PAVM US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

DC 20549

FORM

10-K

(Mark

One)

For

the fiscal year ended December 31, 2024

OR

For

the transition period from ______ to ______

Commission

File Number: 001-37685

PAVMED

INC.

(Exact

Name of Registrant as Specified in Its Charter)

(State or Other Jurisdiction of (IRS Employer

Incorporation or Organization) Identification No.)

360 Madison Avenue

(Address of Principal Executive Offices) (Zip Code)

(917)813-1828

(Registrant’s

Telephone Number, Including Area Code)

Securities

registered pursuant to Section 12(b) of the Exchange Act:

Title of each Class Trading Symbol(s) Name of each Exchange on which Registered

Common Stock, $0.001 par value per share PAVM The NASDAQ Stock Market LLC

Securities

registered under Section 12(g) of the Exchange Act:

None.

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No

☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ☐

No ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically Interactive Data File required to be submitted pursuant to Rule 405

of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was

required to submit such files). Yes ☒ No ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting

company, or an emerging growth company. See the definitions of ”large accelerated filer”, “accelerated filer”

, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large Accelerated filer ☐ Accelerated filed ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☐

If

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to section 13(c) of the Exchange Act ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C.7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

If

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As

of June 30, 2024, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market

value of the registrant’s voting stock held by non-affiliates was approximately $7.0 million, based on 8,630,652 shares of

common stock held by non-affiliates and a last reported sales price per share of the registrant’s common stock of $0.815 on

such date.

As

of December 31, 2024 and March 20, 2025, there were 11,523,408 and 16,787,173 shares, respectively, of the registrant’s Common

Stock, par value $0.001 per share, issued and outstanding (with such number of shares inclusive of shares of common stock underlying

unvested restricted stock awards granted under the PAVmed Inc. 2014 Long-Term Incentive Equity Plan as of such date).

DOCUMENTS

INCORPORATED BY REFERENCE

Portions

of the registrant’s definitive proxy statement for its 2025 annual meeting of stockholders are incorporated by reference into Part

III of this Form 10-K where indicated. Such definitive proxy statement will be filed with the U.S. Securities and Exchange Commission

within 120 days after the year ended December 31, 2024.

TABLE

OF CONTENTS

PART I

Item 1. Business 1

Item 1A Risk Factors 20

Item 1B. Unresolved Staff Comments 39

Item 1C. Cybersecurity 40

Item 2. Property 40

Item 3. Legal Proceedings 40

Item 4. Mine Safety Disclosures 40

PART II

Item 6. [Reserved] 42

Item 7A. Quantitative and Qualitative Disclosure About Market Risk 55

Item 8. Financial Statements and Supplementary Data 55

Item 9A. Controls and Procedures 55

Item 9B. Other Information 55

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 55

PART III

Item 10. Directors, Executive Officers, and Corporate Governance 56

Item 11. Executive Compensation 56

Item 14. Principal Accountant Fees and Services 56

PART IV

Item 15. Exhibits and Financial Statement Schedules 57

i

FORWARD-LOOKING

STATEMENTS

This

Annual Report on Form 10-K (this “Form 10-K”), including the discussion and analysis of our consolidated financial condition

and results of operations set forth under Item 7 of this Form 10-K, contains forward-looking statements that involve substantial risks

and uncertainties. All statements, other than statements of historical facts, contained in this Form 10-K, including statements regarding

our future results of operations and financial position, business strategy and plans and objectives of management for future operations,

are forward-looking statements. The words “may,” “will,” “should,” “expects,” “plans,”

“anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,”

“believes,” “estimates,” “predicts,” “potential” or “continue” or the negative

of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements

contain these identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results

may differ significantly from those expressed or implied in the forward-looking statements. Factors that might cause such differences

include, but are not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”

Important

factors that may affect our actual results include:

● our limited operating history;

● our financial performance, including our ability to generate revenue;

● the ability of our products to achieve market acceptance;

● our potential ability to obtain additional financing when and if needed;

● our ability to protect our intellectual property;

● our ability to complete strategic acquisitions;

● our ability to manage growth and integrate acquired operations;

● the potential liquidity and trading of our securities;

● our regulatory and operational risks;

● cybersecurity risks;

In

addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions,

joint ventures or investments we may make.

We

may not actually achieve the results, plans, and/or objectives disclosed in our forward-looking statements, and the intended or expected

developments and/or other events disclosed in our forward-looking statements may not actually occur, and accordingly you should not place

undue reliance on our forward-looking statements. You should read this Annual Report on Form 10-K and the documents we have filed as

exhibits to this Form 10-K completely and with the understanding our actual future results may be materially different from what we expect.

