Sign in

LUCD on Nasdaq

Lucid Diagnostics Inc.

In its 2026 annual report the company says: “Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics technology company.”4 It is headquartered in New York, New York.1 Its shares trade on Nasdaq under the symbol LUCD.1

Price unavailable

Last updated Oct 21, 2026.

Overview

Compare with Picard Medical, Inc., Plus Therapeutics or INTELLIGENT BIO SOLUTIONS INC., or pick any stock.

  • TickerLUCD on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersNew York, New York1
  • Incorporated inDE2
  • Business address360 Madison Avenue, 25Th Floor, New York, Ny 100172
  • Filer category, Emerging growth company2
  • Legal formCorporation

See how the biggest companies compare on our leaderboards

Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics technology company. Lucid is focused on the millions of patients with gastroesophageal reflux disease (“GERD”), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (“EAC”).4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-1054.8%Operating margin5
-1232.7%Net margin5
8.3%Revenue growth, 20255
-530.4%Return on equity5
-$46.7MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue54¢$6.7M
  • Research and development46¢$5.7M

Out of $4.7M in revenue.5 The company lost money this year.

Financial statements

Revenue6785$4.7M in 2025+841% since 2021
0$2.0M$4.0M$6.0M2021: $500.0K$500.0K20212022: $377.0K$377.0K2022−25%2023: $2.4M$2.4M2023+544%2024: $4.3M$4.3M2024+79%2025: $4.7M$4.7M2025+8%
Gross profit6$377.0K in 2022−25% since 2021
0$200.0K$400.0K$600.0K2021: $500.0K$500.0K20212022: $377.0K$377.0K2022−25%
Operating income96785-$49.6M in 2025+500% since 2020
-$60.0M-$40.0M-$20.0M02020: -$8.3M-$8.3M20202021: -$27.4M-$27.4M2021+231%2022: -$56.3M-$56.3M2022+105%2023: -$48.5M-$48.5M2023−14%2024: -$46.1M-$46.1M2024−5%2025: -$49.6M-$49.6M2025+8%
Net income96785-$58.0M in 2025+601% since 2020
-$60.0M-$40.0M-$20.0M02020: -$8.3M-$8.3M20202021: -$28.1M-$28.1M2021+239%2022: -$56.2M-$56.2M2022+100%2023: -$52.7M-$52.7M2023−6%2024: -$45.5M-$45.5M2024−14%2025: -$58.0M-$58.0M2025+27%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Revenue$4.7M$4.3M
Cost of revenue$6.7M$7.1M
Sales and marketing$17.7M$16.5M
General and administrative$23.9M$20.2M
Amortization of acquired intangible assets$421.0K$688.0K
Research and development$5.7M$6.0M
Total operating expenses$54.3M$50.4M
Operating loss-$49.6M-$46.1M
Interest income$386.0K$322.0K
Interest expense-$22.0K-$26.0K
Change in fair value - Senior Secured Convertible Note-$7.7M$5.4M
Debt extinguishments loss - Senior Secured Convertible Note$0-$5.2M
Equity issuance cost extinguishment-$1.1M$0
Other income (expense), net-$8.4M$523.0K
Loss before provision for income tax-$58.0M-$45.5M
Provision for income taxes$0$0
Net loss attributable to Lucid Diagnostics Inc.-$58.0M-$45.5M
Net loss attributable to Lucid Diagnostics Inc. common stockholders-$70.6M-$53.0M
Net loss per share attributable to Lucid Diagnostics Inc. common stockholders - basic and diluted (in dollars per share)-$0.69-$1.05
Weighted average common shares outstanding, basic and diluted (in shares)101.9M shares50.5M shares

Compare Lucid Diagnostics Inc. with another company

Corporate structure

Lucid Diagnostics Inc. sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Lucid Diagnostics Inc.

