What changed in this filing

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Item 1. Business

2023-03-31 compared with 2022-03-31 · 1383 added, 560 removed, 10 unchanged (99% of the section changed)

References in this report to “we,”

“us” or the “Company” refer to Mana Capital Acquisition Corp.

References to our “management” or our

“management team” refer to our officers and directors, and references to the “Sponsor” refer to Mana Capital LLC,

a Delaware limited liability company.

Company Profile

References in this report to “Cardio,”

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

References to our “management”

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

Mana Capital Acquisition Corp.

was formed on May 19,

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

was formed on

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

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

Our efforts to identify a prospective target business will not be limited to a particular industry or geographic region,

although we intend to focus our search on target businesses operating in North

America, Europe and Asia in the healthcare, technology, green economy, and consumer products sectors.

We believe that we will add

value to these businesses primarily by providing them with access to the U.S.

capital markets.

Our Registration Statement on Form S-1 was declared

effective by the SEC on November 22, 2021.

Ladenburg Thalmann & Co., Inc., acted as lead bookrunner for our initial public offering.

We may refer to our initial public offering in this Annual Report on Form 10-K as our “IPO”.

On November 26, 2021, we consummated

our initial public offering of 6,200,000 units.

Each unit consists of one share of common stock, par value $0.00001 per share, one-half

of one redeemable warrant, with each whole warrant entitling the holder thereof to purchase one share of common stock for $11.50 per share,

subject to adjustment, and one right to receive one-seventh (1/7) of one share of common stock upon the consummation of our initial business

The units were sold at a price of $10.00 per unit, generating gross proceeds to us of $62,000,000.

connection with our initial public offering, the underwriters were granted a 45-day option to purchase up to 930,000 additional

units to cover over-allotments, if any.

On November 30, 2021, the underwriters purchased an additional 300,000 units pursuant to the partial

exercise of the over-allotment option.

The additional units were sold at an offering price of $10.00 per unit, generating additional gross

proceeds of $3,000,000.

Simultaneously with the consummation of the initial

public offering, we completed the private sale of an aggregate of 2,500,000 private warrants to our Sponsor at a purchase price of $1.00

per private warrant, generating gross proceeds to the Company of $2,500,000.

total of $65,000,000 of the proceeds from the sale of the units and private placement warrants, including the sale of the units from the

partial exercise of the over-allotment option, were placed in a U.S.-based trust account at J.P.

Morgan Chase Bank, N.A., with Continental

Stock Transfer & Trust Company acting as trustee.

On June 22, 2021, the Sponsor purchased 1,437,500 shares

of our common stock, or founder shares, for $25,000.

Subsequently, in September 2021, we amended and restated the subscription agreement

(the “First Amended and Restated Subscription Agreement”) and issued the Sponsor an additional 62,500 shares so that it would

hold an aggregate of 20% of our outstanding common stock after our initial public offering.

In November 2021, we entered into a second

amendment and restatement of the subscription agreement with the Sponsor (the “Second Amended and Restated Subscription Agreement”)

pursuant to which we issued it an additional 50,000 shares of Common Stock (so that the Sponsor would hold 20% of our issued and outstanding

shares of common stock after the initial public offering.

Further, we agreed that if the underwriters exercise the over-allotment option,

we will issue the Sponsor such number of additional shares of common stock (up to 232,500 shares) so as to enable it to maintain

its ownership of 20% of our issued and outstanding shares of common stock.

In connection with the partial exercise by the underwriters

of the over-allotment option, on November 30, 2021, we issued an additional 75,000 shares to the Sponsor pursuant to the Second Amended

and Restated Subscription Agreement.

As a result of the IPO and the private placement, and

assuming all of the units separate into their component parts, we had:

(i) 6,500,000 units, (ii) 8,125,000 shares of common stock, (iii)

6,500,000 rights to acquire an aggregate of 928,571 shares of common stock;

and (iv) 5,750,000 whole warrants to acquire 5,750,000 shares

of common stock issued and outstanding as of November 30, 2021.

We have not issued any securities since such date.

Prior to the IPO, there had been no public market for

our units, shares of common stock, rights or warrants.

Our units, are listed for trading on the Nasdaq Global Market, or Nasdaq, under

the symbol “MAAQU”.

The shares of common stock, rights and warrants comprising the units began separate trading on January

14, 2022 and are traded on Nasdaq under the symbols “MAAQ,” “MAAQR” and “MAAQW,” respectively.

our IPO registration statement and Form 8A were not declared effective by the SEC until November 22, 2021, we were not a filing company

under the Securities and exchange Act of 1934, as amended until such date.

A total of $65,000,000

of the proceeds from the sale of the units and private placement warrants, including the sale of the units from the partial exercise of

the over-allotment option, were placed in a U.S.-based trust account at J.P.

Morgan Chase Bank, N.A., with Continental Stock Transfer &

Trust Company acting as trustee.

As of December 31, 2021, there was $65,000,484 in investments

and cash held in the trust account, which includes interest income available to us for franchise tax obligations of approximately $484

and $526,625 of cash held outside the trust account.

As of December 31, 2021, we have not withdrawn any interest earned from the trust

account to pay taxes.

The funds held in trust has been invested only in United

States “government securities” within the meaning of Section 2(a)(16) of the Investment Company Act having a maturity of 180

days or less, or in money market funds meeting certain conditions under Rule 2a-7 promulgated under the Investment Company Act which invest

only in direct U.S.

government treasury obligations, so that we are not deemed to be an investment company under the Investment Company

Except with respect to interest earned on the funds held in the trust account that may be released to us to pay our income or other

tax obligations, the proceeds will not be released from the trust account until the earlier of the completion of a business combination

or our redemption of 100% of the outstanding public shares if we have not completed a business combination in the required time period.

The proceeds held in the trust account may be used as consideration to pay the sellers of a target business with which we complete a business

Any amounts not paid as consideration to the sellers of the target business may be used to finance operations of the target

Since our IPO, our sole business activity has been

identifying and evaluating suitable acquisition transaction candidates and engaging in non-binding discussions with potential target entities.

To date we have not entered into any binding agreement with any target entity.

We presently have no revenue and have had losses since

inception from incurring formation and operating costs since completion of our IPO.

Management Business Combination Experience

Our management team

is led by Jonathan Intrater, Allan Liu and Loren Mortman;

each has distinctive and complementary experience and extensive networks in

the healthcare , technology,

green economy and consumer products sectors as well as various other industries in North America, Europe, and Asia which we believe can

provide a suitable selection of potential targets.

We intend to focus on targeting middle market entities with a valuation in the $150

million to $500 million range.

believe that our management team is well positioned to identify attractive business combination opportunities with compelling characteristics

and further potential.

Members of our management team have extensive experience in executing business combinations, as they are long-term

advisors to buyers and sellers in mergers and acquisitions, private equity investors, or buy and sell-side investment bankers.

Intrater, our Chief Executive Officer, is a Managing Director in the investment banking department at Ladenburg, Thalmann and has extensive

experience in merger advisory and public offerings.

He also served as a member of the Board and Chairman of the audit committee of GreenVision

Acquisition Corp., a Nasdaq Capital Market-listed special purpose acquisition company that completed its initial business combination

in August 2021.

Allan Liu, one of the members of our Board of Directors, is a veteran investment manager in Asia.

He has almost 40 years

of broad experience in the financial industry, specializing in capital markets, private equity and venture capital investment.

Liu has been involved in advising, managing and investing over US $20 billion in capital in hundreds of projects for international

corporations and investors, and participated in building successful funds and asset management platforms.

Mortman, another member of our Board of Directors, has been President of The Equity Group Inc., an investor relations consulting firm

founded in 1974 that specializes in investor communications, investment community outreach, and IR advisory for small-to-mid-cap public

and pre-public companies, since 2013, Ms.

Mortman has over 20 years of experience in developing public company clients’ critical

communications, and advising on transactions and relations with the investment community.

Prior to joining The Equity Group, Ms.

was a Financial Analyst at Brenner Securities, an Investment Bank.

management team will actively source target candidates they believe will be attractive candidates for acquisition, and utilize their deal-making

track record, professional relationships, and capital markets expertise to enhance the growth potential and value of a target business

and provide opportunities for attractive returns to our stockholders.

Past performance of our management team is not a guarantee (i) that

we will be able to identify a suitable candidate for our initial business combination or (ii) of success with respect to any business

combination we may consummate.

You should not rely on the historical record of our management’s performance as indicative of our

future performance.

Business Strategy

Our business strategy is to identify and complete

a business combination with a company that meets one or more of the acquisition criteria described below.

Our objective is to generate an attractive return

for stockholders through a merger with an operating company with a strong record and growth potential.

We expect to favor opportunities

with certain business characteristics including some or all of the following:

compelling long-term growth prospects, attractive competitive

dynamics, consolidation opportunities, leading technological position and strong management.

We will also consider additional factors

such as high barriers to entry, significant streams of recurring revenue, margin profiles, and attractive free cash flow characteristics.

Our efforts to identify a prospective target business will not be limited to a particular industry or geographic region, although we intend

to focus our search on target businesses operating in North America, Europe and Asia in the healthcare, technology, green economy, and

consumer products sectors.

Our selection process will leverage our management

team’s broad and deep relationship network, industry experience, and deal sourcing capabilities to access a range of opportunities.

Our management team has a distinctive combination of capabilities including:

performance, financial and otherwise, of public and private entities;

extensive history of accessing the capital markets across various business cycles, including financing businesses and assisting companies

with transition to public ownership.

Our founders intend to communicate with their networks

of relationships to articulate the parameters for our search for a target company and a potential business combination, and begin the

process of pursuing and reviewing potential opportunities.

Acquisition Criteria

Consistent with our business strategy, we have identified

the following general criteria and guidelines that we believe are important in evaluating prospective target businesses.

We will use these

criteria and guidelines in evaluating acquisition opportunities, but we may ultimately decide to enter into our initial business combination

with a target business that does not meet these criteria and guidelines.

We intend to seek to acquire companies that we believe:

exhibited strong growth in revenue or profit in recent fiscal periods or have healthy cash flow from operations;

offer an attractive return for our stockholders, potential benefit from growth in the target’s business and with an improved capital

structure will provide favorable upside measured against any identified downside risks;

some key characteristics such as being or having the capability of being a disruptive participant within an industry;

capable of achieving significant organic and/or acquisitive growth;

positioned to build stockholder value;

the potential to achieve a leading position in the industry in which it competes;

a proven management team prepared for being a public company.

These criteria are not intended to be exhaustive.

Any evaluation relating to the merits of a particular initial business combination may be based, to the extent relevant, on these general

guidelines as well as other considerations, factors and criteria that our management may deem relevant.

If we decide to enter into our

business combination with a target business that does not meet all or some of the above criteria and guidelines, we will disclose that

the target business does not meet the above criteria in our stockholder communications related to our initial business combination, which

would be in the form of proxy solicitation materials or tender offer documents that we would file with the SEC and deliver to stockholders.

Our Acquisition Process

In evaluating a prospective target business, we

expect to conduct a thorough due diligence review that will encompass, among other things, meetings with incumbent management and key

employees, document reviews and review of facilities, as well as a review of financial and other information that will be made available

We are not prohibited from pursuing an initial

business combination with a company that is affiliated with our sponsor, officers or directors.