We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise,

except as required by applicable law.

ii

Part

I

Item

1. Business

Unless the context otherwise requires, “we”,

“us”, and “our”, the “Company” and “PAVmed” refer to PAVmed Inc. and its subsidiaries,

including its subsidiary Lucid Diagnostics Inc. (Nasdaq:LUCD) (“Lucid Diagnostics” or “Lucid”) and its majority-owned

subsidiary Veris Health Inc. (“Veris Health” or “Veris”).

Background

and Overview

PAVmed

is structured to be a multi-product life sciences company organized to advance a pipeline of innovative healthcare technologies. Led

by a team of highly skilled personnel with a track record of bringing innovative products to market, PAVmed is focused on innovating,

developing, acquiring, and commercializing novel products that target unmet medical needs with large addressable market opportunities.

Leveraging our corporate structure—a parent company that will establish distinct subsidiaries for each financed asset—we

have the flexibility to raise capital at the PAVmed level to fund product development, or to structure financing directly into each subsidiary

in a manner tailored to the applicable product.

Our

current focus is multi-fold. We continue to support the commercial expansion and execution of EsoGuard, which is the flagship

product of our subsidiary Lucid Diagnostics, of which we remain the shareholder with the largest voting interest. In addition,

through a separate majority-owned subsidiary, Veris Health, we offer the Veris Cancer Care Platform. We are focused in the immediate

term on entering into strategic partnership opportunities with leading academic oncology systems to expand access to the Veris

Cancer Care Platform, while concurrently developing an implantable physiological monitor, designed to be implanted alongside a

chemotherapy port, which will interface with the Veris Cancer Care Platform. In terms of other existing products and technologies,

we have adopted an incubator-type platform where we are looking to obtain financing on a product-by-product basis as necessary to

advance each asset to a meaningful inflection point along its path to commercialization. Finally, as resources permit, we will

continue to explore external innovations that fulfill our project selection criteria without limiting ourselves to any target

sector, specialty or condition.

Lucid

Diagnostics

We

believe that Lucid’s flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal

Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread testing

tool with the goal of preventing esophageal adenocarcinoma (“EAC”) deaths, through early detection of esophageal precancer

in at-risk gastroesophageal reflux disease (“GERD,” also commonly known as chronic heartburn, acid reflux or simply reflux)

patients.

EsoGuard

is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It

quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient multicenter

case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal

precancer and all conditions along the BE-EAC spectrum, including on samples collected with EsoCheck (Moinova, et al. Sci Transl Med.

2018 Jan 17;10(424): eaao5848). EsoGuard is commercially available in the U.S. as a Laboratory Developed Test (LDT) performed at our

CLIA-certified laboratory. Cell samples, including those collected with EsoCheck, as discussed below, are sent to our laboratory for

testing and analyses using our proprietary EsoGuard NGS DNA assay.

EsoCheck

is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells

in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter

from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied,

the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted

region during device withdrawal. We believe this proprietary Collect+ProtectTM technology makes EsoCheck the only noninvasive esophageal

cell collection device capable of such anatomically targeted and protected sampling.

EsoGuard

and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and

EsoCheck have been developed to provide accurate, non-invasive, patient-friendly testing for the early detection of EAC and Barrett’s

Esophagus (“BE”), including dysplastic BE and related pre-cursors to EAC in patients with chronic GERD.

Market

Opportunity

In

2024, approximately 22,000 U.S. GERD patients are projected to be diagnosed with EAC and approximately 16,000 will die from it. Over

80% of EAC patients will die within five years of diagnosis, making it the second most lethal cancer in the U.S. The U.S. incidence of

EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly

all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. EAC is nearly always invasive at

diagnosis, and, unlike other common cancers, mortality rates are high even in its earlier stages.

As

discussed below under the heading “Clinical Guidelines for At-Risk Population”, in July 2022, the American Gastroenterology

Association (“AGA”) significantly expanded the target population for esophageal precancer screening, recommending screening

in at-risk patients without symptoms of GERD. Based on this revision, we believe the cohort recommended for screening consists of an

estimated 30 million U.S. individuals with at least 3 established risk factors for BE. Accordingly, we believe EsoGuard’s total

addressable U.S. market opportunity approximates $60 billion based on an effective Medicare payment of $1,938 and the estimated 30 million

U.S. patients recommended for screening by clinical practice guidelines. (In December 2019, Lucid secured “gapfill” determination

for EsoGuard’s PLA code 0114U through the CMS CLFS process. This allowed Lucid to engage directly with Medicare contractor Palmetto

GBA and its MolDx Program on CMS payment and coverage. As discussed below under the heading “Reimbursement and Market Access”,

in October 2020, CMS granted EsoGuard final Medicare payment determination of $1,938.01, effective January 1, 2021.)

Unfortunately,

for a variety of reasons, less than 10% of at-risk patients who are recommended for screening undergo traditional invasive upper gastrointestinal

endoscopy (EGD). We believe that the profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk

patient had been screened and then undergone surveillance and curative endoscopic esophageal ablation of dysplastic BE.

