What changed in this filing

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Item 1A. Risk Factors

2024-03-25 compared with 2023-03-14 · 472 added, 366 removed, 871 unchanged (49% of the section changed)

12 unchanged sentences

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

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.

● 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.

accounting method for convertible debt securities that may be settled in cash, such as the

Senior Convertible Notes, is the subject of recent changes that could have a material effect

on our reported financial results.

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.

have faced significant challenges raising capital under the current market conditions, and therefore are highly dependent on the

ability of each of our subsidiaries to raise capital to fund its own and our operations.

There can be no assurance that our common stock will continue to trade on the Nasdaq Capital Market or another national securities exchange.

Our subsidiary Lucid may issue shares of its common and/or preferred stock in the future which could reduce the equity interest of PAVmed

in Lucid and might cause us to cease to control a majority of the voting stock of Lucid.

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.

accounting method for convertible debt securities that may be settled in cash, such as the Senior Convertible Notes, could have a

material effect on our reported financial results.

Associated with Our Business

will 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.

markets in which we operate are highly competitive, and we may not be able to effectively

compete against other providers of medical devices, particularly those with greater resources.

have finite resources, which may restrict our success in commercializing our current products

and other products we may develop, and we may be unsuccessful in entering into or maintaining

third-party arrangements to support our internal efforts.

we are unable to deploy and maintain effective sales, marketing and medical affairs capabilities,

we will have difficulty achieving market awareness and selling our tests and other products.

will 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.

markets in which we operate are highly competitive, and we may not be able to effectively compete against other providers of medical

devices, particularly those with greater resources.

have finite resources, which may restrict our success in commercializing our current products and other products we may develop,

and we may be unsuccessful in entering into or maintaining third-party arrangements to support our internal efforts.

we are unable to deploy and maintain effective sales, marketing and medical affairs capabilities, we will have difficulty achieving

market awareness and selling our tests and other products.

products may never achieve market acceptance.

Recommendations,

guidelines and quality metrics issued by various organizations may significantly affect payors’

willingness to cover, and healthcare providers’ willingness to prescribe, our products.

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

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

guidelines and quality metrics issued by various organizations may significantly affect payors’ willingness to cover, and healthcare

providers’ willingness to prescribe, our products.

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

testing or consumer demand in a timely manner.

currently perform our EsoGuard test in one laboratory facility.

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 our equipment were damaged or

destroyed, or if we experience a significant disruption in our operations for any reason,

our ability to continue to operate our business could be materially harmed.

may make investments in products we have not yet developed, and those investments may not

products and services may become subject to unfavorable pricing regulations, third-party

reimbursement practices or healthcare reform initiatives, thereby harming our business.

products and services may cause serious adverse side effects or even death or have other

properties that could delay or prevent their regulatory approval, limit the commercial desirability

of an approved label or result in significant negative consequences following any marketing

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

commercialization of any products that we may develop.

may not be able to protect or enforce our intellectual property rights, 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 our intellectual property rights, 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.

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 our equipment were

damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operate

our business could be materially harmed.

may make investments in products we have not yet developed, and those investments may not be realized.

We may not obtain the expected benefits of the incubator financing structure and may incur additional costs.

products and services may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform

initiatives, thereby harming our business.

products and services may cause serious adverse side effects or even death or have other properties that could delay or prevent their

regulatory approval, limit the commercial desirability of an approved label or result in significant negative consequences following

any marketing approval.

liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that

we may develop.

may not be able to protect or enforce our intellectual property rights, 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 our intellectual property rights, 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.

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

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.

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.

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

in our information technology or storage 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.

may become the subject of various claims, threats of litigation, litigation or investigations

which could have a material adverse effect on our business, financial condition, results

of operations or price of our common stock.

Related to Regulatory Matters

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, 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 our information technology or storage 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.

may become the subject of various claims, threats of litigation, litigation or investigations which could have a material adverse

effect on our business, financial condition, results of operations or price of our common stock.

Risks Associated with Healthcare Regulation, Billing

and Reimbursement, and Product Safety and Effectiveness

If 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.

FDA 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.

future products or services we may develop may not be approved for sale in the U.S.

any other country.

In order to obtain approval, we may need to conduct clinical trials necessary

to support a FDA 510(k) notice or PMA application will be expensive and will require the

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

results of the Company’s clinical trials may not support our product candidate claims

or may result in the discovery of adverse side effects.

