CDIOW filing — read by section

Item 1A. Risk Factors

Item
1A. Risk Factors 

 RISK FACTORS 

 Investing in our securities involves risks. You
should carefully consider the risks and uncertainties described below and the other information in this Annual Report on Form 10-K before
making an investment in our Common Stock. Our business, financial condition, results of operations, or prospects could be materially and
adversely affected if any of these risks occurs, and as a result, the market price of our Common Stock could decline and you could lose
all or part of your investment. This Annual Report on Form 10-K also contains forward-looking statements that involve risks and uncertainties.
See “Cautionary Statement Regarding Forward-Looking Statements.” Our actual results could differ materially and adversely
from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below. These disclosures
reflect the Company’s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities
in the future. References to past events are provided by way of example only and are not intended to be a complete listing or a representation
as to whether or not such factors have occurred in the past or their likelihood of occurring in the future. 

 Risks Related to Our Limited Operating History
and Early Stage of Growth 

 We are a medical diagnostic testing company with
a limited operating history and have not yet generated significant revenue from product sales. We have incurred operating losses since
our inception and may never achieve or maintain profitability. 

 We have generated
only nominal revenue in 2024 and 2025, including $34,890 in revenue generated in 2024 and $14,825 in revenue generated in 2025. Our net
losses totaled $8,383,453 and $6,498,167 for the years ended December 31, 2024 and 2025, respectively, and we have an accumulated deficit
of $29,250,000 at December 31, 2025. 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. 

 The healthcare
commercialization process is inherently lengthy and subject to regulatory, reimbursement, evidentiary and behavioral factors, which, combined
with clinical adoption of novel diagnostic technologies that frequently spans multiple years, results in a lengthy period from initial
development to widespread utilization and ultimately to revenue generation, which, in some cases, may span a decade or more. 

 The commercialization lifecycle for diagnostic tests
is lengthy and generally involves multiple stages, including scientific validation, regulatory compliance, the securing of third-party
reimbursement, including coverage determination from government programs including the Centers for Medicare & Medicaid Services (“CMS”)
and subsequently, from commercial payors, physician adoption and incorporation into clinical guidelines and behavioral and workflow integration
as health care providers gain familiarity and comfort with new technologies. These various stages can each take many years, and the entire
process from scientific discovery to broad clinical adoption frequently can extend over a decade.
Despite having two clinically promising diagnostic tests currently available and more tests in the pipeline, we expect that our revenue
growth will continue to be negligible until we have obtained third party reimbursement for our tests, the tests are incorporated into
the broader health care clinical guidelines and are integrated into medical care workflow by health care providers. There is no assurance
that we will be successful in achieving those milestones and begin growing meaningful revenue. We also cannot provide assurance that we
will ever achieve profitability even as we grow revenue. 

 We believe our long-term value as a company will
be greater if we focus on growth, which has in the past, and may continue to negatively impact our results of operations in the near term. 

 We believe our long-term value as a company will
be greater if we focus on longer-term growth over short-term results. As a result, our results of operations may be negatively impacted
in the near term relative to a strategy focused on maximizing short-term profitability. Significant expenditures on marketing efforts,
potential acquisitions and other expansion efforts may not ultimately grow our business or lead to expected long-term results.

 Our business and the markets in which we operate
are new and rapidly evolving, which make it difficult to evaluate our future prospects and the risks and challenges we may encounter. 

 Our business and the markets in which we operate
are new and rapidly evolving, which make it difficult to evaluate and assess the success of our business to date, our future prospects
and the risks and challenges that we may encounter. These risks and challenges include our ability to:

 · 
 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; 

 · 
 anticipate and respond to changes in payor reimbursement rates and the markets in which we operate; 

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 · 
 react to challenges from existing and new competitors; 

 · 
 maintain and enhance our reputation and brand; 

 · 
 effectively manage our growth and business operations, including new geographies; 

 · 
 accurately forecast our revenue and budget for, and manage, our expenses, including capital expenditures; and 

 · 
 hire and retain talented individuals at all levels of our organization; 

 If we fail to understand fully or adequately address
the challenges that we are currently encountering or that we may encounter in the future, including those challenges described here and
elsewhere in this “Risk Factors” section, our business, financial condition and results of operations could be adversely affected.
If the risks and uncertainties that we plan for when operating our business are incorrect or change, or if we fail to manage these risks
successfully, our results of operations could differ materially from our expectations and our business, financial condition and results
of operations could be adversely affected.

 Our limited operating history makes it difficult
to evaluate our 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.

 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 may not
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 fully reflect the underlying performance of our business. 

 Our results of operations and key metrics discussed
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 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 or other customers; 

 · 
 the timing of recognition of revenues; 

 · 
 the amount and timing of operating expenses; 

 · 
 general economic, industry and market conditions, both domestically and internationally, including any economic downturns and adverse impacts resulting from the COVID- 19 pandemic and/or the military conflicts between Russia and Ukraine or in Iran; 

 · 
 the timing of our billing and collections; 

 · 
 adoption rates by participants in our key channels; 

 · 
 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; 

 · 
 the timing and success of new offerings by us or our competitors or any other change in the competitive dynamics of our industry, including consolidation among competitors, practitioners, clinics or outsourcing facilities; extraordinary expenses such as litigation or other dispute-related expenses or settlement payments; 

 · 
 extraordinary expenses such as litigation or other dispute-related expenses or settlement payments; 

 · 
 sales tax and other tax determinations by authorities in the jurisdictions in which we conduct business; 

 · 
 the impact of new accounting pronouncements and the adoption thereof; 

 · 
 fluctuations in stock-based compensation expenses; 

 · 
 expenses in connection with mergers, acquisitions or other strategic transactions; 

 · 
 changes in regulatory and licensing requirements; 

 · 
 the amount and timing of expenses related to our expansion to markets outside the United States; and 

 · 
 the timing of expenses related to the development or acquisition of technologies or businesses and potential future charges for impairment of goodwill or intangibles from acquired companies. 

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 Further, although our revenues currently are only
nominal, once we achieve traction, in any future period, our revenue growth could slow or our revenues could decline for a number of reasons,
including slowing demand for our tests and services, increasing competition, a decrease in the growth of our overall market, or our failure,
for any reason, to continue to capitalize on growth opportunities. In addition, our growth rate may slow in the future as our market penetration
rates increase. As a result, our revenues, operating results and cash flows may fluctuate significantly on a quarterly basis and revenue
growth rates may not be sustainable and may decline in the future, and we may not be able to achieve or sustain profitability in future
periods, which could harm our business and cause the market price of our Common Stock to decline.

 We expect to need to raise additional capital
to fund our existing operations or develop and commercialize new services or expand our operations. 

 We expect to spend significant amounts to expand
our existing operations, including expansion into new geographies, to make additional key hires, to expand our sales channels and constituencies
and to develop new tests and services. Since 2024, our primary source of capital has been sales of our Common Stock under our at-the-market
agreement with Craig-Hallum Capital Group, LLC (the “ATM Agreement”). If we are unable to raise additional capital under the
ATM Agreement or otherwise, 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 expect to finance our cash needs through a combination of equity offerings and debt financings
or other sources. In addition, we may seek additional capital in the event of 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 will
depend on many factors, including:

 · 
 our ability to achieve revenue growth; 

 · 
 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 tests and services; and 

 · 
 the effect of competing technological and market developments. 

