12 unchanged sentences
have incurred operating losses since our inception and may not be able to achieve profitability.
−Removed: We have concluded there is substantial doubt of our ability to continue as a going concern and our independent registered public accounting
−Removed: firm’s report on our financial statements contains an explanatory paragraph describing our ability to continue as a going concern.
+Added: We have concluded there is substantial doubt of our ability to continue as a going concern and our independent registered
+Added: public accounting firm’s report on our financial statements contains an explanatory paragraph describing our ability to continue as a
+Added: 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.
−Removed: There can be no assurance that our common stock will continue to trade on the Nasdaq Capital Market or another national securities exchange.
−Removed: Our subsidiary Lucid may issue shares of its common and/or preferred stock in the future which could reduce the equity interest of PAVmed
−Removed: in Lucid and might cause us to cease to control a majority of the voting stock of Lucid.
−Removed: our indebtedness may require a significant amount of cash, and the restrictive covenants contained in our indebtedness could adversely
−Removed: affect our business plan, liquidity, financial condition, and results of operations.
−Removed: accounting method for convertible debt securities that may be settled in cash, such as the Senior Convertible Notes, could have a
−Removed: material effect on our reported financial results.
+Added: can be no assurance that our common stock will continue to trade on the Nasdaq Capital Market or another national securities exchange.
+Added: Our subsidiary Lucid may issue shares of its common and/or preferred stock
+Added: in the future, and the holder of our convertible debt may exchange such debt for our shares of Lucid common stock.
+Added: These events could
+Added: reduce the percentage equity interest of PAVmed in Lucid.
+Added: and thereby reduce its influence over matters subject to a shareholder vote
+Added: and otherwise adversely affect your investment in PAVmed.
+Added: our indebtedness may require a significant amount of cash, and the restrictive covenants contained in the documents that govern our
+Added: indebtedness and preferred stock could adversely affect our business plan, liquidity, financial condition, and results of operations.
+Added: accounting method for convertible debt securities that may be settled in cash, such as the September 2022 Senior Convertible Note,
+Added: could have a material effect on our reported financial results.
Associated with Our Business
13 unchanged sentences
testing or consumer demand in a timely manner.
−Removed: currently perform our EsoGuard test in one laboratory facility.
−Removed: If demand for our EsoGuard test grows, we may lack adequate facility
−Removed: space and capabilities to meet increased processing requirements.
−Removed: Moreover, if these or any future facilities or our equipment were
−Removed: damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operate
−Removed: our business could be materially harmed.
+Added: demand for our EsoGuard test grows, we may lack adequate facility space and capabilities to meet increased processing requirements.
+Added: Moreover, if these or any future facilities or our equipment were damaged or destroyed, or if we experience a significant disruption
+Added: 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.
−Removed: We may not obtain the expected benefits of the incubator financing structure and may incur additional costs.
+Added: 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
11 unchanged sentences
business may suffer if we are unable to manage our growth.
−Removed: officers may allocate their time to other businesses thereby potentially limiting the amount of time they devote to our affairs.
−Removed: 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.
7 unchanged sentences
effect on our business, financial condition, results of operations or price of our common stock.
−Removed: Risks Associated with Healthcare Regulation, Billing
−Removed: and Reimbursement, and Product Safety and Effectiveness
−Removed: If private or governmental third-party payors do not maintain reimbursement for our products at adequate reimbursement rates, we may be
−Removed: unable to successfully commercialize our products which would limit or slow our revenue generation and likely have a material adverse
−Removed: effect on our business.
−Removed: FDA has proposed a policy under which it would phase out its general enforcement discretion approach for LDTs so that IVDs manufactured
+Added: Associated with Healthcare Regulation, Billing and Reimbursement, and Product Safety and Effectiveness
+Added: private or governmental third-party payors do not maintain reimbursement for our products at adequate reimbursement rates, we may
+Added: be unable to successfully commercialize our products which would limit or slow our revenue generation and likely have a material
+Added: adverse effect on our business.
+Added: 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.
−Removed: While we are confident that the proposed policy
−Removed: will not have a material impact on our business, there can be no assurance that will be the case.
+Added: While we are confident that the proposed
+Added: 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.
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regulatory requirements.
−Removed: reform measures could hinder or prevent our products’ commercial success.
+Added: reform measures, including those targeting Medicare or Medicaid, 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
9 unchanged sentences
might cause a change in control of our ownership.
+Added: holder of our convertible debt and the holder of our Series C Preferred Stock have certain rights with respect to the shares in Lucid
+Added: Diagnostics that we own, which may have a material impact on the return on any investment in shares of our common stock.
management and their affiliates control a substantial interest in us and thus may influence certain actions requiring a stockholder
2 unchanged sentences
stock price may be volatile, and purchasers of our securities could incur substantial losses.
−Removed: outstanding warrants and other convertible securities may have an adverse effect on the market price of our common stock.
+Added: outstanding warrants and other convertible securities may have an adverse effect on the market price of our common stock and the
+Added: value of your investment in us.
do not intend to pay any cash dividends on our common stock at this time.
−Removed: 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
+Added: have made distributions of shares of Lucid common stock to our shareholders in the past, but there is no assurance we will do so
+Added: in the future.
are subject to evolving corporate governance and public disclosure expectations and regulations that impact compliance costs and
10 unchanged sentences
have incurred net losses since our inception.
−Removed: date, since our inception in June 2014, we have financed our operations principally through issuances of common stock, preferred stock,
−Removed: warrants, and debt, in both private placements and public offerings of our securities.
−Removed: Our ability to generate sufficient revenue from
−Removed: any of our products in development, and to transition to profitability and generate consistent positive cash flows is dependent upon
−Removed: factors that may be outside of our control.
−Removed: While we have taken steps to reduce operating expenses, we expect to continue to incur operating
−Removed: expenses in excess of our revenues as we continue to maintain our commercial infrastructure, develop, enhance and commercialize products
−Removed: and incur additional operational and reporting costs associated with being a public company.
−Removed: As a result, we expect to continue to incur
−Removed: operating losses for the foreseeable future.
−Removed: have concluded there is substantial doubt of our ability to continue as a going concern and our independent registered public accounting
−Removed: firm’s report on our financial statements contains an explanatory paragraph describing our ability to continue as a going concern.
−Removed: our December 31, 2023 consolidated financial statements, we have concluded and stated that our recurring losses from operations,
−Removed: recurring cash flows used in operations and the requirement that we will need to raise additional capital in
−Removed: order to fund our ongoing operations beyond March 2025 raise substantial doubt regarding our ability to continue as a going concern.
−Removed: Additionally, our independent registered public accounting firm’s report on our consolidated financial statements includes an
−Removed: explanatory paragraph expressing substantial doubt about our ability to continue as a going concern.