In addition, delays or termination

of our clinical trials may have an adverse impact on our ability to commercialize our product

if we receive regulatory approval for any product we may develop, we 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.

or in any other country.

In order to obtain approval,

we may need to conduct clinical trials necessary to support a FDA 510(k) notice or PMA application will be expensive and will require

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

results of the Company’s clinical trials may not support our product candidate claims or may result in the discovery of adverse

side effects.

if we receive regulatory approval for any product we may develop, we 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.

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

we fail to comply with healthcare regulations, we could face substantial penalties and our

business, operations and financial condition could be adversely affected.

Company’s medical products may in the future be subject to product recalls that could

harm its reputation, business and financial results.

the Company’s 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.

the Company is found to be promoting the use of its devices for unapproved or “off-label”

uses or engaging in other noncompliant activities, the Company may be subject to recalls,

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

actions, resulting in damage to its reputation and business.

we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations and financial condition

could be adversely affected.

Company’s medical products may in the future be subject to product recalls that could harm its reputation, business and financial

the Company’s 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.

the Company is found to be promoting the use of its devices for unapproved or “off-label” uses or engaging in other noncompliant

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

adverse actions, resulting in damage to its reputation and business.

Associated with Ownership of Our Common Stock

may issue shares of our common and /or preferred stock in the future which could reduce the

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

subsidiary Lucid may issue shares of its common and/or preferred stock in the future which

could reduce the equity interest of PAVmed in Lucid and might cause us to cease to control

a majority of the voting stock of Lucid.

management and their affiliates control a substantial interest in us and thus may influence

certain actions requiring a stockholder vote.

can be no assurance that our common stock will continue to trade on the Nasdaq Capital Market

or another national securities exchange.

robust public market for our common stock may not be sustained, which could affect your ability

to sell our common stock or depress the market price of our common stock.

may issue shares of our common and /or preferred stock in the future which could reduce the equity interest of our stockholders and

might cause a change in control of our ownership.

management and their affiliates control a substantial interest in us and thus may influence certain actions requiring a stockholder

robust public market for our common stock may not be sustained, which could affect your ability to sell our common stock or depress

the market price of our common stock.

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

outstanding warrants and other convertible securities may have an adverse effect on the market

price of our common stock.

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

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

that impact compliance costs and risks of noncompliance.

incur significant costs as a result of our and Lucid Diagnostics operating as a public company,

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

we experience material weaknesses in our internal control over financial reporting in the

future, our business may be harmed.

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.

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

outstanding warrants and other convertible securities may have an adverse effect on the market price of our common stock.

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

We have made distributions of shares of Lucid common stock to our shareholders in the past, but there is no assurance we will do so in

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

risks of noncompliance.

incur significant costs as a result of our and Lucid Diagnostics operating as a public company, and our management will be required

to devote substantial time to compliance initiatives.

we experience material weaknesses in our internal control over financial reporting in the future, our business may be harmed.

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.

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.

Related to Financial Position and Capital Resources

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factors that may be outside of our control.

We expect our operating expenses will continue to increase as we continue to build our commercial

infrastructure, develop, enhance and commercialize new products and incur additional operational and reporting costs associated with

being a public company.

As a result, we expect to continue to incur operating losses for the foreseeable future.

While we have taken steps to reduce operating expenses, we expect to continue to incur operating

expenses in excess of our revenues as we continue to maintain our commercial infrastructure, develop, enhance and commercialize products

and incur additional operational and reporting costs associated with being a public company.

As a result, we expect to continue to incur

operating losses for the foreseeable future.

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 that our recurring losses from operations,

recurring cash flows used in operations and the requirement that we will need to 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 at Lucid in addition to the recently completed offering of Lucid Series B Preferred

Stock (Lucid has recently raised over $18 million in such offering), seeking to restructure our and Lucid Diagnostics’

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 concern.

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.

have faced significant challenges raising capital under the current market conditions, and therefore are highly dependent on the ability

of each of our subsidiaries to raise capital to fund its own and our operations.

to challenging market conditions, we have found it difficult to raise capital directly into PAVmed.

As a result, we have become

highly dependent on the ability of each of our subsidiaries to raise capital to fund their own operations.