Since

mortality rates are high even in early stage EAC, preventing EAC deaths requires detection and intervention at the precancer stage. Most

of the necessary elements for such an early detection program are already well established—an at-risk population (at-risk GERD

patients), a precancer (BE), and an intervention which can halt progression to EAC (endoscopic esophageal ablation). Until recently,

the only missing element for such an early detection program is a widespread screening tool that can detect BE prior to EAC.

We

believe EsoGuard, used with EsoCheck, constitutes that missing element—the first and only commercially available diagnostic test

capable of serving as a widespread testing tool with the goal of preventing EAC deaths through early detection of esophageal precancer

and cancer in patients with 3 or more risk factors.

Clinical

Guidelines for At-Risk Population

The

subgroup of long-standing or severe GERD patients at-risk for BE and progression to EAC is well defined in clinical practice guidelines,

including the American College of Gastroenterology (“ACG”) BE Guidelines. In its Recommendation 5, the ACG suggests a single

screening endoscopy in patients with chronic GERD symptoms and 3 or more additional risk factors for BE, including male sex, age greater

than 50 years, White race, tobacco smoking, obesity, and family history of BE or EAC in a first-degree relative.

An

ACG clinical guideline entitled “Diagnosis and Management of Barrett’s Esophagus: An Updated ACG Guideline,”

the first such update since 2016, was published online in April 2022 in the American Journal of Gastroenterology. The clinical guideline

reiterates the ACG’s long-standing recommendation for esophageal precancer screening in at-risk patients with GERD. For the first

time, however, the clinical guideline also endorses non-endoscopic biomarker screening as an acceptable alternative to costly and invasive

endoscopy stating that “a swallowable non-endoscopic capsule device combined with a biomarker is an acceptable alternative to endoscopy

for BE.” The clinical guideline specifically mentions EsoCheck, as such swallowable, non-endoscopic esophageal cell collection

devices, as well as methylated DNA biomarkers such as EsoGuard. The summary of evidence for this recommendation includes a reference

to the seminal NIH-funded, multicenter, case-control study published in 2018 in Science Translational Medicine, which demonstrated

that EsoGuard is highly accurate at detecting esophageal precancer and cancer, including on samples collected with EsoCheck.

In

July 2022, the AGA published in their “Clinical Practice Update on New Technology

and Innovation for Surveillance and Screening in Barrett’s Esophagus” updated clinical guidance that mirrors the same furnished

by the ACG as described above, endorsing the use of non-endoscopic cell collection tools to screen for BE like our EsoCheck Cell Collection

Device, which is cited in the update, as an acceptable alternative to endoscopy to directly address the need for noninvasive screening

tools that are easy to administer, patient friendly, and cost-effective for the detection of BE. The clinical practice update by the

AGA also significantly expands the target population for esophageal precancer screening, including for EsoGuard and EsoCheck, by recommending,

for the first time, screening in at-risk patients without symptoms of GERD. The AGA does so by adding a history of chronic GERD as merely

an additional, seventh risk factor to the six risk factors for BE and EAC that have traditionally identified at-risk symptomatic patients

recommended for screening.

In March 2025, Lucid announced that a recent update to the National Comprehensive Cancer Network® (NCCN) Clinical

Practice Guidelines in Oncology (NCCN Guidelines®) focused on Esophageal and Esophagogastric Junction Cancers (Version 1.2025) has

added a new section on BE screening. The NCCN Guidelines® now reference professional society guidelines on BE screening, including

the most recent ACG clinical guideline discussed above, which recommends non-endoscopic biomarker testing, such as EsoGuard performed

on samples collected with EsoCheck, as an acceptable alternative to invasive upper endoscopy to detect esophageal precancer.

Commercialization

Lucid’s

EsoGuard commercialization efforts span multiple channels including targeting primary care and GI physicians, who have generally embraced

our message that EsoGuard has the potential to expand the funnel of BE-EAC patients who will need long term EGD surveillance and, potentially,

treatment with endoscopic esophageal ablation.

To

assure sufficient testing capacity and geographic coverage, Lucid has undertaken multiple ways for patients to have access to its test.

Initially, Lucid built a limited network of its own physical Lucid Test Centers, staffed by Lucid-employed clinical personnel, where

patients can undergo the EsoCheck procedure and have the sample sent for EsoGuard testing at Lucid’s CLIA-certified laboratory.

Our current test center network currently includes locations in metropolitan areas in Arizona, California, Colorado, Florida, Georgia,

Idaho, Michigan, Nevada, Texas and Utah.

In

addition to our own test center locations, Lucid has broadened patient access to its test by establishing a satellite test center program,

whereby it is making its personnel available to perform cell collection services inside physician offices or in certain geographies,

closely nearby physician offices (in Florida, for the time being) by way of our Lucid Mobile Testing Unit.