−Removed: Our plans to address this going
−Removed: concern risk include pursuing further financings at Lucid in addition to the recently completed offering of Lucid Series B Preferred
−Removed: Stock (Lucid has recently raised over $18 million in such offering), seeking to restructure our and Lucid Diagnostics’
−Removed: outstanding indebtedness and pursuing additional offerings of debt and/or equity securities.
−Removed: The consolidated financial statements
−Removed: do not include any adjustments that might result from our inability to consummate such offerings or our ability to continue as a
−Removed: going concern.
−Removed: Moreover, there is no assurance if we consummate additional offerings, we will raise sufficient proceeds in such
−Removed: offerings to pay our financial obligations as they become due.
−Removed: These factors raise substantial doubt about our ability to continue
−Removed: as a going concern.
+Added: date, since our inception in June 2014, we have financed our operations principally through issuances (by us or by our subsidiaries)
+Added: of common stock, preferred stock, warrants, and debt, in both private placements and public offerings of our securities.
+Added: to generate sufficient revenue from any of our products in development, and to transition to profitability and generate consistent positive
+Added: cash flows is dependent upon factors that may be outside of our control.
+Added: While we have taken steps to reduce operating expenses, we expect
+Added: to continue to incur operating expenses in excess of our revenues as we continue to maintain our commercial infrastructure, develop,
+Added: enhance and commercialize products and incur additional operational and reporting costs associated with being a public company.
+Added: result, we expect to continue to incur operating losses for the foreseeable future.
+Added: We have concluded there is substantial doubt
+Added: of our ability to continue as a going concern and our independent registered public accounting firm’s report on our financial statements
+Added: contains an explanatory paragraph describing our ability to continue as a going concern.
+Added: In our December 31, 2024 consolidated financial statements, we have concluded and stated that our recurring losses
+Added: from operations, recurring cash flows used in operations and the requirement that we will need to raise additional capital in order to
+Added: fund our ongoing operations beyond March 2026 raise substantial doubt regarding our ability to continue as a going concern.
+Added: Additionally,
+Added: our independent registered public accounting firm’s report on our consolidated financial statements includes an explanatory paragraph
+Added: expressing substantial doubt about our ability to continue as a going concern.
+Added: Our plans to address this going concern risk include pursuing
+Added: further financings at PAVmed in addition to the recently completed Series C Preferred Stock Debt Exchange and the PAVmed and Veris Common
+Added: Stock Offering (we recently raised over $2.4 million in such offering) and pursuing additional offerings of debt and/or equity securities.
+Added: The consolidated financial statements do not include any adjustments that might result from our inability to consummate such offerings
+Added: or our ability to continue as a going concern.
+Added: Moreover, there is no assurance if we consummate additional offerings, we will raise sufficient
+Added: proceeds in such offerings to pay our financial obligations as they become due.
+Added: These factors raise substantial doubt about our ability
+Added: 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.
−Removed: to challenging market conditions, we have found it difficult to raise capital directly into PAVmed.
−Removed: As a result, we have become
−Removed: highly dependent on the ability of each of our subsidiaries to raise capital to fund their own operations.
−Removed: There is no assurance that
−Removed: 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
−Removed: reasonable terms.
−Removed: Accordingly, the failure of any of our subsidiaries to raise the capital it needs to fund its operations, could have
−Removed: a material adverse effect on the portion of our business related to such subsidiary.
−Removed: In addition, because of the challenges PAVmed has faced in terms of raising
−Removed: capital, we are highly dependent on our subsidiaries, including Lucid Diagnostics, as resources for funding our operations (notably, PAVmed
−Removed: may elect that Lucid Diagnostics satisfy its obligations under our management services agreement through cash payment).
−Removed: If Lucid Diagnostics
−Removed: is unable to continue to make any such cash payments we elect to receive, or determines to terminate the management services agreement
−Removed: (i.e., because it retains its own management team to oversee its operations), and PAVmed is unable to raise sufficient capital itself,
−Removed: it may not have sufficient capital to fund its operations, which in turn could have a material adverse effect on our business.
−Removed: All intercompany
−Removed: obligations between PAVmed, on the one hand, and any of its subsidiaries (including Lucid Diagnostics), on the other hand, are subject
−Removed: to approval by the PAVmed board and the board of the applicable subsidiary (including, in the case of Lucid Diagnostics, their independent
−Removed: There can be no assurance that our common stock
−Removed: will continue to trade on the Nasdaq Capital Market or another national securities exchange.
−Removed: There can be no assurance that we
−Removed: will be able to continue to meet Nasdaq Capital Market listing standards.
−Removed: If we are unable to maintain compliance with all applicable
−Removed: listing standards, our common stock may no longer be listed on the Nasdaq Capital Market or another national securities exchange and the
−Removed: liquidity and market price of our common stock may be adversely affected.
−Removed: On March 7, 2024, the Company received
−Removed: a notice from the Nasdaq Listing Qualifications Department stating that, for the preceding 30 consecutive business days (through March
−Removed: 6, 2024), the market value of the Company’s listed securities (“MVLS”) had been below the minimum of $35 million required
−Removed: for continued inclusion on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2).
−Removed: The notification letter stated that the Company
−Removed: would be afforded 180 calendar days (until September 3, 2024) to regain compliance.
−Removed: In order to regain compliance, the Company’s
−Removed: MVLS must close at $35 million or more for a minimum of ten consecutive business days.
−Removed: The notification letter also states that in the
−Removed: event the Company does not regain compliance prior to the expiration of the 180-day period, the Company will receive written notification
−Removed: that its securities are subject to delisting.
−Removed: There can be no assurance that the Company will be able to regain compliance by such deadline,
−Removed: in which case, unless the Company is able to obtain an extension for regaining compliance, the Company’s stock would be delisted.
−Removed: If we were so delisted, that could have a material adverse effect on your investment in the Company, including without limitation by substantially
+Added: to challenging market conditions, we have found it difficult to raise capital directly into PAVmed (notwithstanding our recent $2.37
+Added: million capital raise at PAVmed).
+Added: As a result, we have become highly dependent on the ability of each of our subsidiaries to raise capital
+Added: to fund their own operations.
+Added: There is no assurance that our subsidiaries will be able to raise capital as needed to fund its operations,
+Added: or that any of them will be able to do so on commercially reasonable terms.
+Added: Accordingly, the failure of any of our subsidiaries to raise
+Added: the capital it needs to fund its operations, could have a material adverse effect on the portion of our business related to such subsidiary.
+Added: addition, because of the challenges PAVmed has faced in terms of raising capital, we are highly dependent on our subsidiaries, including
+Added: Lucid Diagnostics, as resources for funding our operations (notably, PAVmed may elect that Lucid Diagnostics satisfy its obligations
+Added: under our management services agreement through cash payment and, under the terms of our outstanding convertible debt, we are required
+Added: to elect to receive such payments in cash).
+Added: In addition, under the terms of our outstanding convertible debt, if the price per share
+Added: of our common stock is less than the $1.068 conversion price of our Series C Preferred Stock, we are required to reserve 50% of all management
+Added: services agreement fees we receive, unless the holder of our debt waives such requirement (which it has through March 31, 2025).