There is no assurance that

our subsidiaries will be able to raise capital as needed to fund its operations, or that any of them will be able to do so on commercially

reasonable terms.

Accordingly, the failure of any of our subsidiaries to raise the capital it needs to fund its operations, could have

a material adverse effect on the portion of our business related to such subsidiary.

In addition, because of the challenges PAVmed has faced in terms of raising

capital, we are highly dependent on our subsidiaries, including Lucid Diagnostics, as resources for funding our operations (notably, PAVmed

may elect that Lucid Diagnostics satisfy its obligations under our management services agreement through cash payment).

If Lucid Diagnostics

is unable to continue to make any such cash payments we elect to receive, or determines to terminate the management services agreement

(i.e., because it retains its own management team to oversee its operations), and PAVmed is unable to raise sufficient capital itself,

it may not have sufficient capital to fund its operations, which in turn could have a material adverse effect on our business.

All intercompany

obligations between PAVmed, on the one hand, and any of its subsidiaries (including Lucid Diagnostics), on the other hand, are subject

to approval by the PAVmed board and the board of the applicable subsidiary (including, in the case of Lucid Diagnostics, their independent

There can be no assurance that our common stock

will continue to trade on the Nasdaq Capital Market or another national securities exchange.

There can be no assurance that we

will be able to continue to meet Nasdaq Capital Market listing standards.

If we are unable to maintain compliance with all applicable

listing standards, our common stock may no longer be listed on the Nasdaq Capital Market or another national securities exchange and the

liquidity and market price of our common stock may be adversely affected.

On March 7, 2024, the Company received

a notice from the Nasdaq Listing Qualifications Department stating that, for the preceding 30 consecutive business days (through March

6, 2024), the market value of the Company’s listed securities (“MVLS”) had been below the minimum of $35 million required

for continued inclusion on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2).

The notification letter stated that the Company

would be afforded 180 calendar days (until September 3, 2024) to regain compliance.

In order to regain compliance, the Company’s

MVLS must close at $35 million or more for a minimum of ten consecutive business days.

The notification letter also states that in the

event the Company does not regain compliance prior to the expiration of the 180-day period, the Company will receive written notification

that its securities are subject to delisting.

There can be no assurance that the Company will be able to regain compliance by such deadline,

in which case, unless the Company is able to obtain an extension for regaining compliance, the Company’s stock would be delisted.

If we were so delisted, that could have a material adverse effect on your investment in the Company, including without limitation by substantially

reducing the liquidity of our common stock, and by further limiting our access to capital markets for fundraising.

Our subsidiary Lucid may issue shares of its

common and/or preferred stock in the future which could reduce the equity interest of PAVmed in Lucid and might cause us to cease to control

a majority of the voting stock of Lucid.

As of the date hereof, our subsidiary

Lucid has issued 44,285 shares of Lucid Series B Preferred Stock.

If the maximum amount of common stock underlying such securities were

issued (including shares of Lucid common stock issued as a dividend thereon), the percentage of shares of Lucid common stock held by PAVmed

would be reduced from approximately [●]% to approximately [●]%.

This reduced percentage would be further diluted in the event

of future convertible debt or stock issuances by Lucid or by issuances under Lucid’s long-term incentive plan and employee stock

purchase plan.

While PAVmed would still retain a large ownership interest in Lucid in such event, it may cease to control the vote on

matters requiring shareholder approval, including the election of Lucid’s board of directors.

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 April 2022 Senior Convertible Note and the September 2022 Senior Convertible

Note (collectively, the “Senior Convertible Notes”) or any future permitted indebtedness incurred by us or our subsidiaries,

Despite our right to pay the interest

and principal balance of the Senior Convertible Notes 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.

and our subsidiaries may be required to repay or redeem, or to pay interest on, the April 2022 Senior Convertible Note, the September

2022 Senior Convertible Note and the March 2023 Lucid Senior Convertible Note (collectively, the “Senior Convertible Notes”)

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 Senior Convertible Notes 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

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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;

us at a competitive disadvantage compared to our competitors that have lower fixed costs.

debt service requirements of any other permitted indebtedness we incur or issue in the future, as well as the restrictive covenants contained

in the governing documents for any such indebtedness, could intensify these risks.