Also,

in January 2023, Lucid completed its first #CheckYourFoodTube Precancer Testing Event, with the San Antonio Fire Department (the “SAFD”)

during Firefighter Cancer Awareness Month as designated by the International Association of Fire Fighters (IAFF). A total of 391 members

who were deemed to be at-risk for esophageal precancer, underwent a brief, on-site, noninvasive cell collection procedure, performed

by Lucid’s clinical personnel using EsoCheck. Since then, additional testing events have been hosted with the SAFD, and many similar

events have been held with fire departments throughout the country. These events are ongoing and are an extension of Lucid’s satellite

test center program, which brings Lucid’s precancer testing directly to patients—at their physician’s office and now

at testing day events.

In

March 2023, Lucid launched a direct contracting strategic initiative to engage directly with large Administrative Services Only (“ASO”)

self-insured employers, unions and other entities, seeking to replicate the successes of other cancer screening diagnostic companies

that have deployed similar strategies.

In

January 2025, Lucid expanded on its direct contracting initiative by launching a cash-pay program targeting concierge medicine, as an

important component of its strategic efforts to expand its contractually-guaranteed revenue. Lucid has already contracted with several

concierge medicine practices under this initiative.

Lucid

has also established an EsoGuard Telemedicine Program, in partnership with UpScript, LLC, an independent third-party telemedicine provider,

that accommodates EsoGuard self-referrals from direct-to-consumer marketing.

Reimbursement

and Market Access

As

noted above, in December 2019, Lucid secured “gapfill” determination for EsoGuard’s PLA code 0114U through the CMS

CLFS process. This allowed Lucid to engage directly with Medicare contractor Palmetto GBA and its MolDx Program on CMS payment and coverage.

In October 2020, CMS granted EsoGuard final Medicare payment determination of $1,938.01, effective January 1, 2021.

A

final Local Coverage Determination (“LCD”) L39256, entitled “Molecular Testing for Detection of Upper Gastrointestinal

Metaplasia, Dysplasia, and Neoplasia” became effective in May 2023 on the Center for Medicare and Medicaid Services (“CMS”)

website by MAC Palmetto GBA. (A substantially identical LCD was published by Noridian Healthcare Solutions, the MAC whose geographic

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

precancer and cancer molecular diagnostic tests to meet. These criteria include active GERD with at least two risk factors, as well as

evidence of analytic validity, clinical validity, and clinical utility. Although the LCD indicated that it found that no currently existing

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

on the pertinent literature and society recommendations.” In November 2024, Lucid submitted to MolDx its complete clinical evidence

package in support of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard.

In

parallel with our request for reconsideration of the LCD, Lucid is aggressively pursuing EsoGuard commercial insurer coverage and payment.

Although the claim adjudication cycle can be prolonged during the early commercialization of a new test, Lucid has received and continues

to receive out-of-network commercial insurance payments for the EsoGuard test, which accounts for the vast majority of our revenue to

date.

Additionally,

the legislatures in a number of states have passed laws mandating coverage of comprehensive biomarker testing over the past several years.

Lucid believes that EsoGuard falls within the definition of a biomarker test and thus Lucid is reviewing how to leverage legislation

in those states to expand access to and reimbursement of EsoGuard.

Clinical

Utility and Clinical Trials

Demonstrating

EsoGuard’s clinical utility, which requires providing evidence that the test has a meaningful impact on clinical practice, is very

important for a variety of purposes, including, importantly, for Medicare and private payor payment and coverage. It has been established

that one of the most important factors to private payors in deciding whether to grant payment and coverage will be demonstration that

the EsoGuard test, when ordered by physicians, provides information that can be used to identify or exclude patients who would benefit

from additional management and/or treatment. Clinical utility studies are also important for general EsoGuard commercialization by facilitating

physician understanding of test indications and potential benefit to the patients.

Lucid

continues to expand the EsoGuard and EsoCheck evidence portfolio with additional clinical utility and clinical validity data from a range

of ongoing studies and those that will be completed in the upcoming year. These efforts include completion of the ESOGUARD-BE2 study,

a large multi-center case control study recruiting patients from large academic institutions in the Netherlands and across the U.S.,

in the first half of the year and submission for peer review of a publication of the results in the second half of 2025. This data will

further supplement what has previously been published from the four earlier clinical validation studies from Moinova et. al. (2018),

Moinova et. al. (2024), Greer et. al., (2024), and Shaheen et. al. (2024). A large, nearly 12,000 patient real-world experience of EsoCheck

and EsoGuard from 18 months of commercial data is expected to be submitted for peer review publication in the first half of the year.

Finally, data accrual from the PREVENT and PREVENT-FF registries remains ongoing. Both registries capture information on the diagnostic

and/or therapeutic journey of subjects following EsoGuard testing, and in addition to provider decision impact, will contribute differing

levels of clinical outcomes data to the Lucid evidence portfolio.