+Added: Diagnostics is unable to continue to make any such cash payments we elect to receive, or if we are so required to reserve 50% of the
+Added: management services agreement fees we receive, or if Lucid Diagnostics determines to terminate the management services agreement (i.e.,
+Added: because it retains its own management team to oversee its operations), and PAVmed is unable to raise sufficient capital itself, it may
+Added: not have sufficient capital to fund its operations, which in turn could have a material adverse effect on our business.
+Added: we are successful in raising capital through our subsidiaries, such transaction would dilute PAVmed’s (and accordingly, our shareholders’)
+Added: interest in such subsidiaries, which in turn could reduce the proceeds available to PAVmed (and its shareholders) upon any disposition
+Added: or liquidation of such subsidiaries.
+Added: In addition, the terms of any such investment into our subsidiaries could contain covenants and
+Added: other restrictions that impair PAVmed’s control over such subsidiaries or the manner in which such subsidiaries operate.
+Added: can be no assurance that our common stock will continue to trade on the Nasdaq Capital Market or another national securities exchange.
+Added: can be no assurance that we will be able to continue to meet Nasdaq Capital Market listing standards.
+Added: If we are unable to maintain compliance
+Added: with all applicable listing standards, our common stock may no longer be listed on the Nasdaq Capital Market or another national securities
+Added: exchange and the liquidity and market price of our common stock may be adversely affected.
+Added: Company currently is (and from time to time in the recent past, the Company has been) out of compliance with the standards and requirements
+Added: for continued listing on Nasdaq.
+Added: Most recently,
+Added: on January 23, 2025, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30
+Added: consecutive business days (through January 22, 2025), the closing bid price of the Company’s common stock had been below the minimum
+Added: of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).
+Added: The notification letter
+Added: stated that the Company would be afforded 180 calendar days (until July 22, 2025) to regain compliance.
+Added: In order to regain compliance,
+Added: the closing bid price of the Company’s common stock must be at least $1 for a minimum of ten consecutive business days.
+Added: The notification
+Added: letter also stated that, in the event the Company does not regain compliance within the initial 180-day period, the Company may be eligible
+Added: for an additional 180-day period.
+Added: If the Company is not eligible for the additional 180-day period, or if it appears to the Nasdaq staff
+Added: that the Company will not be able to cure the deficiency, the Nasdaq Listing Qualifications Department will provide notice after the
+Added: end of the initial 180-day period that the Company’s securities will be subject to delisting.
+Added: In any event, there can be no assurance
+Added: that the Company will be able to regain compliance by the current or any extended deadline, in which case, the Company’s stock
+Added: would be delisted.
+Added: we were 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.
−Removed: Our subsidiary Lucid may issue shares of its
−Removed: 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
−Removed: a majority of the voting stock of Lucid.
−Removed: As of the date hereof, our subsidiary
−Removed: Lucid has issued 44,285 shares of Lucid Series B Preferred Stock.
−Removed: If the maximum amount of common stock underlying such securities were
−Removed: issued (including shares of Lucid common stock issued as a dividend thereon), the percentage of shares of Lucid common stock held by PAVmed
+Added: Our subsidiary Lucid may issue shares of its common and/or preferred stock
+Added: in the future, and the holder of our convertible debt may exchange such debt for our shares of Lucid common stock.
+Added: These events could
+Added: reduce the percentage equity interest of PAVmed in Lucid.
+Added: and thereby reduce its influence over matters subject to a shareholder vote
+Added: and otherwise adversely affect your investment in PAVmed.
+Added: of the date hereof, if the maximum amount of common stock underlying Lucid’s outstanding convertible securities were issued
+Added: (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 34% to approximately 18%.
−Removed: This reduced percentage would be further diluted in the event
−Removed: of future convertible debt or stock issuances by Lucid or by issuances under Lucid’s long-term incentive plan and employee stock
−Removed: purchase plan.
−Removed: While PAVmed would still retain a large ownership interest in Lucid in such event, it may cease to control the vote on
−Removed: matters requiring shareholder approval, including the election of Lucid’s board of directors.
−Removed: our indebtedness may require a significant amount of cash, and the restrictive covenants contained in our indebtedness could adversely
−Removed: affect our business plan, liquidity, financial condition, and results of operations.
−Removed: and our subsidiaries may be required to repay or redeem, or to pay interest on, the April 2022 Senior Convertible Note, the September
−Removed: 2022 Senior Convertible Note and the March 2023 Lucid Senior Convertible Note (collectively, the “Senior Convertible Notes”)
−Removed: or any future permitted indebtedness incurred by us or our subsidiaries, in cash.
−Removed: Despite our right to pay the interest and principal
−Removed: balance of the Senior Convertible Notes by issuing shares of our common stock, we may be required to repay such indebtedness in cash,
+Added: This reduced percentage would be further diluted in the
+Added: event of future convertible debt or stock issuances by Lucid or by issuances under Lucid’s long-term incentive plan and
+Added: employee stock purchase plan.
+Added: While PAVmed still has a significant ownership interest in Lucid in such event, the more its interest
+Added: in Lucid is diluted, the less influence it will have on matters requiring shareholder approval, including the election of
+Added: Lucid’s board of directors.
+Added: In addition, so long as any shares
+Added: of our Series C Preferred Stock remain outstanding, the holder of the September 2022 Senior Convertible Note may elect to exchange any
+Added: or all of such debt for the shares of Lucid Diagnostics we own at an exchange price of $0.85 per share, as of the date hereof, which would further reduce our ownership from the 18% to 13% (and as of March 20, 2025, the
+Added: closing bid price of a share of Lucid Diagnostics’ common stock was $1.57).
+Added: If PAVmed’s ownership interest
+Added: in Lucid declines, PAVmed may no longer be deemed to primarily control Lucid for the purposes of the Investment Company Act of 1940, as
+Added: amended (the “Investment Company Act”).
+Added: In such event, the securities of Lucid held by PAVmed would no longer be excluded
+Added: under certain tests used to determine whether PAVmed is deemed to be an investment company under the Investment Company Act.
+Added: could claim that it otherwise does not meet the definition of an investment company, or that it qualifies for an exemption therefrom,
+Added: but there can be no assurance that any such claim would be tenable or any such exemption would be available.
+Added: If PAVmed was deemed to be an investment company, it could seek to rely on the temporary exemption for transient
+Added: investment companies.
+Added: If it was not able to rely on such exemption, or the period for relief under such exemption expired and PAVmed was
+Added: still deemed to be an investment company, PAVmed could be forced to register as an investment company and comply with substantive requirements
+Added: under the Investment Company Act, including limitations on its ability to borrow, limitations on its capital structure, restrictions on
+Added: acquisitions of interests in associated companies, prohibitions on transactions with affiliates, restrictions on specific investments,
+Added: and compliance with reporting, record keeping, voting, proxy disclosure and other rules and regulations.