For example, while the Company is currently in compliance

with the financial covenants under the Senior Convertible Notes, 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 June 30, 2022 and December 31, 2022), the

Company was not in compliance with certain financial covenants thereunder.

While the holders of such notes agreed to waive any such non-compliance

during such aforementioned time periods, there can be no assurance that it will do so in the future.

The debt service

requirements of any other permitted indebtedness we incur or issue in the future, as well as the restrictive covenants contained in

the governing documents for any such indebtedness, could intensify these risks.

For example, while the Company is currently in

compliance with the financial covenants under the Senior Convertible Notes it has issued, 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), the Company was not in compliance with certain financial covenants thereunder.

The holders of such notes agreed

to waive any such non-compliance through August 31, 2024 in consideration of our agreement to pay a $2,000,000 consent fee in cash

(or in such other form as may be mutually agreed in writing) by April 25, 2024.

However, there can be no assurance that we will have

the cash to make such payment or that the holders will be willing to accept payment in another form of consideration, or if they are

willing to do so, that it will be on terms and conditions agreeable to us.

There is also no assurance that the holders will be

willing to waive any future non-compliance with this or any other provision under the Senior Convertible Notes, or if they are

willing to do so, if the terms on which they are so willing will be acceptable to us.

we are unable to make the required cash payments, there could be a default under one or more of the instruments governing our indebtedness.

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it could be dilutive to shareholders or impose onerous terms on us.

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, Lucid entered into the Lucid SPA, pursuant to which Lucid anticipates issuing the March 2023 Lucid Senior

Convertible Note.

However, such issuance is subject to certain closing conditions, some of which are outside of Lucid’s

If any of the closing conditions to the issuance of the March 2023 Lucid Senior Convertible Note are not met, or if the

Lucid Investor fails to purchase the March 2023 Lucid Senior Convertible Note when required to do so under the Lucid SPA, the note

may not be issued.

accounting method for convertible debt securities that may be settled in cash, such as the Senior Convertible Notes, is the subject of

recent changes that could have a material effect on our reported financial results.

accounting method for convertible debt securities that may be settled in cash, such as the Senior Convertible Notes, could have a material

effect on our reported financial results.

May 2008, the Financial Accounting Standards Board (“FASB”) issued FASB Staff Position No.

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or abandon growth initiatives or product development programs.

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

Because we have not generated any revenue or cash flow to date,

we will require additional funds to:

intend to continue to try to raise capital through each of our subsidiaries to support our business growth.

Because we have not generated

substantial revenue or cash flow to date, unless we are able to generate substantial revenue in the near-term (which we do not anticipate

being able to do), we will require additional funds to:

our research and development;

4 unchanged sentences

and expand our sales, marketing, and distribution capabilities for our products and services;

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

third-party patents or other intellectual property rights;

in businesses, products and technologies, although we currently have no commitments or agreements

relating to do so.

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

property rights;

in businesses, products and technologies, although we currently have no commitments or agreements relating to do so;

fund our operations.

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other companies to gain new technologies or products may displace our products;

● manufacture,

market and sell products;

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arrangements for the manufacture and distribution of our tests and other products.

have only two products, EsoGuard and the Veris Cancer Care Platform, that we are actively seeking to commercialize, and have not generated

substantial revenue from product sales to date.

We have limited experience managing a sales force, customer support operation, manufacturing

and clinical laboratory operations for multiple products in multiple locations with divergent regulatory requirements.

We may encounter

difficulties retaining and managing the specialized workforce these activities require.

We may seek to partner with others to assist

us with any or all of these functions.

Additionally, we may be unable to find appropriate third parties with whom to enter into these

arrangements.

only two products, EsoGuard and the Veris Cancer Care Platform, that we are actively seeking to commercialize have not generated substantial

revenue from product sales to date.

Accordingly, we will need to find other sources of capital to fund their activities, and there can

be no assurance that we will be able to do so.

We may also encounter difficulties retaining and managing the specialized workforce our

activities require.

We may seek to partner with others to assist us with any or all of these functions, although we may be unable to

find appropriate third parties with whom to enter into these arrangements.

we are unable to deploy and maintain effective sales, marketing and medical affairs capabilities, we will have difficulty achieving market

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maintaining our sales force may be disproportional compared to the revenues we may be able to generate on sales of our EsoGuard test

and the Veris Cancer Care Platform or any future tests or other products, and in order to establish and maintain these capabilities may

required our raising additional capital, which we may be unable to do.

and the Veris Cancer Care Platform or any future tests or other products.