 To the extent that we raise additional capital through
the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include
liquidation or other preferences that adversely affect your rights as a securityholder. In addition, debt financing and preferred equity
financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such
as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations,
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:

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

 · 
 hire and retain employees, including scientists and medical professionals, operations personnel, financial and accounting staff, and sales and marketing staff; 

 · 
 respond to competitive pressures or unanticipated working capital requirements; or 

 · 
 pursue opportunities for acquisitions of, investments in, or strategic alliances and joint ventures with complementary businesses. 

 We may invest in or acquire other businesses,
and our business may suffer if we are unable to successfully integrate an acquired business into our company or otherwise manage the growth
associated with multiple acquisitions. 

 From time to time, we may acquire, make investments
in, or enter into strategic alliances and joint ventures with, complementary businesses. These transactions may involve significant risks
and uncertainties, including:

 In the case of an acquisition:

 · 
 The potential for the acquired business to underperform relative to our expectations and the acquisition price; 

 · 
 The potential for the acquired business to cause our financial results to differ from expectations in any given period, or over the longer-term; 

 · 
 Unexpected tax consequences from the acquisition, or the tax treatment of the acquired business’s operations going forward, giving rise to incremental tax liabilities that are difficult to predict; 

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 · 
 Difficulty in integrating the acquired business, its operations, and its employees in an efficient and effective manner; 

 · 
 Any unknown liabilities or internal control deficiencies assumed as part of the acquisition; and 

 · 
 The potential loss of key employees of the acquired businesses. 

 In the case of an investment, alliance, joint venture,
or other partnership:

 · 
 Our ability to cooperate with our co-venturer; 

 · 
 Our co-venturer having economic, business, or legal interests or goals that are inconsistent with ours; and 

 · 
 The potential that our co-venturer may be unable to meet is economic or other obligations, which may require us to fulfill those obligations alone or find a suitable replacement. 

 Any such transaction may involve the risk that our
senior management’s attention will be excessively diverted from our other operations, the risk that our industry does not evolve
as anticipate, and that any intellectual property or personnel skills acquired do not prove to be those needed for our future success,
and the risk that our strategic objectives, cost savings or other anticipate benefits are otherwise not achieved.

 We may experience difficulties in managing our
growth and expanding our operations. 

 We expect to experience
significant growth in the scope of our operations. Our ability to manage our operations and future growth will require us to continue
to improve our operational, financial and management controls, compliance programs and reporting systems. We may not be able to implement
improvements in an efficient or timely manner and may discover deficiencies in existing controls, programs, systems and procedures, which
could have an adverse effect on our business, reputation and financial results. Additionally, rapid growth in our business may place
a strain on our human and capital resources. 

 Risks Related to our Business and Industry 

 We have an unproven business model with no assurance
of significant revenues or operating profit. 

 Our 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 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 it may decline or experience limited growth, which would adversely affect our ability to fully realize the potential
of our platform. 

 Epigenetics is at the heart of our technology, products
and services. According to the CDC, epigenetics is the study of how a person’s behaviors and environment can cause changes that
affect the way a person’s genes work. Unlike genetic changes, epigenetic changes are reversible and do not change one’s DNA
sequence, but they can change how a person’s body reads a DNA sequence. The market for epigenetic tests is relatively new and evaluating
the size and scope of the market is subject to a number of risks and uncertainties. We believe that our future success will depend in
large part on the growth of this market. The utilization of our solution is still relatively new, and customers may not recognize the
need for, or benefits of, our tests and services, which may prompt them to cease use of our tests and services or decide to adopt alternative
products and services to satisfy their healthcare requirements. In order to expand our business and extend our market position, we intend
to focus our marketing and sales efforts on educating customers about the benefits and technological capabilities of our tests and services
and the application of our tests and services to specific needs of customers in different market verticals. Our ability to access and
expand the market that our tests and services are designed to address depends upon a number of factors, including the cost, performance
and perceived value of the tests and services. Market opportunity estimates are subject to significant uncertainty and are based on assumptions
and estimates. Assessing the market for our solutions in each of the vertical markets we are competing in, or planning to compete in,
is particularly difficult due to a number of factors, including limited available information and rapid evolution of the market. The market
for our tests and services may fail to grow significantly or be unable to meet the level of growth we expect. As a result, we may experience
lower-than-expected demand for our products and services due to lack of customer acceptance, technological challenges, competing products
and services, decreases in expenditures by current and prospective customers, weakening economic conditions and other causes. If our market
share does not experience significant growth, or if demand for our solution does not increase, then our business, results of operations
and financial condition will be adversely affected.

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 The estimates of market opportunity and forecasts
of market growth included in this Annual Report on Form 10-K may prove to be inaccurate, and even if the market in which we compete achieves
the forecasted growth, our business could fail to grow at similar rates, if at all. 

 Market opportunity estimates and growth forecasts
are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate. The estimates and
forecasts in this Annual Report on Form 10-K relating to the size and expected growth of the cardiovascular diagnostics market may prove
to be inaccurate. Even if the market in which we compete meets our size estimates and forecasted growth, our business could fail to grow
at similar rates, if at all.

 If we are not able to enhance or introduce new
products that achieve market acceptance and keep pace with technological developments, our business, results of operations and financial
condition could be harmed. 

 Our ability to attract
new customers and increase 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. The success of any enhancements or new products depends on
several factors, including timely completion, adequate quality testing, actual performance quality, market-accepted pricing levels and
overall market acceptance and demand. Enhancements and new products that we develop may not be introduced in a timely or cost-effective
manner, may contain defects, may have interoperability difficulties with our solutions, or may not achieve the market acceptance necessary
to generate significant 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. 

 In 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
affected.

 If 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 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 adverse effect on our business, financial condition and results of operations. 

 Many health care industry participants and payers
are consolidating to create larger and more integrated health care delivery systems with greater market power. We expect regulatory and
economic conditions to result in additional consolidation in the health care industry in the future. As consolidation accelerates, the
economies of scale of our customers’ organizations may grow. If a customer experiences sizable growth following consolidation, that
customer may determine that it no longer needs to rely on us and may reduce its demand for our products and services. In addition, 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 price reductions for our products and services. Finally, consolidation may also result
in the acquisition or future development by our customers of products and services that compete with our products and services. Any of
these potential results of consolidation could have a material adverse effect on our business, financial condition and results of operations.

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 If we are not able to compete effectively, our
business and operating results will be harmed. 

 The market for our tests and services is increasingly
competitive, rapidly evolving and fragmented, and is subject to changing technology and shifting customer needs. Although we believe that
the solutions that we offer are unique, many companies develop and market products and services that compete to varying extents with our
offerings, and we expect competition in our market to continue to intensify. Moreover, industry consolidation may increase competition.

 While the clinical
epigenetics market is still fairly new, we face competition from various sources, including large, well-capitalized technology 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. In
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.
If we are unable to provide our tests and services on terms attractive to the customer, the prospective customer may be unwilling to utilize
our solutions. If our competitors’ products, services or technologies become more accepted than our solutions, if they are successful
in bringing their products or services to market earlier than we do, or if their products or services are more technologically capable
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. 

 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. 

 Our 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.

 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 with the use of ML/AI including accuracy, bias, toxicity, privacy, security and data provenance. Developing,
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.