+Added: If PAVmed were forced to comply
+Added: with the Investment Company Act, its operations would significantly change, and it would be prevented from successfully executing its
+Added: business strategy.
+Added: If PAVmed was forced to sell assets to avoid regulation under the Investment Company Act, it also could be prevented
+Added: from successfully executing its business strategy.
+Added: our indebtedness may require a significant amount of cash, and the restrictive covenants contained in the documents that govern our indebtedness
+Added: and preferred stock could adversely affect our business plan, liquidity, financial condition, and results of operations.
+Added: and our subsidiaries may be required to repay or redeem, or to pay interest on, the September 2022 Senior Convertible Note or any future
+Added: permitted indebtedness incurred by us or our subsidiaries, in cash.
+Added: Despite our right to pay the interest and principal balance of the
+Added: September 2022 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.
6 unchanged sentences
and make necessary capital expenditures.
−Removed: In addition, the Senior Convertible Notes contain, and any future indebtedness may contain,
−Removed: restrictive covenants, including financial covenants.
−Removed: These payment obligations and covenants could have important consequences on our
+Added: In addition, the September 2022 Senior Convertible Note contains, and any future indebtedness
+Added: may contain, restrictive covenants, including financial covenants.
+Added: These payment obligations and covenants could have important consequences
+Added: on our business.
In particular, they could:
6 unchanged sentences
us at a competitive disadvantage compared to our competitors that have lower fixed costs.
−Removed: The debt service
−Removed: requirements of any other permitted indebtedness we incur or issue in the future, as well as the restrictive covenants contained in
−Removed: the governing documents for any such indebtedness, could intensify these risks.
−Removed: For example, while the Company is currently in
−Removed: compliance with the financial covenants under the Senior Convertible Notes it has issued, from time to time since the date of
−Removed: issuance of such notes (including, in the case of the indebtedness to market capitalization ratio test under such notes, as of
−Removed: December 31, 2023), the Company was not in compliance with certain financial covenants thereunder.
−Removed: The holders of such notes agreed
−Removed: 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
−Removed: (or in such other form as may be mutually agreed in writing) by April 25, 2024.
−Removed: However, there can be no assurance that we will have
−Removed: 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
−Removed: willing to do so, that it will be on terms and conditions agreeable to us.
−Removed: There is also no assurance that the holders will be
−Removed: willing to waive any future non-compliance with this or any other provision under the Senior Convertible Notes, or if they are
−Removed: willing to do so, if the terms on which they are so willing will be acceptable to us.
+Added: debt service requirements of any other permitted indebtedness we incur or issue in the future, as well as the restrictive covenants
+Added: contained in the governing documents for any such indebtedness, could intensify these risks.
+Added: For example, from time to time since
+Added: the date of issuance of the September 2022 Convertible Note, the Company was not in compliance with certain financial covenants
+Added: The holders of such notes agreed to waive any such non-compliance through December 31, 2025.
+Added: There is also no assurance
+Added: that the holders will be willing to waive any future non-compliance with this or any other provision under the September 2022 Senior
+Added: Convertible Note, 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.
15 unchanged sentences
it could be dilutive to shareholders or impose onerous terms on us.
−Removed: accounting method for convertible debt securities that may be settled in cash, such as the Senior Convertible Notes, could have a material
−Removed: effect on our reported financial results.
+Added: terms of our Series C Preferred Stock also include covenants substantially similar to those in the documentation that governs our
+Added: outstanding indebtedness, and accordingly, those covenants (and our failure to be in compliance with the same) could have the same
+Added: important consequences on our business.
+Added: addition, Lucid may be required to repay or redeem at maturity in 2029 (or sooner, upon the occurrence of certain changes
+Added: of control or an event of default), or to pay interest on, the November 2024 Senior Convertible Notes or any future permitted indebtedness
+Added: incurred by it or its subsidiaries, in cash.
+Added: Such payment obligations could have the same important consequences on its business, and
+Added: these debt service requirements or any debt service requirements in respect of any other permitted indebtedness Lucid may
+Added: incur or issue in the future, as well as the restrictive covenants contained in the governing documents for any such indebtedness, could
+Added: intensify these risks.
+Added: accounting method for convertible debt securities that may be settled in cash, such as the September 2022 Senior Convertible Note, could
+Added: have a material effect on our reported financial results.
May 2008, the Financial Accounting Standards Board (“FASB”) issued FASB Staff Position No.
2 unchanged sentences
as Accounting Standards Codification 470-20, Debt with Conversion and Other Options, or “ASC 470-20.” Under ASC 470-20, an
−Removed: entity must separately account for the liability and equity components of the convertible debt instruments (such as the Senior Convertible
−Removed: Notes) that may be settled entirely or partially in cash in a manner that reflects the issuer’s economic interest cost.
−Removed: of ASC 470-20 on the accounting for the Senior Convertible Notes is that the equity component is required to be included in the additional
−Removed: paid-in capital section of stockholders’ equity on our consolidated balance sheet and the value of the equity component would be
−Removed: treated as original issue discount for purposes of accounting for the debt component of the Senior Convertible Notes.
−Removed: As a result, we
−Removed: will be required to record a greater amount of non-cash interest expense in current periods presented as a result of the amortization
−Removed: of the discounted carrying value of the Senior Convertible Notes to their face amount over the term of the Senior Convertible Notes.
−Removed: We will report lower net income in our financial results because ASC 470-20 will require interest to include both the current period’s
−Removed: amortization of the debt discount and the instrument’s coupon interest, which could adversely affect our reported or future financial
−Removed: results, and the market price of our common stock.
−Removed: addition, under certain circumstances, convertible debt instruments (such as the Senior Convertible Notes) that may be settled entirely
−Removed: or partially in cash are currently accounted for utilizing the treasury stock method, the effect of which is that the shares issuable
−Removed: upon conversion of the Senior Convertible Notes are not included in the calculation of diluted earnings per share except to the extent
−Removed: that the conversion value of the Senior Convertible Notes exceeds their principal amount.
−Removed: Under the treasury stock method, for diluted
−Removed: earnings per share purposes, the transaction is accounted for as if the number of shares of our common stock that would be necessary
−Removed: to settle such excess, if we elected to settle such excess in shares, are issued.
−Removed: We cannot be sure that the accounting standards in
−Removed: the future will continue to permit the use of the treasury stock method.
−Removed: If we are unable to use the treasury stock method in accounting
−Removed: for the shares issuable upon conversion of the Senior Convertible Notes, then our diluted earnings per share would be adversely affected.
+Added: entity must separately account for the liability and equity components of the convertible debt instruments (such as the September 2022
+Added: Senior Convertible Note) that may be settled entirely or partially in cash in a manner that reflects the issuer’s economic interest
+Added: The effect of ASC 470-20 on the accounting for the September 2022 Senior Convertible Note is that the equity component is required
+Added: to be included in the additional paid-in capital section of stockholders’ equity on our consolidated balance sheet and the value
+Added: of the equity component would be treated as original issue discount for purposes of accounting for the debt component of the September
+Added: 2022 Senior Convertible Note.