In the event we seek to complete our initial

business combination with a company that is affiliated with our sponsor, officers or directors, we, or a committee of independent directors,

will obtain an opinion from an independent investment banking firm which is a member of FINRA or an independent accounting firm that our

initial business combination is fair to our company from a financial point of view.

Our stockholders may not be provided with a copy of

such opinion and they may not be able to rely upon such opinion.

Members of our management team and our independent

directors own or will own, directly or indirectly sponsor shares and/or private warrants following this offering which securities will

be worthless if we fail to complete a business combination and, accordingly, may have a conflict of interest in determining whether a

particular target business is an appropriate business with which to effectuate our initial business combination.

Further, each of our

officers and directors may have a conflict of interest with respect to evaluating a particular business combination if the retention or

resignation of any such officers and directors was included by a target business as a condition to any agreement with respect to our initial

business combination.

Each of our officers and directors presently has,

and any of them in the future may have additional fiduciary or contractual obligations to another entity pursuant to which such officer

or director is or will be required to present a business combination opportunity to such entity.

Accordingly, if any of our officers or

directors becomes aware of a business combination opportunity that is suitable for an entity to which he or she has then-current fiduciary

or contractual obligations, he or she will honor his or her fiduciary or contractual obligations to present such business combination

opportunity to such other entity, subject to their fiduciary duties under Delaware law.

We do not believe, however, that the fiduciary

duties or contractual obligations of our officers or directors will materially affect our ability to complete our initial business combination.

Our Certificate of Incorporation will provide that we renounce our interest in any corporate opportunity offered to any director or officer

unless such opportunity is expressly offered to such person solely in his or her capacity as a director or officer of our company subject

to his or her fiduciary duties under the laws of the State of Delaware and such opportunity is one we are legally and contractually permitted

to undertake and would otherwise be reasonable for us to pursue.

Effecting A Business Combination

We will either (1) seek stockholder approval of

our initial business combination at a meeting called for such purpose at which stockholders may seek to redeem their shares, regardless

of whether they vote for or against the proposed business combination, into their pro rata share of the aggregate amount then on deposit

in the trust account (net of taxes payable), or (2) provide our stockholders with the opportunity to sell their shares to us by means

of a tender offer (and thereby avoid the need for a stockholder vote) for an amount equal to their pro rata share of the aggregate amount

then on deposit in the trust account (net of taxes payable), in each case subject to the limitations described herein.

The decision as

to whether we will seek stockholder approval of our proposed business combination or allow stockholders to sell their shares to us in

a tender offer will be made by us, solely in our discretion, and will be based on a variety of factors such as the timing of the transaction

and whether the terms of the transaction would otherwise require us to seek stockholder approval.

In the case of a tender offer, we will

file tender offer documents with the SEC which will contain substantially the same financial and other information about the initial business

combination as is required under the SEC’s proxy rules.

In either case, we will consummate our initial business combination only

if upon such consummation either our shares are listed on a national securities exchange as contemplated by Rule 3a51-1(a) under the Securities

Exchange Act of 1934 (the “Exchange Act”) or we have net tangible assets (as determined in accordance with Rule 3a51-1(g)

of the Exchange Act, or any successor rule) of at least $5,000,001 (in either case, so that we are not subject to Rule 3a51-1, which we

refer to as the SEC’s “penny stock” rules) and, if we seek stockholder approval, a majority of the outstanding shares

of common stock voted are voted in favor of the business combination.

We have nine months (or up to 21 months if we

extend the period of time to consummate a business combination, as described in more detail below) from the consummation of our IPO to

consummate our initial business combination.

Public stockholders will not be offered the opportunity to vote on or redeem their shares

in connection with such extensions.

If we are unable to consummate our initial business combination within such time period, we will distribute

the aggregate amount then on deposit in the trust account including interest earned on the funds held in the trust account (net of taxes

payable), pro rata to our public stockholders, by way of redemption of their shares, and thereafter cease operations except for the purpose

of winding up our affairs, as further described herein.

We expect the pro rata redemption price to be $10.00 per share (regardless of

whether or not the underwriters exercise their over-allotment option), without taking into account any interest earned on such funds.

However, we cannot assure you that we will in fact be able to distribute such amounts as a result of claims of creditors which may take

priority over the claims of our public stockholders.

As stated above, we will have nine months from

the consummation of our IPO to consummate our initial business combination.

However, if we anticipate that we may not be able to consummate

our initial business combination within nine months, we may, but are not obligated to, extend the period of time to consummate a business

combination up to twelve times, each by an additional one month (for a total of up to 21 months to complete a business combination), subject

to our board of directors authorizing such extension and the sponsor or its affiliates or designees depositing additional funds into the

trust account as set out below.

Pursuant to the terms of our amended and restated certificate of incorporation and the trust agreement

entered into between us and Continental Stock Transfer & Trust Company, in order to extend the time available for us to consummate

our initial business combination, our board of directors would adopt a resolution approving such extension and our founders or their respective

affiliates or designees (which may include the potential target business), upon five days advance notice prior to each applicable deadline,

must deposit into the trust account $216,667 (approximately $0.0333 per public share) for each one-month extension, up to an aggregate

of $2,600,004, or $0.40 per public share (for an aggregate of 12 months), on or prior to the date of the applicable deadline, for each

The insiders or sponsor (or their respective affiliates or designees) providing such additional funds will receive non-interest

bearing, unsecured promissory notes equal to the amount of any such deposit.

The final and definitive terms of any such loans have not

yet been negotiated, but any such loan would be interest free and will not be repaid in the event that we are unable to close a business

combination unless there are funds available outside the trust account to do so.

Such notes would either be paid upon consummation of

our initial business combination, or, at the purchaser's discretion, converted upon consummation of our business combination into additional

warrants on the basis of $1.00 per private warrant for each dollar amount deposited.

These warrants would have an exercise price of $11.50

Public stockholders will not be offered the opportunity to vote on or redeem their shares in connection with such extension.

If we are unable to consummate our initial business combination within such time period, we will distribute the aggregate amount then

on deposit in the trust account including interest earned on the funds held in the trust account (net of taxes payable), pro rata to our

public stockholders, by way of redemption of their shares, and thereafter cease operations except for the purpose of winding up our affairs,

as further described herein.

In the event that we receive notice from our sponsor

or their respective affiliates or designees at least five days prior to an applicable deadline of their intent to affect an extension,

we intend to issue a press release announcing such intention at least three days prior to such applicable deadline.

In addition, we intend

to issue a press release the day after such applicable deadline announcing whether or not the funds had been timely deposited.

and its affiliates or designees and their affiliates or designees are not obligated to fund the trust account to extend the time for us

to complete our initial business combination.

To the extent that some, but not all, of our insiders, decide to extend the period of time

to consummate our initial business combination, such insiders (or their affiliates or designees) may deposit the entire amount required.

If we are unable to consummate our initial business combination within such time period, we will, as promptly as possible but not more

than ten business days thereafter, redeem 100% of our outstanding public shares for a pro rata portion of the funds held in the trust

account and then seek to dissolve and liquidate.

In such event, all warrants and rights will expire and will be worthless.

The rules of The Nasdaq Stock Market require that

our business combination must occur with one or more target businesses that together have an aggregate fair market value of at least 80%

of the assets held in the trust account (excluding taxes payable on the interest earned on the trust account) at the time of our signing

a definitive agreement in connection with our business combination.

The fair market value of the target or targets will be determined

by our Board of Directors based upon one or more standards generally accepted by the financial community (such as actual and potential

sales, earnings, cash flow and/or book value).

Although our Board of Directors will rely on generally accepted standards, our Board of

Directors will have discretion to select the standards employed.

In addition, the application of the standards generally involves a substantial

degree of judgment.

Accordingly, investors will be relying on the business judgment of the Board of Directors in evaluating the fair market

value of the target or targets.

The proxy solicitation materials or tender offer documents used by us in connection with any proposed

transaction will provide public stockholders with our analysis of the fair market value of the target business, as well as the basis for

our determinations.

If our Board is not able independently to determine the fair market value of the target business or businesses, we

will obtain an opinion from an independent investment banking firm, or another independent entity that commonly renders valuation opinions,

with respect to the satisfaction of such criteria.

Our stockholders may not be provided with a copy of such opinion nor will they be able

to rely on such opinion.

However, if Nasdaq delists our securities from trading on its exchange after this offering, we would not be required

to satisfy the fair market value requirement described above and could complete a business combination with a target business having a

fair market value substantially below 80% of the balance in the trust account.

We anticipate structuring our initial business

combination so that the post-transaction company in which our public stockholders own or acquire shares will own or acquire 100% of the

outstanding equity interests or assets of the target business or businesses.

We may, however, structure our initial business combination

such that the post-transaction company owns or acquires less than 100% of such interests or assets of the target business in order to

meet certain objectives of the target management team or stockholders or for other reasons, but we will only complete such business combination

if the post-transaction company owns or acquires 50% or more of the outstanding voting securities of the target or otherwise acquires

a controlling interest in the target business sufficient for it not to be required to register as an investment company under the Investment

Even if the post-transaction company owns or acquires 50% or more of the outstanding voting securities of the target, our

stockholders prior to our initial business combination may collectively own a minority interest in the post-transaction company, depending

on valuations ascribed to the target and us in our initial business combination transaction.

For example, we could pursue a transaction

in which we issue a substantial number of new shares in exchange for all of the outstanding capital stock of a target, or issue a substantial

number of new shares to third parties in connection with financing our initial business combination.

In such cases, we would acquire a

100% controlling interest in the target.

However, as a result of the issuance of a substantial number of new shares, our stockholders

immediately prior to our initial business combination could own less than a majority of our outstanding shares subsequent to our initial

business combination.

If less than 100% of the outstanding equity interests or assets of a target business or businesses are owned or

acquired by the post-transaction company, the portion of such business or businesses that is owned or acquired by us is what will be valued

for purposes of the 80% of net assets test.

If our initial business combination involves more than one target business, the 80% of net

assets test will be based on the aggregate value of all of the target businesses.

Status as a Public Company and Financial Considerations

We believe our structure will make us an attractive

business combination partner to target businesses.

As an existing public company, we offer a target business an alternative to the traditional

initial public offering through a merger or other business combination.

In this situation, the owners of the target business would exchange

their shares of stock in the target business for our shares of common stock or for a combination of our shares of common stock and cash,

allowing us to tailor the consideration to the specific needs of the sellers.

We believe target businesses might find this method a more

certain and cost-effective method to becoming a public company than the typical initial public offering.

In a typical initial public offering,

there are additional expenses incurred in marketing, roadshow and public reporting efforts that will likely not be present to the same

extent in connection with a business combination with us.

Furthermore, once the business combination is consummated, the target business

will have effectively become public, whereas an initial public offering is always subject to the underwriters’ ability to complete

the offering, as well as general market conditions that could prevent the offering from occurring.

We believe the target business would

then have greater access to capital and an additional means of providing management incentives consistent with stockholders’ interests

than it would have as a privately-held company.