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 Interruptions or performance problems associated
with our technology and infrastructure may adversely affect our business and operating results. 

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

 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 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 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
of our customers may harm our reputation and our ability to retain existing customers and attract new customers.

 While we have implemented and are continuing to
implement procedures and safeguards that are designed to prevent security breaches and cyberattacks, they may not be able to protect against
all attempts to breach our systems, and we may not become aware in a timely manner of any such security breach. 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 obligations, damages for contract breach,
civil and criminal penalties for violation of applicable laws, regulations or contractual obligations and significant costs, fees and
other monetary payments for remediation. 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.

 We maintain cybersecurity coverage; however, 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.

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 Any failure to offer high-quality customer support
may adversely affect our relationships with our customers. 

 Our 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 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. 

 The information that we provide to our customers
could be inaccurate or incomplete, which could harm our business reputation, financial condition, and results of operations. 

 We aggregate, process, and analyze customers’/patients’
healthcare-related data and information for use by our customers. Because 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.

 In addition, in the future, we may assist our customers
with the management and submission of data to governmental entities, including CMS. These processes and submissions are governed by complex
data processing and validation policies and regulations. 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.

 Our proprietary applications may not operate
properly, which could damage our reputation, give rise to a variety of claims against us, or divert our resources from other purposes,
any of which could harm our business and operating results. 

 Proprietary software, product and application development
is time-consuming, expensive, and complex, and may involve unforeseen difficulties. We may encounter technical obstacles, and it is possible
that we discover additional problems that prevent our proprietary solutions from operating properly. If our solutions and services do
not function reliably or fail to achieve customer expectations in terms of performance, customers could assert liability claims against
us and attempt to cancel their contracts with us. Moreover, material performance problems, defects, or errors in our existing or new solutions
may arise in the future and may result from, among other things, the lack of interoperability of our applications with systems and data
that we did not develop and the function of which is outside of our control or undetected in our testing. Defects or errors in our solutions
might discourage existing or potential customers from purchasing products and services from us. Correction of defects or errors could
prove to be time consuming, costly, impossible, or impracticable. The existence of errors or defects in our solutions and the correction
of such errors could divert our resources from other matters relating to its business, damage our reputation, increase our costs, and
have a material adverse effect on our business, financial condition, and results of operations.

 If we do not keep pace with technological changes,
our solutions may become less competitive, and our business may suffer. 

 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.

 39 

 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™ 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, financial condition and stock price. 

 Concerns over inflation, energy costs, geopolitical
issues, including the ongoing conflict between Russian and Ukraine and the recent commencement of hostilities in Iran, unstable global
credit markets and financial conditions, and volatile oil prices could lead to periods of significant economic instability, diminished
liquidity and credit availability, declines in consumer confidence and discretionary spending, diminished expectations for the global
economy and expectations of slower global economic growth going forward. Our general business strategy may be adversely affected by any
such inflationary fluctuations, economic downturns, volatile business environments and continued unstable or unpredictable economic and
market conditions.

 Additionally, rising costs of goods and services
purchased by us, including raw materials used in manufacturing our tests, may have an adverse effect on our gross margins and profitability
in future periods. If economic and market conditions continue to deteriorate or do not improve, it may make any necessary debt or equity
financing more difficult to complete, more costly and more dilutive to our stockholders. Failure to secure any necessary financing in
a timely manner or on favorable terms could have a material adverse effect on our financial performance and stock price or could require
us to delay or abandon development other business plans. In addition, there is a risk that one or more of our current and future service
providers, manufacturers, suppliers, other partners could be negatively affected by such difficult economic factors, which could adversely
affect our ability to attain our operating goals on schedule and on budget or meet our business and financial objectives.

 Our success depends upon our ability to adapt
to a changing market and our continued development of additional tests and services. 

 Although we believe that we will provide a competitive
range of tests and services, there can be no assurance of acceptance by the marketplace. The procurement of new contracts by us may be
dependent upon the continuing results achieved with current and future customers, upon pricing and operational considerations, as well
as the potential need for continuing improvement to existing products and services. Moreover, the markets for such services may not develop
as expected nor can there be any assurance that we will be successful in our marketing of any such products and services.

 Compliance with changing regulation of corporate
governance and public disclosure result in significant additional expenses. 

 Changing laws, regulations,
and standards relating to corporate governance and public disclosure for public companies, including the Sarbanes-Oxley Act of 2002 and
various rules and regulations adopted by the SEC, are creating uncertainty for public companies. Our management needs to invest significant
time and financial resources to comply with both existing and evolving requirements for public companies, which leads, among other things,
to significantly increased general and administrative expenses and diversion of management time and attention from revenue generating
activities to compliance activities. 

 40 

 Risks Related to our Business Operations 

 We could experience losses or liability not covered
by insurance. 

 Our business exposes us to risks that are inherent
in the provision of testing services that assist clinical decision-making. If customers or customer personnel assert liability claims
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 solutions. The limitations of liability set forth in any contracts we
may enter into now or in the future may not be enforceable or may not otherwise protect us from liability for damages. Additionally, we
may be subject to claims that are not explicitly covered by a contract. We also maintain general liability coverage; however, 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 exclusions for certain products. 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.

 Our future growth could be harmed if we lose
the services of our key personnel. 

 We are highly dependent upon the talents and services
of a number of key employees, specifically Meeshanthini Dogan, PhD, Robert Philibert, MD PhD and Timur Dogan, PhD, and other senior technical
and management personnel, including our other executive officers, all of whom would be difficult to replace. In 2022, we entered into
multi-year employment agreements with each of our executive officers and a consulting agreement with our non-executive chairman. The loss
of the services of one or more of these key employees would disrupt our business and harm its results of operations. As competition is
intense for the type of highly skilled scientific and medical professionals our business requires, we may not be able to successfully
attract and retain senior leadership necessary to grow our business.

 If we are unable to hire, retain and motivate
qualified personnel, 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. 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. 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.

 We may be unable to manage our growth. 

 Currently, we have less than 15 full and two part-time
employees. Our ability to manage our growth effectively will require us to continue to improve our operational, financial and management
controls and information systems to accurately forecast sales demand, to manage our operating 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. If management fails to manage the expected growth, our results of operations, financial condition, business and prospects
could be adversely affected. In addition, our growth strategy may depend on effectively integrating future entities, which requires cooperative
efforts from 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.

 41 

 Our Board of Directors may change its strategies,
policies, and procedures without stockholder approval, and we may become highly leveraged, which may increase our risk of default under
our existing 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. 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. Changes to our policies with regards to the foregoing
could materially adversely affect our financial condition, results of operations, and cash flow.

 Our business is subject to the risks of earthquakes,
fire, floods, pandemics and other natural catastrophic events, and to interruption by man-made problems, such as power disruptions, computer
viruses, data security breaches or terrorism. 

 A significant natural disaster, such as a tornado,
hurricane or a flood, occurring at our headquarters or where a business partner is located could adversely affect our business, results
of operations and financial condition. 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 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 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
disruption caused by a health epidemic or pandemic, natural disaster or man-made problem, we may be unable to continue our operations
and may endure system interruptions, reputational harm, delays in our development activities, lengthy interruptions in service, breaches
of data security and loss of critical data, any of which could adversely affect our business, results of operations and financial condition.

 We may need to seek alternative business opportunities
and change the nature of our business. 

