What changed in this filing

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Item 1A. Risk Factors

2024-03-25 compared with 2023-03-14 · 691 added, 859 removed, 1184 unchanged (57% of the section changed)

12 unchanged sentences

have incurred operating losses since our inception and may not be able to achieve profitability.

quarterly operating results could be subject to significant fluctuation, which could increase

the volatility of our stock price and cause losses to our stockholders.

● The March 2023 Senior Convertible Note has not been issued, and it may not be issued, including if certain closing conditions

to the issuance of such note are not satisfied.

our indebtedness may require a significant amount of cash, and the restrictive covenants

contained in our indebtedness could adversely affect our business plan, liquidity, financial

condition, and results of operations.

We have concluded there is substantial doubt of our ability to continue as a going concern and our independent registered public

accounting firm’s report on our financial statements contains an explanatory paragraph describing our ability to continue as a going concern.

To raise capital, we have issued a significant amount of

convertible securities under which we expect to issue a correspondingly significant amount of shares of our common stock upon

conversion thereof.

In addition, we may issue shares of our capital stock or debt securities in the future in order to raise capital

to fund our operations.

All of the foregoing would dilute the equity interest of our stockholders and might cause a change in

control of our ownership.

expect to need additional capital funding, which may be compounded by our obligations to our parent company, PAVmed, which requires

its own additional capital funding.

quarterly operating results could be subject to significant fluctuation, which could increase the volatility of our stock price and

cause losses to our stockholders.

our indebtedness may require a significant amount of cash, and the restrictive covenants contained in our indebtedness could adversely

affect our business plan, liquidity, financial condition, and results of operations.

Associated with Our Business

we have a limited operating history, and have not generated any significant revenues to date,

you will have little basis upon which to evaluate our ability to achieve our business objective.

markets in which we operate are attractive and other companies or institutions may develop

and market novel or improved technologies, which may make the EsoGuard or EsoCheck technologies

less competitive or obsolete.

we have a limited operating history, and have not generated any significant revenues to date, you will have little basis upon which

to evaluate our ability to achieve our business objective.

markets in which we operate are attractive and other companies or institutions may develop and market novel or improved technologies,

which may make the EsoGuard or EsoCheck technologies less competitive or obsolete.

expect to derive substantially all of our revenues from the EsoGuard and EsoCheck products.

are highly dependent on the License Agreement, the termination of which would prevent us

from commercializing our products, and which imposes significant obligations on us.

are highly dependent on our license agreement with CWRU, the termination of which would prevent us from commercializing our products, and which

imposes significant obligations on us.

products may never achieve market acceptance.

sizes of the markets for our current and future products have not been established with precision,

and may be smaller than we estimate.

sizes of the markets for our current and future products have not been established with precision, and may be smaller than we estimate.

Recommendations

in published clinical practice guidelines issued by various organizations, including professional

societies and federal agencies may significantly affect payors’ willingness to cover,

and physicians’ willingness to prescribe, our products and services.

or our third-party manufacturers may not have the manufacturing and processing capacity to

meet the production requirements of consumer demand or clinical testing in a timely manner.

in published clinical practice guidelines issued by various organizations, including professional societies and federal agencies

may significantly affect payors’ willingness to cover, and physicians’ willingness to prescribe, our products and services.

or our third-party manufacturers may not have the manufacturing and processing capacity to meet the production requirements of consumer

demand or clinical testing in a timely manner.

EsoGuard test is performed in a single commercial clinical laboratory facility.

for our EsoGuard test grows, we may lack adequate facility space and capabilities to meet

increased processing requirements.

Moreover, if these or any future facilities or their equipment

were damaged or destroyed, or if we experience a significant disruption in our commercial

clinical laboratory operations for any reason, our ability to continue to operate our business

could be materially harmed.

may remain dependent on the sales and marketing efforts of third parties if we are unable

to or choose not to develop an extensive sales and marketing staff and other resources.

results of operations can be adversely affected by labor shortages, turnover, and labor cost

expect to rely on courier delivery services to transport EsoCheck devices and EsoGuard Specimen

Kits to physicians and other medical professionals and samples back to laboratory facilities

for analysis.

If these delivery services are disrupted or become prohibitively expensive,

customer satisfaction and our business could be negatively impacted.

we attempt to bring any other products or services to market in addition to the EsoGuard

test and EsoCheck device, we likely will be required to make significant investments in research

and development, which ultimately may prove unsuccessful.

Our future performance may be affected

by the success of products we have not yet developed, licensed, acquired.

officers may allocate their time to other businesses thereby potentially limiting the amount

of time they devote to our affairs.

This conflict of interest could have a negative impact

on our operations.

If demand for our EsoGuard test grows, we may lack

adequate facility space and capabilities to meet increased processing requirements.

Moreover, if these or any future facilities or

their equipment were damaged or destroyed, or if we experience a significant disruption in our commercial clinical laboratory operations

for any reason, our ability to continue to operate our business could be materially harmed.

results of operations can be adversely affected by labor shortages, turnover, and labor cost increases.

expect to rely on courier delivery services to transport EsoCheck devices and EsoGuard specimen kits to physicians and other medical

professionals and samples back to laboratory facilities for analysis.

If these delivery services are disrupted or become prohibitively

expensive, customer satisfaction and our business could be negatively impacted.

we attempt to bring any other products or services to market in addition to the EsoGuard test and EsoCheck device, we likely will

be required to make significant investments in research and development, which ultimately may prove unsuccessful.

Our future performance

may be affected by the success of products we have not yet developed, licensed, acquired.

officers may allocate their time to other businesses thereby potentially limiting the amount of time they devote to our affairs.

This conflict of interest could have a negative impact on our operations.

ability to be successful will be totally dependent upon the efforts of our key personnel.

officers and directors have fiduciary obligations to other companies and, accordingly, may

have conflicts of interest in determining to which entity a particular business opportunity

should be presented.

officers and directors have fiduciary obligations to other companies and, accordingly, may have conflicts of interest in determining

to which entity a particular business opportunity should be presented.

business may suffer if we are unable to manage our growth.

business, financial condition and results of operations could be adversely affected by the

political and economic conditions of the countries in which we conduct business.

business may be adversely affected by health epidemics and or pandemics, including the COVID-19

may engage in acquisitions that are not successful and which could disrupt our business,

cause dilution to our stockholders and reduce our financial resources.

business, financial condition and results of operations could be adversely affected by the political and economic conditions of the

countries in which we conduct business.

may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce

our financial resources.

results in material litigation matters could have a material adverse effect upon our business.

Associated with Healthcare Regulation, Billing and Reimbursement, and Product Safety and Effectiveness.

ability to market EsoGuard, or any other IVD product that we may develop, license, or acquire,

as LDTs without FDA approval, is entirely dependent on FDA continuing to exercise enforcement

discretion with regard to requiring premarket review of LDTs.

If FDA ceases to exercise,

or modifies how it exercises, this discretion through guidance documents, formal rulemaking,

departmental directive, executive order or pursuant to legislation, we may be abruptly forced

to halt commercialization of these diagnostic tests until we are able satisfy FDA’s

modified enforcement regime, or until we secure FDA approval for these IVD products.

we fail to maintain CLIA-certification or otherwise meet the applicable requirements of federal

or state law regulating commercial clinical laboratories, such failure could limit or prevent

our ability to perform our EsoGuard test, or any other tests which we may develop, license

or acquire, affect any payor consideration of such tests, prevent their clearance or approval

entirely, and/or interrupt the commercial sale and/or marketing of any such tests, cause

us to incur significant expense to remedy this failure and otherwise negatively impact our

or any other IVD product without FDA approval we may develop, license, or acquire and market

as an LDT, may not be jointly marketed as a combined product with EsoCheck without first

securing FDA approval of the combined product as an IVD device.

If FDA deems that we are

jointly marketing such an IVD product with EsoCheck without FDA approval of the combined

product as an IVD device, we would be subject to FDA enforcement action which could limit

or halt commercialization of our products, and result in FDA sanctions which could severely

impact our business.

FDA approval of EsoGuard, or any other IVD product we may develop, license, or acquire, as

an IVD device, separately or as a combined product with EsoCheck, is a complex process requiring

substantial time, commitment of resources and expense without any assurance that FDA will

grant such approval.

to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our

products internationally.

private or governmental third-party payors do not maintain reimbursement for our products at adequate reimbursement rates, we may

be unable to successfully commercialize our products which would limit or slow our revenue generation and likely have a material

adverse effect on our business.

has proposed a policy under which it would phase out its general enforcement discretion approach for LDTs so that IVDs manufactured

at a laboratory would generally fall under the same enforcement approach as other IVDs.

While we are confident that the proposed

policy will not have a material impact on our business, there can be no assurance that will be the case.

we fail to maintain CLIA-certification or otherwise meet the applicable requirements of federal or state law regulating commercial

clinical laboratories, such failure could limit or prevent our ability to perform our EsoGuard test, or any other tests which we

may develop, license or acquire, affect any payor consideration of such tests, prevent their clearance or approval entirely, and/or

interrupt the commercial sale and/or marketing of any such tests, cause us to incur significant expense to remedy this failure and

otherwise negatively impact our business.

may not be jointly marketed as a combined product with EsoCheck without first securing FDA approval of the combined product as an

If FDA deems that we are jointly marketing such an IVD product with EsoCheck without FDA approval of the combined product

as an IVD device, we would be subject to FDA enforcement action which could limit or halt commercialization of our products, and

result in FDA sanctions which could severely impact our business.

FDA approval of EsoGuard as an IVD device, separately or as a combined product with EsoCheck, is a complex process requiring substantial

time, commitment of resources and expense without any assurance that FDA will grant such approval.

to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.

Modifications

to our cleared or approved products may require new clearances or premarket approvals, or

may require us to cease marketing or recall the modified products until clearances are obtained.

trials necessary to support regulatory submission will be expensive and will require the

enrollment of large numbers of patients, and suitable patients may be difficult to identify

Delays or failures in our clinical trials will prevent us from expanding our

commercial efforts and will adversely affect our business, operating results and prospects.

results of our clinical trials may not support our product candidate claims or may result

in the discovery of adverse side effects.

our clinical studies do not satisfy providers, payors, patients and others as to the reliability

and performance of our EsoGuard test and the EsoCheck device, or any other product or service

we may develop and seek to commercialize, we may experience reluctance or refusal on the

part of physicians to order, and third-party payors to pay for, such test.

the validity of an informed consent for a clinical trial of one of our products was challenged,

we could be subject to fines, penalties, litigation, or regulatory sanctions, or other adverse

consequences, including invalidating or requiring us to repeat clinical trials which could

negatively affect our business and results of operations.

and any other products we develop that receive regulatory clearance or approval will be subject

to ongoing regulatory obligations and continued regulatory review, which may result in significant

additional expense and subject us to penalties if we fail to comply with applicable regulatory

requirements.

we are found to be promoting the use of our devices for unapproved or “off-label”

uses or engaging in other noncompliant activities, we may be subject to recalls, seizures,

fines, penalties, injunctions, adverse publicity, prosecution, or other adverse actions,

resulting in damage to our reputation and business.

laboratories and medical diagnostic companies are subject to extensive and frequently changing

federal, state, and local laws.

We could be subject to significant fines and penalties if

we fail (or if our prior unrelated third-party laboratory partner previously failed) to comply

with these laws and regulations.

operate patient service centers where prescribing physicians can send patients for EsoGuard

testing, including undergoing specimen collection using EsoCheck.

These patient service centers

are subject to federal and state regulations which may be burdensome, costly or difficult

to our cleared or approved products may require new clearances or premarket approvals, or may require us to cease marketing or recall

the modified products until clearances are obtained.

trials necessary to support regulatory submission will be expensive and will require the enrollment of large numbers of patients,

and suitable patients may be difficult to identify and recruit.

Delays or failures in our clinical trials will prevent us from expanding

our commercial efforts and will adversely affect our business, operating results and prospects.

results of our clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects.

our clinical studies do not satisfy providers, payors, patients and others as to the reliability and performance of our EsoGuard

test and the EsoCheck device, or any other product or service we may develop and seek to commercialize, we may experience reluctance

or refusal on the part of physicians to order, and third-party payors to pay for, such test.

the validity of an informed consent for a clinical trial of one of our products was challenged, we could be subject to fines, penalties,

litigation, or regulatory sanctions, or other adverse consequences, including invalidating or requiring us to repeat clinical trials

which could negatively affect our business and results of operations.

and any other products we develop that receive regulatory clearance or approval will be subject to ongoing regulatory obligations

and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply

with applicable regulatory requirements.

we are found to be promoting the use of our devices for unapproved or “off-label” uses or engaging in other noncompliant

activities, we may be subject to recalls, seizures, fines, penalties, injunctions, adverse publicity, prosecution, or other adverse

actions, resulting in damage to our reputation and business.

laboratories and medical diagnostic companies are subject to extensive and frequently changing federal, state, and local laws.

could be subject to significant fines and penalties if we fail (or if our prior unrelated third-party laboratory partner previously

failed) to comply with these laws and regulations.

operate Lucid Test Centers where prescribing physicians can send patients for EsoGuard testing, including undergoing specimen collection

using EsoCheck.

These Lucid Test Centers are subject to federal and state regulations which may be burdensome, costly or difficult

to comply with.