It can offer further benefits by augmenting a company’s profile among potential

new customers and vendors and aid in attracting talented employees.

While we believe that our status as a public company

will make us an attractive business partner, some potential target businesses may view the inherent limitations in our status as a blank

check company as a deterrent and may prefer to effect a business combination with a more established entity or with a private company.

These inherent limitations include limitations on our available financial resources, which may be inferior to those of other entities

pursuing the acquisition of similar target businesses;

the requirement that we seek stockholder approval of a business combination, which

may delay the consummation of a transaction;

and the existence of our outstanding rights, which may represent a source of future dilution.

With funds in the trust account of $65,000,000 available

to use for a business combination, we offer a target business a variety of options such as providing the owners of a target business with

shares in a public company and a public means to sell such shares, providing capital for the potential growth and expansion of its operations

or strengthening its balance sheet by reducing its debt ratio.

Because we are able to consummate our initial business combination using

our cash, debt or equity securities, or a combination of the foregoing, we have the flexibility to use the most efficient combination

that will allow us to tailor the consideration to be paid to the target business to fit its needs and desires.

In connection with any

potential acquisition, we may be required to obtain acquisition financing.

However, since we have no specific business combination under

consideration, we have not taken any steps to secure third party financing and there can be no assurance that it will be available to

We may seek to raise additional funds through a private offering of debt or equity securities in connection with the completion of

our business combination, and we may effectuate our business combination using the proceeds of such offering rather than using the amounts

held in the trust account.

We chose our net tangible asset threshold of $5,000,001

to ensure that we would avoid being subject to Rule 419 promulgated under the Securities Act of 1933, as amended.

However, if we seek

to consummate an initial business combination with a target business that imposes any type of working capital closing condition or requires

us to have a minimum amount of funds available from the trust account upon consummation of such initial business combination, we may need

to have more than $5,000,001 in net tangible assets upon consummation and this may force us to seek third party financing which may not

be available on terms acceptable to us or at all.

As a result, we may not be able to consummate such initial business combination and

we may not be able to locate another suitable target within the applicable time period, if at all.

Public stockholders may therefore have

to wait up to 21 months from the closing of our IPO in order to be able to receive a pro rata share of the trust account.

Summary Information Related to Our Securities,

Redemption Rights and Liquidation

We are a Delaware corporation and our affairs are governed

by our amended and restated certificate of incorporation, and the Delaware General Corporation Law.

Pursuant to our amended and restated

certificate of incorporation, we are authorized to issue 300,000,000 shares of common stock, $0.00001 par value each.

The information

provided below is a summary only and we refer you to our amended and restated certificate of incorporation and our warrant agreement and

rights agreement with Continental Stock Transfer & Trust Company as warrant and rights agent for additional important and material

Upon completion of our IPO and as of March 29, 2022,

we had and have 8,125,000 shares of common stock issued and outstanding.

Common stockholders of record are entitled to one vote for each

share held on all matters to be voted on by stockholders and vote together as a single class, except as required by law.

Unless specified

by applicable law, our amended and restated certificate of incorporation or applicable stock exchange rules, the affirmative vote of a

majority of our shares of common stock that are voted is required to approve any such matter voted on by our stockholders.

Directors are

elected for a term of one year.

Our stockholders are entitled to receive ratable dividends when, as and if declared by the Board of Directors

out of funds legally available therefor.

We will provide our public stockholders with the opportunity

to redeem all or a portion of their public shares upon the completion of our business combination at a per-share price, payable in cash,

equal to the aggregate amount then on deposit in the trust account as of two business days prior to the consummation of our business combination,

including interest (which interest shall be net of taxes payable) divided by the number of then issued and outstanding public shares,

subject to the limitations described herein.

The amount in the trust account is initially anticipated to be approximately $10.00 per public

share (subject to increase of up to an additional $0.40 per public share in the event that our sponsor elects to extend the period of

time to consummate a business combination).

Our sponsor, officers and directors have entered into

a letter agreement with us, pursuant to which they have agreed to waive their redemption rights with respect to their founder shares,

private placement shares and any public shares they may hold in connection with the completion of our business combination.

If a stockholder vote is not required by law and we

do not decide to hold a stockholder vote for business or other legal reasons, we will, pursuant to our amended and restated certificate

of incorporation, conduct the redemptions pursuant to the tender offer rules of the SEC, and file tender offer documents with the SEC

prior to completing our business combination.

If, however, stockholder approval of the transaction is required by law, or we decide to

obtain stockholder approval for business or other legal reasons, we will, like many blank check companies, offer to redeem shares in conjunction

with a proxy solicitation pursuant to the proxy rules and not pursuant to the tender offer rules.

If we seek stockholder approval, we

will complete our business combination only if a majority of the issued and outstanding shares of common stock voted are voted in favor

of the business combination.

However, the participation of our sponsor, officers, directors or their affiliates in privately-negotiated

transactions, if any, could result in the approval of our business combination even if a majority of our public stockholders vote, or

indicate their intention to vote, against such business combination.

If we seek stockholder approval of our business combination

and we do not conduct redemptions in connection with our business combination pursuant to the tender offer rules, our amended and restated

certificate of incorporation provides that a public stockholder, together with any affiliate of such stockholder or any other person with

whom such stockholder is acting in concert or as a “group” (as defined under Section 13 of the Exchange Act), will be restricted

from redeeming its shares with respect to more than an aggregate of 15% of the shares sold in our IPO, which we refer to as the “Excess

Shares.” However, we would not be restricting our stockholders’ ability to vote all of their shares (including Excess Shares)

for or against our business combination.

If we do not complete a business combination within

9 months (or up to 21 months, as discussed above) from the closing of our IPO, we will (i) cease all operations except for the purpose

of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem 100% of the outstanding

public shares and (iii) as promptly as reasonably possible following such redemption, subject to the approval of our remaining stockholders

and our board of directors, dissolve and liquidate, subject (in the case of (ii) and (iii) above) to our obligations under Delaware law

to provide for claims of creditors and the requirements of other applicable law.

In connection with our IPO and consummation of the

private placement with our sponsor we issued an aggregate of 6,500,000 rights to acquire an aggregate of 928,571 shares of common stock

as a component of the public units.

If we enter into a definitive agreement for a business combination in which we will be the surviving

entity, each holder of a right will receive one-seventh (1/7) of one share upon consummation of our business combination, even if the

holder of such right redeemed all shares of common stock held by him, her or it in connection with the business combination or an amendment

to our certificate of incorporation with respect to our pre-business combination activities.

No additional consideration will be required

to be paid by a holder of rights in order to receive his, her or its additional shares upon consummation of an business combination as

the consideration related thereto has been included in the unit purchase price paid for by investors in our IPO.

The shares issuable upon

exchange of the rights will be freely tradable (except to the extent held by affiliates of ours).

Holders of rights are not entitled to

any redemption of voting rights.

If we are unable to complete an business combination within the required time period and we liquidate

the funds held in the trust account, holders of rights will not receive any of such funds with respect to their rights, nor will they

receive any distribution from our assets held outside of the trust account with respect to such rights, and the rights will expire worthless.

In connection with our IPO we issued an aggregate of

3,250,000 whole warrants to acquire an aggregate of 3,250,000 shares of common stock.

In addition, in the private placement with our sponsor

that we completed simultaneously with the IPO, we issued 2,500,000 warrants to acquire 2,500,000 shares of common stock.

purchased in our IPO have been issued in registered form under a warrant agreement between Continental Stock Transfer & Trust Company,

as warrant agent, and us.

Each warrant entitles the registered holder to purchase one share of common stock at a price of $11.50 per share,

subject to adjustment as discussed below, at any time commencing on the later of 12 months from the date we consummated our IPO or 30

days from the completion of our business combination.

Because the warrants may only be exercised for whole numbers of shares, only an

even number of warrants may be exercised at any given time.

Pursuant to the warrant agreement, a warrantholder may exercise its warrants

only for a whole number of shares.

This means that only an even number of warrants may be exercised at any given time by a warrantholder.

The warrants will expire five years after the completion of our business combination, at 5:00 p.m., New York City time, or earlier upon

redemption or liquidation.

Once the warrants become exercisable, we may call the

warrants for redemption:

whole and not in part;

a minimum of 30 days’ prior written notice of redemption,

if, and only if, the last sales price of our shares of common stock equals or exceeds $18.00 per share for any 20 trading days within

a 30-trading day period ending three business days before we send the notice of redemption, and

and only if, there is a current registration statement in effect with respect to the shares of common stock underlying such warrants

at the time of redemption and for the entire 30-day trading period referred to above and continuing each day thereafter until the date

of redemption.

redemption price for the warrants shall be either (i) if the holder of a warrant has followed the procedures specified in

our notice of redemption and surrendered the warrant, the number of shares of common stock as determined in accordance with the “cashless

exercise” provisions of the warrant agreement or (ii) if the holder of a warrant has not followed such procedures specified in our

notice of redemption, the price of $0.01 per warrant.

If the foregoing conditions

are satisfied and we issue a notice of redemption, each warrant holder can exercise his, her or its warrant prior to the scheduled redemption

date either by paying the cash exercise price or on a “cashless exercise” basis.

However, the price of our shares of common

stock may fall below the $18.00 trigger price, as well as the $11.50 warrant exercise price after the redemption notice is issued.

The private warrants are identical to the warrants

included in the units sold in our IPO except for certain transfer restrictions as described herein.

The purchasers of the private warrants

have agreed not to transfer, assign or sell any of the private warrants or underlying securities (except to the same permitted transferees

as the Sponsor and provided the transferees agree to the same terms and restrictions as the permitted transferees of the Sponsor must

agree to) until the completion of our initial business combination.

In the event of a liquidation prior to our initial business combination,

the private warrants will expire worthless.

In identifying, evaluating and selecting a target business

for our initial business combination, we may encounter intense competition from other entities having a business objective similar to

ours, including other blank check companies, private equity groups and leveraged buyout funds, and operating businesses seeking strategic

business combinations.

Many of these entities are well established and have extensive experience identifying and effecting business combinations

directly or through affiliates.

Moreover, many of these competitors possess greater financial, technical, human and other resources than

Our ability to acquire larger target businesses will be limited by our available financial resources.

This inherent limitation

gives others an advantage in pursuing the initial business combination of a target business.

Furthermore, our obligation to pay cash in

connection with our public stockholders who exercise their redemption rights may reduce the resources available to us for our initial

business combination and our outstanding warrants, and the future dilution they potentially represent, may not be viewed favorably by

certain target businesses.

Either of these factors may place us at a competitive disadvantage in successfully negotiating an initial business

We currently have one officer.

This individual is not

obligated to devote any specific number of hours to our matters, but he intends to devote as much of his time as he deem necessary to

our affairs until we have completed our initial business combination.

The amount of time that he will devote in any time period will vary

based on whether a target business has been selected for our initial business combination and the stage of the initial business combination

process we are in.

We do not intend to have any full-time employees prior to the completion of our initial business combination.

On October 25, 2022 (the “Closing”),

Cardio Diagnostics Holdings, Inc.

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

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

Diagnostics, Inc.

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

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

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

Combination Agreement”).