 As a company in the early stages of its development,
we continuously reevaluate our business, the market in which we operate and potential new opportunities. We may seek other alternatives
within the healthcare field in order to grow our business and increase revenues. Such alternatives may include, but not be limited to,
combinations or strategic partnerships with laboratory companies or with medical practices such as hospitalists or behavioral health.
Pursuing alternative business opportunities could increase our expenses, may require us to obtain additional financing, which may not
be available on favorable terms or at all, and result in potentially dilutive issuances of our equity securities or the incurrence of
debt that may be burdensome to service, any of which could have a material adverse effect on our business and operations. In addition,
pursuing alternative business opportunities may never be successful and may divert significant management time and attention. Moreover,
accomplishing and integrating any business opportunity that is pursued by us may disrupt the existing business and may be a complex, risky
and costly endeavor and could have a material adverse effect on our business, results of operations, financial condition and prospects.

 Any legal proceedings or claims against us could
be costly and 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. 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 

 Our license agreement with the University of
Iowa Research Foundation includes a non-exclusive license of “technical information” that potentially could grant unaffiliated
third parties access to materials and information considered derivative work made by us, which could be used by such licensees to develop
competitive products. 

 The University of Iowa Research Foundation, or UIRF,
license agreement grants to us a worldwide, exclusive, non-transferable license under the Patent Rights, as defined in the agreement,
to make, have made, use, sell, offer for sale and import the Licensed Products(s) and/or Licensed Processes, as defined in the agreement,
in the field of research tools and clinical diagnostics for cardiovascular disease, stroke, congestive heart failure and diabetes in humans.
However, the agreement also confers a non-exclusive license as to Technical Information. Technical Information is defined as certain research
and development information, materials, confidential information, technical data, unpatented inventions, know-how and supportive information
owned and controlled by the licensor that was not in the public domain as of May 2, 2017 and that describes the Invention, as defined
in the agreement, its manufacture and/or use and selected by the licensor to provide to us for use in or with the development, manufacture
or use of the Licensed Products and/or Licensed Processes. Technical Information further includes materials, all progeny and derivatives
of the materials made by us or our sublicensees, as well as software or other copyrightable work, all derivatives of such software and
other copyrightable work made by us and our sublicensees. The ability of UIRF to grant non-exclusive licenses to third parties in and
to this broad definition of Technical Information raises the possibility that unaffiliated third parties could use such Technical Information,
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 in the
future. Increased competition could result in reduced demand for the Company’s products and/or processes, slow its growth and materially
adversely affect its business, operating results and financial condition.

 We could incur substantial costs in protecting
or defending our intellectual property rights, and any failure to protect or defend our intellectual property could adversely affect our
business, results of operations and financial condition. 

 Our success depends, in part, on our ability to
protect our brand and the proprietary methods and technologies that we develop under patent and other intellectual property laws of the
United States and foreign jurisdictions so that we can prevent others from using our inventions and proprietary information. Any patents
that have been issued or that may be issued in the future may not provide significant protection for our intellectual property. If we
fail to protect our intellectual property rights adequately, our competitors might gain access to our technology and our business, results
of operations and financial condition may be adversely affected.

 The particular forms of intellectual property protection
that we seek, or our business decisions about when to file patent applications and trademark applications, may not be adequate to protect
our business. We could be required to expend significant resources to monitor and protect our intellectual property rights. Litigation
may be necessary in the future to enforce our intellectual property rights, determine the validity and scope of our proprietary rights
or those of others, or defend against claims of infringement or invalidity. Such litigation could be costly, time-consuming and distracting
to management, result in a diversion of significant resources, lead to the narrowing or invalidation of portions of our intellectual property
and have an adverse effect on our business, results of operations and financial condition. Our efforts to enforce our intellectual property
rights may be met with defenses, counterclaims and countersuits attacking the validity and enforceability of our intellectual property
rights or alleging that we infringe the counterclaimant’s own intellectual property. Any of our patents, copyrights, trademarks
or other intellectual property rights could be challenged by others or invalidated through administrative process or litigation.

 We also rely, in part, on confidentiality agreements
with our business partners, employees, consultants, advisors, customers and others in our efforts to protect our proprietary technology,
processes and methods. These agreements may not effectively prevent disclosure of our confidential information, and it may be possible
for unauthorized parties to copy our software or other proprietary technology or information, or to develop similar technology independently
without our having an adequate remedy for unauthorized use or disclosure of our confidential information. In addition, others may independently
discover our trade secrets and proprietary information, and in these cases, we would not be able to assert any trade secret rights against
those parties. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and
the failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

 In addition, the laws
of some countries do not protect intellectual property and other proprietary rights to the same extent as the laws of the United States.
To the extent we expand into international activities, our exposure to unauthorized copying, transfer and use of our proprietary technology
or information may increase. 

 Our means of protecting our intellectual property
and proprietary rights may not be adequate or our competitors could independently develop similar technology. If we fail to meaningfully
protect our intellectual property and proprietary rights, our business, results of operations and financial condition could be adversely
affected.

 42 

 Assertions by third parties of infringement or
other violations by us of its intellectual property rights could result in significant costs and harm our business and operating results. 

 Our 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. 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 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 operations.

 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, 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. 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 either party as a result of any material breach of the license which is not remedied within 30 days
after receiving written notice thereof or by UIRF as a result of any breach of the license which has not been cured within 90 days after
UIRF provides written notice of such breach.

 Some of our technologies incorporate “open-source”
software or other similar licensed technologies, which could become unavailable or subject us to increased costs, delays in production
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. 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.

 The 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 of the code. Many of the risks
associated with use of open-source software cannot be eliminated and could negatively affect our business. 

 In addition, the wide availability of open-source
code used in our current and future products could expose us to security vulnerabilities. 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 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.

 43 

 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. government 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
using U.S. 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 

 We conduct business in a heavily regulated industry,
and if we fail to comply with these laws and government regulations, we could incur penalties or be required to make significant changes
to our operations or experience adverse publicity, which could have a material adverse effect on our business, financial condition, and
results of operations. 

 The healthcare industry is heavily regulated and
closely scrutinized by federal, state and local governments. Comprehensive statutes and regulations govern the manner in which we 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:

 · 
 the federal physician self-referral law, commonly referred to as the Stark Law; 

 · 
 the federal Anti-Kickback Act; 

 · 
 the criminal healthcare fraud provisions of HIPAA; 

 · 
 the federal False Claims Act; 

 · 
 reassignment of payment rules that prohibit certain types of billing and collection; 

 · 
 similar state law provisions pertaining to anti-kickback, self-referral and false claims issues; 

 · 
 state laws that prohibit general business corporations, such as us, from practicing medicine; and 

 · 
 laws that regulate debt collection practices as applied to our debt collection practices. 

 Because of the breadth of these laws and the narrowness
of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge
under one or more of such laws. Achieving and sustaining compliance with these laws may prove costly. Failure to comply with these laws
and other laws can result in civil and criminal penalties such as fines, damages, overpayment recoupment loss of enrollment status and
exclusion from the Medicare and Medicaid programs. The risk of us being found in violation of these laws and regulations is increased
by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are sometimes
open to a variety of interpretations. Our failure to accurately anticipate the application of these laws and regulations to our business
or any other failure to comply with regulatory requirements could create liability for us and negatively affect our business. 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 loss of customers and adverse publicity.