+Added: As a result, we will be required to record a greater amount of non-cash interest expense in current periods
+Added: presented as a result of the amortization of the discounted carrying value of the September 2022 Senior Convertible Note to their face
+Added: amount over the term of the September 2022 Senior Convertible Note.
+Added: We will report lower net income in our financial results because
+Added: ASC 470-20 will require interest to include both the current period’s amortization of the debt discount and the instrument’s
+Added: coupon interest, which could adversely affect our reported or future financial results, and the market price of our common stock.
+Added: addition, under certain circumstances, convertible debt instruments (such as the September 2022 Senior Convertible Note) that may be
+Added: settled entirely or partially in cash are currently accounted for utilizing the treasury stock method, the effect of which is that the
+Added: shares issuable upon conversion of the September 2022 Senior Convertible Note are not included in the calculation of diluted earnings
+Added: per share except to the extent that the conversion value of the September 2022 Senior Convertible Note exceeds their principal amount.
+Added: Under the treasury stock method, for diluted earnings per share purposes, the transaction is accounted for as if the number of shares
+Added: of our common stock that would be necessary to settle such excess, if we elected to settle such excess in shares, are issued.
+Added: be sure that the accounting standards in the future will continue to permit the use of the treasury stock method.
+Added: If we are unable to
+Added: use the treasury stock method in accounting for the shares issuable upon conversion of the September 2022 Senior Convertible Note, then
+Added: our diluted earnings per share would be adversely affected.
Associated with Our Business
1 unchanged sentence
or abandon growth initiatives or product development programs.
−Removed: intend to continue to try to raise capital through each of our subsidiaries to support our business growth.
−Removed: Because we have not generated
−Removed: substantial revenue or cash flow to date, unless we are able to generate substantial revenue in the near-term (which we do not anticipate
−Removed: being able to do), we will require additional funds to:
+Added: Notwithstanding
+Added: that we were recently able to raise capital directly into PAVmed and that we believe we have sufficient access to capital (including
+Added: under our management services agreement with Lucid Diagnostics) to maintain our current level of business activity, we intend to raise
+Added: additional capital, likely through each of our subsidiaries, to support any business growth.
+Added: Because we have not generated substantial
+Added: 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
+Added: to do), we will require additional funds to:
our research and development;
7 unchanged sentences
in businesses, products and technologies, although we currently have no commitments or agreements relating to do so.
−Removed: fund our operations.
we do not have, or are not able to obtain, sufficient funds, we may have to delay product development initiatives or license to third
44 unchanged sentences
and the Veris Cancer Care Platform or any future tests or other products.
−Removed: Establishing and maintaining these capabilities may
−Removed: require our raising additional capital, which we may be unable to do.
+Added: Establishing and maintaining these capabilities may require
+Added: our raising additional capital, which we may be unable to do.
products may never achieve market acceptance.
6 unchanged sentences
of any of our products, including:
−Removed: timing of regulatory approvals of our products and services and market entry compared to
−Removed: competitive products;
−Removed: effectiveness of our products and services, including any potential side effects, as compared
−Removed: to alternative treatments;
−Removed: rate of adoption of our products and services by hospitals, doctors and nurses and acceptance
−Removed: by the health care community;
−Removed: labeling and /or inserts required by regulatory authorities for each of our products and
−Removed: competitive features of our products and services, including price, as compared to other
−Removed: similar products and services;
−Removed: availability of insurance or other third-party reimbursement, such as Medicare, for patients
−Removed: using our products and services;
+Added: timing of regulatory approvals of our products and services and market entry compared to competitive products;
+Added: effectiveness of our products and services, including any potential side effects, as compared to alternative treatments;
+Added: rate of adoption of our products and services by hospitals, doctors and nurses and acceptance by the health care community;
+Added: labeling and /or inserts required by regulatory authorities for each of our products and services;
+Added: competitive features of our products and services, including price, as compared to other similar products and services;
+Added: availability of insurance or other third-party reimbursement, such as Medicare, for patients using our products and services;
extent and success of our marketing efforts and those of our collaborators;
−Removed: ● unfavorable
publicity concerning our products and services or similar products and services.
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process these materials in a cost-effective manner.
−Removed: currently perform our EsoGuard test in one laboratory facility.
−Removed: If demand for our EsoGuard test grows, we may lack adequate facility
−Removed: space and capabilities to meet increased processing requirements.
−Removed: Moreover, if these or any future facilities or our equipment were damaged
−Removed: or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operate our business
−Removed: could be materially harmed.
−Removed: currently perform the EsoGuard test in a single laboratory facility in Lake Forest, CA.
−Removed: The laboratory facility, without purchasing additional
−Removed: lab equipment applicable to our test, is expected to have an annual capacity of approximately 50,000 tests per year.
−Removed: If demand for the
−Removed: EsoGuard test outstrips this capacity, and we fail to add additional equipment and staff, or complete, or timely complete, an expansion
−Removed: of its available laboratory facilities, it may significantly delay our EsoGuard processing times and limit the volume of EsoGuard tests
−Removed: we can process, which may adversely affect our business, financial condition and results of operation.
−Removed: In addition, our financial condition
−Removed: may be adversely affected if they are unable to complete these expansion projects on budget and otherwise on terms and conditions acceptable
−Removed: Finally, our financial condition will be adversely affected if demand for our products and services does not materialize in line
−Removed: with our current expectations and if, as a result, we end up building excess capacity that does not yield a reasonable return on our
+Added: demand for our EsoGuard test grows, we may lack adequate facility space and capabilities to meet increased processing requirements.
+Added: if these or any future facilities or our equipment were damaged or destroyed, or if we experience a significant disruption in our operations
+Added: for any reason, our ability to continue to operate our business could be materially harmed.
+Added: currently has adequate capacity to process EsoGuard tests, based on current test volumes.
+Added: If demand for the EsoGuard test outstrips
+Added: this capacity, and we fail to add additional equipment and staff, or complete, or timely complete, an expansion of Lucid’s
+Added: available laboratory facilities, it may significantly delay EsoGuard processing times and limit the volume of EsoGuard tests Lucid can process, which may adversely affect our business, financial condition and results of operation.
+Added: In addition, our
+Added: financial condition may be adversely affected if they are unable to complete these expansion projects on budget and otherwise on
+Added: terms and conditions acceptable to us.
+Added: Finally, our financial condition will be adversely affected if demand for our products and
+Added: services does not materialize in line with our current expectations and if, as a result, we end up building excess capacity that
+Added: does not yield a reasonable return on our investment.
our present, or any future, laboratory facilities were to be damaged, destroyed or otherwise unable to operate, whether due to fire,
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demand, fail to develop viable technologies or otherwise, we may not generate any revenues and our results of operations could be seriously
−Removed: We may not obtain the expected benefits of the
−Removed: incubator financing structure and may incur additional costs.