  • PAVmed Inc. Filed SCHEDULE 13D/A on Lucid Diagnostics Inc., latest Feb 9, 2026 (7 filings since Oct 27, 2021)
  • Ayrton Capital LLC Filed SCHEDULE 13G/A on Lucid Diagnostics Inc., latest Feb 13, 2025 (5 filings since Mar 23, 2023)
  • Lucid Diagnostics Inc. New York, New York
    • CapNostics LLC (84-4876240) Subsidiary · North Carolina, United States
    • LucidDx Labs Inc. (87-41661458) Subsidiary · Delaware, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Lucid Diagnostics Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$2.4M5 Dec 31, 2025$2.2M5 Dec 31, 2024+8.2%
Accumulated depreciation$1.6M5 Dec 31, 2025$1.1M5 Dec 31, 2024+37.9%
Property and equipment, net$809.0K5 Dec 31, 2025$1.1M5 Dec 31, 2024−23.8%
Operating-lease assets (leased space)$1.8M5 Dec 31, 2025$2.6M5 Dec 31, 2024−31.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$22.4M8 Dec 31, 2024$18.9M8 Dec 31, 2023+18.3%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$315.0K5 Dec 31, 2025$736.0K5 Dec 31, 2024−57.2%
Finite-lived intangibles, gross$5.3M5 Dec 31, 2025$5.3M5 Dec 31, 20240%
Accumulated amortization$5.0M5 Dec 31, 2025$4.6M5 Dec 31, 2024+9.2%
Finite-lived intangibles, net$315.0K5 Dec 31, 2025$736.0K5 Dec 31, 2024−57.2%

Inventory

ItemLatestA year beforeChange
Inventory, total$353.0K5 Dec 31, 2025$341.0K5 Dec 31, 2024+3.5%

Properties, in its own words

Our corporate offices are located at 360 Madison Avenue, 25th Floor, New York, NY 10017, which is leased through our parent corporation PAVmed Inc. The lease for this space is for seven years and eight months, starting on February 1, 2023, and may not be terminated prior to expiration of its stated term, except in limited circumstances due to misconduct by our landlord.

The Company has a lease agreement for its CLIA laboratory in California with 21,019 square feet, which has a remaining term expiring December 31, 2027. We also have lease agreements in various locations in Arizona, California, Colorado, Connecticut, Florida, Massachusetts, Nevada and Texas that in the aggregate approximate 4,500 square feet. At this time, we consider our facility space to be commensurate with our current operations. Notwithstanding, we may obtain additional office space in the future, as warranted by our business operations.

Item 2 of the 10-K filed Mar 25, 2026.4

Leadership

Who has led Lucid Diagnostics Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Lishan Aklog2021–now

President

  1. Shaun O'Neil2024–now

Chief financial officer

  1. Dennis M. McGrath2021–now

Chief operating officer

  1. Shaun O'Neil2023–now
2025
Board members and other officers (10)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorRONALD M. SPARKS named Mar 22, 2023 to Dec 6, 202426
  • DirectorSTANLEY N. LAPIDUS named Mar 22, 2023 to Dec 6, 202426

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • CapNostics LLC (84-4876240) North Carolina3
  • LucidDx Labs Inc. (87-41661458) Delaware3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Sep 22, 20268-K Regulation FD disclosure27
  2. Aug 13, 20268-K Results of operations; Regulation FD disclosure28
  3. Jun 24, 20268-K Bylaws or fiscal year changed; Shareholder vote29
  4. May 14, 20268-K Results of operations; Regulation FD disclosure30
  5. Apr 24, 20268-K Regulation FD disclosure; Other events31
  6. Apr 23, 20268-K Entered a material agreement; Regulation FD disclosure32
  7. Mar 26, 20268-K Results of operations; Regulation FD disclosure33
  8. Nov 12, 20258-K Results of operations; Regulation FD disclosure34
  9. Sep 25, 20258-K Executive or director change; Regulation FD disclosure35
  10. Sep 11, 20258-K Regulation FD disclosure; Other events36
  11. Sep 10, 20258-K Entered a material agreement; Regulation FD disclosure37
  12. Aug 13, 20258-K Results of operations; Regulation FD disclosure38
  13. Oct 13, 2021New chief executive Lishan Aklog becomes CEO13

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.11) a share, on Nov 12, 2025.39

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results28
  2. May 14, 2026Reported quarterly or annual results30
  3. Mar 26, 2026Reported quarterly or annual results33
  4. Nov 12, 2025Reported quarterly or annual results34
  5. Aug 13, 2025Reported quarterly or annual results38
  6. May 14, 2025Reported quarterly or annual results40
  7. Mar 25, 2025Reported quarterly or annual results41
  8. Nov 13, 2024Reported quarterly or annual results42

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

269 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 70 major events, 78 insider forms, 12 large holders, 4 private raises, 85 other. The latest 20:

  1. Sep 22, 20268-K EDGAR
  2. Aug 13, 20268-K EDGAR
  3. Aug 12, 202610-Q EDGAR
  4. Jun 24, 20268-K EDGAR
  5. May 21, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  6. May 14, 20268-K EDGAR
  7. May 13, 202610-Q EDGAR
  8. Apr 30, 2026DEFA14A EDGAR
  9. Apr 30, 2026ARS EDGAR
  10. Apr 30, 2026DEF 14A EDGAR
  11. Apr 24, 20268-K EDGAR
  12. Apr 24, 20263/A AMENDED INITIAL STATEMENT OF BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  13. Apr 23, 2026424B5 EDGAR
  14. Apr 23, 20268-K EDGAR
  15. Apr 20, 2026PRE 14A EDGAR
  16. Apr 13, 20263 INITIAL STATEMENT OF BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  17. Apr 3, 2026S-8 EDGAR
  18. Apr 3, 2026S-8 EDGAR
  19. Mar 26, 2026EFFECT EDGAR
  20. Mar 26, 2026424B5 EDGAR

The 269 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

16 open-market trades by officers, directors and large owners since October 2021: 9 buys and 7 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 20, 2026Matheis DennisDirectorBuy245,000$1.00$245.0KForm 4
Aug 20, 2025Matheis DennisDirectorBuy100,000$1.02$102.0KForm 4
May 22, 2025Matheis DennisDirectorBuy33,218$1.32$43.8KForm 4
May 22, 2025Matheis DennisDirectorBuy33,218$1.32$43.8KForm 4
May 21, 2025Matheis DennisDirectorBuy129,684$1.32$171.2KForm 4
May 21, 2025Matheis DennisDirectorBuy129,684$1.32$171.2KForm 4
May 20, 2025Matheis DennisDirectorBuy187,098$1.30$243.2KForm 4
May 20, 2025Matheis DennisDirectorBuy187,098$1.30$243.2KForm 4
Sep 26, 2023Lapidus StanleyDirectorSale29,747$1.45$43.1KForm 4
Sep 25, 2023Lapidus StanleyDirectorSale200$1.43$286Form 4
Sep 21, 2023Lapidus StanleyDirectorSale100$1.44$144Form 4
Sep 21, 2023Lapidus StanleyDirectorSale100$1.44$144Form 4
Sep 20, 2023Lapidus StanleyDirectorSale3,817$1.45$5.5KForm 4
Sep 20, 2023Lapidus StanleyDirectorSale3,817$1.45$5.5KForm 4
Sep 20, 2022Lapidus StanleyDirectorSale33,864$1.71$57.7KForm 4
Oct 18, 2021PAVmed Inc.10% ownerBuy571,428$14.00$8.0MForm 4

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Lishan AklogM.D.60$300.0K$897.0K45
2025Shaun M. O’Neil44$300.0K$822.0K45
2025Michael A. Gordon52$250.0K$759.5K45
2025Dennis M. McGrath69$225.0K$750.8K45
2024Chairman of the Board and Chief Executive Officer$300.0K$712.0K45
2024President and Chief Operating Officer$300.0K$712.0K45
2024General Counsel and Corporate Secretary$250.0K$662.0K45
2024Chief Financial Officer$225.0K$637.0K45