Manufacturing

EsoCheck

is currently manufactured for Lucid by Coastline International (“Coastline”), a high-volume device manufacturer, and Sage

Product Development. Lucid’s current line at Coastline can produce up to 25,000 units per year. With Coastline’s improvement

and expansion, there is capacity to scale exponentially. Lucid’s EsoGuard specimen kits are currently manufactured by Path-Tec.

Path-Tec also manages warehousing, logistics, fulfillment and customer support of Lucid’s products.

License

Agreement

Under

the terms of Lucid’s license agreement with CWRU (as amended to date, the “Amended CWRU License Agreement”), Lucid

acquired an exclusive worldwide right to use the intellectual property rights to the EsoGuard and EsoCheck technology for the detection

of changes in the esophagus and on sample preservation. Lucid is required to pay CWRU royalties on net sales of licensed products as

follows: 5% of net sales of less than $100 million per year; and 8% of net sales greater than $100 million per year. Lucid is also required

to pay CWRU minimum annual royalty payments as follows: $50,000 per year, beginning January 1 following the first anniversary of a commercial

sale of a licensed product; $150,000 per year, if net sales of a licensed product exceed $25 million in a year; $300,000 per year, if

net sales of a licensed product exceed $50 million in a year; and $600,000 per year, if net sales of a licensed product exceed $100 million

in a year. Minimum yearly royalty amounts are subject to increase based on the percentage change in the CPI-W Consumer Price Index and

are credited against the royalties otherwise due. The license agreement was subject to four regulatory and commercialization milestones,

of which one remains unachieved and unpaid. The remaining milestone is the FDA PMA submission of a licensed product, upon the achievement

of which we will pay CWRU a milestone payment of $200,000. The license agreement terminates upon the expiration of the last-to-expire

licensed patent, or on May 12, 2038, in countries where no such patents exist, or upon expiration of any exclusive marketing rights for

a licensed product that have been granted by FDA or other U.S. government agency, whichever comes later.

Regulatory

In

June 2019, Lucid received FDA 510(k) clearance to market EsoCheck in the U.S. as a device indicated for use in the collection and retrieval

of surface cells of the esophagus in adults followed by FDA 510(k) clearance in 2022, expanding the use of EsoCheck in adults and pediatric

populations in the U.S. In December 2019, Lucid’s CLIA-certified then-laboratory partner, completed documentation of EsoGuard analytical

validity allowing Lucid to commercialize it as a LDT.

In

February 2020, Lucid received FDA “Breakthrough Device Designation” for EsoGuard as an in-vitro diagnostic (“IVD”)

medical device. The FDA Breakthrough Device Program was created to offer patients more timely access to breakthrough technologies which

provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions by expediting

their development, assessment and review through enhanced communications and more efficient and flexible clinical study design, including

more favorable pre/post market data collection balance.

In

May 2021, Lucid received CE Mark certification for EsoCheck (under the Medical Devices Directive 93/42/EEC), and in June 2021, Lucid

completed CE Mark self-certification for EsoGuard (under the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC)), indicating

both may be marketed in CE Mark European countries.

In

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

IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. On May 6, 2024, the FDA issued

a final rule aimed at helping to ensure the safety and effectiveness of LDTs. The rule amends the FDA’s regulations to make explicit

that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”), including when the manufacturer of the IVD

is a laboratory. Along with this amendment, the FDA is finalizing a policy under which the FDA will provide greater oversight of IVDs

offered as LDTs through a phaseout of its general enforcement discretion approach for LDTs over the course of four years, as well as

targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.

The

phaseout policy contains the following five stages:

The

FDA also intends to exercise enforcement discretion and generally not enforce some or all applicable requirements for certain categories

of IVDs manufactured by a laboratory. The categories of enforcement discretion that are applicable to EsoGuard are summarized in the

table below.

Category of IVD Stage 1 Stage 2 Stage 3 Stages 4 & 5 (Premarket Review)

As

EsoGuard was marketed prior to rule publication and is also NYS CLEP approved, hence, enforcement discretion is applicable for

compliance with Stages 4 and 5. We will be implementing compliance with MDR requirements, correction and removal reporting

requirements, and quality system (QS) requirements regarding complaint files by March 31, 2025, well before the deadline of May 6,

2025. 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. We are

confident that the proposed final rule will not have a commercial impact as the Company already has a robust QS management platform

for medical devices and EsoGuard will be able to easily transition to the platform to fulfill the QS requirements, as required by

the FDA.

Our

longer-term strategy is to secure a specific indication, based on published guidelines, for BE testing in certain at-risk populations

using EsoGuard on samples collected with EsoCheck. This use of EsoGuard together with EsoCheck as a testing system must be cleared or

approved by the FDA as an IVD device.