Establishing and maintaining these capabilities may

require our raising additional capital, which we may be unable to do.

products may never achieve market acceptance.

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and services, and to achieve profitability will depend upon our ability to successfully commercialize our products and services.

only recently began to market our two products and services for sale, we have no basis to predict whether our current products and services

(or potential future products and services) will achieve market acceptance.

A number of factors may limit the market acceptance of any

of our products, including:

only relatively recently began to market our two products and services for sale, we have no basis to predict whether our current products

and services (or potential future products and services) will achieve market acceptance.

A number of factors may limit the market acceptance

of any of our products, including:

timing of regulatory approvals of our products and services and market entry compared to

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with these processes at any time that could result in delays in clinical trials, regulatory submissions or the commercialization of products.

some of our products, we or our third-party manufacturers will need to have sufficient production and processing capacity in order to

conduct human clinical trials, to produce products for commercial sale at an acceptable cost.

We have limited experience in large-scale

product manufacturing, nor do we have the resources or facilities to manufacture most of our products on a commercial scale.

guarantee that we or our third-party manufacturers will be able to increase capacity in a timely or cost-effective manner, or at all.

we will not directly manufacture our products and will rely on third parties to do so for us.

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may make investments in products we have not yet developed, and those investments may not be realized.

we are currently focused on the commercialization of our EsoGuard test and the Veris Cancer Care Platform, technology remains an important

component of our business and growth strategy, and our success may depend on the development, implementation and acceptance of new products.

Commitments 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.

We may expend considerable funds and other resources on the development of new products without any guarantee these products will be

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

fail to develop viable technologies or otherwise, we may not generate any revenues and our results of operations could be seriously harmed.

may expend considerable funds and other resources on the development of new and existing products without any guarantee these products

will be successful.

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

demand, fail to develop viable technologies or otherwise, we may not generate any revenues and our results of operations could be seriously

We may not obtain the expected benefits of the

incubator financing structure and may incur additional costs.

We believe that the incubator financing

structure will provide us with future benefits.

These expected benefits are not guaranteed and may not be obtained if market conditions

or other circumstances prevent us from taking advantage of the investment, financing and structuring flexibility we expect to gain as

a result of the incubator financing structure.

If we fail to achieve some or all of the expected benefits of our incubator financing structure,

it could have a material adverse effect on our competitive position, business, financial condition, results of operations and cash flows.

The implementation of our incubator financing structure also may result in substantial direct costs, which are expected to consist primarily

of attorneys’ fees and accountants’ fees, as well as loss of certain efficiencies.

Moreover, the incubator financing structure

may be not fully insulate the liabilities of our subsidiaries from each other or from PAVmed, especially if we do not observe the requisite

corporate formalities or adequately capitalize PAVmed or its subsidiaries.

products and services may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform

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authorities may withdraw their approvals of such product;

authorities may require additional warnings on the label that could diminish the usage or

otherwise limit the commercial success of such products;

FDA or other regulatory bodies may issue safety alerts, Dear Healthcare Provider letters,

press releases or other communications containing warnings about such product;

FDA may require the establishment or modification of Risk Evaluation Mitigation Strategies

or a comparable foreign regulatory authority may require the establishment or modification

of a similar strategy that may, for instance, restrict distribution of our products and impose

burdensome implementation requirements on us;

may be required to change the way the product is administered or conduct additional clinical

authorities may require additional warnings on the label that could diminish the usage or otherwise limit the commercial success

of such products;

FDA or other regulatory bodies may issue safety alerts, Dear Healthcare Provider letters, press releases or other communications

containing warnings about such product;

FDA may require the establishment or modification of Risk Evaluation Mitigation Strategies or a comparable foreign regulatory authority

may require the establishment or modification of a similar strategy that may, for instance, restrict distribution of our products

and impose burdensome implementation requirements on us;

may be required to change the way the product is administered or conduct additional clinical trials;

could be sued and held liable for harm caused to subjects or patients;

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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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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.

of the foregoing could affect our ability to compete or have a material adverse effect on our business, financial condition and results

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

As of March 9, 2023, we only

have 672,190 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.

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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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 COVID-19 pandemic, 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.