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

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

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

On the Closing, the Company changed its name

from Mana Capital Acquisition Corp.

to Cardio Diagnostics Holdings, Inc.

As of the opening of trading on October 26,

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

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

respectively.

At the Closing and subject to the conditions

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

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

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

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

(the “Extension Notes”).

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

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

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

Legacy Cardio

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

It was formed in January

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

Cardio was formed to further develop and commercialize

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

stroke, heart failure and diabetes, by leveraging our Artificial Intelligence (“AI”)-driven Integrated Genetic-Epigenetic

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

Cardio aims to become one of the leading medical technology companies for enabling improved prevention, early detection and treatment

of cardiovascular disease.

Cardio is transforming the approach to cardiovascular disease from reactive to proactive and hopes to accelerate

the adoption of Precision Medicine for all.

We believe that incorporating our solutions into routine practice in primary care and prevention

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

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

We believe that we are the first company to develop and commercialize epigenetics-based clinical tests for cardiovascular disease

that have clear value propositions for multiple stakeholders including (i) patients, (ii) clinicians, (iii) hospitals/health systems,

(iv) employers and (v) payors.

An estimated 80% of cardiovascular disease ("CVD”)

is preventable, yet, it is responsible for one in every four deaths and remains the number one killer in the United States for both men

Coronary heart disease is the most common type of CVD and the major cause of heart attacks.

The enormous number of unnecessary

heart attacks and deaths associated with CHD is attributable to the failure of current primary prevention approaches in clinical practice

to effectively detect, reduce and monitor risk for CHD prior to life altering and costly health complications.

Several reasons for this

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

associated decrease in primary care visits for preventive screening;

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

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

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

A highly accessible,

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

Furthermore, with the ongoing COVID-19 pandemic,

preventable illnesses such as CHD are expected to spike.

Therefore, now more than ever, there is an urgent need for a highly sensitive,

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

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

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

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

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

The Company earned only $901 and $950 in revenue

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

Rather than using its resources to actively

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

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

For example, hospitals

routinely take a year or longer to make purchasing decisions.

While these relationships take considerable time to establish, we believe

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

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

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

authorization or other FDA clearance or approval.

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

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

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

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

Industry Background

According to the American Heart Association

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

cause of death in the United States and globally.

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

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

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

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

Unfortunately, the incidence of CVD is expected to continue to rise

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

CVD represents conditions that affect the heart

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

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

The National Center

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

20 or older in the United States have CHD.

CHD is also the major cause of heart attacks.

According to the AHA, every 40 seconds, someone

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

The CDC reported that in 2020, stroke

was responsible for one in six CVD-related deaths.

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

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

According to the AHA, over six

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

There are numerous risk factors

that could increase an individual’s risk for CVD.

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

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

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

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

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

In addition to the enormous morbidity and mortality

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

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

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

burden associated with CVD is expected to continue to soar.

According to the CDC

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

The AHA reports that in 2016, the cost of CVD

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

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

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

By 2035, the medical costs associated with CVD are expected

to increase 135% to $749 billion, while the indirect costs are expected

to rise by 55% to $368 billion.

Currently, among the various types of CVD, the medical costs of CHD are the highest at $89 billion and

are expected to rise to $215 billion by 2035 as depicted in the figure below from the Cardiovascular Disease:

A Costly Burden For America,

Projections Through 2035 report by the AHA.

To address this expected significant rise in human

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

This same trend is playing out across developed nations around the globe as the burden of CVD continues to grow due to a rise in major

risk factors such as obesity, poor diet and Type 2 diabetes.

This is consistent with the cardiovascular diagnostic testing market trends

reported by Research and Markets in their Outlook on the Cardiovascular Diagnostic Testing Global Market to 2027 - Increasing Number of

Insurance Providers Presents Opportunities press release published on July 4, 2022.

They estimate that the Global Cardiovascular Diagnostic

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

There are several healthcare tailwinds that

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

The aging population:

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

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

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

The rise of chronic diseases:

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

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

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

The shift to value-based care:

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

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

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

The growth of telemedicine:

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

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

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

The adoption of Artificial Intelligence (AI):

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

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

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

The rise of patient engagement:

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

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

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

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

Building compelling evidence.

Our AI-driven Integrated Genetic-Epigenetic

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

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

PrecisionCHD™ for the early detection of coronary heart disease, were developed through rigorous studies that are

peer-reviewed and published and others that are being prepared for peer-reviewed publication in collaboration with leading

healthcare and research institutions.

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

tests, the evidence bases for the Epi+Gen CHD™ test also include an economic case to drive a more holistic and compelling

argument for adoption.

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

Engaging experts and key stakeholders.

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

Prioritizing and executing strategic acquisitions .

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

Prioritizing payor coverage.

We believe that to continue to grow the market traction of our solutions, it would require pursuing additional payor coverage.

We are engaging the appropriate experts, building necessary evidence, and have a roadmap in place for this.

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

We expect that it will take six to twelve months to engage additional payors.

Evaluating FDA pathway.

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

Targeting multiple revenue channels.

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

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

Launching synergistic products.

To more fully address cardiovascular health, Cardio is

leveraging our AI-driven Integrated Genetic-Epigenetic Engine™ to develop a series of clinical tests for major types of

cardiovascular disease and associated co-morbidities, including coronary heart disease, stroke and congestive heart failure.

Our Technology

At the core of Cardio is our proprietary AI-driven

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

Our technology

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

biomarkers and their translation into clinical tests for cardiovascular disease.

This engine consists of multiple layers.

It begins with

genome-wide genetic (single nucleotide polymorphisms or SNPs), genome-wide epigenetic (DNA methylation) and clinical data points.

high-performance computing, ML/AI techniques and deep domain expertise in medicine, molecular biology and engineering, a panel of SNP-DNA

methylation biomarkers and mined, modeled and translated into standalone laboratory assays.

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

The first is a laboratory component, which involves epigenetic

DNA biomarkers.

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

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

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

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

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

The second is an analytical component, which involves applying

a proprietary interpretive predictive machine learning model to predict risk and provide personalized insights to assist physicians in

tailoring a prevention and care plan.

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

test we develop.

Our Products and Services

We have and will continue to leverage our AI-driven

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

As of March 2023, we have

leveraged this Engine to develop two products:

Epi+Gen CHD™ and PrecisionCHD™ .

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

is the first epigenetics-based clinical test capable of assessing near-term (three-year) risk for coronary heart disease (“CHD”) and our

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

Clinicians’ Current Approach to Cardiovascular Disease

Currently, a patient’s risk for CVD is

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

FRS and PCE are 10-year CVD risk calculators that aggregate common clinical variables such as cholesterol and diabetes, demographics and

subjective, self-reported information such as smoking status.

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

setting include stress echocardiograms.

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

In a peer-reviewed published study by Cardio in

collaboration with Intermountain Healthcare (Dogan, Meeshanthini & Knight, Stacey & Dogan, Timur & Knowlton, Kirk &

Philibert, Robert.

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

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

sensitivity of FRS and PCE was 44% in men and 32% in women.

This means that for every 100 men and 100 women deemed

"at-risk” for a coronary heart disease event, the test only correctly identifies 44 men and 32 women.

A similar study was

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

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

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

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

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

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

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

Epi+Gen CHD™ is the Only Epigenetics-based

Clinical Test for Coronary Heart Disease Risk Assessment

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

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

& Knowlton, Kirk & Philibert, Robert, 2021;

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

10.2217/epi-2021-0123),

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

that for every 100 men and 100 women deemed "at-risk” for a coronary

heart disease event, the test correctly identifies 76 men and 78 women.

In comparison, the average sensitivity of the Framingham Risk

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

The performance of the test in

this study was evaluated across two cohorts that were independent of each other.

One cohort was used for the development of this test

and the other was used to independently validate the performance of the test, showing Epi+Gen CHD™ to be approximately 1.7 times

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

In another peer-reviewed

study focusing on the cost utility of Epi+Gen CHD™ (Jung, Younsoo & Frisvold, David & Dogan, Timur & Dogan, Meeshanthini

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

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

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

The blood-based version of this test was introduced

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

The current charge to perform the test

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

The price of the test and revenue streams could change in the future

depending on market forces and payor requirements, as well as on the customer and the region in which the test is being sold.

We are building

additional clinical and health economics evidence to pursue payor coverage.

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

customers who are patients through a telemedicine provider platform.

We believe that the Epi+Gen CHD™ test empowers

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

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

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

In addition, we believe that our products can

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

We have a worldwide exclusive license agreement

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

Under the terms of that license

agreement, Cardio is required to pay each of:

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

into one or more sublicensing agreements.

In addition to that licensed technology, we have

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

strategic importance to the Company.

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

from their inventions.

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

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

PrecisionCHD™ is the Only Epigenetics-based Clinical Test

for the Early Detection of Coronary Heart Disease

PrecisionCHD™

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

early detection of coronary heart disease.

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

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

Using epigenetic (DNA methylation) and

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

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

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

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

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

Cardio intends to accelerate the adoption of

Epi+Gen CHD™ and PrecisionCHD™ by:

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

leveraging industry organizations to engage and educate providers;

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

developing a customized customer portal to reduce transaction friction.

Cardio foresees potential opportunities to increase

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

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

processing patient samples in the laboratory in larger batches;

shipping sample collection kits in larger batches;

increasing the level of automation to reduce manual processing.

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

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

from the FDA.

We have engaged regulatory experts and attorneys for this process.

Product Pipeline

In March 2023, we announced the debut of the

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

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

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

However, as a company in the early stages of

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

We may modify

our product pipeline, seek other alternatives within the healthcare field in order

to grow the Company’s business and increase revenues.

Such alternatives may include, but not be limited to, combinations or strategic

partnerships with other laboratory companies or with medical practices such as hospitalists or behavioral health.

Our Market Opportunity

Cardiovascular

disease (“CVD”) is the leading cause of death in the United States, accounting for one in four deaths.

Despite being largely preventable,

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

One of the key ways to

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

such, technologies that can more precisely assess the risk for and detect CVD before symptoms emerge or a catastrophic cardiac event occurs

becomes even more critical.

According to Research and Markets in their Outlook

on the Cardiovascular Diagnostic Testing Global Market to 2027 - Increasing Number of

Insurance Providers Presents Opportunities press release published on July 4, 2022, the Global Cardiovascular Diagnostic Testing Market

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

The increasing prevalence of cardiovascular

diseases, technological advancements in cardiovascular disease diagnostics, and the growing number of initiatives to promote cardiovascular

disease testing are the major factors driving the growth of this market.

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

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

Our initial product, Epi+Gen CHD™,

is a highly sensitive and accessible clinical test for three-year coronary heart disease (“CHD”) risk assessment.

Our second product, PrecisionCHD™,

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

Using data from the US Census Bureau, Cardio

estimates that 146 million adults would potentially benefit from our Epi+Gen CHD™ test, 157 million adults for our PrecisionCHD™

test, 152 million adults for the congestive heart failure test, 153 million adults for the stroke test and 140 million adults for the

diabetes test.