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Nov 22, 2024Raised $21.9 million in a private offering of debt Form D: 7 investors so far Form D
  2. Oct 18, 2023Raised $5 million in a private offering of equity Form D: 2 investors so far Form D
  3. Mar 21, 2023Raised $11.1 million in a private offering of debt Form D: 1 investor so far Form D
  4. Mar 7, 2023Raised $13.6 million in a private offering of equity Form D: $20 million offered in all Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Alyeska Investment Group, L.P.8,856,844$9.5M0.0%New
BlackRock, Inc.8,373,117$9.0M0.0%+3,734,874
Vanguard Capital Management LLC6,556,344$7.0M0.0%+2,401,574
Two Seas Capital LP6,000,000$6.4M0.2%+3,000,000
Masters Capital Management LLC4,000,000$4.3M0.6%No change
Aberdeen Group plc3,822,997$4.1M0.0%+178,720
Geode Capital Management, LLC3,789,948$4.1M0.0%+1,544,598
State Street Corp2,437,337$2.6M0.0%+882,756
First Manhattan Co. Llc.2,188,550$2.3M0.0%+1,865,100
Wells Fargo & Company/mn2,067,046$2.2M0.0%+792,656
Russell Investments Group, Ltd.1,651,788$1.8M0.0%+68,180
Northern Trust Corp1,219,879$1.3M0.0%+549,294
Perkins Capital Management Inc1,125,000$1.2M0.9%−1,000
Vanguard Fiduciary Trust Co1,068,109$1.1M0.0%+444,552
Vanguard Portfolio Management LLC1,022,262$1.1M0.0%+493,493
UBS Group AG845,314$904.5K0.0%+399,835
Aqr Capital Management LLC723,200$773.8K0.0%+488,431
Raymond James Financial Inc577,381$617.8K0.0%+52,445
Lido Advisors, LLC446,739$478.0K0.0%+63,657
Charles Schwab Investment Management Inc325,312$348.1K0.0%+127,888
XML Financial, LLC323,195$345.8K0.0%+100,000
Bank of New York Mellon Corp301,703$322.8K0.0%+95,397
Bank Of Montreal /can/289,936$310.2K0.0%+4,700
Nuveen, LLC195,065$208.7K0.0%+104,831
Tripletail Wealth Management, LLC183,417$196.3K0.2%New

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Lucid Diagnostics Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARLucid Diagnostics Inc.1
  • CIK0001799011
  • Employer ID (EIN)82-54880424
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address360 Madison Avenue, 25Th Floor, New York, NY 100171
  • Phone212 949 43191
  • Shares outstanding203,243,970 as of Aug 10, 202612
  • Public float$82.7M as of Jun 30, 20254
  • AuditorMarcum LLP, New York, NY PCAOB ID 199; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceJan 21, 20201
  • Filings279 in all: 8-K (69), 4 (59), 10-Q (15), 3 (15), CORRESP (10), S-8 (10), 424B5 (9), UPLOAD (8)1
    All 38 form types

    DEFA14A (7), EFFECT (7), DEF 14A (6), PRE 14A (6), 10-K (5), S-3 (5), 424B3 (4), D (4), S-1/A (4), SC 13D/A (4), 4/A (3), ARS (3), DRS/A (2), DRSLTR (2), S-1 (2), S-3/A (2), SC 13G (2), SC 13G/A (2), SCHEDULE 13D/A (2), SEC STAFF LETTER (2), 144 (1), 3/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS (1), NT 10-K (1), SC 13D (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 25, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Sep 22, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per shareLUCDThe NASDAQ Stock Market LLC

From the cover page of the 10-K filed Mar 25, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Lucid Diagnostics Inc. names in Item 1A of its 10-K filed Mar 25, 2026: 68 risks under these headings, as written.4