Failure to comply with these regulations could result in sanctions, fines

or other enforcement actions which may be costly, time-consuming and limit our ability to

utilize them and adversely impact our business.

intend to engage with one or more third-party telemedicine companies to provide physicians

to evaluate patients who respond to our direct-to-consumer (“DTC”) marketing

activities seeking EsoGuard testing and, if clinically indicated, refer the patient to our

patient service centers to undergo EsoCheck specimen collection for EsoGuard testing.

Telemedicine,

and its specific use in conjunction with DTC, is subject to numerous federal and state regulations

and faces particularly intense scrutiny by these regulators.

If we fail to comply with federal

healthcare regulations, we could face substantial penalties, sanctions, fines or prosecution

and our business, operations and financial condition could be adversely affected.

aspects of our business, beyond the specific elements described above, are subject to complex,

intertwined, costly and/or burdensome federal health care laws and regulations which may

open to interpretation and be subject to varying levels of discretionary enforcement.

we fail to comply with these laws and regulations, we could face substantial penalties and

our business, operations and financial condition could be adversely affected.

private or governmental third-party payors do not maintain reimbursement for our products

at adequate reimbursement rates, we may be unable to successfully commercialize our products

which would limit or slow our revenue generation and likely have a material adverse effect

on our business.

regulations that govern pricing and reimbursement for new products vary widely from country

to country, and may adversely affect the pricing, coverage and reimbursement rates of our

products in other countries.

to billing complexities in the diagnostic and laboratory service industry, we may not be

able to collect payment for the EsoGuard tests we perform.

Failure to comply with these regulations could result in sanctions, fines or other enforcement actions which may

be costly, time-consuming and limit our ability to utilize them and adversely impact our business.

intend to engage with one or more third-party telemedicine companies to provide physicians to evaluate patients and, if clinically

indicated, refer the patient to our Lucid Test Centers or to a #CheckYourFoodTube Precancer Testing Event, to undergo EsoCheck specimen

collection for EsoGuard testing.

Telemedicine is subject to numerous federal and state regulations and faces particularly intense

scrutiny by these regulators.

If we fail to comply with federal healthcare regulations, we could face substantial penalties, sanctions,

fines or prosecution and our business, operations and financial condition could be adversely affected.

aspects of our business, beyond the specific elements described above, are subject to complex, intertwined, costly and/or burdensome

federal health care laws and regulations which may open to interpretation and be subject to varying levels of discretionary enforcement.

If we fail to comply with these laws and regulations, we could face substantial penalties and our business, operations and financial

condition could be adversely affected.

regulations that govern pricing and reimbursement for new products vary widely from country to country, and may adversely affect

the pricing, coverage and reimbursement rates of our products in other countries.

to billing complexities in the diagnostic and laboratory service industry, we may not be able to collect payment for the EsoGuard

tests we perform.

reform measures could hinder or prevent our products’ commercial success.

medical products may in the future be subject to product recalls that could harm our reputation,

business, and financial results.

our medical products cause or contribute to a death or a serious injury, or malfunction in

certain ways, we will be subject to medical device reporting regulations, which can result

in voluntary corrective actions or agency enforcement actions.

liability lawsuits against us could cause us to incur substantial liabilities and to limit

commercialization of our products.

medical products may in the future be subject to product recalls that could harm our reputation, business, and financial results.

our medical products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical

device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.

liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our products.

with the HIPAA security, privacy and breach notification regulations may increase our costs.

Associated with Our Intellectual Property and Technology Infrastructure

may not be able to protect or enforce the intellectual property rights for the technology

used in, or expected to be used in, our products, which could impair our competitive position.

may be subject to intellectual property infringement claims by third parties which could

be costly to defend, divert management’s attention and resources, and may result in

● Competitors

may violate the intellectual property rights for the technology used in, or expected to be

used in, our products, and we may bring litigation to protect and enforce our intellectual

property rights, which may result in substantial expense and may divert our attention from

implementing our business strategy.

in our information technology systems could significantly disrupt our operations and our

research and development efforts, which could adversely impact our revenues, as well as our

research, development and commercialization efforts.

internal computer systems, or those used by our third-party research institution collaborators,

vendors or other contractors or consultants, may suffer security breaches.

may not be able to protect or enforce the intellectual property rights for the technology used in, or expected to be used in, our

products, which could impair our competitive position.

may be subject to intellectual property infringement claims by third parties which could be costly to defend, divert management’s

attention and resources, and may result in liability.

may violate the intellectual property rights for the technology used in, or expected to be used in, our products, and we may bring

litigation to protect and enforce our intellectual property rights, which may result in substantial expense and may divert our attention

from implementing our business strategy.

in our information technology systems could significantly disrupt our operations and our research and development efforts, which

could adversely impact our revenues, as well as our research, development and commercialization efforts.

internal computer systems, or those used by our third-party research institution collaborators, vendors or other contractors or consultants,

may suffer security breaches.

Associated with Our Relationship with PAVmed

owns a majority of our voting stock and thus may control certain actions requiring a stockholder

conflicts of interest may arise between us and our affiliated companies, including PAVmed,

and in some cases we have waived certain rights with respect thereto.

ability to operate our business effectively may suffer if the MSA with PAVmed is insufficient

to meet our needs or if, upon the termination of the MSA, we do not cost-effectively establish

our own fully functional financial, administrative, operational and other support systems

in order to operate as a stand-alone company.

order to preserve the ability for PAVmed to distribute its shares of our common stock on

a tax-free basis for U.S.

federal income tax purposes, we may be prevented from pursuing

opportunities to raise capital, to effectuate acquisitions or to provide equity incentives

to our employees, which could hurt our ability to grow.

disputes that arise between us and PAVmed with respect to our past and ongoing relationships

could harm our business operations.

owns a majority of our voting stock and thus it (or any successor to its stake in the Company), may control certain actions requiring

a stockholder vote.

If PAVmed’s debt is accelerated due to its default under the terms thereof, PAVmed could cease to have voting

control of the Company.

conflicts of interest may arise between us and our affiliated companies, including PAVmed, and in some cases we have waived certain

rights with respect thereto.

ability to operate our business effectively may suffer if the MSA with PAVmed is insufficient to meet our needs or if, upon the termination

of the MSA, we do not cost-effectively establish our own fully functional financial, administrative, operational and other support

systems in order to operate as a stand-alone company.

disputes that arise between us and PAVmed with respect to our past and ongoing relationships could harm our business operations.

Associated with Ownership of Our Common Stock

may issue shares of our capital stock or debt securities in the future which could reduce

the equity interest of our stockholders and might cause a change in control of our ownership.

securities or industry analysts do not publish research, or publish inaccurate or unfavorable

research, about our business, our stock price and trading volume could decline.

may in the future delist our common stock, which could limit investors’ ability to

make transactions in our securities and subject us to additional trading restrictions.

stock price may be volatile, and purchasers of our common stock could incur substantial losses.

securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock

price and trading volume could decline.

may in the future delist our common stock, which could limit investors’ ability to make transactions in our securities and

subject us to additional trading restrictions.

stock price may be volatile, and holders of our common stock could incur substantial losses.

do not intend to pay any dividends on our common stock at this time.

will incur significantly increased costs as a result of operating as a public company, and

our management will be required to devote substantial time to compliance initiatives.

we fail to establish and maintain proper and effective internal control over financial reporting,

investors may lose confidence in the accuracy and completeness of our financial reports and

the market price of our common stock could decline significantly.

are subject to evolving corporate governance and public disclosure expectations and regulations

that impact compliance costs and risks of noncompliance.

are an “emerging growth company,” and we cannot be certain if the reduced reporting

requirements applicable to emerging growth companies will make our common stock less attractive

to investors.

in our corporate charter documents and under Delaware law could make an acquisition of us

more difficult and may prevent attempts by our stockholders to replace or remove our current

charter provides, subject to limited exceptions, that the Court of Chancery of the State

of Delaware will be the sole and exclusive forum for certain stockholder litigation matters,

which could limit our stockholders’ ability to obtain a favorable judicial forum for

disputes with us or our directors, officers, employees or stockholders.

incur significant costs as a result of operating as a public company, and our management will be required to devote substantial time

to compliance initiatives.

we fail to establish and maintain proper and effective internal control over financial reporting, investors may lose confidence in

the accuracy and completeness of our financial reports and the market price of our common stock could decline significantly.

are subject to evolving corporate governance and public disclosure expectations and regulations that impact compliance costs and

risks of noncompliance.

are an “emerging growth company,” and we cannot be certain if the reduced reporting requirements applicable to emerging

growth companies will make our common stock less attractive to investors.

in our corporate charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts

by our stockholders to replace or remove our current management.

charter provides, subject to limited exceptions, that the Court of Chancery of the State of Delaware will be the sole and exclusive

forum for certain stockholder litigation matters, which could limit our stockholders’ ability to obtain a favorable judicial

forum for disputes with us or our directors, officers, employees or stockholders.

Associated with Our Financial Condition

1 unchanged sentence

have incurred net losses since our inception.

For the years ended December 31, 2022 and December 31, 2021, we had a net loss of $56.2

For the years ended December 31, 2023 and 2022, we had a net loss of $52.7

million and $56.2 million, respectively.

7 unchanged sentences

its efforts to the commercialization of its initial products and services and ongoing research and development activities and clinical

may need substantial additional funding and may be unable to raise capital when needed, which could force us to delay, reduce, eliminate

or abandon growth initiatives or product development programs.

intend to continue to make investments to support our business growth, and we may require additional funds to:

have concluded there is substantial doubt of our ability to continue as a going concern and our independent registered public accounting

firm’s report on our financial statements contains an explanatory paragraph describing our ability to continue as a going concern.

our December 31, 2023 consolidated financial statements, we have concluded and stated our recurring losses from operations, recurring

cash flows used in operations and the requirement we raise additional capital in order to fund our ongoing operations

beyond March 2025 raise substantial doubt regarding our ability to continue as a going concern.

Additionally, our independent registered

public accounting firm’s report on our consolidated financial statements includes an explanatory paragraph expressing substantial doubt

about our ability to continue as a going concern.

Our plans to address this going concern risk include pursuing further financings in

addition to the recently completed offering of Series B Preferred Stock (in which we raised over $18 million), seeking to restructure

our outstanding indebtedness and pursuing additional offerings of debt and/or equity securities.

The consolidated financial statements

do not include any adjustments that might result from our inability to consummate such offerings or our ability to continue as a going

Moreover, there is no assurance if we consummate additional offerings, we will raise sufficient proceeds in such offerings to

pay our financial obligations as they become due.

These factors raise substantial doubt about our ability to continue as a going concern.

raise capital, we have issued a significant amount of convertible securities under which we expect to issue a correspondingly

significant amount of shares of our common stock upon conversion thereof.

In addition, we may issue shares of our capital stock or

debt securities in the future in order to raise capital to fund our operations.

All of the foregoing would dilute the equity

interest of our stockholders and might cause a change in control of our ownership.

certificate of incorporation authorizes the issuance of up to 200,000,000 shares of common stock, par value $.001 per share, and 20,000,000

shares of preferred stock, par value $.001 per share.

There are 151,755,202 authorized but unissued shares of our common stock available

for issuance as of March 21, 2024 (inclusive of granted but unvested restricted stock awards granted as of each such date under

the Lucid Diagnostics 2018 Long-Term Incentive Equity Plan).

March 2023 through March 2024, we issued shares of Series A Preferred Stock, Series A-1 Preferred, and Series B Preferred Stock that,

in accordance with the terms thereof, could be converted into, in the aggregate, up to 49,822,240 shares of our common stock

(which amount includes all future dividends that may be potentially payable in shares of our common stock).

of March 21, 2024, 2,203,800 shares of our common stock were issuable under the March 2023 Senior Convertible Note, assuming the

noteholder elected to convert the March 2023 Senior Convertible Note in full on such date at the fixed conversion price of $5.00 per

share (based on $11.0 million in aggregate principal amount outstanding as of such date and no accrued and unpaid interest thereon).

The number of shares of our common stock to be issued under the March 2023 Senior Convertible Note may be substantially greater than

this amount if we make the required amortization payments in shares of our common stock (or upon conversion of the principal and

interest in certain other circumstances as described elsewhere in this filing), because in such event the number of shares to be

issued will be determined based on the then current market price (but in any event not more than fixed conversion price per share or

less than $0.30 per share).

We cannot predict the market price of our common stock at any future date, and therefore, we are unable

to accurately forecast or predict the total amount of shares that ultimately may be issued under the March 2023 Senior Convertible

However, assuming that all amortization payments are made as scheduled in shares of common stock at a price equal to the

current market price of $1.11 per share, we estimate that we would issue 9,927,027 shares to the noteholder.

March 2024, we entered into an eighth amendment to the management services agreement with PAVmed (the “MSA”), pursuant

to which PAVmed may elect to receive payment of the monthly fee under the management services agreement in cash or in shares of our

common stock valued at a price based on the current market price, subject to a floor price and a maximum number of shares.

amendment, the monthly fee due from the Company to PAVmed was increased from $0.75 million to $0.83 million.

In accordance with the

MSA and the PBERA, on January 26, 2024, PAVmed elected to receive payment of $4.675 million of fees and reimbursements accrued under

the MSA and the PBERA through the issuance of 3,331,771 shares of the Company’s common stock.

To the extent PAVmed elects for

us to satisfy our obligations under the MSA and PBERA in shares of our common stock in the future, the interest of other shareholder

of the Company would be diluted.

we have issued and expect to continue to issue equity awards, including stock options, under our 2018 Long-Term Incentive Equity Plan

(the “Lucid Diagnostics Inc.