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

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

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

This total addressable market evaluation also assumes

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

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

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

Since the launch of Epi+Gen CHD™ in 2021

via telemedicine, the predominant initial go-to-market (“GTM”) strategy was bottom-up consumer-led sales focused on directly acquiring and

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

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

Sales were handled through our telemedicine partner to multiple customers.

Moving forward, with additional resources and a growing

team, in addition to this bottom-up GTM motion, we have adopted a product-led innovation growth strategy that emphasizes enterprise-wide

adoption across key healthcare sub-verticals with a particular emphasis on deeply centralized key opinion and health trend leaders like

innovative providers, health systems, and employers.

Healthcare Sub-Vertical Priorities for Epi+Gen CHD™ and

PrecisionCHD™

assessing the risk for CHD early and/or detecting CHD early to potentially avert a heart attack, we believe that the clinical and economic

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

We believe that Epi+Gen

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

by insurance and eligible for approval for reimbursement.

While we believe that such coverage and reimbursement would be necessary to

gain widespread adoption, obtaining such coverage and reimbursement from federal and private payors is expected to take several years,

if it is obtained at all.

We intend to focus on the following key channels:

Innovative Health Systems

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

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

By assessing the

risk for CHD before a cardiac event, Epi+Gen CHD™ has the potential to improve population health.

We believe that the improved performance

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

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

Similarly, with PrecisionCHD ™ ,

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

patient outcomes.

Physician-Directed Channels, Including Concierge Practices

adoption is driven by practices committed to innovation in medicine for patients who are more focused on preventive health and

wellness and have the financial means to pay out-of-pocket for concierge subscription services.

There is a convergence in innovative providers,

health-conscious consumers, and best-in-class tests and technologies in concierge medicine practices to provide on-demand elite personalized

and readily accessible healthcare.

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

high-end healthcare services with an equal demand for innovative diagnostic tools.

Additionally, concierge practices are not price-sensitive,

so reimbursement is not a top priority.

Early adoption in the employer space will be

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

We believe the two reasons for this are replacing

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

Health equity is top-of-mind

for many employers to ensure that their employees are healthy and productive.

Employers view healthcare investments as another investment in the business.

Employers leveraging innovative diagnostic solutions can

connect better health for employees to drive overall business objectives and have a competitive advantage in attracting and retaining

Telemedicine and Marketplaces

Many Americans are concerned about being proactive

with their health needs.

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

According to the U.S.

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

more annually.

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

their health to constitute the initial attainable market.

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

or health savings account ("HSA”) funds.

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

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

According to the Global Wellness Institute,

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

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

a Focus on Strategic Channel Partnerships

While our overall sales and marketing initiatives

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

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

By prioritizing strategic channel partnerships, we

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

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

for each of our distribution channels.

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

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

Utilizing and developing such strategic channel partnerships,

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

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

We are targeting accelerating the

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

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

Strategic channel partnerships are key for the

growth of our solutions.

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

Defensibility and Displacement

Strategic channel partners would have exclusivity

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

Distribution and Network Effects

Channel partners under consideration for Epi+Gen

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

as part of the relationship.

Bi-Directional Value

The cardiovascular disease space is of paramount

concern to stakeholders across the healthcare continuum;

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

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

Pricing Differentiation

The economics of each channel partnership can

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

Complementary Goods

Bundling Epi+Gen CHD™, PrecisionCHD™

and future Cardio solutions alongside complementary clinical, analytics, treatment pathways, and services-consulting for primary prevention

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

Hiring and Talent to Accelerate Growth

Our growth strategy will require investment

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

By combining best-in-class revenue operations

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

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

New hires will be targeting

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

Manufacture/Supply Chain

The sample collections kits for both Epi+Gen

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

a blood sample to the lab for processing.

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

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

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

However, since there are no particular

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

minimal after the contents are sourced.

Proprietary genetic and DNA methylation components

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

There are alternative manufacturers

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

Laboratory assays that are manufactured under cGMP to specifications

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

Both the Epi+Gen CHD™ and PrecisionCHD™

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

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

However, we intend to acquire a laboratory

and are currently evaluating potential lab candidates for acquisition.

Our Competitive Strengths

is the key to success.

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

deep technical and business expertise to deliver a market differentiating suite of products for our customers to address unmet

clinical needs in the cardiovascular space and help us dominate our market.

The pillar of our strategy has been innovation,

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

partnership efforts that bring together key healthcare.

We believe that,

among other reasons, the future belongs to Cardio based on the following competitive strengths:

Technology and products are strongly backed by science.

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

and research experts from leading organizations.

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

with highly-cited peer-reviewed publications.

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

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

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

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

patent, six patent applications pending worldwide, one

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

directed to biomarkers associated with cardiovascular disease and diabetes for diagnosis

and other applications.

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

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

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

Our expertise

in processing billions of clinical genotypic, epigenetic and phenotypic data points to generate

critical insights allows us to continue to develop innovative products.

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

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

informed by biology and its expert domain knowledge that was designed and built over the past decade

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

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

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

Genetic-Epigenetic Engine™ to continue to build market traction.

We believe that our current and future products have

strong value propositions for various key stakeholders in healthcare.

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

our products.

Products that can potentially drive value in multiple ways.

that our tests are the first epigenetics-based clinical tests for heart disease.

Unlike genetic biomarkers that are static, the DNA methylation

(epigenetic) biomarkers included in our products are generally dynamic.

Therefore, DNA methylation biomarkers can change over time and

as a result, in addition to initial assessment , our products could potentially be used to

personalize interventions and help monitor the effectiveness of these interventions.

Commercial processes that are inherently scalable to meet demand.

Our commercial pipeline is

inherently scalable.

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

can be kitted months in advance.

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

from several vendors.

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

In addition, the

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

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

Cardio is led by a management team with experience

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

Even though we believe that our solutions provide

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

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

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

Some of our potential and current competitors have

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

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

This could enable our competitors

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

adapt to meet new trends in the market.

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

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

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

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

establishing strategic partnerships.

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

There is a likelihood

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

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

To compete effectively, we must scale our organization and

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

The clinical cardiovascular diagnostic space

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

Even though we believe our solutions offer significant advantages

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

With respect to coronary

heart disease (CHD) risk assessment and early detection, our competitors use a variety of technologies including genetic, serum lipid-based,

imaging, proteomic and "people tracking” approaches, but no competitors of which we are aware use epigenetics.

Genetic testing, both whole genome and more

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

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

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

In addition, whereas

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

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

The best-known biomarker approach is that embodied

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

calculator or Pooled Cohort Equation).

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

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

artery disease) using a standard algebraic equation.

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

by the medical community.

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

We believe that our test has superior

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

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

a more relevant period of time for patient management.

Imaging modalities coupled to machine

learning are also used to assess risk for and detect CHD.

Perhaps the most commonly used imaging method for predicting risk for CHD

is Coronary Artery Calcium (“CAC”) screening.

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

scan is taken of the heart.

Then using this data, the amount of calcium laden plaque is determined and the result used to assess

10-year risk for CHD.

Strengths of this approach include the general acceptance of the medical community.

Weaknesses include the

necessity of exposing patients to x-ray radiation and the inability of the CAC test to monitor patient response.

In many ways, this

test competes with our test.

At the same time, we note that this test is not yet recommended as a primary method for screening low

risk individuals, uses a longer risk assessment window, and could actually be used as secondary testing to evaluate patients who are

not found to be at low risk using Epi+Gen CHD™ or who are flagged for CHD by the PrecisionCHD™ test.

Proteomic methods, as exemplified by serologic

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

from Prevencio are another risk assessment tool.

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

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

at risk for developing a major adverse cardiovascular event.

Important differences between our tests and their offerings include the window

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

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

Because we believe that digital PCR

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

Finally, researchers have described methods

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

Although people doubtlessly use these

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

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

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

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

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

The test for prevalent coronary heart disease, whose basis

was published in 2018, is well underway, and we expect this test to become a strong competitor for other methods of establishing current

CHD, such as exercise treadmill testing, and for monitoring response to CHD treatment.

In summary, the cardiovascular diagnostic space

is extremely competitive and fast moving.

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

are direct competitors for customers and enjoy both large existing market share and substantial financial backing.

In addition, it is

clear that these existing alternative assessment strategies have significant degrees of scientific literature supporting their use, enjoy

backing from key medical constituencies for their use in certain circumstances, and have established strategies for obtaining third party

reimbursement.

As the population ages, this competition is likely to increase.

At the same time, we believe that there are important differences

between the current tests offered and our solutions with respect to clinical performance, window of clinical assessment, scalability,

capacity for assisting with interventions and response monitoring .

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

in our business space.

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

better value for our customers.

Intellectual Property

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

for the assessment and monitoring of cardiovascular disease, specifically coronary heart disease, congestive heart failure and stroke,

as well as diabetes.

Our portfolio falls into three patent families.

These patent applications have been filed in the United States and

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

In the European Union a patent has already been granted.

Recently, a new provisional patent application was filed.

In the U.S., Patent No.

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

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

the co-inventors of which are Dr.

Dogan and Dr.

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

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

Our issued and pending patents cover general methods as well

as key technological steps that enable these core approaches while facilitating the continued patenting of material included in the patent

applications.

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

The initial work on our AI-driven Integrated

Genetic-Epigenetic Engine™ is derived from work done by our founders while at the University of Iowa, around which there is currently

a family of patent and patent applications.

Follow-on work on our core technology also is derived from work done by our founders while

at the University of Iowa but was furthered by our founders and Cardio’s Chief Technology Officer independent of the University

The follow-on work is described in the second and third families of patent applications.

The initial work is described in the first family

of patents and patent applications and is generally directed to a number of single nucleotide polymorphism (“SNP”) biomarkers

and a number of methylation site biomarkers that are highly associated, at a statistically significant level, with the presence or the

early onset of a number of cardiovascular diseases.

The first family of patents and patent applications is owned solely by UIRF and is

exclusively licensed by Cardio.

As of March 2023, this family includes seven granted patents, one soon-to-be issued patent (received notice

of allowance), and six pending patent applications.

Any and all patents issuing in this family will be solely owned by UIRF and, barring

any changes to the UIRF exclusive license agreement, will fall under the exclusive license to Cardio.

The first family includes a granted patent in

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

The issued claims in the EP patent are directed to compositions ( e.g ., a kit) for determining the methylation status of at least

one CpG dinucleotide and a genotype of at least one SNP that includes at least one primer that detects the presence or absence of methylation

in a particular region of the genome (referred to as cg26910465) and at least one primer that detects a

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

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

The allowed claims in the U.S.

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

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

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

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

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

The original algorithm developed during the initial work is not

disclosed in the first family of patents and patent applications.

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

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

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

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

This family includes a pending

PCT International application, with claims directed to compositions ( e.g ., a kit) that include at least one primer for determining

the methylation status of at least one CpG dinucleotide from a group of five different methylation sites, or a different CpG dinucleotide

in linkage disequilibrium with one of the listed CpG dinucleotides, and at least one primer for determining the genotype of at least one

SNP from a group of five different SNPs, or a different SNP in linkage disequilibrium with one of the listed SNPs.

The PCT application

also includes claims to methods of determining the presence of biomarkers associated with diabetes, claims to a computer-readable medium

for performing such methods, and claims to a system for determining the methylation status of at least one CpG dinucleotide and the genotype

of at least one SNP.