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

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on our business, financial condition, results of operations and price of our common stock.

Relating to Regulatory Matters

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

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 Lucid’s 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.” Lucid expects to submit EsoGuard for Technical Assessment under this foundational

LCD later this year.

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

that MolDx will determine that EsoGuard meets the criteria for coverage as specified in the LCD.

If Lucid is not granted coverage, or

if a determination is substantially delayed, that could have a material adverse effect on Lucid’s 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, 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.

For example, with

respect to EsoGuard and EsoCheck, 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 these 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 (or any other product or service we develop), 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 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 or any other product or service we develop at an adequate reimbursement

rate, other factors may have a significant impact on the actual reimbursement we receive 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 product or service to the patient, notwithstanding any applicable coverage mandate.

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 a product

or service is out of network for a given payor, physicians may be less likely to prescribe such product or service 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 a product or service 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 our product or service for their

patients, and may make patients less likely to comply with physician orders for the same, 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

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 (like EsoGuard) 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, Lucid 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 Lucid

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 Lucid will be able to successfully transition the

platform to fulfill the QS requirements, if and when required by FDA, and its failure to do so could have a material impact on Lucid’s

ability to commercialize EsoGuard and on our business as a whole.

future products or services we may develop may not be approved for sale in the U.S.

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side effects.

In addition, delays or termination of our clinical trials may have an adverse impact on our ability to commercialize our

product candidates.

of unanticipated delays, the Company has been unable to successfully complete its clinical trials related to the EsoGuard test to generate

clinical utility data showing that the results of the test influence’s provider decisionmaking in providing medical care.

clinical utility data 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.

if any of the Company’s clinical trials are completed as planned, it cannot be certain that study results will support product

candidate claims or that the FDA or foreign regulatory authorities will agree with our conclusions regarding them.

Success in pre-clinical

evaluation and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later

trials will replicate the results of prior trials and pre-clinical studies.

The clinical trial process may fail to demonstrate that our

product candidates are safe and effective for the proposed indicated uses or otherwise influence medical decisions in the manner we need

to show to evidence the clinical utility of our product candidates, which could cause us to abandon a product candidate and may delay

development of others.

In addition, if clinical data does not support our product candidate claims, the FDA could then bring legal or

regulatory enforcement actions against the Company and/or its products including, but not limited to, recalls or requirements for pre-market

510(k) authorizations.

the Company’s clinical trials are completed as planned, it cannot be certain that study results will support product candidate

claims or that the FDA or foreign regulatory authorities will agree with our conclusions regarding them.

Success in pre-clinical evaluation

and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials

will replicate the results of prior trials and pre-clinical studies.

The clinical trial process may fail to demonstrate that our product

candidates are safe and effective for the proposed indicated uses or otherwise influence medical decisions in the manner we need to show

to evidence the clinical utility of our product candidates, which could cause us to abandon a product candidate and may delay development

In addition, if clinical data does not support our product candidate claims, the FDA could then bring legal or regulatory

enforcement actions against the Company and/or its products including, but not limited to, recalls or requirements for pre-market 510(k)

authorizations.

The Company can give no assurance that its data will be substantiated in studies involving more patients.

a case, the Company may never achieve significant revenues or profitability.

Any delay or termination of our clinical trials will delay

the filing of any related product submissions and, ultimately, our ability to commercialize our product candidates and generate revenues

(in particular where evidence of clinical utility is a critical factor to payor’s decisions around reimbursement).

It is also possible

that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s

In such a case,

the Company may never achieve significant revenues or profitability.

Any delay or termination of our clinical trials will delay the filing

of any related product submissions and, ultimately, our ability to commercialize our product candidates and generate revenues (in particular

where evidence of clinical utility is a critical factor to payor’s decisions around reimbursement).

It is also possible that patients

enrolled in clinical trials will experience adverse side effects that 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—EsoGuard and EsoCheck—Clinical Utility

and Clinical Trials ”.

if we receive regulatory approval for any product we may develop, we will be subject to ongoing regulatory obligations and continued

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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 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 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;

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.

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;

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.

our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us,

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adversely affect prevailing market prices for our common stock.

subsidiary Lucid may issue shares of its common and/or preferred stock in the future which could reduce the equity interest of PAVmed

in Lucid and might cause us to cease to control a majority of the voting stock of Lucid.