Laboratory

Operations

On

February 25, 2022, a newly-formed wholly owned subsidiary of Lucid, LucidDx Labs Inc. (“LucidDx Labs”), acquired from ResearchDx

Inc. (“RDx”), certain licenses and other related assets necessary for LucidDx Labs to operate its own new

CLIA-certified, CAP-accredited clinical laboratory located in Lake Forest, CA. Since March 2022, Lucid has conducted EsoGuard

testing at its own laboratory.

In

November 2023, LucidDx Labs launched EsoGuard 2.0, which uses multiplexing thereby allowing both genes to be interrogated on a single

DNA sample. The next-generation assay underwent rigorous analytical and clinical validation studies, including head-to-head comparisons

of multiplexed triplicate consensus versus singleplex techniques, consistent with CLIA standards. Clinical validation analysis demonstrated

improved sensitivity and specificity for the detection of esophageal precancer, having demonstrated enhanced assay performance and lower

costs in extensive validation studies.

Competition

The

U.S. market for esophageal cancer (i.e., EAC) and pre-cancer (i.e., BE, with or without dysplasia) testing is large, consisting of more

than 30 million at-risk individuals over the age of 50. Given the large market for pre-cancer testing, Lucid likely will face numerous

competitors, some of which possess significantly greater financial and other resources and development capabilities than Lucid. The EsoGuard

test faces competition from procedure-based detection technologies such as upper endoscopy, and other testing technologies such as multi-cancer

early detection products. The EsoCheck device faces competition from other manufacturers with devices designed to collect cell samples

from targeted regions of the esophagus. For example, EndoSign, commercialized by Cyted, and much like Cytosponge, is a small mesh sponge

within a soluble gelatin capsule that needs to reside in the stomach and then is pulled thru the targeted region brushing the lining

of the esophagus and then later retrieved, although, unlike EsoCheck, it is unprotected from sample contamination as the brush later

passes regions of the upper esophagus and mouth. Lucid’s competitors may also be developing additional methods of detecting esophageal

cancer and pre-cancer that have not yet been announced.

Most

of Lucid’s existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing

and technological resources. Lucid may be unable to compete effectively against our competitors either because their products and services

are superior or more cost efficient, or because they have access to greater resources than Lucid. These competitors may have greater

name recognition than Lucid does. Many of these competitors have obtained all desirable FDA or other regulatory approvals, and superior

patent protection, for their products. Certain of Lucid’s competitors have already commercialized their products, and others may

commercialize their products in advance of Lucid’s products. In addition, Lucid’s competitors may make technical advances

that render Lucid’s products obsolete. Lucid may be unable to respond to such technical advances.

Veris

Health

Overview

In

May 2021, we formed Veris Health, a majority-owned subsidiary, focused on digital health technology. In connection with its formation,

Veris Health acquired Oncodisc, a digital health company with groundbreaking tools to improve personalized cancer care through remote

patient monitoring. Oncodisc’s core technologies include designs and patents that would be the foundation for the first intelligent

implantable vascular access port with biologic sensors and wireless communication, combined with an oncologist-designed remote digital

healthcare platform that provides patients and physicians with new tools to improve outcomes and optimize the delivery of cost-effective

care through remote monitoring and data analytics.

Veris

Health’s lead product, the Veris Cancer Care Platform, is a comprehensive digital cancer care platform with remote physiological

data collection, symptom reporting, telehealth capability and electronic health record (“EHR”) integration. The platform offers enhanced

personalized cancer care through the early detection of complications, reduced unplanned hospitalizations, the provision of longitudinal

trends of physiological and clinical data, data-driven risk management tools, and increased patient and provider satisfaction. Cancer

patients enrolled on the platform receive a VerisBoxTM of Veris-branded connected health care devices which transmit physiologic

data to the cloud-based clinician portal via embedded cellular connections. A complementary patient portal enables patients to report

symptoms, as well as general health and quality of life parameters, to their cancer care team through the Veris patient smartphone app.

The app also allows caretakers and family members to follow along on the patient’s cancer care journey. Veris is developing an

implantable physiological monitor, designed to be implanted alongside a vascular access port, which will interface with the Veris Cancer

Care Platform. The implantable monitor will further enhance the clinical and commercial value of the platform by providing remote physiologic

data independent of patient compliance.

Market

Opportunity

In

2024, approximately 2.0 million people in the U.S. were newly diagnosed with cancer, and cancer incidence in the U.S. is expected to

continue to increase. Cancer patients face high rates of complications during the courses of their treatment which drive poor patient

outcomes and healthcare costs. One driver of these issues is avoidable hospitalizations. We believe Veris Health’s offerings can

help drive costs down and improve outcomes through providing care teams with better, more continuous data.