2018 Equity Plan”) and our Employee Stock Purchase Plan (the “Lucid Diagnostics Inc.

In addition, in March 2022, we entered into a committed equity facility with an affiliate of Cantor.

Under the terms of the facility,

Cantor has committed to purchase up to $50 million in shares of our common shares stock from time to time at the our request.

2022, we also entered into an “at-the-market offering” for up to $6.5 million of our common stock that may be offered and

sold under a Controlled Equity Offering Agreement between us and Cantor.

Also in November 2022, we entered into the PBERA with PAVmed,

pursuant to which PAVmed will continue to pay certain payroll and benefit-related expenses on our behalf and we will reimburse PAVmed,

in cash or, subject to approval by each of our boards of directors, in shares of our common stock valued at a price based on the current

market price, subject to a floor price and a maximum number of shares.

addition, we may issue a substantial number of additional shares of our common stock or preferred stock or incur indebtedness, or issue

or incur a combination of common and preferred stock and indebtedness, to raise additional funds or in connection with any strategic

acquisition or as compensation to our officers, directors, employees and consultants or to fund investments in our current operations.

issuance of additional shares of our common stock or any number of shares of our preferred stock, and the availability for sale of such

shares in the public markets:

significantly dilute the equity interest of our current investors;

subordinate the rights of holders of common stock if preferred stock is issued with rights

senior to those afforded to our common stockholders;

cause a change in control if a substantial number of our shares of common stock are issued,

which may affect, among other things, our ability to use our net operating loss carryforwards,

if any, and most likely also result in the resignation or removal of some or all of our present

officers and directors;

adversely affect prevailing market prices for our common stock.

if we incur indebtedness, it could result in:

and foreclosure on our assets if our operating revenues are insufficient to pay our debt

obligations and we are not able to refinance such obligations;

● acceleration

of our obligations to repay the indebtedness even if we have made all principal and interest

payments when due if the debt security contains covenants that require the maintenance of

certain financial ratios or reserves, and any such covenant is breached without a waiver

or renegotiation of that covenant;

immediate payment of all principal and accrued interest, if any, if the debt security is

payable on demand and a demand is made;

inability to obtain additional financing, if necessary, if the debt security contains covenants

restricting our ability to obtain additional financing while such security is outstanding;

● our inability to conduct acquisitions, joint ventures or similar arrangements if the debt security contains covenants restricting such

transactions or the funding thereof or requiring prior approval of the debt holders.

expect to need additional capital funding, which may be compounded by our obligations to our parent company, PAVmed, which requires its

own additional capital funding.

future capital requirements depend on many factors, including our research, development, and sales and marketing activities.

intend to continue to make investments to support our business growth.

Because we have not generated significant revenue or cash

flow to date, and despite our recently having raised approximately $18.1 million in the Series B Offering and Exchange, we may require

additional funds to:

our research and development including existing and new clinical trials;

additional regulatory clearances and approvals for our products;

our intellectual property rights or defend, in litigation or otherwise, any claims that we

infringe third-party patents or other intellectual property rights;

our operations;

● manufacture

our intellectual property rights or defend, in litigation or otherwise, any claims that we infringe third-party patents or other

intellectual property rights;

and distribute our products;

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effect of competing technological and market developments;

extent to which we acquire or invest in businesses, products and technologies, although we

currently have no commitments or agreements relating to any of these types of transactions.

extent to which we acquire or invest in businesses, products and technologies, although we currently have no commitments or agreements

relating to any of these types of transactions.

our existing management services agreement and payroll and benefit expense reimbursement agreement with PAVmed, PAVmed may determine

the form and timing of our satisfaction of our obligations under such agreements.

To the extent PAVmed elects for this obligation to

be paid in cash, that would increase our need to raise additional capital.

In this regard, because of the challenges PAVmed has faced in terms of raising capital itself, PAVmed has become

highly dependent on us to fund its operations, primarily through electing for the payment in cash by us of our obligations under our management

services agreement with PAVmed.

or preferred stock financing, if available, may involve covenants restricting our operations or our ability to incur additional debt

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products, may fluctuate significantly, depending on a variety of factors, including the following:

success in marketing and selling, and changes in demand for, our products, and the level

of reimbursement and collection obtained for our products;

variations affecting physician recommendations for esophageal precancer and cancer screenings

and patient compliance with physician recommendations, including without limitation holidays,

weather events, and circumstances such as the outbreak of COVID-19, influenza or other disease

that may limit patient access to medical practices for preventive services such as esophageal

precancer and cancer screening;

success in collecting payments from third-party payors, patients and collaborative partners,

variation in the timing of these payments and recognition of these payments as revenues;

pricing of our products, including potential changes in CMS reimbursement rates or other

reimbursement rates;

success in marketing and selling, and changes in demand for, our products, and the level of reimbursement and collection obtained

for our products;

variations affecting physician recommendations for esophageal precancer and cancer screenings and patient compliance with physician

recommendations, including without limitation holidays, weather events, and other circumstances that may limit patient access to

medical practices for preventive services such as esophageal precancer and cancer screening;

success in collecting payments from third-party payors, patients and collaborative partners, variation in the timing of these payments

and recognition of these payments as revenues;

pricing of our products, including potential changes in CMS reimbursement rates or other reimbursement rates;

circumstances

affecting our ability to provide our products, including weather events, supply shortages,

or regulatory or other circumstances that adversely affect our ability to manufacture our

products or process tests in our clinical laboratory;

● fluctuations

in the amount and timing of our selling and marketing costs and our ability to manage costs

and expenses and effectively implement our business;

affecting our ability to provide our products, including weather events, supply shortages, or regulatory or other circumstances that

adversely affect our ability to manufacture our products or process tests in our clinical laboratory;

in the amount and timing of our selling and marketing costs and our ability to manage costs and expenses and effectively implement

our business;

research and development activities, including the timing of costly clinical trials.

March 2023 Senior Convertible Note has not been issued, and it may not be issued, including if certain closing conditions to the issuance

of such note are not satisfied.

March 13, 2023, we entered into the SPA, pursuant to which we anticipate issuing the March 2023 Senior Convertible Note.

However, such

issuance is subject to certain closing conditions, some of which are outside of our control.

If any of the closing conditions to the

issuance of the March 2023 Senior Convertible Note are not met, or if the Investor fails to purchase the March 2023 Senior Convertible

Note when required to do so under the SPA, the note may not be issued.

our indebtedness may require a significant amount of cash, and the restrictive covenants contained in our indebtedness could adversely

affect our business plan, liquidity, financial condition, and results of operations.

may be required to repay or redeem, or to pay interest on, the March 2023 Senior Convertible Note (if issued) or any future

permitted indebtedness incurred by us or our subsidiaries, in cash.

Despite our right to pay the interest and principal balance of

the March 2023 Senior Convertible Note (if issued) by issuing shares of our common stock, we may be required to repay such

indebtedness in cash, if we do not meet certain customary equity conditions (including minimum price and volume thresholds) or in

certain other circumstances.

For example, we may be required to repay the outstanding principal balance and accrued but unpaid

interest, along with a premium, upon the occurrence of certain changes of control or an event of default.

may be required to repay or redeem, or to pay interest on, the March 2023 Senior Convertible Note or any future permitted indebtedness

incurred by us or our subsidiaries, in cash.

Despite our right to pay the interest and principal balance of the March 2023 Senior Convertible

Note by issuing shares of our common stock, we may be required to repay such indebtedness in cash, if we do not meet certain customary

equity conditions (including minimum price and volume thresholds) or in certain other circumstances.

For example, we may be required

to repay the outstanding principal balance and accrued but unpaid interest, along with a premium, upon the occurrence of certain changes

of control or an event of default.

ability to make payments of the principal of, to pay interest on, or to redeem our indebtedness in cash, depends on our future performance,

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and make necessary capital expenditures.

In addition, the March 2023 Senior Convertible Note (if issued) would contain, and any future indebtedness may

contain, restrictive covenants, including financial covenants.

In addition, the March 2023 Senior Convertible Note would contain, and any future indebtedness

may contain, restrictive covenants, including financial covenants.

These payment obligations and covenants could have important consequences

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In particular, they could:

us to dedicate a substantial portion of our cash flow from operations to payments on our

indebtedness;

among other things, our ability to borrow additional funds and otherwise raise additional

capital, and our ability to conduct acquisitions, joint, ventures or similar arrangements,

as a result of our obligations to make such payments and comply with the restrictive covenants

us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness;

among other things, our ability to borrow additional funds and otherwise raise additional capital, and our ability to conduct acquisitions,

joint, ventures or similar arrangements, as a result of our obligations to make such payments and comply with the restrictive covenants

in the indebtedness;

our flexibility in planning for, or reacting to, changes in our businesses and the industries

in which we operate;

our flexibility in planning for, or reacting to, changes in our businesses and the industries in which we operate;

our vulnerability to general adverse economic and industry conditions;

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which may make the EsoGuard or EsoCheck technologies less competitive or obsolete.

the large market opportunity for esophageal precancer screening we may face multiple competitors in the future, some of which possess

significantly greater financial and other resources and development capabilities than us.

Our EsoGuard test may face competition from

new biomarkers also designed to detect esophageal precancer and conditions along the BE-EAC spectrum.

the large market opportunity for esophageal precancer testing we may face multiple competitors in the future, some of which possess significantly

greater financial and other resources and development capabilities than us.

Our EsoGuard test may face competition from new biomarkers

also designed to detect esophageal precancer and conditions along the BE-EAC spectrum.

Mayo Clinic and Exact Sciences Inc.

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to advancing them to commercialization.

Investigators at Johns Hopkins University associated with a privately held firm called Capsulomics

LLC have published limited data on methylation biomarkers for BE.

Investigators at Johns Hopkins University associated with a privately held firm called Previse

have published limited data on methylation biomarkers for BE.

Of note, both groups used the EsophaCap “sponge-on-a-string”

cell collection device.

manufactures have developed noninvasive esophageal cell collection devices most notably “sponge-on-a-string” devices which

manufacturers have developed noninvasive esophageal cell collection devices most notably “sponge-on-a-string” devices which

may compete with EsoCheck.

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esophagus as it is withdrawn and retrieved.

Although, unlike EsoCheck, this device does not provide anatomic targeting nor protect their

sample from dilution and contamination during device withdrawal, future biomarkers may have sufficient sensitivity to detect BE-EAC despite

such dilution and contamination.

Manufacturers may also be developing new tools that have not yet been announced that provide noninvasive

esophageal cell sampling with the same or better protection from dilution and contamination as EsoCheck.

EndoSign, commercialized by Cyted, and much like Cytosponge and our own EsophaCap before

it, is a small mesh sponge within a soluble gelatin capsule that needs to reside in the stomach for some time until it fully dissolves

and then is pulled thru the targeted region brushing the lining of the esophagus and then later retrieved.

Although, unlike EsoCheck,

these devices do not provide anatomic targeting nor protect their sample from dilution and contamination during device withdrawal, future

biomarkers may have sufficient sensitivity to detect BE-EAC despite such dilution and contamination.

Manufacturers may also be developing

new tools that have not yet been announced that provide noninvasive esophageal cell sampling with the same or better protection from

dilution and contamination as EsoCheck.

well-capitalized companies are developing “liquid biopsy” tests for early cancer detection based on circulating tumor DNA.

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Such advances could put EsoGuard and EsoCheck at a significant

competitive disadvantage in the esophageal precancer screening market as it would be logistically much simpler to send the patient for

competitive disadvantage in the esophageal precancer testing market as it would be logistically much simpler to send the patient for

a routine blood draw instead of a specialized office procedure like EsoCheck, and patients would generally prefer such a blood draw over

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For example, there is early data to suggest that an “electric nose”

device which measures volatile organic compounds (VOCs) developed by Aeonose, The eNose Company, based in the Netherlands, may be able

to identify patients with BE.

Preliminary published data from Columbia University School of Medicine found differences in the oral bacterial

microbiome, obtain with a simple saliva sample or oral swab, may correlate with the presence of BE.

device which measures volatile organic compounds (VOCs) developed by The eNose Company, based in the Netherlands, may be able to identify

patients with BE.

Preliminary published data from Columbia University School of Medicine found that differences in the oral bacterial

microbiome, obtained with a simple saliva sample or oral swab, may correlate with the presence of BE.

there can be no assurance that we will pursue the development of any products other than EsoGuard and EsoCheck, if we seek to develop

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condition and results of operations, and could threaten the viability of our business.

are highly dependent on the License Agreement, the termination of which would prevent us from commercializing our products, and which

are highly dependent on our license agreement with CWRU, the termination of which would prevent us from commercializing our products, and which

imposes significant obligations on us.

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may terminate the exclusivity of the license or terminate the License Agreement in full.

Furthermore, if we breach the agreement, including

by failing to use our commercially best efforts to achieve the milestones prescribed by the agreement, and we do not cure such breach

within the applicable time period, in addition to seeking damages, CWRU could terminate the License Agreement.

Any termination of the

License Agreement resulting in the loss of the licensed rights would prevent us from marketing and selling the EsoGuard and EsoCheck

products and any other products or services we may develop based on the same underlying technology.

Any termination of the exclusivity

of the license could damage our competitive position within the marketplace.

In addition, disputes may also arise between us and CWRU

regarding the License Agreement.