 44 

 To enforce compliance with the federal laws, the
U.S. Department of Justice and the Office of the Inspector General (“OIG”) have recently increased their scrutiny of healthcare providers,
which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing with investigations
can be time- and resource-consuming and can divert management’s attention from the business. Any such investigation or settlement
could increase our costs or otherwise have an adverse effect on our business. In addition, because of the potential for large monetary
exposure under the federal False Claims Act, which provides for treble damages and mandatory minimum penalties of $5,500 to $11,000 per
false claim or statement, healthcare providers often resolve allegations without admissions of liability for significant and material
amounts to avoid the uncertainty of treble damages that may be awarded in litigation proceedings. Such settlements often contain additional
compliance and reporting requirements as part of a consent decree, settlement agreement or corporate integrity agreement. Given the significant
size of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating
healthcare providers’ compliance with the healthcare reimbursement rules and fraud and abuse laws.

 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.

 If the FDA were to begin actively regulating our tests or software, we could incur substantial costs and delays associated
with trying to obtain premarket 510(k) clearance, de novo classification, or premarket approval and incur costs associated with complying
with post-market controls. 

 We believe 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. Our laboratories are currently
regulated under CLIA and must comply with CAP requirements, and we are subject to extensive federal and state laws and regulations. The
FDA issued a final rule in May 2024 that would have subjected many LDTs to regulatory requirements including, in some cases, premarket
authorization. A federal district court vacated the FDA final rule in May 2025, holding that LDTs are not subject to FDA regulation. The
FDA rescinded the final rule in September 2025. The FDA has not indicated how it will interpret the court ruling or whether it will seek
a different regulatory approach with respect to LDTs or components thereof. In June 2025, Congress re-introduced the Verifying Accurate,
Leading-edge IVCT Development Act (“VALID Act”) to establish a new risk-based regulatory framework for in vitro clinical tests
(“IVCTs”), including IVDs, LDTs, collection devices and instruments used with such tests. This legislation was previously
introduced in 2021 and 2023.

 If the FDA were to develop an alternate approach
to regulating LDTs, or if Congress were to enact legislation giving FDA authority to regulate our current or future LDTs, or any components,
materials, or software we use in our tests we could be forced to stop selling our tests or be required to modify claims for or make other
changes to our tests while we or our suppliers work to comply with FDA requirements including, potentially, premarket authorization. Our
business could be adversely affected while such review was ongoing and if we or our supplier were ultimately unable to obtain such authorization.
Completing such submissions would require the expenditure of time, attention and financial and other resources, and may not yield the
desired results, which could delay, limit or prevent regulatory authorization.

 We also believe that our Actionable Clinical Intelligence
and HeartRisk platform are not subject to regulation by the FDA.In particular, the Actionable Clinical Intelligence platform is offered
as a component of the PrecisionCHD LDT which, as noted above, FDA does not have authority to regulate. HeartRisk is intended for
use by business leaders as a population health analytics platform and as such does not meet the device definition. If
the FDA were to disagree with our position, this could have an adverse impact on our ability to offer our tests and related services.
If the FDA required us to obtain marketing authorization for one or more of our platforms, our business could be adversely affected while
such review was in process or if we are unable to obtain marketing authorization.

 If our products do not receive adequate coverage
and reimbursement from third-party payors, our ability to expand access to our tests beyond the initial sales channels will be limited
and our overall commercial 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 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
of the price of the products. If we are not able to obtain adequate coverage and an acceptable level of reimbursement for our products
from third-party payors, there could be a greater co-insurance or co-payment obligation for any individual for whom a test is ordered.
The individual may be forced to pay the entire cost of a test out-of-pocket, which could dissuade physicians from ordering our products
and, if ordered, could result in delay in or decreased likelihood of collection of payment.

 45 

 Medicare is the single largest U.S. payor and a
particularly important payor for many cardiac-related laboratory services, given the demographics of the Medicare population. Generally,
traditional Medicare fee-for-service will not cover screening tests that are performed in the absence of signs, symptoms, complaints,
personal history of disease, or injury except when there is a statutory provision that explicitly covers the test. Epi+Gen CHD™
could be considered a screening test under Medicare and, accordingly, may not be eligible for traditional Medicare fee-for- service coverage
and reimbursement unless we pursue substantial additional measures, which would require significant investments, and may ultimately be
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. 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, laboratory-reported private payor rates are used to establish
Medicare payment rates for tests reimbursed via the CLFS. This 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.

 Even 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 levels. 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™ and PrecisionCHD™ tests are 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, financial condition, and results of
operations.

 46 

 Risks Related to Customer Privacy, Cybersecurity
and Data 

 Our use and disclosure of personally identifiable
information, including health information, is subject to federal and state privacy and security regulations, and our failure to comply
with those regulations or to adequately secure the information we hold could result in significant liability or reputational harm and,
in turn, a material adverse effect on our customer base and revenue. 

 Numerous state and
federal laws and regulations govern the collection, dissemination, use, privacy, confidentiality, security, availability and integrity
of Personally Identifiable Information (“PII”), including protected health information. These laws and regulations include
the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). HIPAA establishes a set of basic national privacy
and security standards for the protection of protected health information, (“PHI”), by health plans, healthcare clearinghouses
and certain healthcare providers, referred to as covered entities, and the business associates with whom such covered entities contract
for services, which includes Cardio. 

 HIPAA requires healthcare providers like Cardio
to develop and maintain policies and procedures with respect to PHI that is used or disclosed, including the adoption of administrative,
physical and technical safeguards to protect such information. HIPAA also implemented the use of standard transaction code sets and standard
identifiers that covered entities must use when submitting or receiving certain electronic healthcare transactions, including activities
associated with the billing and collection of healthcare claims.

 HIPAA imposes mandatory penalties for certain violations.
Penalties for violations of HIPAA and its implementing regulations start at $100 per violation and are not to exceed $50,000 per violation,
subject to a cap of $1.5 million for violations of the same standard in a single calendar year. However, a single breach incident can
result in violations of multiple standards. HIPAA also authorizes state attorneys general to file suit on behalf of their residents. Courts
will be able to award damages, costs and attorneys’ fees related to violations of HIPAA in such cases. While HIPAA does not create
a private right of action allowing individuals to sue us in civil court for violations of HIPAA, its standards have been used as the basis
for duty of care in state civil suits such as those for negligence or recklessness in the misuse or breach of PHI.

 In addition, HIPAA mandates that the Secretary of
Health and Human Services, or HHS, conduct periodic compliance audits of HIPAA-covered entities or business associates for compliance
with the HIPAA Privacy and Security Standards. It also tasks HHS with establishing a methodology whereby harmed individuals who were the
victims of breaches of unsecured PHI may receive a percentage of the Civil Monetary Penalty fine paid by the violator.

 HIPAA further requires that patients be notified
of any unauthorized acquisition, access, use or disclosure of their unsecured PHI that compromises the privacy or security of such information,
with certain exceptions related to unintentional or inadvertent use or disclosure by employees or authorized individuals. HIPAA specifies
that such notifications must be made “without unreasonable delay and in no case later than 60 calendar days after discovery of the
breach.” If a breach affects 500 patients or more, it must be reported to HHS without unreasonable delay, and HHS will post the
name of the breaching entity on its public web site. Breaches affecting 500 patients or more in the same state or jurisdiction must also
be reported to the local media. If a breach involves fewer than 500 people, the covered entity must record it in a log and notify HHS
at least annually.