−Removed: We believe that the incubator financing
−Removed: structure will provide us with future benefits.
−Removed: These expected benefits are not guaranteed and may not be obtained if market conditions
−Removed: or other circumstances prevent us from taking advantage of the investment, financing and structuring flexibility we expect to gain as
−Removed: a result of the incubator financing structure.
+Added: may not obtain the expected benefits of the incubator financing structure and may incur additional costs.
+Added: believe that the incubator financing structure will provide us with future benefits.
+Added: These expected benefits are not guaranteed and may
+Added: not be obtained if market conditions or other circumstances prevent us from taking advantage of the investment, financing and structuring
+Added: flexibility we expect to gain as a result of the incubator financing structure (to date, we have been unsuccessful in our efforts to
+Added: raise capital through this structure).
If we fail to achieve some or all of the expected benefits of our incubator financing structure,
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Moreover, the incubator financing structure
−Removed: may be not fully insulate the liabilities of our subsidiaries from each other or from PAVmed, especially if we do not observe the requisite
+Added: may 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.
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are adequate to support our business and its anticipated growth.
−Removed: officers may allocate their time to other businesses thereby potentially limiting the amount of time they devote to our affairs.
−Removed: conflict of interest could have a negative impact on our operations.
−Removed: officers are not required to commit their full time to our affairs, which could create a conflict of interest when allocating their time
−Removed: between our operations and their other commitments.
−Removed: We presently expect each of our employees to devote such amount of time as they reasonably
−Removed: believe is necessary to our business.
−Removed: Certain of our officers are engaged in other business endeavors.
−Removed: If our officers’ other business
−Removed: affairs require them to devote more substantial amounts of time to such affairs, it could limit their ability to devote time to our affairs
−Removed: and could have a negative impact on our operations.
−Removed: We cannot assure you these conflicts will be resolved in our favor.
ability to be successful will be totally dependent upon the efforts of our key personnel.
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We may also be unable to attract and retain additional key personnel in the future.
−Removed: We are limited in shares available for issuance under our long-term incentive plan, which could limit our ability
−Removed: to attract and retain key personnel, until such amount is increased.
−Removed: An inability to attract and retain key personnel may impact our
−Removed: ability to continue and grow our operations.
+Added: We are limited
+Added: in shares available for issuance under our long-term incentive plan, which could limit our ability to attract and retain key personnel,
+Added: until such amount is increased.
+Added: 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
10 unchanged sentences
These factors include:
+Added: practices of the regulatory, tax, judicial and administrative bodies in the U.S.
+Added: and other jurisdictions where we operate;
+Added: burdensome taxation and changes in domestic and foreign tariffs;
associated with cultural differences, languages and distance;
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threat that our operations or property could be subject to nationalization and expropriation.
−Removed: practices of the regulatory, tax, judicial and administrative bodies in the jurisdictions where we operate;
−Removed: burdensome taxation and changes in foreign tax.
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.
−Removed: Associated with Healthcare Regulation, Billing and Reimbursement, and Product Safety and Effectiveness If
+Added: Associated with Healthcare Regulation, Billing and Reimbursement, and Product Safety and Effectiveness
private or governmental third-party payors do not maintain reimbursement for our products at adequate reimbursement rates, we may be
1 unchanged sentence
effect on our business.
−Removed: commercialization of Lucid’s EsoGuard test and EsoCheck device, and of any other product or service we develop, license or acquire
−Removed: depends, in large part, on the availability of adequate reimbursement from private or governmental third-party payors.
+Added: our initiative to establish a robust cash pay program, successful commercialization of Lucid’s EsoGuard test and EsoCheck device,
+Added: and of any other product or service we develop, license or acquire depends, in large part, on the availability of adequate reimbursement
+Added: 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
12 unchanged sentences
has fulfilled all these criteria, it indicated that it will “monitor the evidence and may revise this determination based on the
−Removed: pertinent literature and society recommendations.” Lucid expects to submit EsoGuard for Technical Assessment under this foundational
−Removed: LCD later this year.
−Removed: However, even if Lucid does submit EsoGuard for Technical Assessment as currently planned, there can be no assurance
−Removed: that MolDx will determine that EsoGuard meets the criteria for coverage as specified in the LCD.
−Removed: If Lucid is not granted coverage, or
−Removed: if a determination is substantially delayed, that could have a material adverse effect on Lucid’s ability to commercialize EsoGuard.
+Added: pertinent literature and society recommendations.” In November 2024, we announced that we submitted to MolDx our complete clinical
+Added: evidence package in support of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for
+Added: However, there can be no assurance that MolDx will determine that EsoGuard meets the criteria for coverage as specified in
+Added: If Lucid is not granted coverage, or if a determination is substantially delayed, that could have a material adverse effect
+Added: 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.
61 unchanged sentences
will not have a material impact on our business, there can be no assurance that will be the case.
−Removed: October 2023, FDA proposed a policy under which FDA intends to phase out its general enforcement discretion approach for LDTs so that
−Removed: IVDs (like EsoGuard) manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs.
−Removed: If finalized,
−Removed: FDA believes that this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable
−Removed: assurance of safety and effectiveness.
−Removed: As such, FDA has structured the proposed phaseout policy to contain five key stages:
−Removed: End the general enforcement discretion approach with respect to Medical Device Regulation (MDR) requirements and correction and
−Removed: removal reporting requirements 1 year after FDA publishes a final phaseout policy, which FDA intends to issue in the preamble of
−Removed: the final rule.
−Removed: End the general enforcement discretion approach with respect to requirements other than MDR, correction and removal reporting,
−Removed: Quality System (QS), and premarket review requirements 2 years after FDA publishes a final phaseout policy.
−Removed: End the general enforcement discretion approach with respect to QS requirements 3 years after FDA publishes a final phaseout policy.
−Removed: End the general enforcement discretion approach with respect to premarket review requirements for high-risk IVDs 3.5 years after
−Removed: FDA publishes a final phaseout policy, but not before October 1, 2027.
−Removed: End the general enforcement discretion approach with respect to premarket review requirements for moderate risk and low risk IVDs
−Removed: (that require premarket submissions) 4 years after FDA publishes a final phaseout policy, but not before April 1, 2028.
−Removed: is currently anticipated that FDA will finalize the proposed policy by April 2024.
−Removed: Once the final policy is released, we will implement
−Removed: the QS requirements in the recommended staged approach and conduct pre-submission meetings with FDA to seek agreement on regulatory pathway
−Removed: for EsoGuard premarket submission.
−Removed: As required by the final policy, Lucid will submit the regulatory premarket submission to the FDA
−Removed: as per the timeframe defined in the final policy.
−Removed: We are confident that the proposed policy will not have a commercial impact as Lucid
−Removed: already has a robust QS management platform for medical devices and EsoGuard will be able to transition to the platform to fulfill the
−Removed: QS requirements, if and when required by FDA.