If any such dispute results in an impairment of our ability to use the intellectual property, we may

be unable to commercialize the EsoGuard and EsoCheck products and any other product or service we may develop based on the same underlying

Furthermore, if we breach the agreement, and

we do not cure such breach within the applicable time period, in addition to seeking damages, CWRU could terminate the License Agreement.

Any termination of the License Agreement resulting in the loss of the licensed rights would prevent us from marketing and selling the

EsoGuard and EsoCheck products and any other products or services we may develop based on the same underlying technology.

Any termination

of the exclusivity of the license could damage our competitive position within the marketplace.

In addition, disputes may also arise

between us and CWRU regarding the License Agreement.

If any such dispute results in an impairment of our ability to use the intellectual

property, we may be unable to commercialize the EsoGuard and EsoCheck products and any other product or service we may develop based

on the same underlying technology.

Accordingly, any such termination or dispute could threaten the viability of our business.

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A number of factors may limit the market acceptance of any of our products, including:

effectiveness, reliability and safety of our products, including any potential side effects,

and the other competitive features of our products, including price, as compared to alternatives;

rate of adoption of our products by hospitals, doctors and nurses and acceptance by the health

care community, and the ease of the ordering process for doctors;

and other recommendations from medical societies and other similar organizations relating

to screening for, monitoring, diagnosing and treating esophageal precancer and cancer or

other medical conditions for which our products are used;

effectiveness, reliability and safety of our products, including any potential side effects, and the other competitive features of

our products, including price, as compared to alternatives;

rate of adoption of our products by hospitals, doctors and nurses and acceptance by the health care community, and the ease of the

ordering process for doctors;

and other recommendations from medical societies and other similar organizations relating to screening for, monitoring, diagnosing

and treating esophageal precancer and cancer or other medical conditions for which our products are used;

product labeling or product inserts required by regulatory authorities for each of our products;

availability and amount of insurance or other third-party reimbursement, such as Medicare,

for patients using our products;

availability and amount of insurance or other third-party reimbursement, such as Medicare, for patients using our products;

extent and success of our marketing efforts and those of our collaborators;

● unfavorable

publicity concerning our products or similar products;

the case of FDA PMA approval of the EsoGuard combined with EsoCheck as an IVD device, and

in the case of any other products or services we may develop in the future, the timing of

regulatory approvals of our products and market entry compared to competitive products.

the case of FDA PMA approval of the EsoGuard combined with EsoCheck as an IVD device, and in the case of any other products or services

we may develop in the future, the timing of regulatory approvals of our products and market entry compared to competitive products.

sizes of the markets for our current and future products have not been established with precision, and may be smaller than we estimate.

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to coverage under our insurance policies, we may not be able to cover our losses.

may remain dependent on the sales and marketing efforts of third parties if we are unable to or choose not to develop an extensive sales

and marketing staff and other resources.

expect to continue to depend, at least in part, on the efforts of third parties (including independent sales representatives and, potentially

in the future, distributors) to carry out the sales and marketing of our products.

We anticipate that each third party will control the

amount and timing of resources generally devoted to these activities.

However, these third parties may not be able to generate demand

for our products.

In addition, there is a risk that these third parties will develop products competitive to ours, which would likely

decrease their incentive to vigorously promote and sell our products.

Various market factors may force us to expend substantially more

time and resources to develop an effective internal sales infrastructure on a larger scale, requiring more capital and much sooner than

we might have anticipated or budgeted.

However, it may not be economical for us to market our own products, or we may be unable to effectively

market our products.

Therefore, our business could be harmed if we fail to enter into arrangements with third parties for the sales and

marketing of our products or otherwise fail to establish sufficient marketing capabilities.

results of operations can be adversely affected by labor shortages, turnover, and labor cost increases.

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If we are unable to hire and retain employees capable of performing at a high

level, or if mitigation measures we may take to respond to a decrease in labor availability have unintended negative effects, our business

level, or if mitigating measures we may take to respond to a decrease in labor availability have unintended negative effects, our business

could be adversely affected.

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and development efforts, which ultimately may prove unsuccessful.

new or improved diagnostic tests and other medical products and services is a speculative and risky endeavor.

Candidate products and

services that may initially show promise may fail to achieve the desired results in larger clinical studies or may not achieve acceptable

levels of clinical accuracy.

Any test we develop will need to demonstrate a high level of accuracy in clinical studies.

If in a clinical

study a candidate product or service fails to identify even a small number of cases, the sensitivity rate may be materially and adversely

affected, and we may have to abandon the candidate product or service.

may need to explore a number of different designs, methods or technologies, alter our candidate products or services, and repeat clinical

studies before we identify a potentially successful candidate.

We may need to acquire, whether through purchase, license or otherwise,

technologies owned by third parties, and we may not be able to acquire such technologies on commercially reasonable terms or at all.

Product development is expensive, may take years to complete and can have uncertain outcomes.

Failure can occur at any stage of the development.

If, after development, a candidate product or service appears successful, we may, depending on the nature of the product or service,

still need to obtain FDA and other regulatory clearances or approvals before we can market it.

FDA’s clearance or approval pathways

are likely to involve significant time, as well as additional research, development and clinical study expenditures.

There can be no

guarantee that FDA would clear or approve any future product or service we may develop.

Even if FDA clears or approves a new product

or service we develop, we would need to commit substantial resources to commercialize, sell and market it before it could be profitable,

and the product or service may never be commercially viable.

Additionally, development of any product or service may be disrupted or

made less viable by the development of competing products or services.

to develop new products must be made well in advance of any resulting sales, and technologies and standards may change during development,

potentially rendering our products outdated or uncompetitive before their introduction.

Our ability to develop products to meet evolving

industry requirements and at prices acceptable to our customers will be significant factors in determining our competitiveness.

expend considerable funds and other resources on the development of our products without any guarantee that these products will be successful.

If we attempt to bring, but are not successful in bringing, one or more products to market, whether because we fail to address marketplace

demand, fail to develop viable products or otherwise, our results of operations could be seriously harmed.

we determine that any of our current or future development programs is unlikely to succeed, we may abandon it without any return on our

investment into the program.

We may need to raise significant additional capital to bring any new products or services to market, which

may not be available on acceptable terms, if at all.

officers may allocate their time to other businesses thereby potentially limiting the amount of time they devote to our affairs.

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ability to be successful will be totally dependent upon the efforts of our key personnel.

Our ability to successfully carry out our business plan is dependent upon

the efforts of our key personnel.

We cannot assure you that any of our key personnel will remain with us for the immediate or foreseeable

The unexpected loss of the services of our key personnel could have a detrimental effect on us.

We may also be unable to attract

and retain additional key personnel in the future.

As of March 9, 2023, we only have only 3,725,723 shares available for issuance under

our long-term incentive plan, which could limit our ability to attract and retain key personnel, until such amount is increased.

to attract and retain key personnel may impact our ability to continue and grow our operations.

ability to successfully carry out our business plan is dependent upon the efforts of our key personnel.

We cannot assure you that

any of our key personnel will remain with us for the immediate or foreseeable future.

The unexpected loss of the services of our key

personnel could have a detrimental effect on us.

We may also be unable to attract and retain additional key personnel in the future.

We are limited in shares available for issuance under our long-term incentive plan, which could limit our ability to attract and

retain key personnel, until such amount is increased.

An inability to attract and retain key personnel may impact our ability to

continue and grow our operations.

officers and directors have fiduciary obligations to other companies and, accordingly, may have conflicts of interest in determining

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business, financial condition and results of operations could be adversely affected by the political and economic conditions of the countries

in which we conduct business.

in which we conduct business (although our near-term focus is on our U.S.

These factors include:

associated with cultural differences, languages and distance;

● differences

in clinical practices, needs, products, modalities and preferences;

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and economic instability and export restrictions;

● variability

in sterilization requirements for multi-usage surgical devices;

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in implementing educational programs required by our approach to doing business;

economic developments in economies around the world and the instability of governments, including

the threat of war, terrorist attacks, epidemic or civil unrest;

economic developments in economies around the world and the instability of governments, including the threat of war, terrorist attacks,

epidemic or civil unrest;

changes in laws and governmental policies, especially those affecting trade and investment;

epidemics and /or pandemics, such as the epidemics resulting from the Ebola virus, or the

enterovirus, or the avian influenza virus, or the pandemic resulting from a novel strain

of a coronavirus designated “Severe Acute Respiratory Syndrome Coronavirus 2”

- or “SARS-CoV-2”, which may adversely affect our workforce as well as our local

suppliers and customers;

epidemics and /or pandemics, such as the epidemics resulting from the Ebola virus, or the enterovirus, or the avian influenza virus,

or the pandemic resulting from a novel strain of a coronavirus designated “Severe Acute Respiratory Syndrome Coronavirus 2”

- or “SARS-CoV-2”, which may adversely affect our workforce as well as our local suppliers and customers;

or export licensing requirements imposed by governments;

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threat that our operations or property could be subject to nationalization and expropriation;

practices of the regulatory, tax, judicial and administrative bodies in the jurisdictions

where we operate;

● potentially

practices of the regulatory, tax, judicial and administrative bodies in the jurisdictions where we operate;

burdensome taxation and changes in foreign tax.

business may be adversely affected by health epidemics and or pandemics, including the COVID-19 pandemic.

COVID-19 pandemic may have an adverse impact on our operations, supply chains, and distribution systems and /or those of our contractors

of our laboratory partner, and increase our expenses, including as a result of impacts associated with preventive and precautionary measures

being taken, restrictions on travel, quarantine polices.

Such adverse impact may include, for example, the inability of our employees

and /or those of our contractors or laboratory partner to perform their work or curtail their services provided to us.

addition, the COVID-19 pandemic has disrupted the United States’ healthcare and healthcare regulatory systems which could divert

healthcare resources away from, or materially delay United States Food and Drug Administration (“FDA”) approval with respect

to our products.

our clinical trials have been and may be further affected by the COVID-19 pandemic, as site initiation and patient enrollment may be

delayed, for example, due to prioritization of hospital resources toward the virus and /or illness response, as well as travel restrictions

imposed by governments, and the inability to access clinical test sites for initiation and monitoring.

COVID-19 pandemic may have an adverse impact on the economies and financial markets of many countries, including the United States, resulting

in an economic downturn that could adversely affect demand for our products and services and /or our product candidates.

we are continuing to monitor and assess the effects of the COVID-19 pandemic on our business, the ultimate impact of the COVID-19 pandemic

(or a similar health epidemic) is highly uncertain and subject to change, and therefore, its impact on our consolidated financial condition,

consolidated results of operations, and /or consolidated cash flows, the adverse impact could be material.

may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce

our financial resources.

have entered into, and may in the future enter into transactions to acquire other businesses, products, services or technologies.

we recently completed several small acquisitions, because we have not made any major acquisitions to date, our ability to do so successfully

If we do identify suitable candidates, we may not be able to make such acquisitions on favorable terms or at all.

an insufficient amount of time has passed to evaluate whether the acquisitions we completed were cost effective and otherwise beneficial

to our business.

The acquisitions we have completed and any acquisitions we make in the future may not strengthen our products, technologies

or businesses or otherwise improve our competitive position, and these transactions may be viewed negatively by investors, healthcare

providers, patients and others.

For examples, we may be unable to timely and effectively integrate the acquired businesses into our business;

may in the future enter into transactions to acquire other businesses, products, services or technologies.

Because we have not made

any major acquisitions to date, our ability to do so successfully is unproven.

If we do identify suitable candidates, we may not be

able to make such acquisitions on favorable terms or at all.

Any acquisitions we make in the future may not strengthen our products,

technologies or businesses or otherwise improve our competitive position, and these transactions may be viewed negatively by

investors, healthcare providers, patients and others.

For example, we may be unable to timely and effectively integrate the acquired

businesses into our business;

we may lose key employees;

we may encounter potential unknown liabilities and unforeseen risks, including liabilities associated with

contracts containing consent and/or other provisions that may be triggered by the acquisitions;

we may be unable to realize the anticipated

benefits of the acquisitions or do so within the anticipated timeframe;

or we may be unable to effectively manage our expanded operations.

In addition to the risks outlined above, we may decide to incur debt in connection with an acquisition or issue our common stock or other

securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders.

cannot predict the number, timing or size of future acquisitions or the effect that any such transactions might have on our operating

For the foregoing reasons, the market price of our common stock may decline as a result of any acquisitions.

we may encounter potential unknown liabilities and unforeseen risks,

including liabilities associated with contracts containing consent and/or other provisions that may be triggered by the

acquisitions;

we may be unable to realize the anticipated benefits of the acquisitions or do so within the anticipated timeframe;

we may be unable to effectively manage our expanded operations.

In addition to the risks outlined above, we may decide to incur debt

in connection with an acquisition or issue our common stock or other securities to the stockholders of the acquired company, which

would reduce the percentage ownership of our existing stockholders.

We cannot predict the number, timing or size of future

acquisitions or the effect that any such transactions might have on our operating results.

For the foregoing reasons, the market

price of our common stock may decline as a result of any acquisitions.

results in material litigation matters could have a material adverse effect upon our business.

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Associated with Healthcare Regulation, Billing and Reimbursement, and Product Safety and Effectiveness

ability to market EsoGuard, or any other IVD product that we may develop, license, or acquire, as LDTs without FDA approval, is entirely

dependent on FDA continuing to exercise enforcement discretion with regard to requiring premarket review of LDTs.