 Numerous other federal and state laws protect the
confidentiality, privacy, availability, integrity and security of personally identifiable information, or PII, including PHI. These laws
in many cases are more restrictive than, and may not be preempted by, the HIPAA rules and may be subject to varying interpretations by
courts and government agencies, creating complex compliance issues for us, and our customers and potentially exposing us to additional
expense, adverse publicity and liability.

 New 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 complying 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.

 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 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.

 47 

 We outsource important
aspects of the storage and transmission of customer and customer personnel information, and 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. states are adopting new laws or
amending existing laws and regulations, requiring attention to frequently changing regulatory requirements applicable to data related
to individuals. For example, California has enacted the California Consumer Privacy Act (“CCPA”). The CCPA gives California
residents expanded rights to access and delete their personal information, opt out of certain personal information sharing and receive
detailed information about how their personal information is used by requiring covered companies to provide new disclosures to California
consumers (as that term is broadly defined and which can include any of our current or future employees who may be California residents
or any other California residents whose data we collect or process) and provide such residents new ways to opt out of certain sales of
personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that
is expected to increase data breach litigation. As we expand our operations and customer base, the CCPA may increase our compliance costs
and potential liability. Additionally, the California Privacy Rights Act (“CPRA”), which was approved by California voters
in the election in November 2020, created obligations relating to consumer data with implementing regulations that, although delayed,
did take effect during 2024. The CPRA modifies the CCPA significantly, potentially resulting in further uncertainty and requiring us to
incur additional costs and expenses in an effort to comply. Additionally, about 20 U.S. states have adopted, privacy-focused legislation
such as Colorado, Virginia, Utah and Connecticut. Aspects of these state laws remain unclear, resulting in further uncertainty and potentially
requiring us to modify our data practices and policies and to incur substantial additional costs and expenses in an effort to comply.

 Privacy and data security laws and regulations
could require us 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 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. 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 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 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.

 48 

 General Risks Affecting Our Company 

 A pandemic, epidemic or outbreak of an infectious
disease in the United States or worldwide, including the re-emergence of the novel strain of coronavirus disease, COVID-19, could adversely
affect our business. 

 If a pandemic, epidemic
or outbreak of an infectious disease occurs in the United States or worldwide, our business may be adversely affected. 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 operations. 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 financial performance or financial condition. Refer to Note 2, “Summary
of Significant Accounting Policies” to the Audited Financial Statements included elsewhere in this Annual Report on Form 10-K for
a description of recent accounting pronouncements.

 Risks Related to Our Securities 

 We are an “emerging growth company”
and “smaller reporting company” within the meaning of the Securities Act, and if we take advantage of certain exemptions from
disclosure requirements available to emerging growth companies, it could make our securities less attractive to investors and may make
it more difficult to compare our performance to the performance of other public companies. 

 We are an “emerging growth company”
as defined in Section 2(a)(19) of the Securities Act, as modified by the Jumpstart our Business Startups Act (the “JOBS Act”).
As such, we are eligible for and take advantage of certain exemptions from various reporting requirements applicable to other public companies
that are not emerging growth companies for as long as we continue to be an emerging growth company, including, but not limited to, (a)
not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley”),
(b) reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and (c) exemptions from
the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments
not previously approved. As a result, our stockholders may not have access to certain information they may deem important. We will remain
an emerging growth company until December 31, 2026, which is the last day of the fiscal year following the fifth anniversary of the date
of the first sale of Common Stock in Mana’s initial public offering. We cannot predict whether investors have found or will continue
to find our securities less attractive because it will rely on these exemptions. If some investors find our securities less attractive
as a result of our reliance on these exemptions, the trading prices of our securities may be lower than they otherwise would be, there
may be a less active trading market for our securities and the trading prices of our securities may be more volatile.

 Further, Section 102(b)(1) of the JOBS Act exempts
emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that
is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered
under the Exchange Act) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company
can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but
any such election to opt out is irrevocable. We have elected not to opt out of such extended transition period, which means that when
a standard is issued or revised and it has different application dates for public or private companies, we, as an emerging growth company,
can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of our
financial statements with another public company that is neither an emerging growth company nor an emerging growth company that has opted
out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.
However, once we lose emerging growth company status on December 31, 2026, we will lose this exemption and will be required to adopt revised
or new accounting standards on the time schedule applicable to non-emerging growth companies.

 49 

 Additionally, we are
a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K and a non-accelerated filer. Smaller reporting
companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited
financial statements and reduced executive compensation disclosure. In addition, as a non-accelerated filer and smaller reporting company,
we will continue to be exempt from complying with the auditor attestation requirements of Section 404 of Sarbanes-Oxley. We expect that
we will remain a smaller reporting company until the last day of any fiscal year for so long as either (a) the market value of our Common
Stock held by non-affiliates does not equal or exceed $250 million as of the prior June 30th, or (b) our annual revenues did not equal
or exceed $100 million during such completed fiscal year and the market value of our Common Stock held by non-affiliates did not equal
or exceed $700 million as of the prior June 30th. To the extent we take advantage of such reduced disclosure obligations, it may also
make comparison of our financial statements with other public companies difficult or impossible. 

 Our stock price may be volatile and may decline
regardless of our operating performance. 

 The market price of our Common Stock may fluctuate
significantly in response to numerous factors and may continue to fluctuate for these and other reasons, many of which are beyond our
control, including:

 · 
 actual or anticipated fluctuations in our revenue and results of operations; 

 · 
 failure of securities analysts to maintain coverage of the Company, changes in financial estimates or ratings by any securities analysts who follow us or our failure to meet these estimates or the expectations of investors; 

 · 
 announcements by us or our competitors of significant technical innovations, acquisitions, strategic partnerships, joint ventures, results of operations or capital commitments; 

 · 
 changes in operating performance and stock market valuations of other healthcare-related companies generally, or those in the medical diagnostics industry in particular; 

 · 
 price and volume fluctuations in the overall stock market, including as a result of trends in the economy as a whole; 

 · 
 trading volume of our Common Stock; 

 · 
 the inclusion, exclusion or removal of our Common Stock from any indices; 

 · 
 changes in the Board or management; 

 · 
 transactions in our Common Stock by directors, officers, affiliates and other major investors; 

 · 
 lawsuits threatened or filed against us; 

 · 
 changes in laws or regulations applicable to our business; 

 · 
 changes in our capital structure, such as future issuances of debt or equity securities; 

 · 
 short sales, hedging and other derivative transactions involving our capital stock; 

 · 
 general economic conditions in the United States; 

 · 
 pandemics or other public health crises, including, but not limited to, the COVID-19 pandemic (including additional variants such as the Omicron variant); 

 · 
 other events or factors, including those resulting from war, incidents of terrorism or responses to these events; and 

 · 
 the other factors described in this “Risk Factors” section. 

 The stock market generally, as well as our Common
Stock in particular, have recently experienced extreme price and volume fluctuations. The market prices of securities of companies have
experienced fluctuations that often have been unrelated or disproportionate to their operating results. In the past, stockholders have
sometimes instituted securities class action litigation against companies following periods of volatility in the market price of their
securities. Any similar litigation against us could result in substantial costs, divert management’s attention and resources, and
harm its business, financial condition, and results of operations.

