by our executive officers, directors and principal stockholders

or sales of substantial amounts of Common Stock;

• loss of any of our key management personnel.

In the past, following periods of volatility

in the market price of a particular company’s securities, litigation has often been brought against that company.

Any such lawsuit

could consume resources and Management time and attention, which could adversely affect our business.

If securities or industry analysts do not publish research or

publish unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our Common Stock will

depend in part on the research and reports that securities or industry analysts publish about us, our business, our market, or our competitors.

Securities and industry analysts do not currently, and may never, publish research on the company.

Because the Business Combination will

result in Cardio being acquired by a special purpose acquisition company (“SPAC”), research coverage from industry analysts

may be limited.

If no securities or industry analysts commence coverage of our company, our stock price and trading volume could be negatively

If any of the analysts who may cover the company

change their recommendation regarding our stock adversely, provide more favorable relative recommendations about our competitors or publishes

inaccurate or unfavorable research about our business, our stock price would likely decline.

If any analyst who may cover us ceases coverage

of us or fails to publish reports on us regularly, demand for our stock could decrease, which could cause our stock price and trading

volume to decline.

Furthermore, if one or more of the analysts who

do cover us downgrade our securities stock, its price would likely decline.

If one or more of these analysts cease coverage of us, we

could lose market visibility, which in turn could cause the price of our securities to decline.

We have broad discretion in the use of our existing cash, cash

equivalents and the net proceeds from the Business Combination and may not use them effectively.

Our Management will have broad discretion in

the application of our existing cash, cash equivalents and the net proceeds from the Business Combination, and you will not have the opportunity

as part of your investment decision to assess whether such proceeds are being used appropriately.

Because of the number and variability

of factors that will determine our use of our existing cash, cash equivalents and the net proceeds from the Business Combination, their

ultimate use may vary substantially from their currently intended use.

Our Management might not apply our cash resources in ways that

ultimately increase the value of your investment.

The failure by our Management to apply these funds effectively could harm our business.

Pending their use, we may invest our cash resources in short-term, investment-grade, interest-bearing securities.

These investments may

not yield a favorable return to our stockholders.

A significant number of shares of our Common Stock are subject

to issuance upon exercise of outstanding warrants and options and conversion of Convertible Debentures, which upon such exercise or conversion,

as the case may be, may result in dilution to our security holders.

We have outstanding:

• 3,249,993 public warrants, exercisable at a price of $11.50 per share, subject to adjustment

and subject to Cardio having an effective registration on file with the SEC which allows for the exercise for cash of the Public Warrants;

• 2,500,000 warrants issued to the Sponsor, exercisable at a price of $11.50 per share, subject

to adjustment;

• 1,759,600 Exchanged Options that were issued in exchange for Legacy Cardio options with an

exercise price of $3.90 per share, subject to adjustment;

• 2,204,627 Legacy Cardio Private Placement Warrants that were issued in exchange for outstanding

Cardio warrants, with exercise prices ranging between $3.90 and $6.21 per share, subject to adjustment;

100,000 of these warrants were

exercised in March 2023.

In March 2023, we issued a Convertible Debenture in the principal

amount of $5.0 million and are obligated to issue a second Convertible Debenture in the principal amount of $6.2 million upon satisfaction

of certain conditions.

These Convertible Debentures may be converted at the option of the holder at varying prices that will depend on

the trading price of our Common Stock at the time of conversion.

The conversion price could be as low as $0.55, although given current

trading prices of our Common Stock, we would expect any conversions to be at prices well above the “Floor Price.” Nevertheless,

it is possible that conversions of the Convertible Debentures will result in substantial dilution to our securityholders.

To the extent such warrants and options are exercised

or debentures converted, additional shares of our Common Stock will be issued, which will result in dilution to the then existing holders

of our Common Stock and increase the number of shares eligible for resale in the public market.

Sales of substantial numbers of such shares

in the public market could adversely affect the market price of our Common Stock.

Exercise of our Warrants is dependent upon the trading price

of our Common Stock.