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

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

this aspect as a trade secret.

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

adjustments or extensions.

The second family of patent applications is

co-owned by UIRF and Cardio, since Cardio expanded on and further refined some of the original research that was done at the University

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

The ownership of any and all patents that ultimately issue in this family will depend on the specific subject matter that is claimed in

each issued patent;

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

For example, depending upon the specific

biomarkers claimed and when those biomarkers were identified ( e.g ., during the initial work at the University of Iowa or during

the follow-on work at Cardio), ownership could lie solely with UIRF or Cardio, or ownership could be shared between UIRF and Cardio ( e.g .,

if a claimed biomarker was initially identified at the University of Iowa and its significance with respect to diabetes was further refined

or if one of the claimed biomarkers was identified at the University of Iowa and another one of the claimed biomarkers

was identified at Cardio).

The third family of patent applications, also

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

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

This family includes

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

application, with claims directed to compositions (e.g., a kit) that include

at least one primer for determining the methylation status of at least one CpG dinucleotide from a group of three different methylation

sites, or a different CpG dinucleotide in linkage disequilibrium with one of the listed CpG dinucleotides, and at least one primer for

determining the genotype of at least one SNP from a group of five different SNPs, or a different SNP in linkage disequilibrium with one

of the listed SNPs.

The PCT application also includes claims to methods of determining the presence of biomarkers associated with three-year

incidence of cardiovascular disease, claims to a computer-readable medium for performing such methods, and claims to a system for determining

the methylation status of at least one CpG dinucleotide and the genotype of a SNP.

The specific algorithm developed for the association

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

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

This family of patents is owned exclusively by Cardio.

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

well as a one U.S.

utility application.

Any and all patents issuing in this family

will be solely owned by Cardio.

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

adjustments or extensions.

Exclusive License Agreement entered into with UIRF and those licenses granted under that license agreement terminate on the expiration

of the patent rights licensed under the license agreement, unless certain proprietary, non-patented technical information is still being

used by us, in which case the license agreement will not terminate until the date of termination of such use.

The licenses under the license

agreement could terminate prior to the expiration of the licensed patent rights if we materially breach our obligations under the license

agreement, including failing to pay the applicable license fees and any

interest on such fees, and failing to fully remedy such breach within the period specified in the license agreement, or if we enter liquidation,

have a receiver or administrator appointed over any assets related to the license agreement, or cease to carry on business, or file for

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

Additionally,

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

machine learning algorithms used to identify genetic and epigenetic biomarkers for various products and to interpret genetic and epigenetic

data from patient samples to generate clinically actionable information, as well as the methods to develop new methylation sensitive assays.

We protect our proprietary information, which includes, but is not limited to, trade secrets, know-how, trademarks and copyrights.

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

on the IP rights of others.

Where appropriate, we will assess the operating space and acquire licenses for critical technologies that

we do not possess or cannot create.

We continue to invest in technological innovation and will seek mutualistic and symbiotic licensing

opportunities to promote and maintain our competitive position.

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

assessment and data processing technologies.

The terms of these agreements for the non-exclusive use of these technologies are subject

to change without notice and could affect our ability to deliver our solutions.

In addition, from time to time, we may face claims

from third parties asserting ownership of, or demanding release of, the open-source software or derivative works that we developed using

such software (which could include our proprietary source code), or otherwise seeking to enforce the terms of the applicable open-source

These claims could result in litigation that could be costly to defend, have a negative effect on our operating results and financial

condition or require us to devote additional research and development resources to change our existing or future solutions.

to any infringement or noncompliance claim by an open-source vendor, regardless of its validity, discovering certain open-source software

code in our products, or a finding that we have breached the terms of an open-source software license, could harm our business, results

of operations and financial condition.

In each case, we would be required to either seek licenses to software or services from other parties

and redesign our products to function with such other parties’ software or services or develop these components internally, which

would result in increased costs and could result in delays to product launches.

Furthermore, we might be forced to limit the features

available in our current or future solutions.

Government Regulation

laboratory testing and healthcare industry and the practice of medicine are extensively regulated at both the state and federal levels,

and additionally, the practice of medicine is similarly extensively regulated by the various states.

our ability to operate profitably

will depend in part upon its ability, and that of its vendor partners, to maintain all necessary licenses and to operate in compliance

with applicable laws and rules.

Those laws and rules continue to evolve, and therefore we devote significant resources to monitoring

relevant developments in FDA, CLIA, healthcare and medical practice regulation.

Those laws and rules include, but are not limited to,

ones that govern the regulation of clinical laboratories in general and the regulation of laboratory-developed tests ("LDTs”)

in particular.

As discussed below, legislation has been introduced in Congress that would substantially alter federal regulation of diagnostic

tests, including LDTs.

As the applicable laws and rules change, we are likely to make conforming modifications

in our business processes from time to time.

In many jurisdictions where we operate, neither our current nor our anticipated business

model has been the subject of judicial or administrative interpretation.

We cannot be assured that a review of our business by courts

or regulatory authorities will not result in determinations that could adversely affect our operations or that the laboratory and healthcare

regulatory environment will not change in a way that restricts our operations.

State and Federal Regulatory Issues

Clinical Laboratory Improvement Amendments

of 1988 and State Regulation

laboratories are required to hold certain federal and state licenses, certifications and permits to conduct our business.

As to federal

certifications, in 1988, Congress passed the Clinical Laboratory Improvement Amendments of 1988, or CLIA, establishing more rigorous

quality standards for all commercial laboratories that perform testing on human specimens for the purpose of providing information for

the diagnosis, prevention, or treatment of disease or the assessment of the health of human beings.

CLIA requires such laboratories to

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

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

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

payers, for laboratory testing services.

must comply with all applicable CLIA requirements.

If a clinical laboratory is found not to comply with CLIA standards ,

the government may impose sanctions, limit or revoke the laboratory’s CLIA certificate (and prohibit the owner, operator or laboratory

director from owning, operating, or directing a laboratory for two years following license revocation), subject the laboratory to a directed

plan of correction, on-site monitoring, civil monetary penalties, civil actions for injunctive relief, criminal penalties, or suspension

or exclusion from the Medicare and Medicaid programs.

provides that a state may adopt laboratory licensure requirements and regulations that are more stringent than those under federal law

and requires compliance with such laws and regulations.

New York State in particular, has implemented its own more stringent laboratory

regulatory requirements.

State laws may require the laboratory to obtain state licensure and/ or laboratory personnel to meet certain

qualifications, specify certain quality control procedures or facility requirements, or prescribe record maintenance requirements.

several states impose the same or similar state requirements on out-of-state laboratory testing specimens collected or received from,

or test results reported back to, residents within that state.

Therefore, the laboratory is required to meet certain laboratory licensing

requirements for those states in which we offer services or from which we accept specimens and that have adopted regulations beyond CLIA.

For more information on state licensing requirements, see "— California Laboratory Licensing,” "— New York

Laboratory Licensing” and "— Other State Laboratory Licensing Laws.”

The laboratory running the

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

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

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

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

California Laboratory Licensing

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

a California state license and comply with California state laboratory laws and regulations.

Similar to the federal CLIA regulations,

the California state laboratory laws and regulations establish standards for the operation of a clinical laboratory and performance of

test services, including the education and experience requirements of the laboratory director and personnel (including requirements for

documentation of competency), equipment validations, and quality Management practices.

All testing personnel must maintain a California

state license or be supervised by licensed personnel.

Clinical laboratories are subject to both routine

and complaint-initiated on-site inspections by the state.

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

standards, the California Department of Public Health, or CDPH , may suspend, restrict

or revoke the California state laboratory license to operate the clinical laboratory (and exclude persons or entities from owning, operating,

or directing a laboratory for two years following license revocation), assess civil money penalties, and/or impose specific corrective

action plans, among other sanctions.

Clinical laboratories must also provide notice to CDPH of any changes in the ownership, directorship,

name or location of the laboratory.

Failure to provide such notification may result in revocation of the state license and sanctions under

the CLIA program.

Any revocation of a CLIA certificate or exclusion from participation in Medicare or Medicaid programs may result in

suspension of the California state laboratory license.

New York Laboratory Licensing

currently do not conduct tests on specimens originating from New York State.

In order to test specimens originating from, and return results

to New York State, a clinical laboratory is required to obtain a New York state laboratory permit and comply with New York state laboratory

laws and regulations.

The New York state laboratory laws, regulations and rules are equal to or more stringent than the CLIA regulations

and establish standards for the operation of a clinical laboratory and performance of test services, including education and experience

requirements of a laboratory director and personnel, physical requirements of a laboratory facility, equipment validations, and

quality Management practices.

The laboratory director(s) must maintain a Certificate of Qualification issued by the New York State Department

of Health, or NYS DOH, in the permitted test categories.

A clinical laboratory conducting tests on specimens

originating in New York is subject to proficiency testing and on-site survey inspections conducted by the Clinical Laboratory Evaluation

Program, or CLEP, under the NYS DOH.

If a laboratory is found to be out of compliance with New York’s CLEP standards, the NYS DOH,

may suspend, limit, revoke or annul the New York laboratory permit, censure the holder of the license or assess civil money penalties.

Statutory or regulatory noncompliance may result in a laboratory’s operator, owners and/or laboratory director being found guilty

of a misdemeanor under New York law.

Clinical laboratories must also provide notice to CLEP of any changes in ownership, directorship,

name or location of the laboratory.

Failure to provide such notification may result in revocation of the state license and sanctions under

the CLIA program.

Any revocation of a CLIA certificate or exclusion from participation in the Medicare or Medicaid programs may result

in suspension of the New York laboratory permit.

The NYS DOH also must approve

each LDT before that test is offered to patients located in New York.

Other State Laboratory Licensing Laws

addition to New York and California, certain other states require licensing

of out-of-state laboratories under certain circumstances.

We have obtained licenses in the states that we believe require us to do so

and believe we are in compliance with applicable state laboratory licensing laws, including Maryland and Pennsylvania.

sanctions for violation of state statutes and regulations can include significant monetary fines, the rejection of license applications,

the suspension or loss of various licenses, certificates and authorizations, and in some cases criminal penalties, which could harm our

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

Laboratory-Developed Tests

The FDA generally considers a laboratory-developed

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

The FDA has historically taken the position

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

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

This means that even though the FDA believes it

can impose regulatory requirements on LDTs, such as requirements to obtain premarket approval, de novo authorization, or 510(k) clearance

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

However, there have been situations in which FDA, because

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

including the requirement for premarket review and authorization.

Separately, the Centers for Medicare and Medicaid

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

The regulatory environment for LDTs has changed

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

2021, HHS reversed its policy.

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

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

Various bills have been

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

The VALID Act

In March 2020, the Verifying

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

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

offered as LDTs.

The VALID Act was reintroduced in

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

The VALID Act was included in the

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

Pensions (HELP) Committee in June 2022.

The FDASLA will now be considered by the full Senate.

In May 2022, the House Energy and Commerce

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

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

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

If enacted, VALID will foreseeably have a significant

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

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

Depending on the final version of the legislation, some tests

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

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

Additionally, the FDA will need to undertake rulemaking

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

It is therefore not possible to predict

the specific impact of VALID on our operations.