  • Risks Factor Summary
  • Risks Associated with Our Financial Condition
  • Risks Associated with Our Business
  • Risks Associated with Healthcare Regulation, Billing and Reimbursement, and Product Safety and Effectiveness.
  • Risks Associated with Our Intellectual Property and Technology Infrastructure
  • Risks Associated with Our Relationship with PAVmed
  • Risks Associated with Ownership of Our Common Stock
  • We have incurred operating losses since our inception and may not be able to achieve profitability.
  • We have concluded there is substantial doubt of our ability to continue as a going concern and our independent registered public accounting firm’s report on our financial statements contains an explanatory paragraph describing our ability to continue as a going concern.
  • To raise capital, we have issued a significant amount of convertible securities under which we expect to issue a correspondingly significant amount of shares of our common stock upon conversion thereof. In addition, we may issue shares of our capital stock or debt securities in the future in order to raise capital to fund our operations. All of the foregoing would dilute the equity interest of our stockholders and might cause a change in control of our ownership.
  • We expect to need additional capital funding, which may be compounded by our obligations to our parent company, PAVmed, which requires its own additional capital funding.
  • Our quarterly operating results could be subject to significant fluctuation, which could increase the volatility of our stock price and cause losses to our stockholders.
The other 62 risks
  • Servicing 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.
  • Since we have a limited operating history, and have not generated any significant revenues to date, you will have little basis upon which to evaluate our ability to achieve our business objective.
  • The markets in which we operate are attractive and other companies or institutions may develop and market novel or improved technologies, which may make the EsoGuard or EsoCheck technologies less competitive or obsolete.
  • We expect to derive substantially all of our revenues from the EsoGuard and EsoCheck products.
  • We are highly dependent on our license agreement with CWRU, the termination of which would prevent us from commercializing our products, and which imposes significant obligations on us.
  • Our products may never achieve market acceptance, despite our investment of significant time and resources to drive adoption.
  • The sizes of the markets for our current and future products have not been established with precision, and may be smaller than we estimate.
  • Recommendations in published clinical practice guidelines issued by various organizations, including professional societies and federal agencies may significantly affect payors’ willingness to cover, and physicians’ willingness to prescribe, our products and services.
  • We or our third-party manufacturers may not have the manufacturing and processing capacity to meet the production requirements of consumer demand or clinical testing in a timely manner.
  • If demand for our EsoGuard test grows, we may lack adequate facility space and capabilities to meet increased processing requirements. Moreover, if these or any future facilities or their equipment were damaged or destroyed, or if we experience a significant disruption in our commercial clinical laboratory operations for any reason, our ability to continue to operate our business could be materially harmed.
  • Our results of operations can be adversely affected by labor shortages, turnover, and labor cost increases.
  • We expect to rely on courier delivery services to transport EsoCheck devices and EsoGuard specimen kits to physicians and other medical professionals and samples back to laboratory facilities for analysis. If these delivery services are disrupted or become prohibitively expensive, customer satisfaction and our business could be negatively impacted.
  • If we attempt to bring any other products or services to market in addition to the EsoGuard test and EsoCheck device, we likely will be required to make significant investments in research and development, which ultimately may prove unsuccessful. Our future performance may be affected by the success of products we have not yet developed, licensed, acquired.
  • Our ability to be successful will be totally dependent upon the efforts of our key personnel.
  • Our 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.
  • Our business may suffer if we are unable to manage our growth.
  • Our business, financial condition and results of operations could be adversely affected by the political and economic conditions of the U.S. and the other countries in which we conduct business.
  • We may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.
  • Adverse results in material litigation matters could have a material adverse effect upon our business.
  • 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.
  • If we fail to maintain CLIA-certification or otherwise meet the applicable requirements of federal or state law regulating commercial clinical laboratories, such failure could limit or prevent our ability to perform our EsoGuard test, or any other tests which we may develop, license or acquire, affect any payor consideration of such tests, prevent their clearance or approval entirely, and/or interrupt the commercial sale and/or marketing of any such tests, cause us to incur significant expense to remedy this failure and otherwise negatively impact our business.
  • EsoGuard may not be jointly marketed as a combined product with EsoCheck without first securing FDA approval of the combined product as an IVD device. If FDA deems that we are jointly marketing such an IVD product with EsoCheck without FDA approval of the combined product as an IVD device, we would be subject to FDA enforcement action which could limit or halt commercialization of our products, and result in FDA sanctions which could severely impact our business.
  • Securing FDA approval of EsoGuard as an IVD device, separately or as a combined product with EsoCheck, is a complex process requiring substantial time, commitment of resources and expense without any assurance that FDA will grant such approval.
  • Failure to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.
  • Modifications to our cleared or approved products may require new clearances or premarket approvals, or may require us to cease marketing or recall the modified products until clearances are obtained.
  • Clinical trials necessary to support regulatory submission will be expensive and will require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Delays or failures in our clinical trials will prevent us from expanding our commercial efforts and will adversely affect our business, operating results and prospects.
  • The results of our clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects.
  • If our clinical studies do not satisfy providers, payors, patients and others as to the reliability and performance of our EsoGuard test and the EsoCheck device, or any other product or service we may develop and seek to commercialize, we may experience reluctance or refusal on the part of physicians to order, and third-party payors to pay for, such test.