Based

on the aforementioned cancer prevalence in the U.S. and our current business model, we believe Veris Health’s total addressable

U.S. market opportunity exceeds $2 billion. In the future, we believe this will only expand through the implantable physiologic monitor,

as well as other opportunities or enhancements Veris may pursue as resources permit, such as data commercialization, incorporating additional

AI-based features and the expansion into other markets aside from oncology.

Commercialization/Sales

We

are currently pursuing strategic partnerships with leading academic oncology systems, whereby we would become the exclusive digital health

solution for these institutions’ oncology departments. To this end, Veris and The Ohio State University Comprehensive Cancer Center

- The James Cancer Hospital and Solove Research Institute (OSUCCC – The James), a National Cancer Institute-Designated Comprehensive

Cancer Center, executed a memorandum of understanding to implement a pilot program where cancer patients would be enrolled on the Veris

Cancer Care PlatformTM. The pilot program was launched in June 2024, and has been extended through the end of March 2025. This collaboration

represents a significant step forward in Veris Health’s commercialization strategy, allowing the company to demonstrate the value

of its platform and gather data on its effectiveness in improving personalized cancer care.

Veris

is continuing to pursue similar partnerships with other leading institutions. Veris has a software-as-a-service recurring-revenue business

model, where it seeks to generate recurring revenue through oncology practice and hospital-based subscriptions. These entities pay monthly

fees for each patient on the platform, through which they are able to derive revenues from remote physiologic monitoring (and, in the

future, device implantation) under existing CPT codes. Veris also plans to build a commercialization model around the oncology data it

is collecting, as resources permit. We have identified multiple potential use cases across a number of verticals, including clinical

trials, commercial use cases, and as a means to improve patient care.

Manufacturing

The

components comprising the Veris Cancer Care Platform are currently supplied to us by our partners TransTek and their U.S.-based

subsidiary, Mio Labs. Each has passed a SOC-2 audit by an outside auditor. The final packaging of the overall box and order

fulfillment is managed by PAVmed at its Foxborough, MA location. Customer support is currently managed internally, while partnering

with Zendesk for customer service management.

Regulatory

The

Veris Cancer Care Platform qualifies as a Non-Device Clinical Decision Software (“CDS”) that is excluded from the

definition of a medical device under the FDCA, as amended by the 21st Century Cures Act, and therefore is not subject to the

FDA’s regulatory requirements for devices, as confirmed in the FDA’s Clinical Decision Support Software

Guidance.

Veris

Health is also developing an implantable cardiac monitor and is currently interacting with the FDA via pre-submission process, seeking

agreement on regulatory strategy and required testing to seek clearance of the monitor. We plan to make our 510(k) submission for the

implantable monitor, which could happen as early as late 2025, if and to the extent resources permit us to do so.

Competition

The

U.S. market for cancer patient care is large. There are many existing competitors in the remote physiological monitoring space, some

of which possess significantly greater financial and other resources and development capabilities than us. Our Veris Cancer Care

Platform faces competition from other digital care platforms providing many of the same features, including EHR integration and

remote patient monitoring capabilities. While we are not aware of other implantable physiologic monitors containing biologic

sensors, our competitors may also be developing similar devices that have not yet been announced.

Incubator

Program

On

March 21, 2024, PAVmed announced that it had launched a wholly owned incubator, PMX, to complete development and commercialization

of existing portfolio technologies, including PortIO, EsoCure and CarpX. Although PMX may seek to expand its portfolio with internal

or externally sourced technologies in the future, its initial assets will include the following products:

PortIO

Our

PortIO implantable intraosseous vascular access device is being developed as a means for infusing fluids, medications and other substances

directly into the bone marrow cavity and from there into the central venous circulation. The intraosseous route provides a means for

infusing fluids, medications and other substances directly into the bone marrow cavity which communicates with the central venous circulation

via nutrient and emissary veins. This route is well established, having been used for decades in a variety of settings including trauma,

especially military trauma, and pediatric emergencies. It has been shown to be bioequivalent to the intravenous route. Complication rates

are low and there are few contraindications. Currently available intraosseous devices pass through the skin into the bone and are therefore

limited to short term use. PortIO is a novel, implantable intraosseous vascular access device which does not require accessing the central

venous system and does not have an indwelling intravascular component. It is designed to be highly resistant to occlusion and, we believe,

may not require regular flushing. It features simplified, near-percutaneous insertion and removal, without the need for surgical dissection

or radiographic confirmation.

Esocure

In

connection with our efforts to expand our presence in the EAC diagnostic market, we were developing the EsoCure Esophageal Ablation Device,

with the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer, and to

do so without the need for complex and expensive capital equipment. We have successfully completed a pre-clinical feasibility animal

study of EsoCure demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining. An acute and survival

animal study of EsoCure Esophageal Ablation Device has also been completed, demonstrating successful direct thermal balloon catheter

ablation of esophageal lining through the working channel of a standard endoscope. When resources permit, we plan to conduct additional

development work and animal testing of EsoCure to support a future FDA 510(k) submission.