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

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

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

The VITAL Act

In March 2020, the Verified

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

of LDTs from the FDA to CMS.

The VITAL Act was reintroduced in May 2021.

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

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

In addition to potential legislation affecting

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

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

Enforcement actions

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

and equitable monetary relief.

Neither the VALID Act nor the VITAL Act has been

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

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

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

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

Congress may, through the enactment

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

for LDTs through other legislation.

Regulation by the U.S.

Food and Drug Administration

Should the FDA decide not to exercise enforcement

discretion for LDTs, LDTs would be subject to extensive regulation as medical devices under

the FDC Act and its implementing regulations, which govern, among other things, medical device development, testing, labeling, storage,

premarket clearance or approval, advertising and promotion and product sales and distribution.

To be commercially distributed in the United

States, medical devices, including collection devices used to collect samples for testing, and certain types of software must receive

from the FDA prior to marketing, unless subject to an exemption, clearance of a premarket notification, or 510(k), premarket approval,

or a PMA, or a de novo authorization.

In vitro diagnostics, or IVDs, are a type of

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

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

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

genetic information or other biomarkers related to health or disease.

IVDs include tests for disease prediction, prognosis, diagnosis,

and screening.

The FDC Act classifies medical devices into

one of three categories based on the risks associated with the device and the level of control necessary to provide reasonable assurance

of safety and effectiveness.

Class I devices are deemed to be low risk and are subject to the fewest regulatory controls.

devices are exempt from FDA premarket review requirements.

Class II devices, including some software products to the extent that they

qualify as a device, are deemed to be moderate risk, and generally require clearance

through the premarket notification , or 510(k) clearance, process.

III devices are generally the highest risk devices and are subject to the highest level of regulatory control to provide reasonable assurance

of the device's safety and effectiveness.

Class III devices typically require a

PMA by the FDA before they are marketed.

A clinical trial is almost always required to support a PMA application or de novo authorization

and is sometimes required for 510(k) clearance.

All clinical studies of investigational devices must be

conducted in compliance with any applicable FDA and Institutional Review Board requirements.

Devices that are exempt from FDA premarket

review requirements must nonetheless comply with post-market general controls as described below, unless the FDA has chosen otherwise.

510(k) clearance pathway.

To obtain 510(k)

clearance, a manufacturer must submit a premarket notification demonstrating to the FDA’s satisfaction that the proposed device

is substantially equivalent to a previously 510(k)-cleared device or to a device that was in commercial distribution before May 28, 1976

for which the FDA has not called for submission of a PMA application.

The previously cleared device is known as a predicate .

The FDA’s 510(k) clearance pathway usually takes from three to 12 months from submission, but it can take longer, particularly for

a novel type of product.

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

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

The PMA pathway requires

proof of the safety and effectiveness of the device to the FDA’s satisfaction.

The PMA pathway is costly, lengthy, and uncertain.

A PMA application must provide extensive preclinical and clinical trial data as well as information about the device and its components

regarding, among other things, device design, manufacturing, and labeling.

As part of its PMA review process, the FDA will typically inspect

the manufacturer’s facilities for compliance with QSR requirements, which impose extensive testing, control, documentation, and

other quality assurance procedures.

The PMA review process typically takes one to three years from submission but can take longer, including,

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

De novo pathway.

If no predicate device

can be identified, a device is automatically classified as Class III, requiring a PMA application.

However, the FDA can reclassify, either

on its own initiative or in response to a request for de novo classification, for a device for which there was no predicate device if

the device is low- or moderate-risk.

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

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

Subsequent applicants can rely upon the de novo

product as a predicate for a 510(k) clearance, unless the FDA exempts subsequent devices from the need for a 510(k).

The de novo route

is intended to be less burdensome than the PMA process.

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

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

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

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

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

Post-market general controls.

device, including a device exempt from FDA premarket review, is placed on the market, numerous regulatory requirements apply.

These include:

the QSR, labeling regulations, registration and listing, the Medical Device Reporting regulation (which requires that manufacturers report

to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause

or contribute to a death or serious injury if it were to recur), and the Reports of Corrections and Removals

regulation (which requires manufacturers to report to the FDA corrective actions made to products in the field, or removal of products

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

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

The FDA enforces compliance with its requirements

through inspection and market surveillance.

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

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

recall or seizure of products;

operating restrictions, partial suspension or total shutdown of production;

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

new products;

withdrawal of PMAs already granted;

and criminal prosecution.

Corporate Practice of Medicine;

Fee-Splitting

We contract with a healthcare telemedicine company

to deliver services to our patients.

This contractual relationship is subject to various state laws, including those of New York, Texas

and California, that prohibit fee-splitting or the practice of medicine by lay entities or persons and are intended to prevent unlicensed

persons from interfering with or influencing the physician’s professional judgment.

In addition, various state laws also generally

prohibit the sharing of professional services income with nonprofessional or business interests.

Activities other than those directly

related to the delivery of healthcare may be considered an element of the practice of medicine in many states.

Under the corporate practice

of medicine restrictions of certain states, decisions and activities such as scheduling, contracting, setting rates and the hiring and

management of non-clinical personnel may implicate the restrictions on the corporate practice of medicine.

State corporate practice of medicine and fee-splitting

laws vary from state to state and are not always consistent among states.

In addition, these requirements are subject to broad powers

of interpretation and enforcement by state regulators.

Some of these requirements may apply to any telemedicine company we contract with.

Failure to comply with regulations could lead to adverse judicial or administrative action against us and/or the telemedicine providers

we work with, civil or criminal penalties, receipt of cease-and-desist orders from state regulators, loss of provider licenses, the need

to make changes to the terms of engagement with any telemedicine company we contract with that interfere with our business and other materially

adverse consequences.

Federal and State Fraud and Abuse Laws

Healthcare Laws Generally

The federal Health Insurance Portability and

Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their

implementing regulations, which is collectively referred to as HIPAA, established several separate criminal penalties for making

false or fraudulent claims to insurance companies and other non-governmental payors of healthcare services.

Under HIPAA, these two additional

federal crimes are:

"Healthcare Fraud” and "False Statements Relating to Healthcare Matters.” The Healthcare Fraud

statute prohibits knowingly and recklessly executing a scheme or artifice to defraud any healthcare benefit program, including private

A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government-sponsored programs.

The False Statements Relating to Healthcare Matters statute prohibits knowingly and willfully falsifying, concealing or covering up a

material fact by any trick, scheme or device or making any materially false, fictitious or fraudulent statement in connection with the

delivery of or payment for healthcare benefits, items or services.

A violation of this statute is a felony and may result in fines or

imprisonment.

This statute could be used by the government to assert criminal liability if a healthcare provider knowingly fails to refund

an overpayment.

These provisions are intended to punish some of the same conduct in the submission of claims to private payors as the

federal False Claims Act covers in connection with governmental health programs.

In addition, the Civil Monetary Penalties Law

imposes civil administrative sanctions for, among other violations, inappropriate billing of services to federally funded healthcare programs

and employing or contracting with individuals or entities who are excluded from participation in federally funded healthcare programs.

Moreover, a person who offers or transfers to a Medicare or Medicaid beneficiary any remuneration, including waivers of co-payments and

deductible amounts (or any part thereof), that the person knows or should know is likely to influence the beneficiary’s selection

of a particular provider, practitioner or supplier of Medicare or Medicaid payable items or services may be liable for civil monetary

penalties of up to $10,000 for each wrongful act.

Moreover, in certain cases, providers who routinely waive copayments and deductibles

for Medicare and Medicaid beneficiaries can also be held liable under the Anti-Kickback Statute and civil False Claims Act, which can

impose additional penalties associated with the wrongful act.

One of the statutory exceptions to the prohibition is non-routine, unadvertised

waivers of copayments or deductible amounts based on individualized determinations of financial need or exhaustion of reasonable collection

The OIG emphasizes, however, that this exception should only be used occasionally to address special financial needs of a particular

Although this prohibition applies only to federal healthcare program beneficiaries, the routine waivers of copayments and deductibles

offered to patients covered by commercial payers may implicate applicable state laws related to, among other things, unlawful schemes

to defraud, excessive fees for services, tortious interference with patient contracts and statutory or common law fraud.

Federal Stark Law

We are subject to the federal self-referral

prohibitions, commonly known as the Stark Law.

Where applicable, this law prohibits a physician from referring Medicare patients to an

entity providing "designated health services” if the physician or a member of such physician’s immediate family has a

"financial relationship” with the entity, unless an exception applies.

The penalties for violating the Stark Law include the

denial of payment for services ordered in violation of the statute, mandatory refunds of any sums paid for such services, civil penalties

of up to $15,000 for each violation and twice the dollar value of each such service and possible exclusion from future participation in

the federally-funded healthcare programs.

A person who engages in a scheme to circumvent the Stark Law’s prohibitions may be fined

up to $100,000 for each applicable arrangement or scheme.

The Stark Law is a strict liability statute, which means proof of specific intent

to violate the law is not required.

In addition, the government and some courts have taken the position that claims presented in violation

of the various statutes, including the Stark Law can be considered a violation of the federal False Claims Act (described below) based

on the contention that a provider impliedly certifies compliance with all applicable laws, regulations and other rules when submitting

claims for reimbursement.

A determination of liability under the Stark Law could have a material adverse effect on our business, financial

condition and results of operations.

Federal Anti-Kickback Statute

We are also subject to the federal Anti-Kickback

The Anti-Kickback Statute is broadly worded and prohibits the knowing and willful offer, payment, solicitation or receipt of

any form of remuneration in return for, or to induce, (i) the referral of a person covered by Medicare, Medicaid or other governmental

programs, (ii) the furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid or other

governmental programs or (iii) the purchasing, leasing or ordering or arranging or recommending purchasing, leasing or ordering of

any item or service reimbursable under Medicare, Medicaid or other governmental programs.

Certain federal courts have held that the Anti-Kickback

Statute can be violated if "one purpose” of a payment is to induce referrals.

In addition, a person or entity does not need

to have actual knowledge of this statute or specific intent to violate it to have committed a violation, making it easier for the government

to prove that a defendant had the requisite state of mind or "scienter” required for a violation.

Moreover, the government

may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent

claim for purposes of the False Claims Act, as discussed below.

Violations of the Anti-Kickback Statute can result in exclusion from Medicare,

Medicaid or other governmental programs as well as civil and criminal penalties, including fines of $50,000 per violation and three times

the amount of the unlawful remuneration.

Imposition of any of these remedies could have a material adverse effect on our business, financial

condition and results of operations.

In addition to a few statutory exceptions, the U.S.

Department of Health and Human Services Office

of Inspector General, or OIG, has published safe-harbor regulations that outline categories of activities that are deemed protected from

prosecution under the Anti-Kickback Statute provided all applicable criteria are met.

The failure of a financial relationship to meet

all of the applicable safe harbor criteria does not necessarily mean that the particular arrangement violates the Anti-Kickback Statute.

However, conduct and business arrangements that do not fully satisfy each applicable safe harbor may result in increased scrutiny by government

enforcement authorities, such as the OIG.