As of the date hereof, our subsidiary

Lucid has sold $13.625 million in shares of Series A Preferred Stock.

If the maximum amount of common stock underlying such securities

were issued, the percentage of shares of Lucid common stock held by PAVmed would be reduced from approximately 72% to approximately 59%.

This reduced percentage would be further diluted in the event of future convertible debt or stock issuances by Lucid or by issuances under

Lucid’s long-term incentive plan and employee stock purchase plan.

While PAVmed would still retain a large ownership interest in

Lucid in such event, it may cease to control the vote on matters requiring shareholder approval, including the election of Lucid’s

board of directors.

management and their affiliates control a substantial interest in us and thus may influence certain actions requiring a stockholder vote.

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because of their ownership position, will have considerable influence regarding the outcome.

can be no assurance that our common stock will continue to trade on the Nasdaq Capital Market or another national securities exchange.

can be no assurance that we will be able to continue to meet Nasdaq Capital Market listing standards.

If we are unable to maintain compliance

with all applicable listing standards, our common stock may no longer be listed on the Nasdaq Capital Market or another national securities

exchange and the liquidity and market price of our common stock may be adversely affected.

On December 29, 2022, the Company received

a notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC stating that, for the prior 30 consecutive business

days (through December 28, 2022), the closing bid price of the Company’s common stock had been below the minimum of $1 per share

required for continued listing on the Nasdaq Capital Market.

The notification letter stated that the Company would be afforded 180 calendar

days (until June 27, 2023) to regain compliance.

The Company intends to regain compliance through a reverse stock split.

A special annual

meeting at which the reverse stock split will be voted on is scheduled for March 31, 2023.

However, there can be no assurance that the

Company will be able to obtain the requisite shareholder vote to approve such a transaction.

robust public market for our common stock may not be sustained, which could affect your ability to sell our common stock or depress the

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any reason, it may be difficult for you to sell your securities at the time you wish to sell them, at a price that is attractive to you,

If the proposed reverse stock split discussed above is completed, the related reduction in outstanding shares would likely

reduce the liquidity in our common stock.

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

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The market price for our common stock may be influenced by many factors, including the following:

in the public trading market for our stock that may produce price movements that may or may

not comport with macro, industry or company-specific fundamentals, including, without limitation,

the sentiment of retail investors (including as may be expressed on financial trading and

other social media sites and online forums), the direct access by retail investors to broadly

available trading platforms, the amount and status of short interest in our securities, access

to margin debt, trading in options and other derivatives on our common stock and any related

hedging and other trading factors

● speculation

in the public trading market for our stock that may produce price movements that may or may not comport with macro, industry or company-specific

fundamentals, including, without limitation, the sentiment of retail investors (including as may be expressed on financial trading

and other social media sites and online forums), the direct access by retail investors to broadly available trading platforms, the

amount and status of short interest in our securities, access to margin debt, trading in options and other derivatives on our common

stock and any related hedging and other trading factors;

in the press or investment community about our company or industry;

ability to successfully commercialize, and realize revenues from sales of, any products we

ability to successfully commercialize, and realize revenues from sales of, any products we may develop;

performance, safety and side effects of any products we may develop;

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or legal developments in the U.S.

and other countries, especially changes in laws or regulations

applicable to any products we may develop;

and other countries, especially changes in laws or regulations applicable to any products we may

introductions

and announcements of new products by us, our commercialization partners, or our competitors,

and the timing of these introductions or announcements;

taken by regulatory agencies with respect to our products, clinical studies, manufacturing

process or sales and marketing terms;

and announcements of new products by us, our commercialization partners, or our competitors, and the timing of these introductions

or announcements;

taken by regulatory agencies with respect to our products, clinical studies, manufacturing process or sales and marketing terms;

in our financial results or those of companies that are perceived to be similar to us;

success of our efforts to acquire or in-license additional products or other products we

● developments

concerning our collaborations, including but not limited to those with our sources of manufacturing

supply and our commercialization partners;

● developments

concerning our ability to bring our manufacturing processes to scale in a cost-effective

success of our efforts to acquire or in-license additional products or other products we may develop;

concerning our collaborations, including but not limited to those with our sources of manufacturing supply and our commercialization

concerning our ability to bring our manufacturing processes to scale in a cost-effective manner;

announcements

by us or our competitors of significant acquisitions, strategic partnerships, joint ventures

or capital commitments;