CarpX

CarpX

is a patented, single-use, disposable, minimally invasive surgical device for use in the treatment of carpal tunnel syndrome. CarpX

is designed to allow the physician to relieve the compression on the median nerve without an open incision or the need for

endoscopic or other imaging equipment, and therefore we believe it will be significantly less invasive than existing treatments. To

use CarpX, the operator first advances a guidewire through the carpal tunnel under the ligament, and then advanced over the wire and

positioned in the carpal tunnel under ultrasonic and/or fluoroscopic guidance. When the CarpX balloon is inflated it creates tension

in the ligament positioning the cutting electrodes underneath it and creates space within the tunnel, providing anatomic separation

between the target ligament and critical structures such as the median nerve. Radiofrequency energy is briefly delivered to the

electrodes, rapidly cutting the ligament, and relieving the pressure on the nerve. We believe CarpX will be significantly less

invasive than existing treatments.

CarpX

received FDA 510(k) marketing clearance in April 2020, with the first commercial procedure successfully performed in December 2020. In

May 2021 European CE Mark Certification was received for CarpX. Our limited-release commercialization efforts through 2022 were focused

on engaging key opinion hand surgeons designed to solicit input for ergonomic improvements to the device, procedure development and surgical-time

optimization, and ease of use. As a result of this clinical input, we have initiated a product development project to incorporate intraluminal

ultrasound into the device to include real time imaging of the ligament to be cut together with critical anatomic structures, and will

continue to pursue that project, as resources permit.

Recent

Developments

Business

EsoGuard

Medicare Coverage

In

November 2024, Lucid submitted to MolDx its complete clinical evidence package in support of a request for reconsideration of the non-coverage

language in the LCD to secure Medicare coverage for EsoGuard. The EsoGuard clinical evidence package included six new peer-reviewed publications:

three clinical validation studies (two in the intended use population, one case control), two clinical utility studies, and one analytical

validation study. The current LCD provides clear coverage criteria consistent with the ACG guidelines

for esophageal precancer testing. The package was submitted as part of a request for reconsideration of the non-coverage language in

the LCD to secure Medicare coverage for EsoGuard.

NCCN Clinical Practice Guidelines Update

In March 2025, Lucid announced that

a recent update to the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

focused on Esophageal and Esophagogastric Junction Cancers (Version 1.2025) has added a new section on BE screening. The NCCN Guidelines®

now reference professional society guidelines on BE screening, including the most recent ACG clinical guideline discussed above, which

recommends non-endoscopic biomarker testing, such as EsoGuard performed on samples collected with EsoCheck, as an acceptable alternative

to invasive upper endoscopy to detect esophageal precancer.

Clinical Study Publications

On March 18, 2025, Lucid announced

that its ENVET-BE clinical utility study has been accepted for publication in Gastroenterology & Hepatology—the fifth peer-reviewed

publication of clinical utility data for Lucid’s EsoGuard® Esophageal DNA Test, and the second to present findings from a real-world

screening population. The manuscript, entitled “Enhancing the Diagnostic Yield of EGD for Diagnosis of Barrett’s Esophagus Through

Methylated DNA Biomarker Triage,” demonstrates that confirmatory upper endoscopy (EGD) performed in EsoGuard-positive patients had

a substantially higher diagnostic yield for detecting esophageal precancer (Barrett’s Esophagus or BE) than the expected yield of screening

EGD alone in at-risk patients. The ENVET-BE study reviewed real-world data from a cohort of 199 EsoGuard-positive patients who completed

confirmatory EGD. The overall positive diagnostic yield for BE was 2.4-fold higher than the expected yield of screening EGD alone, based

on disease prevalence within an at-risk population. The yield was nearly three-fold higher in patients meeting American College of Gastroenterology

(ACG) screening criteria.

On November 7, 2024, Lucid announced that its

manuscript for its multi-center ESOGUARD BE-1 study has been accepted for publication in The American Journal of Gastroenterology,

the official journal of the American College of Gastroenterology (ACG). This is the fourth publication presenting clinical

validation data for Lucid’s EsoGuard® Esophageal DNA Test, and the second to demonstrate its performance in an

intended-use screening population. Consistent with previous studies, EsoGuard showed high sensitivity and negative predictive value

in detecting esophageal precancer (Barrett’s Esophagus or BE). The prospective, multi-center study presented data from a cohort of

patients who met ACG guideline criteria for esophageal precancer screening and underwent non-endoscopic EsoGuard testing followed by

traditional upper endoscopy. EsoGuard sensitivity and negative predictive value for detecting BE were approximately 88% and 99%,

respectively. Specificity and positive predictive value were approximately 81% and 30%, respectively. No serious adverse events were

reported.