 An active trading market for our Common Stock
may not be created or sustained. 

 We have listed our Common Stock and Warrants on
Nasdaq under the symbols “CDIO” and “CDIOW,” respectively. We cannot assure you that an active trading market
for our Common Stock can be sustained. Accordingly, we cannot assure you of the liquidity of any trading market, your ability to sell
your shares of our Common Stock when desired or the prices that you may obtain for your shares.

 50 

 Future sales of Common Stock in the public market
could cause our share price to decline significantly, even if our business is doing well. 

 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
was used for an at-the-market offering of up to $17 million; (iii) up to $9,476,508 in securities on a shelf registration statement that
we are currently using for an at-the-market offering of up to $9,476,508; (iii) a registration statement on Form S-8 covering our 2022
Equity Incentive Plan. Public sales of securities can continue to be made under these registration statements, and (iv) a registration
statement covering the resale of Common Stock and shares underlying warrants that were sold in a private placement effected in February
2024. 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
statements or pursuant to Rule 144 may make it more difficult for us to sell equity securities in the future at a time and at a price
that we deem appropriate. These sales also could cause the trading price of our Common Stock to fall and make it more difficult for investors
to sell shares of our Common Stock at a time and price that they deem appropriate.

 If securities or industry analysts either do
not publish research about us or publish inaccurate or unfavorable research about us, our business, or our market, or if they change their
recommendations regarding our Common Stock adversely, the trading price or trading volume of our Common Stock could decline. 

 The trading market for our Common Stock is influenced
in part by the research and reports that securities or industry analysts may publish about us, our business, our market, or our competitors.
If one or more of the analysts initiate research with an unfavorable rating or downgrade our Common Stock, provide a more favorable recommendation
about our competitors, or publish inaccurate or unfavorable research about our business, the trading price of our Common Stock would likely
decline. In addition, we currently expect that securities research analysts will establish and publish their own periodic projections
for our business. These projections may vary widely and may not accurately predict the results we actually achieve. Our stock price may
decline if our actual results do not match the projections of these securities research analysts. Furthermore, if no analysts commence
coverage of our Company, the trading price and volume for our Common Stock could be adversely affected. If any analyst who may cover us
were to cease coverage of the Company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which
in turn could cause the trading price or trading volume of our Common Stock to decline.

 Delaware law and provisions in our Charter and
Bylaws could make a merger, tender offer, or proxy contest difficult, thereby depressing the trading price of our Common Stock. 

 Our Charter and Bylaws contain provisions that could
depress the trading price of our Common Stock by acting to discourage, delay, or prevent a change of control of the Company or changes
in our management that our stockholders may deem advantageous. These provisions include the following:

 · 
 the right of the board of directors to establish the number of directors and fill any vacancies and newly created directorships; 

 · 
 director removal solely for cause; 

 · 
 “blank check” preferred stock that the Board could use to implement a stockholder rights plan; 

 · 
 the right of the Board to issue our authorized but unissued Common Stock and preferred stock without stockholder approval; 

 · 
 no ability of our stockholders to call special meetings of stockholders; 

 · 
 no right of our stockholders to act by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders; 

 · 
 limitations on the liability of, and the provision of indemnification to, our director and officers; 

 · 
 the right of the board of directors to make, alter, or repeal the Bylaws; and 

 · 
 advance notice requirements for nominations for election to the Board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings. 

 51 

 Any provision of the
Charter or Bylaws that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to
receive a premium for their shares of our Common Stock, and could also affect the price that some investors are willing to pay for our
Common Stock. 

 Our Bylaws provide that the Court of Chancery
of the State of Delaware will be the exclusive forum for substantially all disputes between the Company and our stockholders, which could
limit our stockholders’ ability to obtain a favorable judicial forum for disputes with the Company or our directors, officers or
employees. 

 The Bylaws provide that the Court of Chancery of
the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a breach
of fiduciary duty, any action asserting a claim against us arising pursuant to the DGCL, the Charter or Bylaws or any action asserting
a claim against us that is governed by the internal affairs doctrine. These choice of forum provisions may limit a stockholder’s
ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees
and may discourage these types of lawsuits. This provision would not apply to claims brought to enforce a duty or liability created by
the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. The Bylaws provide further that, to the
fullest extent permitted by law, the federal district courts of the United States will be the exclusive forum for resolving any complaint
asserting a cause of action arising under the Securities Act. However, Section 22 of the Securities Act provides that federal and state
courts have concurrent jurisdiction over lawsuits brought under the Securities Act or the rules and regulations thereunder. To the extent
the exclusive forum provision restricts the courts in which claims arising under the Securities Act may be brought, there is uncertainty
as to whether a court would enforce such a provision. We note that investors cannot waive compliance with the federal securities laws
and the rules and regulations thereunder. Furthermore, the enforceability of similar choice of forum provisions in other companies’
certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types of provisions
to be inapplicable or unenforceable. While the Delaware courts have determined that such choice of forum provisions are facially valid,
a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions, and there
can be no assurance that such provisions will be enforced by a court in those other jurisdictions. If a court were to find the exclusive-forum
provision contained in the Bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving
such action in other jurisdictions, which could harm our business.

 We do not intend to pay dividends for the foreseeable
future. 

 We currently intend to retain any future earnings
to finance the operation and expansion of our business and we do not expect to declare or pay any dividends in the foreseeable future.

 Moreover, the terms of any revolving credit facility
into which we or any of our subsidiaries enters may restrict our ability to pay dividends, and any additional debt we or any of our subsidiaries
may incur in the future may include similar restrictions. As a result, stockholders must rely on sales of their Common Stock after price
appreciation as the only way to realize any future gains on their investment.

 We may issue additional shares of our Common
Stock or other equity securities without your approval, which would dilute your ownership interests and may depress the market price of
our Common Stock. 

 On January 26, 2024, the Company entered into an
At-the-Market Issuance Sales Agreement (the “Sales Agreement”) with Craig-Hallum Capital Group LLC (“Craig-Hallum”).
Sales of our Common Stock pursuant to the Sales Agreement were made under the Company’s Registration Statement on Form S-3 filed
on January 26, 2024 (File No. 333-276725) declared effective by the SEC on February 1, 2024 and have been, and may continue to be made,
under the Company’s Registration Statement on Form S-3 filed on February 7, 2025 (File No. 333-284775) declared effective by the
SEC on February 14, 2025. As of March 13, 2026, we have sold 2,251,181 shares of our Common Stock under the Sales Agreement and may sell
up to another $5,298,889 of our Common Stock through Craig-Hallum under the Sales Agreement.

 As of March 13, 2026, we have Warrants
outstanding to purchase 284,292 shares of our Common Stock. We will also have the ability to initially issue an aggregate of 239,920
shares of our Common Stock under the Cardio Equity Incentive Plan, of which 144,320 options have been granted and are currently
exercisable and 14,972 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.

 52 

 We may issue additional shares of our Common Stock
or other equity securities of equal or senior rank in the future in connection with, among other things, future acquisitions or repayment
of outstanding indebtedness, without stockholder approval, in a number of circumstances.