  • EsoCheck and any other products we develop that receive regulatory clearance or approval will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.
  • If we are found to be promoting the use of our devices for unapproved or “off-label” uses or engaging in other noncompliant activities, we may be subject to recalls, seizures, fines, penalties, injunctions, adverse publicity, prosecution, or other adverse actions, resulting in damage to our reputation and business.
  • Clinical laboratories and medical diagnostic companies are subject to extensive and frequently changing federal, state, and local laws. We could be subject to significant fines and penalties if we fail (or if our prior unrelated third-party laboratory partner previously failed) to comply with these laws and regulations.
  • We operate Lucid Test Centers where prescribing physicians can send patients for EsoGuard testing, including undergoing specimen collection using EsoCheck. These Lucid Test Centers are subject to federal and state regulations which may be burdensome, costly or difficult to comply with. Failure to comply with these regulations could result in sanctions, fines or other enforcement actions which may be costly, time-consuming and limit our ability to utilize them and adversely impact our business.
  • Many aspects of our business, beyond the specific elements described above, are subject to complex, intertwined, costly and/or burdensome federal and state health care laws and regulations which may open to interpretation and be subject to varying levels of discretionary enforcement. If we fail to comply with these laws and regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
  • The regulations that govern pricing and reimbursement for new products vary widely from country to country, and may adversely affect the pricing, coverage and reimbursement rates of our products in other countries.
  • Due to billing complexities in the diagnostic and laboratory service industry, we may not be able to collect payment for the EsoGuard tests we perform.
  • Healthcare reform measures, including those targeting Medicare or Medicaid, could hinder or prevent our products’ commercial success.
  • Our medical products may in the future be subject to product recalls that could harm our reputation, business, and financial results.
  • If our medical products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our products.
  • Compliance with the HIPAA security, privacy and breach notification regulations may increase our costs.
  • We may not be able to protect or enforce the intellectual property rights for the technology used in, or expected to be used in, our products, which could impair our competitive position.
  • We 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.
  • Competitors may violate the intellectual property rights for the technology used in, or expected to be used in, our products, and we may bring litigation to protect and enforce our intellectual property rights, which may result in substantial expense and may divert our attention from implementing our business strategy.
  • Failure in our information technology systems could significantly disrupt our operations and our research and development efforts, which could adversely impact our revenues, as well as our research, development and commercialization efforts.
  • Our internal computer systems, or those used by our third-party research institution collaborators, vendors or other contractors or consultants, may suffer security breaches.
  • PAVmed holds more voting stock than any of our other shareholders and thus it (or any successor to its stake in the Company), may have significant influence over certain actions requiring a stockholder vote.
  • As a result of the exercise by the holder of PAVmed’s debt of its rights under the agreements governing that instrument, such holder could acquire voting control of the Company.
  • Certain conflicts of interest may arise between us and our affiliated companies, including PAVmed, and in some cases we have waived certain rights with respect thereto.
  • Our ability to operate our business effectively may suffer if the MSA with PAVmed is insufficient to meet our needs or if, upon the termination of the MSA, we do not cost-effectively establish our own fully functional financial, administrative, operational and other support systems in order to operate as a stand-alone company.
  • Any disputes that arise between us and PAVmed with respect to our past and ongoing relationships could harm our business operations.
  • If 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.
  • Nasdaq may in the future delist our common stock, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.
  • Our stock price may be volatile, and holders of our common stock could incur substantial losses.
  • We do not intend to pay any dividends on our common stock at this time.
  • We are obligated to pay dividends in shares of our common stock to the holders of shares of our Series B-1 Preferred Stock, which stock dividend will dilute our existing shareholders.
  • We incur significant costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance initiatives.
  • If we fail to establish and maintain proper and effective internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could decline significantly.
  • We are subject to evolving corporate governance and public disclosure expectations and regulations that impact compliance costs and risks of noncompliance.
  • We are an “emerging growth company,” and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our common stock less attractive to investors.
  • Provisions 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.
  • Our charter provides, subject to limited exceptions, that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for certain stockholder litigation matters, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or stockholders.

Legal proceedings

In the ordinary course of the Company’s business, particularly as it begins commercialization of its products, the Company may be subject to certain other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may arise from time to time. The Company is not aware of any such pending legal or other proceedings that are reasonably likely to have a material impact on the Company. Notwithstanding, legal proceedings are subject to inherent uncertainties, and an unfavorable outcome could include monetary damages, and excessive verdicts can result from litigation, and as such, could result in a material adverse impact on the Company’s business, financial position, results of operations, and /or cash flows. Additionally, although the Company has specific insurance for certain potential risks, the Company may in the future incur judgments or enter into settlements of claims which may have a material adverse impact on the Company’s business, financial position, results of operations, and /or cash flows.

The opening of Item 3, Legal Proceedings.4

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45