−Removed: However, there can be no assurance that Lucid will be able to successfully transition the
−Removed: 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
−Removed: ability to commercialize EsoGuard and on our business as a whole.
+Added: May 6, 2024, the FDA issued a final rule aimed at helping to ensure the safety and effectiveness of LDTs.
+Added: The rule amends the FDA’s
+Added: regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer
+Added: of the IVD is a laboratory.
+Added: Along with this amendment, the FDA is finalizing a policy under which the FDA will provide greater oversight
+Added: of IVDs offered as LDTs through a phaseout of its general enforcement discretion approach for LDTs over the course of four years, as
+Added: well as targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.
+Added: phaseout policy contains the following five stages:
+Added: Beginning on May 6, 2025, which is one year after the publication date of the final LDT rule, FDA will expect compliance with
+Added: medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements
+Added: regarding complaint files.
+Added: Beginning on May 6, 2026, which is 2 years after the publication date of the final LDT rule, FDA will expect compliance with requirements
+Added: not covered during other stages of the phaseout policy, including registration and listing requirements, labeling requirements, and
+Added: investigational use requirements.
+Added: Beginning on May 6, 2027, which is 3 years after the publication date of the final LDT rule, FDA will expect compliance with QS
+Added: requirements (other than requirements regarding complaint files which are already addressed in stage 1).
+Added: Beginning on November 6, 2027, which is 3½ years after the publication date of the final LDT rule, FDA will expect compliance
+Added: with premarket review requirements for high-risk IVDs offered as LDTs (IVDs that may be classified into class III or that are subject
+Added: to licensure under section 351 of the Public Health Service Act), unless a premarket submission has been received by the beginning
+Added: of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review.
+Added: Beginning on May 6, 2028, which is 4 years after the publication date of the final LDT rule, FDA will expect compliance with premarket
+Added: review requirements for moderate-risk and low-risk IVDs offered as LDTs (that require premarket submissions), unless a premarket
+Added: submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion
+Added: for the pendency of its review.
+Added: FDA also intends to exercise enforcement discretion and generally not enforce some or all applicable requirements for certain categories
+Added: of IVDs manufactured by a laboratory.
+Added: The categories of enforcement discretion that are applicable to EsoGuard are summarized in the
+Added: marketed IVDs offered as LDTs first marketed prior to rule publication date and not modified beyond scope described in preamble Section
+Added: V.B.3 of preamble
+Added: generally expected beginning May 6, 2025
+Added: generally expected beginning May 6, 2026
+Added: with 21 CFR 820.180-820.186 generally expected beginning May 6, 2027;
+Added: generally not expected with other QS requirements (except for complaint files)
+Added: generally not expected
+Added: approved by NYS CLEP Section V.B.2 of preamble
+Added: generally expected beginning May 6, 2025
+Added: generally expected beginning May 6, 2026
+Added: generally expected beginning May 6, 2027
+Added: generally not expected
+Added: EsoGuard was marketed prior to rule publication and is also NYS CLEP approved, hence, enforcement discretion is applicable for
+Added: compliance with Stages 4 and 5.
+Added: We will be implementing compliance with MDR requirements, correction and removal reporting
+Added: requirements, and quality system (QS) requirements regarding complaint files by March 31, 2025, well before the deadline of May 6,
+Added: Gap analysis has been completed and we are expecting our compliance activities to be completed for Stages 2 and 3 before the FDA’s expected timeframes in 2026 and 2027, respectively.
+Added: confident that the proposed final rule will not have a commercial impact as the Company already has a robust QS management platform
+Added: for medical devices and EsoGuard will be able to easily transition to the platform to fulfill the QS requirements, as required by
+Added: However, there can be no assurance that Lucid will be able to successfully transition the platform to fulfill the QS
+Added: requirements, as required by FDA, and its failure to do so could have a material impact on Lucid’s ability to commercialize
+Added: 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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or suspension of manufacturing.
−Removed: reform measures could hinder or prevent our products’ commercial success.
+Added: reform measures, including those targeting Medicare or Medicaid, 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
−Removed: We cannot predict the initiatives that may be adopted in the future or their full impact.
−Removed: The continuing efforts of the government,
−Removed: insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of health care may
−Removed: adversely affect:
+Added: care, including those targeting Medicare or Medicaid.
+Added: We cannot predict the initiatives that may be adopted in the future or their full
+Added: The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services
+Added: to contain or reduce costs of health care may adversely affect:
ability to set a price that we believe is fair for our products;
77 unchanged sentences
No recalls of the Company’s medical
−Removed: products have been reported to the FDA.
+Added: products that we are seeking to commercialize have been reported to the FDA.
the Company’s medical products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject
55 unchanged sentences
significantly reduce the equity interest of investors;
−Removed: subordinate the rights of holders of common stock if preferred stock is issued with rights
−Removed: senior to those afforded to our common stockholders;
−Removed: cause a change in control if a substantial number of our shares of common stock are issued,
−Removed: which may affect, among other things, our ability to use our net operating loss carryforwards,
−Removed: if any, and most likely also result in the resignation or removal of some or all of our present
−Removed: officers and directors;
+Added: subordinate the rights of holders of common stock if preferred stock is issued with rights senior to those afforded to our common
+Added: stockholders;
+Added: cause a change in control if a substantial number of our shares of common stock are issued, which may affect, among other things,
+Added: our ability to use our net operating loss carryforwards, if any, and most likely also result in the resignation or removal of some
+Added: or all of our present officers and directors;
adversely affect prevailing market prices for our common stock.
+Added: holder of our convertible debt and the holder of our Series C Preferred Stock have certain rights with respect to the shares in Lucid
+Added: Diagnostics that we own, which may have a material impact on the return on any investment in shares of our common stock.
+Added: the terms of the September 2022 Senior Convertible Note and the Series C Preferred Stock, the holders thereof have certain rights that
+Added: may impact the extent to which our shareholders would participate in any disposition of our shares of Lucid Diagnostics.
+Added: any change of control of Lucid Diagnostics or any other disposition by us of our shares of Lucid Diagnostics requires the consent of
+Added: such holders.
+Added: In addition, so long as any shares of our Series C Preferred Stock remain outstanding, the holder of the September 2022
+Added: Senior Convertible Note may elect to exchange any or all of such debt for the shares of Lucid Diagnostics we own at an exchange price
+Added: of $0.85 per share (and as of March 20, 2025, the closing bid price of a share of Lucid Diagnostics’ common stock was $1.57).
+Added: Further, upon any change of control of Lucid Diagnostics or any other transaction involving the disposition of our shares in Lucid Diagnostics,
+Added: we are obligated to use the proceeds thereof to redeem the September 2022 Senior Convertible Note (plus any interest through maturity)
+Added: at a premium of 132.5%, and, moreover, we may elect to use a portion of the proceeds of such transaction to redeem our outstanding Series
+Added: C Preferred Stock (i.e., in lieu of allowing such holder to exchange the debt for our Lucid shares or to convert the Series C Preferred
+Added: Stock into shares of our common stock, in each case at a more favorable price), which in turn would substantially reduce the proceeds
+Added: available to holders of our common stock as a result of such transaction.