● developments

or disputes concerning patents or other proprietary rights, including patents, litigation

matters and our ability to obtain patent protection for our products;

by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent

protection for our products;

ability or inability to raise additional capital and the terms on which we raise it;

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conditions in the medical device, pharmaceutical and biotechnology sectors;

or anticipated changes in earnings estimates or changes in stock market analyst recommendations

regarding our common stock, other comparable companies or our industry generally;

or anticipated changes in earnings estimates or changes in stock market analyst recommendations regarding our common stock, other

comparable companies or our industry generally;

volume of our common stock;

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and outstanding:

options to purchase 11,568,655 shares of our common stock at a weighted average exercise price of $2.71 per share, with such total number

inclusive of both stock options granted under the PAVmed Inc.

2014 Long-Term Incentive Equity Plan (“PAVmed Inc.

2014 Equity Plan”);and

2,563,843 shares of our common stock reserved for issuance, but not subject to outstanding stock-based equity awards under the PAVmed

stock options to purchase 1,192,458 shares of our common stock at a weighted average exercise price of $26.18 per share, with such

total number inclusive of both stock options granted under the PAVmed Inc.

2014 Long-Term Incentive Equity Plan (“PAVmed 2014

Equity Plan”);

77,518 shares of our common stock reserved for issuance, but not subject to outstanding stock-based equity

awards under the PAVmed 2014 Equity Plan;

and 7,528 shares of our common stock reserved for issuance under the PAVmed Inc.

Employee Stock Purchase Plan

(“PAVmed Inc.

Z Warrants to purchase 11,937,450 shares of our common stock at an exercise price of $1.60 per share;

B Convertible Preferred Stock of 1,205,759 shares, convertible into the same number of shares of our common stock.

Employee Stock Purchase Plan (“PAVmed ESPP”)

11,937,450 Series Z Warrants, representing the right to purchase 795,830 shares of the Company’s common stock

at an exercise price of $23.48 per whole share;

1,305,213 shares of Series B Convertible Preferred Stock, convertible into 87,015 shares of our common

addition, the Senior Convertible Notes have a current outstanding principal amount of $26.7 million, which are convertible into 355,520

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price of $75.00 per share).

The number of shares of our common stock underlying the Senior Convertible Notes may increase if we conduct

additional closings under the March 2022 SPA, pursuant to which we may issue Senior Convertible Notes with up to an additional $11,250,000

of principal amount.

Furthermore, the number of shares of common stock to be issued under the Senior Convertible Notes may be substantially

The number of shares of common stock to be issued under the Senior Convertible Notes may be substantially

greater than the estimate set forth in this paragraph, if we pay the interest and the installments of principal in shares of our common

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issuance of these shares will dilute our other equity holders, which could cause the price of our common stock to decline.

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

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

have not paid any cash dividends on our shares of common stock to date.

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warrants) will result solely from the appreciation of such shares.

have made distributions of shares of Lucid common stock to our shareholders in the past, but there is no assurance we will do so in the

February 15, 2024, the Company distributed by special dividend to the Company stockholders 3,331,747 shares of Lucid Diagnostics

common stock held by the Company.

On such date, each PAVmed shareholder as of the January 15, 2024 record date received a stock

dividend of approximately 38 shares of Lucid common stock for every 100 shares of PAVmed common stock they held as of such date.

However, our Board of Directors has no intention to make any further distributions of shares of Lucid common stock or other assets at this time.

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

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Among others, these provisions include the following.

Board of Directors is 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 has 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 prohibits cumulative voting in the election of directors, which

limits the ability of minority stockholders to elect director candidates;

stockholders are 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 is able to issue, without stockholder approval, shares of undesignated

preferred stock, which makes it possible for our Board of Directors to issue preferred stock

with voting or other rights or preferences that could impede the success of any attempt to

Board of Directors is 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 has 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 prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders

to elect director candidates;

stockholders are 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 is able to issue, without stockholder approval, shares of undesignated preferred stock, which makes it possible

for our Board of Directors to issue preferred stock with voting or other rights or preferences that could impede the success of any

attempt to acquire us.

because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law (“DGCL”),

3 unchanged sentences

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