Because of the disparity between the current stock price and the respective Warrant exercise prices, the Warrants

may never be in the money and may expire worthless.

The exercise prices of our currently outstanding

Warrants range from a high of $11.50 to a low of $3.90 per share.

We believe the likelihood that warrant holders will exercise the Warrants,

and therefore, the amount of cash proceeds that we would receive, is dependent upon the trading price of our Common Stock, the last reported

sales price for which was $4.25 per share on March 27, 2023.

If the trading price for our Common Stock is less than the applicable exercise

price of our Warrants, we believe holders of those Warrants will be unlikely to exercise their Warrants.

There is no guarantee that the

Warrants will be in the money prior to their expiration, and, as such, the Warrants may expire worthless, and we may receive no proceeds

from the exercise of the Warrants.

We have never paid dividends on our Common Stock, and we do not

anticipate paying any cash dividends on our Common Stock in the foreseeable future.

We have never declared or paid cash dividends

on our Common Stock.

We do not anticipate paying any cash dividends on our Common Stock in the foreseeable future.

We currently intend

to retain all available funds and any future earnings to fund the development and growth of our business.

As a result, capital appreciation,

if any, of our Common Stock will be our stockholders’ sole source of gain for the foreseeable future.

Sales of a substantial number of shares of our Common Stock in

the public market by our existing stockholders could cause our stock price to decline.

Sales of a substantial number of shares of our

Common Stock in the public market or the perception that these sales might occur, could depress the market price of our Common Stock

and could impair our ability to raise capital through the sale of additional equity securities.

We are unable to predict the effect that

sales may have on the prevailing market price of our Common Stock.

Our Second Amended and Restated Certificate of Incorporation

designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings

that may be initiated by the Company’s stockholders, which could limit the Company’s stockholders’ ability to obtain

a favorable judicial forum for disputes with the Company or our directors, officers and employees.

Our Second Amended and Restated Certificate of

Incorporation will require, unless we consent in writing to the selection of an alternative forum, that (i) any derivative action or proceeding

brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee

to us or our stockholders, (iii) any action asserting a claim against us, our directors, officers or employees arising pursuant to any

provision of the DGCL or our Second Amended and Restated Certificate of Incorporation or bylaws, or (iv) any action asserting a claim

against us, our directors, officers or employees governed by the internal affairs doctrine may be brought only in the Court of Chancery

in the State of Delaware, except any claim (A) as to which the Court of Chancery of the State of Delaware determines that there is an

indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent to the personal

jurisdiction of the Court of Chancery within ten days following such determination), (B) which is vested in the exclusive jurisdiction

of a court or forum other than the Court of Chancery, (C) for which the Court of Chancery does not have subject matter jurisdiction, or

(D) any action arising under the Securities Act of 1933 or the Securities Exchange Act of 1934.

This choice of forum provision may limit

a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the Company or its directors,

officers or other employees, which may discourage such lawsuits against the Company and its directors, officers and employees.

Alternatively,

if a court were to find these provisions of the Second Amended and Restated Certificate of Incorporation inapplicable to, or unenforceable

in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such

matters in other jurisdictions, which could materially and adversely affect our business, financial condition and results of operations

and result in a diversion of the time and resources of our management and board of directors.

This provision would not apply to any action

brought to enforce a duty or liability created by the Exchange Act and inclusive of rules and regulations thereunder.

Section 22 of the

Securities Act establishes concurrent jurisdiction for federal and state courts over Securities Act claims.

Accordingly, both state and

federal courts have jurisdiction to hear such claims.

Any person or entity purchasing or otherwise

acquiring or holding or owning (or continuing to hold or own) any interest in any of the Company’s securities shall be deemed to

have notice of and consented to the foregoing bylaw provisions.

Although we believe these exclusive forum provisions benefit the Company

by providing increased consistency in the application of Delaware law and federal securities laws in the types of lawsuits to which each

applies, the exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum of its choosing for

disputes with the Company or the Company’s current or former directors, officers, stockholders or other employees, which may discourage

such lawsuits against the Company and its current and former directors, officers, stockholders and other employees.