+Added: Any or all of these events could have a material impact on
+Added: the return on any investment in shares of our common stock.
management and their affiliates control a substantial interest in us and thus may influence certain actions requiring a stockholder vote.
56 unchanged sentences
which could materially and adversely affect our business, financial condition, results of operations and growth prospects.
−Removed: outstanding warrants and other convertible securities may have an adverse effect on the market price of our common stock.
+Added: outstanding warrants and other convertible securities may have an adverse effect on the market price of our common stock and the value
+Added: of your investment in us.
of December 31, 2024, there were 11,198,977 shares of our common stock issued and outstanding, and, as of such date, we also had issued
and outstanding:
−Removed: 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
−Removed: total number inclusive of both stock options granted under the PAVmed Inc.
−Removed: 2014 Long-Term Incentive Equity Plan (“PAVmed 2014
−Removed: Equity Plan”);
−Removed: 77,518 shares of our common stock reserved for issuance, but not subject to outstanding stock-based equity
−Removed: awards under the PAVmed 2014 Equity Plan;
+Added: options to purchase 1,065,319 shares of our common stock at a weighted average exercise price of $25.50 per share, with such total number
+Added: inclusive of both stock options granted under the PAVmed Inc.
+Added: 2014 Long-Term Incentive Equity Plan (“PAVmed 2014 Equity Plan”);
+Added: 247,109 shares of our common stock reserved for issuance, but not subject to outstanding stock-based equity awards under the PAVmed 2014
and 139,863 shares of our common stock reserved for issuance under the PAVmed Inc.
−Removed: Employee Stock Purchase Plan (“PAVmed ESPP”)
−Removed: 11,937,450 Series Z Warrants, representing the right to purchase 795,830 shares of the Company’s common stock
−Removed: at an exercise price of $23.48 per whole share;
−Removed: 1,305,213 shares of Series B Convertible Preferred Stock, convertible into 87,015 shares of our common
−Removed: addition, the Senior Convertible Notes have a current outstanding principal amount of $26.7 million, which are convertible into 355,520
−Removed: shares of our common stock (assuming the Senior Convertible Notes were converted in full on such date at the initial fixed conversion
−Removed: price of $75.00 per share).
−Removed: The number of shares of common stock to be issued under the Senior Convertible Notes may be substantially
−Removed: greater than the estimate set forth in this paragraph, if we pay the interest and the installments of principal in shares of our common
−Removed: stock, because in such cases (and in certain other cases as described elsewhere in this Annual Report on Form 10-K) the number of shares
−Removed: issued will be determined based on the then current market price (but in any event not more than fixed conversion price per share or
−Removed: less than a floor price specified in the notes).
−Removed: We cannot predict the market price of our common stock at any future date, and therefore,
−Removed: we are unable to accurately forecast or predict the total amount of shares that ultimately may be issued under these notes.
−Removed: the number of shares issued under these notes may be substantially greater if we voluntarily lower the conversion price, which we are
−Removed: permitted to do pursuant to the terms thereof.
+Added: Employee Stock Purchase Plan (“PAVmed
+Added: (ii) 11,937,450
+Added: Series Z Warrants, representing the right to purchase 795,830 shares of the Company’s common stock at an exercise price of $23.48
+Added: per whole share;
+Added: (iii) 1,412,865
+Added: shares of Series B Convertible Preferred Stock, convertible into 94,191 shares of our common stock.
+Added: shares of Series C Preferred Stock, convertible into 23,408,240 of our common stock (assuming the shares of Series C Preferred Stock
+Added: were converted in full on such date at the fixed conversion price of $1.068 per share).
+Added: addition, the September 2022 Senior Convertible Note has an outstanding principal amount, as of March 20, 2025, of $6.6 million,
+Added: which is convertible into 6,160,664 shares of our common stock (assuming the September 2022 Senior Convertible Note was
+Added: converted in full on such date at the fixed conversion price of $1.068 per share).
+Added: The number of shares of common stock to be issued
+Added: under the September 2022 Senior Convertible Note may be substantially greater than the estimate set forth in this paragraph, if we
+Added: pay the interest and the installments of principal in shares of our common stock, because in such cases (and in certain other cases
+Added: as described elsewhere in this Annual Report on Form 10-K) the number of shares issued will be determined based on the then current
+Added: market price (but in any event not more than fixed conversion price per share or less than a floor price specified in the notes), or
+Added: if we agree to voluntarily reduce the conversion price under the note (for example, in consideration of any waiver or consent we
+Added: We cannot predict the market price of our common stock at any future date, and therefore, we are unable to accurately
+Added: forecast or predict the total amount of shares that ultimately may be issued under these notes.
+Added: In addition, the number of shares
+Added: issued under this note may be substantially greater if we voluntarily lower the conversion price, which we are permitted to do
+Added: pursuant to the terms thereof.
+Added: the number of shares of common stock to be issued upon conversion of the shares of Series C Preferred Stock may be substantially
+Added: greater than the estimate set forth in clause (iv) above, if a “triggering event” occurs, because in such event, the
+Added: number of shares issued will be determined based on the then current market price (but in any event not more than the fixed
+Added: conversion price per share or less than a floor price specified in the certificate of designations for the Series C Preferred
+Added: Stock), or if we agree to voluntarily reduce the conversion price for the Series C Preferred Stock (for example, in consideration of
+Added: any waiver or consent we might need).
issuance of these shares will dilute our other equity holders, which could cause the price of our common stock to decline.
+Added: These convertible
+Added: securities will also reduce the proceeds distributable to our shareholders, including any distributions of the proceeds of any sale
+Added: of the shares of Lucid Diagnostics held by us or any other transaction involved a disposition of one of our subsidiaries.
do not intend to pay any cash dividends on our common stock at this time.
9 unchanged sentences
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
−Removed: February 15, 2024, the Company distributed by special dividend to the Company stockholders 3,331,747 shares of Lucid Diagnostics
−Removed: common stock held by the Company.
−Removed: On such date, each PAVmed shareholder as of the January 15, 2024 record date received a stock
−Removed: dividend of approximately 38 shares of Lucid common stock for every 100 shares of PAVmed common stock they held as of such date.
−Removed: 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.
+Added: February 15, 2024, the Company distributed by special dividend to the Company stockholders 3,331,747 shares of Lucid Diagnostics common
+Added: stock held by the Company.
+Added: On such date, each PAVmed shareholder as of the January 15, 2024 record date received a stock dividend of
+Added: approximately 38 shares of Lucid common stock for every 100 shares of PAVmed common stock they held as of such date.
+Added: However, our Board
+Added: 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
114 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.