 The issuance of additional shares of Common Stock
or other equity securities of equal or senior rank would have the following effects:

 · 
 our existing stockholders’ proportionate ownership interest in the Company will decrease; 

 · 
 the amount of cash available per share, including for payment of dividends (if any) in the future, may decrease; 

 · 
 the relative voting strength of each previously outstanding share of Common Stock may be diminished; and 

 · 
 the market price of our shares of Common Stock may decline. 

 We may redeem the Public Warrants and the Sponsor
Warrants prior to their exercise at a time that is disadvantageous to you, as a warrant holder, thereby making your Public Warrants or
Sponsor Warrants worthless. 

 We have the ability to redeem outstanding Public
Warrants and Sponsor Warrants at any time after they become exercisable and prior to their expiration, at a price of $0.01 per warrant,
provided that the last reported sales price of our Common Stock equals or exceeds $540.00 per share (as adjusted for stock splits, stock
dividends, reorganizations, recapitalizations and the like) for any 20 trading days within a 30 trading-day period ending on the 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 $540.00 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 separate registration statement, most recently updated by Post-Effective Amendment No.
3, which the SEC declared effective on September 9, 2025, 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 Public
Warrants and the Sponsor Warrants, holders would be notified of such redemption as described in the Warrant Agreement. Specifically, we
would be required to fix a date for the redemption (the “Redemption Date”). Notice of redemption would be mailed by first
class mail, postage prepaid, by the Company not less than 30 days prior to the Redemption Date to the registered holders of the Public
Warrants and the Sponsor Warrants to be redeemed at their last addresses as they appear on the registration books. In addition, beneficial
owners of the redeemable Public Warrants and the Sponsor Warrants will be notified of such redemption via the Company’s posting
of the redemption notice to DTC. Redemption of the Public Warrants and the Sponsor Warrants could force you (i) to exercise your Public
Warrants and the Sponsor Warrants and pay the exercise price therefor at a time when it may be disadvantageous for you to do so, (ii)
to sell your Public Warrants and the Sponsor Warrants at the then-current market price when you might otherwise wish to hold your Public
Warrants and the Sponsor Warrants or (iii) to accept the nominal redemption price which, at the time the outstanding Public Warrants and
the Sponsor Warrants are called for redemption, is likely to be substantially less than the market value of your Public Warrants and the
Sponsor Warrants. None of the Private Placement Warrants will be redeemable.

 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 $345 to a low of $53.4 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 $4.76 per share on March 11, 2026. 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.

 53 

 The Warrant Agreement designates the courts of
the State of New York or the United States District Court for the Southern District of New York as the sole and exclusive forum for certain
types of actions and proceedings that may be initiated by holders of the Warrants, which could limit the ability of warrant holders to
obtain a favorable judicial forum for disputes with our Company. 

 The Warrant Agreement
provides that, subject to applicable law, (i) any action, proceeding or claim against us arising out of or relating in any way to the
Warrant Agreement, including under the Securities Act, will be brought and enforced in the courts of the State of New York or the United
States District Court for the Southern District of New York, and (ii) that we irrevocably submit to such jurisdiction, which jurisdiction
shall be the exclusive forum for any such action, proceeding or claim. We will waive any objection to such exclusive jurisdiction and
that such courts represent an inconvenient forum. Notwithstanding the foregoing, these provisions of the Warrant Agreement will not apply
to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal district courts
of the United States of America are the sole and exclusive forum. 

 Any person or entity purchasing or otherwise acquiring
any interest in Warrants shall be deemed to have notice of and to have consented to the forum provisions in the Warrant Agreement. If
any action, the subject matter of which is within the scope the forum provisions of the Warrant Agreement, is filed in a court other than
a court of the State of New York or the United States District Court for the Southern District of New York (a “foreign action”)
in the name of any holder of Warrants, such holder shall be deemed to have consented to: (x) the personal jurisdiction of the state and
federal courts located in the State of New York in connection with any action brought in any such court to enforce the forum provisions
(an “enforcement action”), and (y) having service of process made upon such warrant holder in any such enforcement action
by service upon such warrant holder’s counsel in the foreign action as agent for such warrant holder.

 This choice-of-forum provision may limit a warrant
holder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us, which may discourage such lawsuits.

 Alternatively, if a court were to find this provision
of the Warrant Agreement inapplicable or unenforceable with respect to 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.

 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 Sarbanes-Oxley, the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd Frank”),
and the Nasdaq listing requirements. 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 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.

 We have 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. 

 54 

 We will need to grow the size of our organization
and may experience difficulties in managing this growth. 

 As our expansion plans and strategies develop, 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; 

 · 
 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; and 

 · 
 improving our operational, financial and management controls, reporting systems and procedures. 

 Our future financial performance and our ability
to expand our business will depend, in part, on our ability to effectively manage any future growth, and our management may also have
to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to
managing these growth activities.

 If we are not able to effectively expand our organization
by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks
necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development and
commercialization goals.

 There can be no assurance that we will be able
to comply with the continued listing standards of Nasdaq, and delisting of our securities could become more likely if a proposed Nasdaq
rule currently being considered is adopted, as expected . 

 Our Common Stock is listed on The Nasdaq Capital
Market ("Nasdaq”). In recent years, Nasdaq has adopted, and currently is proposing, revised standards that could make it more
difficult for a small company to maintain its listing. In order to maintain our listing, we must satisfy minimum financial and other
requirements including, without limitation, a requirement that the closing bid price of our Common Stock be at least $1.00 per share..
Under Nasdaq’s listing rules, if a company’s security fails to meet the continued listing requirement for minimum bid price
of no less than $1.00 for 30 consecutive business days, and the Company has effected a reverse stock split over the prior one-year period;
or has effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one,
then that company loses eligibility for any additional compliance cure period and risks immediate delisting with respect to that security.
The Company effected a reverse stock split on May 12, 2025 in order to cure the $1.00 minimum bid deficiency, making these time periods
relevant. In addition, Nasdaq has recently proposed a rule change that if a company’s listed securities fail to have a market value
of listed securities (“MVLS”) of at least $5 million for 30 consecutive business days, then Nasdaq will immediately suspend
that company’s securities, with delisting to follow without Nasdaq’s historically-customary cure period. The only basis of
appeal will be to correct calculation errors, and any suspension will remain in effect during that appeal process. The proposal is subject
to SEC approval, which is currently expected in March 2026, and would become effective 60 days thereafter. If the proposal is implemented
and becomes effective, our securities will be more vulnerable to being delisted if we are unable to maintain a MVLS of at least $5.0
million. On March 11, 2026, our Common Stock closed at $4.76, so we currently have a MVLS above $5.0 million, but our stock is volatile
and could be subject to delisting in the future.

 If Nasdaq delists our shares of Common Stock and
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 more limited amount of analyst coverage; and 

 · 
 a decreased ability to issue additional securities or obtain additional financing in the future, including that we would no longer be able to rely on our ATM Offering, which has been its primary source of financing for the last two years. 

 We may acquire other companies or technologies,
which could divert our management’s attention, result in dilution to our stockholders and otherwise disrupt our operations and adversely
affect our 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.

 55 

 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; 

 · 
 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; 

 · 
 the potential loss of key employees; 

 · 
 use of resources that are needed in other parts of our business; and 

 · 
 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.
In addition, if an acquired business fails to meet our expectations, our operating results, business and financial position may suffer.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.
Cardio Diagnostics Holdings, Inc. 10-K

Item 1A. Risk Factors