If FDA ceases to exercise,

or modifies how it exercises, this discretion through guidance documents, formal rulemaking, departmental directive, executive order

or pursuant to legislation, we may be abruptly forced to halt commercialization of these diagnostic tests until we are able satisfy FDA’s

modified enforcement regime, or until we secure FDA approval for these IVD products.

is currently being marketed as an LDT and has not received FDA approval to be marketed as an IVD.

We would very likely also choose to

market as LDTs, at least initially, any other IVD product without FDA approval that we may develop, license, or acquire.

defines an LDT as “an IVD product that is intended for clinical use and designed, manufactured and used within a single laboratory.”

Thus, LDTs are considered “devices”, specifically IVD products, as defined by the FDCA.

FDA has long maintained that it has

clear regulatory authority over LDTs and could, therefore, require them to fully comply with the regulatory requirements governing device

safety and effectiveness.

FDA, however, has generally not enforced these regulatory requirements for LDTs and has generally not required

LDTs to undergo FDA premarket review of analytical validity and clinical validity, as other IVD products must.

For over a decade, FDA

has expressed the opinion that its enforcement discretion was based on the fact that, historically, most LDTs were low-risk, and that

it has become concerned about insufficient regulatory oversight over increasingly high-risk LDTs.

FDA has also exercised enforcement

discretion of elements of its “single laboratory” definition of LDTs which by strict interpretation would require the LDT

to have been “designed” at the “single laboratory” and not transferred from another research or commercial laboratory.

FDA has demonstrated its position that it has regulatory authority over all IVD products, by choosing to fully exercise its authority

for certain classes of “single laboratory” IVD products which would satisfy its definition of an LDT, such as direct-to-consumer

tests that do not involve a health care provider.

July 2010, FDA announced its intent to reconsider its long-standing policy of enforcement discretion with respect to LDTs after identifying

issues with several high-risk LDTs and hosted a public workshop to gather feedback from industry stakeholders.

In October 2014, FDA published

two draft guidance documents describing a proposed risk-based framework under which it might regulate LDTs.

FDA’s draft framework

proposed, among other things, premarket review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or

cleared diagnostics currently on the market.

In November 2015, FDA issued a report citing evidence for the need for additional regulation

of LDTs and stated FDA is continuing to work to finalize premarket review requirements for LDTs.

However, in November 2016, FDA announced

it would not issue a final guidance for LDTs.

In January 2017, FDA issued a Discussion Paper on LDTs, which confirmed it would not finalize

guidance on the regulation of LDTs to allow more time for public discussion and time for the congressional authorizing committees to

develop a legislative solution.

In March 2020, the bipartisan Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020, which

seeks to revamp the regulatory framework of diagnostic tests, including LDTs, was introduced in both chambers of the 116th Congress but

was never brought to a vote.

The VALID Act is expected to be reintroduced in 2021.

In August 2020, HHS announced that, effective immediately,

it was rescinding all guidance, compliance manuals, website statements, or other informal issuances concerning FDA premarket review of

LDTs, and that FDA may not require premarket review of LDTs absent a formal notice-and-comment rulemaking process.

long-standing ambiguity of the regulatory status for LDTs makes it impossible for us to predict the future regulatory status of LDTs,

and if or when it may be substantially modified through guidance documents, formal rulemaking, departmental directive, executive order

or pursuant to legislation.

For example, the current administration could abruptly rescind the August 2020 HHS directive of the prior

administration, which could restore FDA regulatory authority over LDTs and herald a return to enforcement discretion.

Similarly, passage

of the VALID Act could usher a new era of full FDA oversight of LDTs.

We cannot predict the potential effect of such shifts in LDT regulation

on EsoGuard or any other LDT we may develop, license or acquire, or the potential impact of such shifts on our business, financial condition

or results of operation.

business could also be materially affected if FDA regains enforcement discretion and modifies it, for example, to require that LDTs be

truly “home brewed” at a single laboratory, since EsoGuard was designed and developed at the CWRU laboratory and transferred

to our third-party CLIA-certified laboratory partner and then to our own CLIA-certified commercial clinical laboratory.

It could also

be materially affected if FDA is granted broader authority and a mandate to regulate LDTs, through pending legislation such as the VALID

If any of these were to occur, we may be required to change business plans regarding the development and commercialization of EsoGuard

and any other LDTs we develop, license or acquire.

They may significantly slow the time it would take us to bring LDTs to market, may

materially increase the costs of developing, and decrease the profitability of providing, EsoGuard and any other LDTs we may develop,

license or acquire, and may prevent us from commercializing certain products or services.

We cannot provide any assurance that FDA clearance

or approval will not be required in the future for EsoGuard or any other LDTs we develop, license or acquire, whether as a result of

additional guidance or regulations issued by FDA, new enforcement policies adopted by FDA or new legislation adopted by Congress.

is possible that legislation will be enacted into law, regulations could be promulgated or guidance could be issued by FDA that may result

in increased regulatory burdens for us to continue to offer diagnostic tests or to develop and introduce new tests.

Moreover, if pre-market

review is required by FDA or if we decide to voluntarily pursue FDA’s pre-market review for any of our IVD products, there can

be no assurance that they will be approved, or timely approved, nor can there be assurance that labeling claims will be consistent with

our current claims or adequate to support continued adoption of and reimbursement for our tests.

If pre-market review is required, our

business could be negatively impacted as a result of commercial delay that may be caused by any new requirements.

private or governmental third-party payors do not maintain reimbursement for our products at adequate reimbursement rates, we may be

unable to successfully commercialize our products which would limit or slow our revenue generation and likely have a material adverse

effect on our business.

commercialization of our EsoGuard test and EsoCheck device, and of any other product or service we develop, license or acquire depends,

in large part, on the availability of adequate reimbursement from private or governmental third-party payors.

PLA code 0114U has been granted “gapfill” determination through the CMS CLFS process, allowing us to engage directly with

Medicare Administrative Contractor (“MAC”) Palmetto GBA, whose Molecular Diagnostics Program (“MolDx”) performs

technical assessment of molecular diagnostic tests on behalf of itself and other MACs.

Although CMS granted EsoGuard final Medicare payment

determination of $1,938.01, effective January 1, 2021, we have not received a final Medicare local coverage determination from MolDx.

Most recently, in May 2023, a final Local Coverage Determination (“LCD”) L39256, entitled “ Molecular Testing for

Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia ” became effective on the CMS website by MAC Palmetto

(A substantially identical LCD was published by Noridian Healthcare Solutions, the MAC whose geographic jurisdiction covers our

CLIA laboratory in Lake Forest, CA.) The LCD outlines criteria for future coverage that MolDX expects upper gastrointestinal precancer

and cancer molecular diagnostic tests to meet.

These criteria include active GERD with at least two risk factors, as well as evidence

of analytic validity, clinical validity, and clinical utility.

Although the LCD indicated that it found that no currently existing test

has fulfilled all these criteria, it indicated that it will “monitor the evidence and may revise this determination based on the

pertinent literature and society recommendations.” We expect to submit EsoGuard for Technical Assessment under this foundational

LCD later this year.

However, even if we do submit EsoGuard for Technical Assessment as currently planned, there can be no assurance

that MolDx will determine that we meet the criteria for coverage as specified in the LCD.

If we are not granted coverage, or if a determination

is substantially delayed, that could have a material adverse effect on our ability to commercialize EsoGuard.

third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies.

payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new healthcare

As a result, there is uncertainty surrounding whether EsoGuard or EsoCheck will be eligible for coverage by third-party payors

or, if eligible for coverage, what the reimbursement rates will be.

Reimbursement of esophageal precancer and cancer screening by a third-party

payor may depend on a number of factors, including a payor’s determination that tests using our technologies are sufficiently sensitive

and specific for esophageal cancer and precancer;

not experimental or investigational;

approved or recommended by the major guidelines

organizations;

reliable, safe and effective;

medically necessary;

appropriate for the specific patient;

and cost-effective.

determinations and reimbursement rates are also subject to the effects of federal and state coverage mandates and other healthcare regulations

and reform initiatives as described below.

As noted below, federal and state coverage mandates may be deemed not to apply to EsoGuard

and EsoCheck, may be interpreted in a manner unfavorable to us, may be difficult to enforce and are subject to repeal or modification.

addition to the risk of adverse reimbursement decisions, we also may experience material delays in obtaining such reimbursement decisions

and payment for our EsoGuard test and EsoCheck device that are beyond our control.

Further, there can be no assurance that CMS and other

third-party payors who initially decide to cover our products will continue to do so.

Coverage determinations and reimbursement rates

are subject to change, including as a result of reimbursement rate adjustments under the Protecting Access to Medicare Act of 2014, (“PAMA”)

as described below, and we cannot guarantee that even if we initially achieve coverage and adequate reimbursement rates, they will continue

to be applicable to our products in the future.

Furthermore, it is possible that Medicare or other federal payors that provide reimbursement

for our tests may suspend, revoke or discontinue coverage at any time, may require co-payments from patients, or may reduce the reimbursement

rates payable to us.

we are unable to obtain favorable decisions from third-party payors, including CMS and managed care organizations, approving reimbursement

at adequate levels for our EsoGuard test and EsoCheck device, and any other product or service we may develop, or if coverage is later

revoked or reimbursement levels are reduced, our commercial success will be compromised, our ability to raise capital may be restricted

and our revenues would be significantly limited.

Healthcare providers may be reluctant to prescribe our products if they believe that

reimbursement for the test will not be available for a significant number of their patients.

where a third-party payor agrees to cover EsoGuard and EsoCheck at an adequate reimbursement rate, other factors may have a significant

impact on the actual reimbursement we receive for an EsoGuard test or EsoCheck device from that payor.

For example, if we do not have

a contract with a given payor, we may be deemed an “out-of-network” provider by that payor, which could result in the payor

allocating a portion of the cost of the EsoGuard test or EsoCheck device to the patient, notwithstanding any applicable coverage mandate.

We may be unsuccessful in our efforts to enter into, or maintain, a network contract with a given payor, and we expect that our network

status with a given payor may change from time to time for a variety of reasons, many of which may be outside our control.

To the extent

EsoGuard or EsoCheck is out of network for a given payor, physicians may be less likely to prescribe EsoGuard and EsoCheck for their

patients and their patients may be less likely to comply with those prescriptions that are written.

Also, some payors may require that

they give prior authorization for an EsoGuard test or EsoCheck device before they are willing to pay for it or review claims post-service

to ensure the service was medically appropriate for specific patients.

Prior authorization and other medical management practices may

require that we, patients or physicians provide the payor with extensive medical records and other information.

Prior authorization and

other medical management practices impose a significant additional cost on us, may be difficult to comply with given our position as

a laboratory that generally does not have direct access to patient medical records, may make physicians less likely to prescribe EsoGuard

and EsoCheck for their patients, and may make patients less likely to comply with physician orders for EsoGuard and EsoCheck, all or

any of which may have an adverse effect on our revenues.

Payment rates also may vary according to the use of the product and the clinical

setting in which it is used, may be based on payments allowed for lower cost products that are already reimbursed and may be incorporated

into existing payments for other services.

has proposed a policy under which it would phase out its general enforcement discretion approach for LDTs so that IVDs manufactured at

a laboratory would generally fall under the same enforcement approach as other IVDs.

While we are confident that the proposed policy

will not have a material impact on our business, there can be no assurance that will be the case.

October 2023, FDA proposed a policy under which FDA intends to phase out its general enforcement discretion approach for LDTs so that

IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs.

If finalized, FDA believes

that this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance

of safety and effectiveness.

As such, FDA has structured the proposed phaseout policy to contain five key stages:

End the general enforcement discretion approach with respect to Medical Device Regulation (MDR) requirements and correction and

removal reporting requirements 1 year after FDA publishes a final phaseout policy, which FDA intends to issue in the preamble of

the final rule.

End the general enforcement discretion approach with respect to requirements other than MDR, correction and removal reporting,

Quality System (QS), and premarket review requirements 2 years after FDA publishes a final phaseout policy.

End the general enforcement discretion approach with respect to QS requirements 3 years after FDA publishes a final phaseout policy.

End the general enforcement discretion approach with respect to premarket review requirements for high-risk IVDs 3.5 years after

FDA publishes a final phaseout policy, but not before October 1, 2027.

End the general enforcement discretion approach with respect to premarket review requirements for moderate risk and low risk IVDs

(that require premarket submissions) 4 years after FDA publishes a final phaseout policy, but not before April 1, 2028.

is currently anticipated that FDA will finalize the proposed policy by April 2024.

Once the final policy is released, we will implement

the QS requirements in the recommended staged approach and conduct pre-submission meetings with FDA to seek agreement on regulatory pathway

for EsoGuard premarket submission.

As required by the final policy, we will submit the regulatory premarket submission to the FDA as

per the timeframe defined in the final policy.

We are confident that the proposed policy will not have a commercial impact as the Company

already has a robust QS management platform for medical devices and EsoGuard will be able to transition to the platform to fulfill the

QS requirements, if and when required by FDA.

However, there can be no assurance that we will be able to successfully transition the

platform to fulfill the QS requirements, if and when required by FDA, and our failure to do so could have a material impact on our ability

to commercialize EsoGuard and on our business as a whole.

we fail to maintain CLIA-certification or otherwise meet the applicable requirements of federal or state law regulating commercial clinical

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and otherwise negatively impact our business.

or any other IVD product without FDA approval we may develop, license, or acquire and market as an LDT, may not be jointly marketed as

a combined product with EsoCheck without first securing FDA approval of the combined product as an IVD device.