False Claims Act

Both federal and state government agencies have

continued civil and criminal enforcement efforts as part of numerous ongoing investigations of healthcare companies and their executives

and managers.

Although there are a number of civil and criminal statutes that can be applied to healthcare providers, a significant number

of these investigations involve the federal False Claims Act.

These investigations can be initiated not only by the government but also

by a private party asserting direct knowledge of fraud.

These "qui tam” whistleblower lawsuits may be initiated against any

person or entity alleging such person or entity has knowingly or recklessly presented, or caused to be presented, a false or fraudulent

request for payment from the federal government or has made a false statement or used a false record to get a claim approved .

In addition, the improper retention of an overpayment for 60 days or more is also a basis for a False Claim Act action, even if the

claim was originally submitted appropriately.

Penalties for False Claims Act violations include fines ranging from $5,500 to $11,000 for

each false claim, plus up to three times the amount of damages sustained by the federal government.

A False Claims Act violation may provide

the basis for exclusion from the federally-funded healthcare programs.

In addition, some states have adopted similar fraud, whistleblower

and false claims provisions.

State Fraud and Abuse Laws

states in which we operate have also adopted similar fraud and abuse laws as described above.

The scope of these laws and the interpretations

of them vary from state to state and are enforced by state courts and regulatory authorities, each with broad discretion.

Some state fraud

and abuse laws apply to items or services reimbursed by any third-party payor, including commercial insurers, not just those reimbursed

by a federally-funded healthcare program.

A determination of liability under such state fraud and abuse laws could result in fines and

penalties and restrictions on our ability to operate in these jurisdictions.

State and Federal Health Information Privacy and Security Laws

There are numerous U.S.

federal and state laws

and regulations related to the privacy and security of personally identifiable information, or PII, including health information.

In particular,

HIPAA establishes privacy and security standards that limit the use and disclosure of protected health information, or PHI, and require

the implementation of administrative, physical, and technical safeguards to ensure the confidentiality, integrity and availability of

individually identifiable health information in electronic form.

Since the effective date of the HIPAA Omnibus Final Rule on September 23,

2013, HIPAA’s requirements are also directly applicable to the independent contractors, agents and other "business associates”

of covered entities that create, receive, maintain or transmit PHI in connection with providing services to covered entities.

Cardio is a covered entity under HIPAA, Cardio is also a business associate of other covered entities when Cardio is working on behalf

of our affiliated medical groups.

Violations of HIPAA may result in civil and

criminal penalties.

The civil penalties range from $100 to $50,000 per violation, with a cap of $1.5 million per year for violations

of the same standard during the same calendar year.

However, a single breach incident can result in violations of multiple standards.

Cardio must also comply with HIPAA’s breach notification rule.

Under the breach notification rule, covered entities must notify

affected individuals without unreasonable delay in the case of a breach of unsecured PHI, which may compromise the privacy, security or

integrity of the PHI.

In addition, notification must be provided to the HHS and the local media in cases where a breach affects more than

500 individuals.

Breaches affecting fewer than 500 individuals must be reported to HHS on an annual basis.

The regulations also require

business associates of covered entities to notify the covered entity of breaches by the business associate.

State attorneys general also have the right

to prosecute HIPAA violations committed against residents of their states.

While HIPAA does not create a private right of action that

would allow individuals to sue in civil court for a HIPAA violation, its standards have been used as the basis for the duty of care in

state civil suits, such as those for negligence or recklessness in misusing personal information.

In addition, HIPAA mandates that HHS

conduct periodic compliance audits of HIPAA covered entities and their business associates for compliance.

It also tasks HHS with establishing

a methodology whereby harmed individuals who were the victims of breaches of unsecured PHI may receive a percentage of the Civil Monetary

Penalty fine paid by the violator.

In light of the HIPAA Omnibus Final Rule, recent enforcement activity, and statements from HHS, we

expect increased federal and state HIPAA privacy and security enforcement efforts.

HIPAA also required HHS to adopt national standards

establishing electronic transaction standards that all healthcare providers must use when submitting or receiving certain healthcare transactions

electronically.

On January 16, 2009, HHS released the final rule mandating that everyone covered by HIPAA must implement ICD-10 for

medical coding on October 1, 2013, which was subsequently extended to October 1, 2015 and is now in effect.

Many states in which we operate and in which

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

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

For example, the laws of the State of

California, in which we operate, are more restrictive than HIPAA.

Where state laws are more protective than HIPAA, we must comply with

the state laws we are subject to, in addition to HIPAA.

In certain cases, it may be necessary to modify our planned operations and procedures

to comply with these more stringent state laws.

Not only may some of these state laws impose fines and penalties upon violators, but also

some, unlike HIPAA, may afford private rights of action to individuals who believe their personal information has been misused.

state laws are changing rapidly, and there is discussion of a new federal privacy law or federal breach notification law, to which we

may be subject.

In addition to HIPAA, state health information

privacy and state health information privacy laws, we may be subject to other state and federal privacy laws, including laws that prohibit

unfair privacy and security practices and deceptive statements about privacy and security and laws that place specific requirements on

certain types of activities, such as data security and texting.

In recent years, there have been a number of

well-publicized data breaches involving the improper use and disclosure of PII and PHI.

Many states have responded to these incidents

by enacting laws requiring holders of personal information to maintain safeguards and to take certain actions in response to a data breach,

such as providing prompt notification of the breach to affected individuals and state officials.

In addition, under HIPAA and pursuant

to the related contracts that we enter into with our business associates, we must report breaches of unsecured PHI to our contractual

partners following discovery of the breach.

Notification must also be made in certain circumstances to affected individuals, federal authorities

State Privacy Laws

Various states have enacted laws governing the

privacy of personal information collected and used by businesses online.

For example, California adopted the California Consumer Privacy

Act of 2018 ("CCPA”), which went into effect on January 1, 2020 and was recently amended by the California Privacy Rights Act

of 2020 which significantly modified the CCPA in ways that affect businesses.

This law, in part, requires that companies make certain

disclosures to consumers via their privacy policies, or otherwise at the time the personal data is collected.

We will have to determine

what personal data it is collecting from individuals and for what purposes, and to update its privacy policy every 12 months to make the

required disclosures, among other things.

Employees and Human Capital Resources

As of March 27, 2023, we had seven

full-time employees and one part-time employee.

Three of our employees hold Ph.D.

We also engage consultants from

time to time.

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

Our human capital resources objectives include,

identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees into our collaborative culture.

Our compensation program is designed to retain, motivate and attract highly qualified executives and talented employees and consultants.

We are committed to fostering a culture that supports diversity and an environment of mutual respect, equity and collaboration that helps

drive our business and our mission to become one of the leading medical technology companies for enabling improved prevention, early detection

and treatment of cardiovascular disease.

Corporate Information

Acquisition Corp.

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

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

with one or more target businesses or entities.

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

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

Upon completion

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

Our corporate headquarters is located at 400

Aberdeen St., Suite 900, Chicago IL 60642.

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

The information contained on, or that can be accessed through, our website is not incorporated by reference in this Annual Report on Form

10-K and does not form a part of this Annual Report on Form 10-K.

The reference to our website address does not constitute incorporation

by reference of the information contained at or available through our website, and you should not consider it to be a part of this registration

Emerging Growth Status

We are an “emerging growth company , ”

as defined in Section 2(a) of the Securities Act of 1933, as amended, or the Securities Act, as modified by the Jumpstart Our Business

Startups Act of 2012, or the JOBS Act.

As such, we are eligible to take advantage of certain exemptions from various reporting requirements

that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not

being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act,

reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the

requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments

not previously approved.

If some investors find our securities less attractive as a result, there may be a less active trading market

for our securities and the prices of our securities may be more volatile.

In addition, Section 107 of the JOBS Act also provides

that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the

Securities Act for complying with new or revised accounting standards.

In other words, an “emerging growth company” can delay

the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We intend to take advantage

of the benefits of this extended transition period.

We will remain an emerging growth company until the

earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our IPO, (b) in which we have

total annual gross revenue of at least $1.07 billion, or (c) in which we are deemed to be a large accelerated filer, which means

the market value of our shares of common stock that is held by non-affiliates exceeds $700 million as of the prior June 30 th ,

and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

References herein to “emerging growth company” shall have the meaning associated with it in the JOBS Act.

Additionally, we are a “smaller reporting company”

as defined in Item 10(f)(1) of Regulation S-K.

Smaller reporting companies may take advantage of certain reduced disclosure obligations,

including, among other things, providing only two years of audited financial statements.

We will remain a smaller reporting company until

the last day of the fiscal year in which (1) the market value of our common stock held by non-affiliates exceeds $250 million as

of the end of that year’s second fiscal quarter, or (2) our annual revenues exceeded $100 million during such completed fiscal

year and the market value of our common stock held by non- affiliates exceeds $700 million as of the end of that year’s second fiscal

We are a Delaware corporation incorporated on May

Our executive offices are located at 8 The Green, Suite #12490, Dover,

Delaware 19901 , and our telephone number is (302) 281-2147.

as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS

Act”), and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies

that are not emerging growth companies, including, but not limited to, not being required to comply with the auditor attestation requirements

of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”), reduced disclosure obligations

regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding

advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

Further, Section 102(b)(1) of the JOBS

Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies

(that is, those that have not had a registration statement under the Securities Act declared effective or do not have a class of securities

registered under the Securities Exchange Act of 1934, as amended the “Exchange Act”), are required to comply with the new

or revised financial accounting standards.

The JOBS Act provides that a company can elect to opt out of the extended transition period

and comply with the requirements that apply to non-emerging growth companies but any such an election to opt out is 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

which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period

difficult or impossible because of the potential differences in accounting standards used.

We will remain an emerging growth company until

the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of the IPO, (b) in

which we have total annual gross revenue of at least $1.07 billion, or (c) in which we are deemed to be a large accelerated

filer, which means the market value of our Common Stock held by non-affiliates equaled or exceeded $700 million as of the

prior June 30, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities

during the prior three-year period.

Additionally, we are a “smaller reporting

company” as defined in Item 10(f)(1) of Regulation S-K.

Smaller reporting companies may take advantage of certain reduced

disclosure obligations, including, among other things, providing only two years of audited financial statements.

We will remain a smaller

reporting company until the last day of the fiscal year in which (1) the market value of our Common Stock held by non-affiliates

equaled or exceeded $250 million as of the end of the prior June 30th, or (2) our annual revenues equaled or exceeded $100 million

during such completed fiscal year and the market value of our Common Stock held by non-affiliates equaled or exceeded $700 million

as of the prior June 30th.

Available Information

We are required to file Annual Reports on Form 10-K

and Quarterly Reports on Form 10-Q with the SEC on a regular basis, and are required to disclose certain material events in a Current

We are required to file Annual Reports on Form

10-K and Quarterly Reports on Form 10-Q with the SEC on a regular basis, and are required to disclose certain material events in a Current

Report on Form 8-K.

3 unchanged sentences

In addition, the

Company will provide copies of these documents without charge upon request from us in writing at 8

The Green, Suite #12490, Dover, Delaware 19901.

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

Aberdeen St., Suite 900, Chicago

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business