In addition, a stockholder

that is unable to bring a claim in the judicial forum of its choosing may be required to incur additional costs in the pursuit of actions

which are subject to the exclusive forum provisions described above.

The Company’s stockholders will not be deemed to have waived

its compliance with the federal securities laws and the rules and regulations thereunder as a result of the Company’s exclusive

forum provisions.

Further, the enforceability of similar exclusive

forum provisions in other companies’ organizational documents has been challenged in legal proceedings and it is possible that a

court of law could rule that these types of provisions are inapplicable or unenforceable if they are challenged in a proceeding or otherwise.

If a court were to find either exclusive forum provision contained in the Company’s bylaws to be inapplicable or unenforceable in

an action, the Company may incur significant additional costs associated with resolving such action in other jurisdictions, all of which

could harm the Company’s results of operations.

The Company’s anti-takeover provisions could prevent or

delay a change in control of the company, even if such change in control would be beneficial to its stockholders.

Provisions of the Company’s Second Amended

and Restated Certificate of Incorporation and Bylaws, as well as provisions of Delaware law could discourage, delay or prevent a merger,

acquisition or other change in control of the Company, even if such change in control would be beneficial to its stockholders.

These provisions

• the authority to issue “blank check” preferred stock that could be issued by

the Board of Directors to increase the number of outstanding shares and thwart a takeover attempt;

• prohibiting the use of cumulative voting for the election of directors;

• requiring all stockholder actions to be taken at a meeting of its stockholders;

• advance notice requirements for nominations for election to the Board of Directors or for

proposing matters that can be acted upon by stockholders at stockholder meetings.

These provisions could also discourage proxy

contests and make it more difficult for you and other stockholders to elect directors of your choosing and cause the Company to take other

corporate actions you desire.

In addition, because the Board of Directors is responsible for appointing the members of our management

team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team.

In addition, the Delaware General Corporation

Law (the “DGCL”), to which the post-combination Company is subject, prohibits it, except under specified circumstances, from

engaging in any mergers, significant sales of stock or assets or business combinations with any stockholder or group of stockholders who

owns at least 15% of its Common Stock.

a decreased ability to issue additional securities or obtain additional financing in the future.

We may acquire other companies or technologies, which could divert

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operating results.

We may in the future seek to acquire

or invest in businesses, applications and services or technologies that we believe could complement or expand our services, enhance our

technical capabilities or otherwise offer growth opportunities.

The pursuit of potential acquisitions may divert the attention of management

and cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated.

In addition, we do not have any

experience in acquiring other businesses.

If we acquire additional businesses, we may not be able to integrate the acquired personnel,

operations and technologies successfully, or effectively manage the combined business following the acquisition.

We also may not achieve

the anticipated benefits from the acquired business due to a number of factors, including:

• inability to integrate or benefit from acquired technologies or services in a profitable

We may in the future seek to acquire or invest

in businesses, applications and services or technologies that we believe could complement or expand our services, enhance our technical

capabilities or otherwise offer growth opportunities.

The pursuit of potential acquisitions may divert the attention of management and

cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated.

In addition, we do not have any experience

in acquiring other businesses.

If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations

and technologies successfully, or effectively manage the combined business following the acquisition.

We also may not achieve the anticipated

benefits from the acquired business due to a number of factors, including:

inability to integrate or benefit from acquired technologies or services in a profitable manner;

unanticipated costs or liabilities associated with the acquisition;

difficulty integrating the accounting systems, operations, and personnel of the acquired

• difficulties and additional expenses associated with supporting legacy products and hosting

infrastructure of the acquired business;

• difficulty converting the customers of the acquired business onto the Platform and contract

terms, including disparities in the revenue, licensing, support, or professional services model of the acquired company;

difficulties and additional expenses associated with supporting legacy products and hosting infrastructure of the acquired business;

difficulty converting the customers of the acquired business onto the Platform and contract terms, including disparities in the revenue, licensing, support, or professional services model of the acquired company;

diversion of management’s attention from other business concerns;

• adverse effects to our existing business relationships with business partners and customers

as a result of the acquisition;

adverse effects to our existing business relationships with business partners and customers as a result of the acquisition;

the potential loss of key employees;

1 unchanged sentence

use of substantial portions of our available cash to consummate the acquisition.

In addition, a significant portion

of the purchase price of companies we acquire may be allocated to acquired goodwill and other intangible assets, which must be assessed

for impairment at least annually.

In the future, if our acquisitions do not yield expected returns, we may be required to take charges

to our operating results based on this impairment assessment process, which could adversely affect our results of operations.

Acquisitions could also result

in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operating results.

if an acquired business fails to meet our expectations, our operating results, business and financial position may suffer.

Financial reporting obligations of being a public company in

the United States are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters.

As a publicly traded company,

we will incur significant additional legal, accounting and other expenses that we did not incur as a privately company.

The obligations

of being a public company in the United States require significant expenditures and will place significant demands on our management and

other personnel, including costs resulting from public company reporting obligations under the Exchange Act and the rules and regulations

regarding corporate governance practices, including those under the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley”) the Dodd-Frank

Wall Street Reform and Consumer Protection Act, and the listing requirements of the stock exchange on which our securities are listed.

These rules require the establishment and maintenance of effective disclosure and financial controls and procedures, internal control

over financial reporting and changes in corporate governance practices, among many other complex rules that are often difficult to implement,

monitor and maintain compliance with.

Moreover, despite recent reforms made possible by the JOBS Act, the reporting requirements, rules,

and regulations will make some activities more time-consuming and costly, particularly after we are no longer an “emerging growth

company.” In addition, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director

and officer liability insurance.

Our management and other personnel will need to devote a substantial amount of time to ensure that we

comply with all of these requirements and to keep pace with new regulations, otherwise we may fall out of compliance and risk becoming

subject to litigation or being delisted, among other potential problems.

If we fail to comply with the rules under Sarbanes-Oxley related

to accounting controls and procedures in the future, or, if we discover material weaknesses and other deficiencies in our internal control

and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.

Section 404 of Sarbanes-Oxley

requires annual management assessments of the effectiveness of our internal control over financial reporting.

If we fail to comply with

the rules under Sarbanes-Oxley related to disclosure controls and procedures in the future, or, if we discover material weaknesses and

other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital

could be more difficult.

If material weaknesses or significant deficiencies are discovered or if we otherwise fail to achieve and maintain

the adequacy of our internal control, we may not be able to ensure that we can conclude on an ongoing basis that we have effective internal

controls over financial reporting in accordance with Section 404 of Sarbanes-Oxley.

Moreover, effective internal controls are necessary

for us to produce reliable financial reports and are important to helping prevent financial fraud.

If we cannot provide reliable financial

reports or prevent fraud, our business and operating results could be harmed, investors could lose confidence in our reported financial

information, and the trading price of our Common Stock could drop significantly.

incurred and will continue to incur additional costs to remediate material weaknesses in our internal control over financial reporting,

as described in Item 9A.

“Controls and Procedures.” The additional reporting and other obligations imposed by these rules

and regulations will increase legal and financial compliance costs and the costs of related legal, accounting and administrative activities.

These increased costs will require us to divert a significant amount of money that could otherwise be used to expand the business and

achieve strategic objectives.

Staff Comments

Not applicable.

In addition, a significant portion of the purchase

price of companies we acquire may be allocated to acquired goodwill and other intangible assets, which must be assessed for impairment

at least annually.

In the future, if our acquisitions do not yield expected returns, we may be required to take charges to our operating

results based on this impairment assessment process, which could adversely affect our results of operations.

Acquisitions could also result in dilutive

issuances of equity securities or the incurrence of debt, which could adversely affect our operating results.

In addition, if an acquired

business fails to meet our expectations, our operating results, business and financial position may suffer.

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 1A. Risk Factors