If FDA deems that we are

jointly marketing such an IVD product with EsoCheck without FDA approval of the combined product as an IVD device, we would be subject

to FDA enforcement action which could limit or halt commercialization of our products, and result in FDA sanctions which could severely

impact our business.

may not be jointly marketed as a combined product with EsoCheck without first securing FDA approval of the combined product as an IVD

If FDA deems that we are jointly marketing such an IVD product with EsoCheck without FDA approval of the combined product as

an IVD device, we would be subject to FDA enforcement action which could limit or halt commercialization of our products, and result

in FDA sanctions which could severely impact our business.

has received FDA 510(k) clearance permitting us to market it in the U.S.

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and EsoCheck as separate products.

Jointly marketing EsoGuard, or any other IVD product that we develop, license or acquire, as a combined

product with EsoCheck would require us to secure FDA approval of the combined product as an IVD device.

If we were to jointly market

such products, even inadvertently, without such FDA approval we would be subject to FDA enforcement actions which could result in fines,

unanticipated compliance expenditures, recall or seizures of our products, total or partial suspension of production or distribution,

restrictions on labeling and promotion, termination of ongoing research, disqualification of data for submission to regulatory authorities,

enforcement actions, injunctions and criminal prosecution.

Responding to such actions could cause us to incur significant expense, limit

or halt commercialization of our products and severely impact our business.

FDA approval of EsoGuard, or any other IVD product we may develop, license, or acquire, as an IVD device, separately or as a combined

product with EsoCheck, is a complex process requiring substantial time, commitment of resources and expense without any assurance that

FDA will grant such approval.

Jointly marketing EsoGuard as a combined product with EsoCheck would require us to secure FDA approval

of the combined product as an IVD device.

If we were to jointly market such products, even inadvertently, without such FDA approval we

would be subject to FDA enforcement actions which could result in fines, unanticipated compliance expenditures, recall or seizures of

our products, total or partial suspension of production or distribution, restrictions on labeling and promotion, termination of ongoing

research, disqualification of data for submission to regulatory authorities, enforcement actions, injunctions and criminal prosecution.

Responding to such actions could cause us to incur significant expense, limit or halt commercialization of our products and severely

impact our business.

FDA approval of EsoGuard as an IVD device, separately or as a combined product with EsoCheck, is a complex process requiring substantial

time, commitment of resources and expense without any assurance that FDA will grant such approval.

has indicated to us through its pre-submission process that jointly marketing EsoGuard combined with EsoCheck as an IVD device would

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its intended use(s).

Any other IVD product we may develop, license, or acquire, would likely also require PMA premarket approval to be

marketed with EsoCheck as an IVD device.

If we choose, or are required, as a result of changes in LDT regulation, to secure FDA approval

of EsoGuard, or any other IVD product we may develop, license or acquire, as an IVD device, even if not combined with EsoCheck, we expect

we would this require FDA PMA approval.

If we choose, or are required, as a result of changes in LDT regulation, to secure FDA approval of EsoGuard as an

IVD device, even if not combined with EsoCheck, we expect we would this require FDA PMA approval.

process of securing FDA PMA approval is complex and requires substantial time, commitment of resources and expense.

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facilities, processes and controls for any products we may develop are adequate.

can be no assurance that FDA will ever permit us to market EsoGuard, used with EsoCheck, as a combined product or any new product or

service that we develop.

Also, any regulatory clearance or approval of a product, once obtained, may be withdrawn.

If we are unable to

successfully obtain or maintain regulatory clearance or approval to sell any products we may develop in the U.S., our business, financial

condition, results of operations and growth prospects could be adversely affected.

Furthermore, delays in receipt of clearances or approvals

could materially delay or prevent us from commercializing our products and services or result in substantial additional costs that could

decrease our profitability.

Even if we were to successfully obtain and maintain regulatory clearance or approval for a product, any clearance

or approval might contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications,

or may be subject to burdensome post-approval study or risk management requirements.

can be no assurance that FDA will ever permit us to market EsoGuard, used with EsoCheck, as a combined product.

Also, any regulatory

clearance or approval of a product, once obtained, may be withdrawn.

If we are unable to successfully obtain or maintain regulatory clearance

or approval to sell any products we may develop in the U.S., our business, financial condition, results of operations and growth prospects

could be adversely affected.

Furthermore, delays in receipt of clearances or approvals could materially delay or prevent us from commercializing

our products and services or result in substantial additional costs that could decrease our profitability.

Even if we were to successfully

obtain and maintain regulatory clearance or approval for a product, any clearance or approval might contain significant limitations related

to use restrictions for specified age groups, warnings, precautions or contraindications, or may be subject to burdensome post-approval

study or risk management requirements.

can delay, limit, or deny clearance or approval of a future product for many reasons, including but not limited to:

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are not currently part of the product candidate’s profile.

principal ongoing clinical trials are those that relate to EsoGuard.

For a summary of the status and certain information concerning the

results of those trials, please see above under “ Background and Overview—Clinical Utility and Clinical Trials ”.

our clinical studies do not satisfy providers, payors, patients and others as to the reliability and performance of our EsoGuard test

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to order, and third-party payors to pay for, EsoGuard or EsoCheck, which could adversely affect our business prospects.

the results of our research and clinical studies and our sales and marketing activities relating to new products or services we may develop

and seek to commercialize in the future do not convince FDA and other regulators, guidelines organizations, physicians and other healthcare

providers, third-party payors and patients that such other products and services are safe and reliable, those tests may not receive or

sustain necessary regulatory clearances or approvals and we may experience reluctance or refusal on the part of physicians to order,

and third-party payors to pay for, those tests, which could adversely affect our business prospects.

this regard, we have been unable to successfully complete our clinical trials related to the EsoGuard test to generate clinical utility

data showing that the results of the test influence’s provider decision making in providing medical care.

As such clinical utility

is important to decisions by payor’s to provide reimbursement for the test, continued delays in such trials will adversely impact

our ability to commercialize the EsoGuard test and generate revenues from sales of the same.

the validity of an informed consent for a clinical trial of one of our products was challenged, we could be subject to fines, penalties,

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using our products have been on, subjects who have provided appropriate informed consent.

We also act as a sponsor of clinical trials

in connection with the development of our tests, which are frequently conducted in collaboration with different parties.

We seek to receive

approval from an ethical review board, or institutional review board (“IRB”) for projects that meet the definition of “human

subjects research,” which includes review and approval of processes for subject informed consent and authorization for use of personal

information or waivers thereof.

We could conduct clinical trials in a number of different countries.

When we utilize clinical research

contractor or partner with other third parties, we rely upon them to comply with the requirements to obtain the subject’s informed

consent and to comply with applicable laws and regulations.

The collection of data and samples in many different countries results in

complex legal questions regarding the adequacy of informed consent and the status of genetic material under a large number of different

When we utilize clinical research contractor

or partner with other third parties in connection with our studies, we rely upon them to comply with the requirements to obtain the subject’s

informed consent and to comply with applicable laws and regulations.

The collection of data and samples in many different countries results

in complex legal questions regarding the adequacy of informed consent and the status of genetic material under a large number of different

legal systems.

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sales and pricing practices;

information privacy and security, including the Health Insurance Portability and Accountability

Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical

Health Act of 2009, or HITECH, and comparable state laws;

● anti-markup

information privacy and security, including the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended

by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and comparable state laws;

are also required to comply with FDA regulations, including with respect to our labeling and promotion activities.

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which could materially disrupt our business.

operate patient service centers where prescribing physicians can send patients for EsoGuard testing, including undergoing specimen collection

operate Lucid Test Centers where prescribing physicians can send patients for EsoGuard testing, including undergoing specimen collection

using EsoCheck.

These patient service centers are subject to federal and state regulations which may be burdensome, costly or difficult

to comply with.

These Lucid Test Centers are subject to federal and state regulations which may be burdensome, costly or difficult to

Failure to comply with these regulations could result in sanctions, fines or other enforcement actions which may be costly,

time-consuming and limit our ability to utilize them and adversely impact our business.

part of our commercialization efforts for EsoGuard, we are operating patient service centers in jurisdictions where a licensed health

care professional, employed or contracted by us, will perform the esophageal cell collection procedure using EsoCheck and then package

the specimen for transport to our CLIA-certified commercial clinical laboratory.

The patient service centers may be deemed laboratory

draw stations or outpatient centers or clinics, which may be subject to state licensure and operating requirements.

In addition, states

may require personnel performing the specimen collection procedure to be licensed and may require collaboration with or supervision by

part of our commercialization efforts for EsoGuard, we are operating Lucid Test Centers in jurisdictions where a licensed health care

professional, employed or contracted by us, will perform the esophageal cell collection procedure using EsoCheck and then package the

specimen for transport to our CLIA-certified commercial clinical laboratory.

The Lucid Test Centers may be deemed laboratory draw stations

or outpatient centers or clinics, which may be subject to state licensure and operating requirements.

In addition, states may require

personnel performing the specimen collection procedure to be licensed and may require collaboration with or supervision by a physician.

The health care professionals may also be subject to malpractice claims.

We will need to purchase insurance policies to

cover such claims but the coverage limits on such policies may be insufficient to cover any monetary awards for damages granted for such

In certain states, our patient service centers may trigger the corporate practice of medicine doctrine, a general prohibition

in some jurisdictions against non-licensed individuals or corporations owning medical practices or employing physicians and other licensed

In many states, a general business corporation cannot directly employ health care professionals or enter any arrangement where

the physicians or the healthcare professional is in any way controlled or directed by the corporation.

Complying with these state regulations

can be complex, burdensome and costly and we may be unable to do so in certain states, limiting our commercialization efforts and business

in those states.

The patient service centers may be subject to additional state regulations relating to the distribution of the collection

devices, test orders, patient consents, medical necessity requirements and billing regulations.

We will need to purchase insurance policies to cover such claims

but the coverage limits on such policies may be insufficient to cover any monetary awards for damages granted for such claims.

states, our Lucid Test Centers may trigger the corporate practice of medicine doctrine, a general prohibition in some jurisdictions against

non-licensed individuals or corporations owning medical practices or employing physicians and other licensed HCPs.

In many states, a

general business corporation cannot directly employ health care professionals or enter any arrangement where the physicians or the healthcare

professional is in any way controlled or directed by the corporation.

Complying with these state regulations can be complex, burdensome

and costly and we may be unable to do so in certain states, limiting our commercialization efforts and business in those states.

Lucid Test Centers may be subject to additional state regulations relating to the distribution of the collection devices, test orders,

patient consents, medical necessity requirements and billing regulations.

have invested heavily in regulatory and compliance infrastructure in an effort to ensure compliance with this regulatory framework, however,

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Our failure to comply with these regulations in

the operation of these patient service centers or in managing the personnel interacting with patients at these centers could subject

us to sanctions, fines or other enforcement actions.

Responding to these actions may be costly and time-consuming and may require us

to cease operations at these centers which may limit our commercialization efforts and adversely impact our business.

intend to engage with one or more third-party telemedicine companies to provide physicians to evaluate patients who respond to our direct-to-consumer

(“DTC”) marketing activities seeking EsoGuard testing and, if clinically indicated, refer the patient to our patient service

centers to undergo EsoCheck specimen collection for EsoGuard testing.

Telemedicine, and its specific use in conjunction with DTC, is

subject to numerous federal and state regulations and faces particularly intense scrutiny by these regulators.

If we fail to comply with

federal healthcare regulations, we could face substantial penalties, sanctions, fines or prosecution and our business, operations and

financial condition could be adversely affected.

element of our growth strategy is to expand EsoGuard commercialization across multiple channels, including DTC marketing.

The logistics

required to manage a patient’s journey through a DTC/telemedicine program, in a manner which is compliant with all applicable regulations,

are complex and require very careful coordination between us and our third-party telemedicine and laboratory partners broadly operating

within our quality management system.

Our activities and the activities of our third-party partners on our behalf within this DTC/telemedicine

program are subject to numerous federal and state regulations.

The telemedicine provider itself may be subject to additional state regulations

relating to the corporate practice of medicine, test orders, patient consents, medical necessity requirements and billing regulations.

Telemedicine, and its specific use in conjunction with DTC, faces particularly intense scrutiny from regulators due to numerous cases

of companies failing to operate in this space with a properly functioning regulatory and compliance infrastructure.

the operation of these Lucid Test Centers or in managing the personnel interacting with patients at these centers could subject us to

sanctions, fines or other enforcement actions.

Responding to these actions may be costly and time-consuming and may require us to cease

operations at these centers which may limit our commercialization efforts and adversely impact our business.

intend to engage with one or more third-party telemedicine companies to provide physicians to evaluate patients and, if clinically indicated,

refer the patient to our Lucid Test Centers or to a #CheckYourFoodTube Precancer Testing Event, to undergo EsoCheck specimen collection

for EsoGuard testing.

Telemedicine is subject to numerous federal and state regulations and faces particularly intense scrutiny by these

If we fail to comply with federal healthcare regulations, we could face substantial penalties, sanctions, fines or prosecution

and our business, operations and financial condition could be adversely affected.

element of our growth strategy is to expand EsoGuard commercialization across multiple channels, including by partnership with telemedicine

The logistics required to manage a patient’s journey through a telemedicine program, in a manner which is compliant

with all applicable regulations, are complex and require very careful coordination between us and our third-party telemedicine and laboratory

partners broadly operating within our quality management system.

Our activities and the activities of our third-party partners on our

behalf within this telemedicine program are subject to numerous federal and state regulations.

The telemedicine provider itself may be

subject to additional state regulations relating to the corporate practice of medicine, test orders, patient consents, medical necessity

requirements and billing regulations.

Telemedicine faces particularly intense scrutiny from regulators due to numerous cases of companies

failing to operate in this space with a properly functioning regulatory and compliance infrastructure.

cannot guarantee that our personnel or those of our third-party partners will comply with the applicable regulations at all times.

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The regulations that may affect our ability to operate include, without limitation:

federal healthcare program Anti-Kickback Statute, which prohibits, among other things, any

person from knowingly and willfully offering, soliciting, receiving, or providing remuneration,

directly or indirectly, in exchange for or to induce either the referral of an individual

for, or the purchase, order or recommendation of, any good or service for which payment may

be made under federal healthcare programs, such as the Medicare and Medicaid programs;

Foreign Corrupt Practices Act, or “FCPA,” which prohibits payments or the

provision of anything of value to foreign officials for the purpose of obtaining or keeping

federal False Claims Act, or “FCA,” which prohibits, among other things, individuals

or entities from knowingly presenting, or causing to be presented, false claims, or knowingly

using false statements, to obtain payment from the federal government, and which may apply

to entities like us which provide coding and billing advice to customers;

criminal laws that prohibit executing a scheme to defraud any healthcare benefit program

or making false statements relating to healthcare matters;

federal transparency requirements under the Health Care Reform Law requires manufacturers

of drugs, devices, biologics and medical supplies to report to the Department of Health and

Human Services information related to physician payments and other transfers of value and

physician ownership and investment interests;

federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health

Information Technology for Economic and Clinical Health Act, which governs the conduct of

certain electronic healthcare transactions and protects the security and privacy of protected

health information, and

law equivalents of each of the above federal laws, such as anti-kickback and false claims

laws which may apply to items or services reimbursed by any third-party payor, including

commercial insurers.

PPACA, among other things, amends the intent requirement of the Federal Anti-Kickback Statute and criminal healthcare fraud statutes.

A person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it.

In addition, the PPACA

provides that the government may assert that a claim including items or services resulting from a violation of the Federal Anti-Kickback

Statute constitutes a false or fraudulent claim for purposes of the FCA.

federal healthcare program Anti-Kickback Statute, which prohibits, among other things, any person from knowingly and willfully offering,

soliciting, receiving, or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an

individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare

programs, such as the Medicare and Medicaid programs;

Foreign Corrupt Practices Act, or “FCPA,” which prohibits payments or the provision of anything of value to foreign

officials for the purpose of obtaining or keeping business;

federal False Claims Act, or “FCA,” which prohibits, among other things, individuals or entities from knowingly presenting,

or causing to be presented, false claims, or knowingly using false statements, to obtain payment from the federal government, and

which may apply to entities like us which provide coding and billing advice to customers;

criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare

federal transparency requirements under the Health Care Reform Law requires manufacturers of drugs, devices, biologics and medical

supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of

value and physician ownership and investment interests;

federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic

and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy

of protected health information, and

law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services

reimbursed by any third-party payor, including commercial insurers.

Patient Protection and Affordable Care Act (the “PPACA”), among other things, amends the intent requirement of the Federal

Anti-Kickback Statute and criminal healthcare fraud statutes.

A person or entity no longer needs to have actual knowledge of this statute

or specific intent to violate it.

In addition, the PPACA provides that the government may assert that a claim including items or services

resulting from a violation of the Federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA.

2018, Congress passed Eliminating Kickbacks in Recovery Act (“EKRA”) as part of the Substance Use-Disorder Prevention that

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healthcare programs but applies more broadly to services covered by “healthcare benefit programs,” including commercial insurers.

As currently drafted, EKRA potentially expands the universe of arrangements that could be subject to government enforcement under federal

fraud and abuse laws.

In addition, while the Anti-Kickback Statute includes certain exceptions that are widely relied upon in the healthcare

industry, not all of those same exceptions apply under EKRA.

Because EKRA is a relatively new law, there is no agency guidance or court

precedent to indicate how and to what extent it will be applied and enforced.

We cannot assure you that our relationships with healthcare

providers, sales representatives, hospitals, customers, or any other party will not be subject to scrutiny or will survive regulatory

challenge under EKRA.

the medical device industry has been under heightened scrutiny as the subject of government investigations and regulatory or legal enforcement

actions involving manufacturers who allegedly offered unlawful inducements to potential or existing customers in an attempt to procure

their business, including arrangements with physician consultants.

If our operations or arrangements are found to be in violation of

any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil

and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the curtailment or restructuring of our

Any penalties, damages, fines, exclusions, curtailment or restructuring of our operations could adversely affect our ability

to operate our business and our financial results.

The risk of us being found in violation of these laws is increased by the fact that

many of these laws are broad and their provisions are open to a variety of interpretations.

Any action against us for violation of these

laws, even if we successfully defend against that action and the underlying alleged violations, could cause us to incur significant legal

expenses and divert our management’s attention from the operation of our business.

If the physicians or other providers or entities

with whom we do business are found to be non-compliant with applicable laws, they may be subject to sanctions, which could also have

a negative impact on our business.

Moreover, achieving and sustaining compliance with applicable federal and state privacy, security

and fraud laws may prove costly.

private or governmental third-party payors do not maintain reimbursement for our products at adequate reimbursement rates, we may be

unable to successfully commercialize our products which would limit or slow our revenue generation and likely have a material adverse

effect on our business.

commercialization of our EsoGuard test and EsoCheck device, and of any other product or service we develop, license or acquire depends,

in large part, on the availability of adequate reimbursement from private or governmental third-party payors.

PLA code 0114U has been granted “gapfill” determination through the CMS CLFS process, allowing us to engage directly with

Medicare Administrative Contractor (“MAC”) Palmetto GBA, whose Molecular Diagnostics Program (“MolDx”) performs

technical assessment of molecular diagnostic tests on behalf of itself and other MACs.

We submitted EsoGuard payment and coverage dossiers

to MolDx in 2020.

Although CMS granted EsoGuard final Medicare payment determination of $1,938.01, effective January 1, 2021, we are

awaiting Medicare local coverage determination from MolDx, where the Covid-19 pandemic and change of administrations has resulted in

a significant backlog of local coverage reviews.

We have no information on when MolDx will complete its technical assessment of our dossier,

cannot predict whether or not it will grant EsoGuard local coverage determination and whether other MACs will utilize the MolDx determination.

third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies.

payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new healthcare

As a result, there is uncertainty surrounding whether EsoGuard or EsoCheck, or any other product or service we develop, will

be eligible for coverage by third-party payors or, if eligible for coverage, what the reimbursement rates will be.

Reimbursement of esophageal

precancer and cancer screening by a third-party payor may depend on a number of factors, including a payor’s determination that

tests using our technologies are sufficiently sensitive and specific for esophageal cancer and precancer;

not experimental or investigational;

approved or recommended by the major guidelines organizations;

reliable, safe and effective;

medically necessary;

appropriate for the

specific patient;

and cost-effective.

determinations and reimbursement rates are also subject to the effects of federal and state coverage mandates and other healthcare regulations

and reform initiatives as described below.

As noted below, federal and state coverage mandates may be deemed not to apply to EsoGuard

and EsoCheck, may be interpreted in a manner unfavorable to us, may be difficult to enforce and are subject to repeal or modification.

For example, the Patient Protection and Affordable Care Act (the “PPACA”) may be repealed or materially modified, in whole

or in part, or replaced with an alternative legal framework governing healthcare matter.

Such repeal, modification or replacement may

eliminate or modify coverage mandates for preventive services, and any such elimination or modification may have an adverse effect on

our business prospects.

addition to the risk of adverse reimbursement decisions, we also may experience material delays in obtaining such reimbursement decisions

and payment for our EsoGuard test and EsoCheck device that are beyond our control.

Further, there can be no assurance that CMS and other

third-party payors who initially decide to cover our products will continue to do so.

Coverage determinations and reimbursement rates

are subject to change, including as a result of reimbursement rate adjustments under the Protecting Access to Medicare Act of 2014, (“PAMA”)

as described below, and we cannot guarantee that even if we initially achieve coverage and adequate reimbursement rates, they will continue

to be applicable to our products in the future.

Furthermore, it is possible that Medicare or other federal payors that provide reimbursement

for our tests may suspend, revoke or discontinue coverage at any time, may require co-payments from patients, or may reduce the reimbursement

rates payable to us.

we are unable to obtain favorable decisions from third-party payors, including CMS and managed care organizations, approving reimbursement

at adequate levels for our EsoGuard test and EsoCheck device, and any other product or service we may develop, or if coverage is later

revoked or reimbursement levels are reduced, our commercial success will be compromised, our ability to raise capital may be restricted

and our revenues would be significantly limited.

Healthcare providers may be reluctant to prescribe our products if they believe that

reimbursement for the test will not be available for a significant number of their patients.

where a third-party payor agrees to cover EsoGuard and EsoCheck at an adequate reimbursement rate, other factors may have a significant

impact on the actual reimbursement we receive for an EsoGuard test or EsoCheck device from that payor.

For example, if we do not have

a contract with a given payor, we may be deemed an “out-of-network” provider by that payor, which could result in the payor

allocating a portion of the cost of the EsoGuard test or EsoCheck device to the patient, notwithstanding any applicable coverage mandate.

We may be unsuccessful in our efforts to enter into, or maintain, a network contract with a given payor, and we expect that our network

status with a given payor may change from time to time for a variety of reasons, many of which may be outside our control.

To the extent

EsoGuard or EsoCheck is out of network for a given payor, physicians may be less likely to prescribe EsoGuard and EsoCheck for their

patients and their patients may be less likely to comply with those prescriptions that are written.

Also, some payors may require that

they give prior authorization for an EsoGuard test or EsoCheck device before they are willing to pay for it or review claims post-service

to ensure the service was medically appropriate for specific patients.

Prior authorization and other medical management practices may

require that we, patients or physicians provide the payor with extensive medical records and other information.

Prior authorization and

other medical management practices impose a significant additional cost on us, may be difficult to comply with given our position as

a laboratory that generally does not have direct access to patient medical records, may make physicians less likely to prescribe EsoGuard

and EsoCheck for their patients, and may make patients less likely to comply with physician orders for EsoGuard and EsoCheck, all or

any of which may have an adverse effect on our revenues.

Payment rates also may vary according to the use of the product and the clinical

setting in which it is used, may be based on payments allowed for lower cost products that are already reimbursed and may be incorporated

into existing payments for other services.

Net prices for products may be reduced by mandatory discounts or rebates required by government

healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of products from countries

where they may be sold at lower prices than in the U.S.

EKRA potentially expands the universe of arrangements that could be subject to government enforcement under federal fraud and abuse laws.

In addition, while the Anti-Kickback Statute includes certain exceptions that are widely relied upon in the healthcare industry, not

all of those same exceptions apply under EKRA.

We cannot assure you that our relationships with healthcare providers, sales representatives,

hospitals, customers, or any other party will not be subject to scrutiny or will survive regulatory challenge under EKRA.

our operations or arrangements are found to be in violation of any of the laws described above or any other governmental regulations

that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from the Medicare

and Medicaid programs and the curtailment or restructuring of our operations.

Any penalties, damages, fines, exclusions, curtailment

or restructuring of our operations could adversely affect our ability to operate our business and our financial results.

us being found in violation of these laws is increased by the fact that many of these laws are broad and their provisions are open to

a variety of interpretations.

Any action against us for violation of these laws, even if we successfully defend against that action and

the underlying alleged violations, could cause us to incur significant legal expenses and divert our management’s attention from

the operation of our business.

If the physicians or other providers or entities with whom we do business are found to be non-compliant

with applicable laws, they may be subject to sanctions, which could also have a negative impact on our business.

Moreover, achieving

and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.

regulations that govern pricing and reimbursement for new products vary widely from country to country, and may adversely affect the

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reform measures could hinder or prevent our products’ commercial success.

likely will be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health

may well be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health

We cannot predict the initiatives that may be adopted in the future or their full impact.

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of patients from clinical studies or cancellation of studies;

● significant

costs to defend the related litigation and distraction to our management team;

● substantial

monetary awards to patients;

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The regulations establish a complex regulatory framework on a variety of subjects, including:

circumstances under which uses and disclosures of PHI are permitted or required without a

specific authorization by the patient, including but not limited to treatment purposes, activities

to obtain payments for our services, and our healthcare operations activities;

patient’s rights to access, amend and receive an accounting of certain disclosures

● requirements

circumstances under which uses and disclosures of PHI are permitted or required without a specific authorization by the patient,

including but not limited to treatment purposes, activities to obtain payments for our services, and our healthcare operations activities;

patient’s rights to access, amend and receive an accounting of certain disclosures of PHI;

to notify individuals if there is a breach of their PHI;

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us to redesign, reengineer or rebrand our products and technologies;

us to enter into royalty or licensing agreements in order to obtain the right to use a third

party’s intellectual property on terms that may not be favorable or acceptable to us;

us to develop alternative non-infringing technology, which could require significant effort

us to indemnify third parties pursuant to contracts in which we have agreed to provide indemnification

for intellectual property infringement claims;

in our customers or potential customers deferring or limiting their purchase or use of the

affected products impacted by the claims until the claims are resolved;

us to enter into royalty or licensing agreements in order to obtain the right to use a third party’s intellectual property

on terms that may not be favorable or acceptable to us;

us to develop alternative non-infringing technology, which could require significant effort and expense;

us to indemnify third parties pursuant to contracts in which we have agreed to provide indemnification for intellectual property

infringement claims;

in our customers or potential customers deferring or limiting their purchase or use of the affected products impacted by the claims

until the claims are resolved;

have a material adverse effect on our business.

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attack, and any such attach could cause our management to conclude that our disclosure controls and procedures were not effective.

Associated with Our Relationship with PAVmed Inc.

owns a majority of our voting stock and thus may control certain actions requiring a stockholder vote.

Associated with Our Relationship with PAVmed

owns a majority of our voting stock and thus it (or any successor to its stake in the Company), may control certain actions requiring

a stockholder vote.

owns approximately 70.1% as of December 31, 2023 and 64.9% as of March 21, 2024 of our issued common stock (with such percentage

inclusive of shares of our common stock underlying granted but unvested restricted stock awards).

Thus, we are a majority-owned subsidiary

of PAVmed, and PAVmed has a controlling financial interest.

Accordingly, for the foreseeable future, PAVmed will control us and our corporate

So long as PAVmed continues to control more than 50% of the voting control of our common stock, PAVmed will be able to direct

the election of all the members of our board of directors.

In addition, as long as PAVmed continues to control more than 50% of our common

stock, PAVmed will have the ability to take stockholder action without the vote of any other stockholder and without having to call a

stockholder meeting.

inclusive of shares of our common stock underlying granted but unvested restricted stock awards), but excluding the voting power of

any convertible securities.

Presently, PAVmed controls more than 50% of the combined voting power of our common stock and our

convertible securities and for as long as PAVmed continues to control more than 50% of our voting securities, PAVmed will be able to

direct the election of all the members of our board of directors.

Thus, we are a majority-owned subsidiary of PAVmed, and PAVmed has

a controlling financial interest.

In addition, as long as PAVmed continues to control more than 50% of our voting securities, PAVmed

will have the ability to take stockholder action without the vote of any other stockholder and without having to call a stockholder

Similarly, PAVmed will have the ability to prevent the approval of any action submitted to the stockholders.

PAVmed does not provide any requisite consent allowing us to take any such action when requested, we will not be able to engage in the

related activities and, as a result, our business and our operating results may be harmed.

If PAVmed does

not provide any requisite consent allowing us to take any such action when requested, we will not be able to engage in the related

activities and, as a result, our business and our operating results may be harmed.

interests and objectives as a stockholder may not align with, or may even directly conflict with, your interests and objectives as a

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be disclosed in our annual proxy statement.

If PAVmed’s debt is accelerated due to

its default under the terms thereof, PAVmed could cease to have voting control of the Company.

currently has a significant amount of convertible debt outstanding, which begins to mature in April 2025, and has from time to time

been in default thereunder.

PAVmed is currently in compliance with the financial and other covenants under such indebtedness,

although from time to time since the date of issuance of such notes (including, in the case of the indebtedness to market

capitalization ratio test under such notes, as of December 31, 2023), PAVmed was not in compliance with certain financial covenants

While the holder of such indebtedness agreed to waive any such non-compliance, there can be no assurance that it will do

so in the future.

If the debtholder elects to accelerate PAVmed’s indebtedness rather than waiving any such non-compliance, it

is likely PAVmed will not have sufficient cash on hand to pay the amounts due on an acceleration, in which case it may be required

to satisfy its obligations through the transfer of its shares of common stock of the Company to such debtholder.

In such event, the

debtholder in turn would be entitled to exercise the voting control and contractual rights of PAVmed and may do so in a manner that

could vary significantly from that of PAVmed.

conflicts of interest may arise between us and our affiliated companies, including PAVmed, and in some cases we have waived certain rights

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cash flow and profits.

order to preserve the ability for PAVmed to distribute its shares of our common stock on a tax-free basis for U.S.

federal income tax

purposes, we may be prevented from pursuing opportunities to raise capital, to effectuate acquisitions or to provide equity incentives

to our employees, which could hurt our ability to grow.

ownership of at least 80% of the total voting power and 80% of each class of non-voting capital stock is required in order for PAVmed

to effect a spin-off of our company that is tax-free for U.S.

federal income tax purposes.

PAVmed has advised us that it does not have

any present intention or plans to undertake any spin-off.

However, PAVmed may wish to preserve its ability to engage in a spin-off in

If PAVmed decides to retain its ability to effectuate a spin-off, it may use its controlling position to prevent us from

raising capital, effectuating acquisitions or providing equity incentives to our employees.

This could cause us to forgo capital raising

or acquisition opportunities that would otherwise be available to us.

As a result, we may be precluded from pursuing certain growth initiatives.

disputes that arise between us and PAVmed with respect to our past and ongoing relationships could harm our business operations.

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Associated with Ownership of Our Common Stock

may issue shares of our capital stock or debt securities in the future which could reduce the equity interest of our stockholders and

might cause a change in control of our ownership.

certificate of incorporation authorizes the issuance of up to 100,000,000 shares of common stock, par value $.001 per share, and 20,000,000

shares of preferred stock, par value $.001 per share.

There are 56,606,284 authorized but unissued shares of our common stock available

for issuance as of March 9, 2023 (inclusive of granted but unvested restricted stock awards granted as of each such date under

the Lucid Diagnostics 2018 Long-Term Incentive Equity Plan).

have issued and expect to continue to issue equity awards, including stock options, under our 2018 Long-Term Incentive Equity Plan

(the “Lucid Diagnostics Inc.

2018 Equity Plan”) and our Employee Stock Purchase Plan (the “Lucid Diagnostics Inc.

In addition, in March 2022, we entered into a committed equity facility with an affiliate of Cantor.

Under the terms

of the facility, Cantor has committed to purchase up to $50 million in shares of our common shares stock from time to time at the

In August 2022, we entered into a sixth amendment to the management services agreement with PAVmed, pursuant to which

PAVmed may elect to receive payment of the monthly fee under the management services agreement in cash or in shares of our common

stock valued at a price based on the current market price, subject to a floor price and a maximum number of shares.

2022, we also entered into an “at-the-market offering” for up to $6.5 million of our common stock that may be offered

and sold under a Controlled Equity Offering Agreement between us and Cantor Fitzgerald & Co.

Also in November 2022, we entered into the PBERA with PAVmed, pursuant to which PAVmed will continue to pay certain

payroll and benefit-related expenses on our behalf and we will reimburse PAVmed, in cash or, subject to approval by each of our boards

of directors, in shares of our common stock valued at a price based on the current market price, subject to a floor price and a maximum

number of shares.

Furthermore, in March 2023, we

issued shares of Series A Preferred Stock that, in accordance with the terms thereof, could be converted into, in the aggregate, up

to 9,782,750 million shares of our common stock.

In addition, we may issue a substantial

number of additional shares of our common stock or preferred stock or incur indebtedness, or issue or incur a combination of common and

preferred stock and indebtedness, to raise additional funds or in connection with any strategic acquisition or as compensation to our

officers, directors, employees and consultants.

The issuance of additional shares of

our common stock or any number of shares of our preferred stock, and the availability for sale of such shares in the public

significantly dilute the equity interest of our current investors;

subordinate the rights of holders of common stock if preferred stock is issued with rights

senior to those afforded to our common stockholders;

cause a change in control if a substantial number of our shares of common stock are issued,

which may affect, among other things, our ability to use our net operating loss carryforwards,

if any, and most likely also result in the resignation or removal of some or all of our present

officers and directors;

adversely affect prevailing market prices for our common stock.

if we incur indebtedness, it could result in:

and foreclosure on our assets if our operating revenues were insufficient to pay our debt

● acceleration

of our obligations to repay the indebtedness even if we have made all principal and interest

payments when due if the debt security contains covenants that require the maintenance of

certain financial ratios or reserves, and any such covenant is breached without a waiver

or renegotiation of that covenant;

immediate payment of all principal and accrued interest, if any, if the debt security is

payable on demand;

inability to obtain additional financing, if necessary, if the debt security contains covenants

restricting our ability to obtain additional financing while such security is outstanding;

inability to conduct acquisitions, joint ventures or similar arrangements if the debt security

contains covenants restricting such transactions or the funding thereof or requiring prior

approval of the debt holders.

securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock

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us or our business.

Securities and industry analysts do not currently, and may never, publish research on our company.

If no securities

or industry analysts commence coverage of our company, the trading price for our common stock would likely be negatively impacted.

the event securities or industry analysts initiate coverage, if one or more of the analysts who cover us downgrade our stock or publish

inaccurate or unfavorable research about our business, our stock price would likely decline.

In addition, if our operating results fail

to meet the forecast of analysts, our stock price would likely decline.

If one or more of these analysts cease coverage of our company

or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our stock price and trading

volume to decline.

Securities and industry analysts currently publish research on our company, but there is no assurance that they will

continue to do so.

If no securities or industry analysts cover our company, the trading price for our common stock would likely be negatively

If one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business,

our stock price would likely decline.

In addition, if our operating results fail to meet the forecast of analysts, our stock price would

likely decline.

If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for

our common stock could decrease, which might cause our stock price and trading volume to decline.

may in the future delist our common stock, which could limit investors’ ability to make transactions in our securities and subject

us to additional trading restrictions.

common stock is listed on the Nasdaq Global Market.

common stock is listed on the Nasdaq Capital Market.

We are required to meet certain financial and liquidity criteria to maintain the

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liquidity with respect to our common stock;

determination that our shares of common stock are “penny stock” which will require

brokers trading in our shares of common stock to adhere to more stringent rules, possibly

resulting in a reduced level of trading activity in the secondary trading market for our

shares of common stock;

determination that our shares of common stock are “penny stock” which will require brokers trading in our shares of common

stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market

for our shares of common stock;

limited amount of news and analyst coverage for our company;

decreased ability to issue additional securities or obtain additional financing in the future.

stock price may be volatile, and purchasers of our common stock could incur substantial losses.

stock price may be volatile, and holders of our common stock could incur substantial losses.

stock price is likely to be volatile.

The stock market in general, and the market for life science companies, and medical device companies

in particular, have experienced extreme volatility that has often been unrelated to the operating performance of particular companies.

As a result of this volatility, investors may not be able to sell their common stock at or above the initial public offering price.

The stock market in general, and the market for life science companies, and medical device

companies in particular, have experienced extreme volatility that has often been unrelated to the operating performance of

particular companies.

As a result of this volatility, investors may experience losses on their investment in our common stock.

example, on March 21, 2024, the last reported sale price of our common stock was $1.11.

In the last six months, between

September 21, 2023 and March 21, 2024, the intra-day sale price of our common stock fluctuated between a reported low

sale price of $0.99 and a reported high sale price of $1.58.

We may incur rapid and substantial increases or decreases in

our stock price in the foreseeable future that may or may not coincide in timing with the disclosure of news or developments by

addition, on February 15, 2024, PAVmed paid a distribution to its shareholders of approximately 3.3 million shares of our common

stock, thereby increasing our public float and the size of our shareholder base, both of which could increase volatility of our

common stock.

PAVmed could make similar distributions in the future, which could further increase the volatility of our stock

market price for our common stock may be influenced by many broad market and industry factors.

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As a result, any gain you will realize on our common stock will result solely from the appreciation of such shares.

will incur significantly increased costs as a result of operating as a public company, and our management will be required to devote

substantial time to compliance initiatives.

a public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company.

incur significant costs as a result of operating as a public company, and our management will be required to devote substantial time

to compliance initiatives.

a public company, we will incur significant legal, accounting and other expenses that we would not incur as a private company.

be subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, the other rules and regulations of the Securities

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These rules and regulations will continue to increase our legal and financial compliance costs

and will make some activities more time-consuming and costly.

For example, we expect these rules and regulations to make it more difficult

and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits

on coverage or incur substantial costs to maintain the same or similar coverage.

The impact of these events could also make it more difficult

for us to attract and retain qualified personnel to serve on our Board of Directors, our board committees, or as executive officers.

and will make some activities more time-consuming and costly, and could also make it more difficult for us to attract and retain qualified

personnel to serve on our Board of Directors, our board committees, or as executive officers.

we fail to establish and maintain proper and effective internal control over financial reporting, investors may lose confidence in the

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Among others, these provisions include the following.

Board of Directors will be divided into three classes with staggered three-year terms which

may delay or prevent a change of our management or a change in control;

Board of Directors will have the right to elect directors to fill a vacancy created by the

expansion of our Board of Directors or the resignation, death or removal of a director, which

will prevent stockholders from being able to fill vacancies on our Board of Directors;

certificate of incorporation will not permit cumulative voting in the election of directors,

which limits the ability of minority stockholders to elect director candidates;

stockholders will be required to provide advance notice and additional disclosures in order

to nominate individuals for election to our Board of Directors or to propose matters that

can be acted upon at a stockholders’ meeting, which may discourage or deter a potential

acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate

of directors or otherwise attempting to obtain control of our company.

Board of Directors will be divided into three classes with staggered three-year terms which may delay or prevent a change of our

management or a change in control;

Board of Directors will have the right to elect directors to fill a vacancy created by the expansion of our Board of Directors or

the resignation, death or removal of a director, which will prevent stockholders from being able to fill vacancies on our Board of

certificate of incorporation will not permit cumulative voting in the election of directors, which limits the ability of minority

stockholders to elect director candidates;

stockholders will be required to provide advance notice and additional disclosures in order to nominate individuals for election

to our Board of Directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or

deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise

attempting to obtain control of our company.

because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors