What changed in this filing

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Item 1. Business

2024-03-25 compared with 2023-03-14 · 511 added, 532 removed, 535 unchanged (66% of the section changed)

is a highly differentiated, multi-product, commercial-stage medical technology company organized to advance a broad pipeline of innovative

medical technologies from concept to commercialization, employing a business model focused on capital efficiency and speed to market.

current central focus is predominantly on commercial expansion and execution including the acceleration of EsoGuard and Veris Cancer

Care Platform commercialization.

As resources permit, we will continue to explore internal and external innovations that fulfill our

project selection criteria without limiting ourselves to any target specialty or condition.

More broadly, we strive to maintain balance

within our pipeline with shorter-term, lower-risk projects with the prospect for rapid commercialization and revenue generation supporting

development of longer-term projects.

At the same time, we are continuously re-assessing each project’s long-term commercial potential

relative to other projects in our pipeline, accelerating or decelerating the project and reallocating resources accordingly.

Company operates in one segment as a medical technology company, with the following lines of business:

Diagnostics, Medical Devices

and Digital Health.

Below is a summary of each of our key products within these sectors, including in particular EsoGuard and the

Veris Cancer Care Platform, currently our two leading products.

We are also pursuing a number of research and development project

and product opportunities across these three lines of business, which have either been developed internally or have been presented

to us by clinician innovators and academic medical institutions for consideration.

believe that the flagship product of our majority-owned subsidiary Lucid Diagnostics Inc.

LUCD) (“Lucid”), 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 screening tool to prevent 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.

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

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 needs with large addressable market opportunities.

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, the latter of which is our current strategy given prevailing market conditions.

current focus is multi-fold.

We continue to pursue commercial expansion and execution of EsoGuard, which is the flagship product of

our majority-owned subsidiary Lucid Diagnostics Inc.

LUCD) (“Lucid” or “Lucid Diagnostics”).

addition, through a separate majority-owned subsidiary, Veris Health Inc.

(“Veris” or “Veris Health”), we are focused on entering into

strategic partnership opportunities with leading academic oncology systems to expand access to the Veris Platform.

In terms of other

existing products and technologies, we have created 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.

believe that the flagship product of our majority-owned subsidiary Lucid, 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.

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

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

EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly screening test for the early detection of adenocarcinoma

of the esophagus (“EAC”) and Barrett’s Esophagus (“BE”), including dysplastic BE and related pre-cursors

to EAC in patients with chronic gastroesophageal reflux (“GERD”).

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.

2023, approximately 20,000 U.S.

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

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

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

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.

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addressable U.S.

market opportunity exceeds $60 billion based on an effective Medicare payment of $1,938 and the estimated 30 million

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

patients recommended for screening by clinical practice guidelines.

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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.)

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,

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

The only missing

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

Until recently,

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

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

capable of serving as a widespread screening tool to prevent EAC deaths through early detection of esophageal precancer and cancer in

patients with 3 or more risk factors.

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.

Guidelines for At-Risk Population

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An Updated ACG Guideline ,”

the first such update since 2016, was published online last year in the American Journal of Gastroenterology.

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

The clinical guideline

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collected with EsoCheck.

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.

July 2022, the American Gastroenterology Association (“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.

Commercialization

EsoGuard commercialization efforts span multiple channels including targeting primary care physicians 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.

assure sufficient testing capacity and geographic coverage, we have built our own network of 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, Idaho, Illinois, Nevada, Ohio, Oregon, Texas and Utah.

addition to our base test center network, Lucid has established a satellite test center program, whereby we are expanding our footprint

by making our personnel available to perform cell collection services in physician offices.

Further, we have sought to expand our outreach

by successfully conducting multiple “#CheckYourFoodTube Precancer Testing Event” for organizations such as the San Antonio

Fire Department, where samples are collected from the organization’s employees for testing with EsoGuard at Lucid’s CLIA-certified

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.

assure sufficient testing capacity and geographic coverage, we have undertaken multiple ways for patients have access to our test.

we built a limited network of our 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, Idaho, Illinois, Nevada, Ohio,

Oregon, Texas and Utah.

addition to our own test center locations, we have broadened patient access to our test by establishing a satellite test center program,

whereby we are making our 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.

in January 2023, we completed our 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

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 our 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 our precancer testing directly to patients—at their

physician’s office and now at testing day events.

March 2023, we launched a Direct Contracting Strategic Initiative (“DCSI”) 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 August 2023, we contracted with the Ancira Automotive

Group as a result of this initiative, providing access to esophageal precancer testing for its employees at all 12 San Antonio locations.

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

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

proposed Local Coverage Determination (“LCD”) DL39256, entitled “ Molecular Testing for Detection of Upper Gastrointestinal

Metaplasia, Dysplasia, and Neoplasia ” was published recently on the Center for Medicare and Medicaid Services (“CMS”)

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.

The proposed LCD is a further step in Lucid’s efforts to secure Medicare coverage and payment for

The proposed LCD, which the CMS website explicitly characterizes as a “work in progress” for “public review,”

outlines criteria 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.

the proposed LCD indicated that it found that no currently existing test has fulfilled all criteria, it indicated that it will “monitor

the evidence and will provide coverage based on the pertinent literature and society recommendations.” Notably, the proposed LCD

pre-dated, and therefore does not include consideration of, the most recent AGA clinical practice update endorsing swallowable, nonendoscopic

capsule devices combined with a biomarker, such as EsoCheck and EsoGuard, as an alternative to endoscopy.

The publication of the proposed

LCD triggers a written comment period, and MolDX also held an open meeting on May 10, 2022, during which stakeholders and other interested

parties will have the opportunity to address the proposed LCD.

We presented at the public meeting and made a written submission during

the comment period as well.

A final LCD will not be issued until the MAC has had the opportunity to assess and consider all stakeholder

we await a Palmetto MolDX LCD coverage determination, Lucid is aggressively pursuing EsoGuard commercial insurer payment and coverage.

Although the claim adjudication cycle can be prolonged during the early commercialization of a new test, Lucid has received out-of-network

commercial insurance payments for the EsoGuard test, and has entered into agreements with insurers that provide access to, in the aggregate,

over 70 million patients.

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

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

precancer and cancer molecular diagnostic tests to meet.

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

evidence of analytic validity, clinical validity, and clinical utility.

Although the LCD indicated that it found that no currently existing

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

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

LCD later this year.

parallel with preparing to submit EsoGuard for Technical Assessment with MolDX, Lucid is aggressively pursuing EsoGuard commercial insurer

payment and coverage.

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.

We believe that

EsoGuard falls within the definition of a biomarker test and thus we are reviewing how to leverage legislation in those states to expand

access to EsoGuard.

Utility and Clinical Trials

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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.

are currently seeking to accelerate our collection of clinical utility data through a range of trials that can be efficiently executed.

These efforts include a planned investigator-initiated, retrospective analysis of prospectively collected data on the approximately 400

San Antonio fire fighters who underwent testing as part of a community-sponsored cancer awareness event (in

respect of which we expect to publish results in the first half of 2023) ;

an ongoing investigator-initiated, retrospective, single-center,

study with 500 patients (in respect of which we expect to publish results mid-2023), a virtual-patient randomized controlled trial with

intended recruitment of 100-200 physician participants (in respect of which we expect to publish

results this year) ;

a Lucid-sponsored multi-center, prospective, observational study with 500 patients;

and a Lucid-sponsored

registry at existing Lucid Test Centers, whereby all patients undergoing EsoCheck testing will be given the opportunity to provide informed

consent and contribute data about their risk factors, EsoGuard results, and subsequent diagnostic and/or therapeutic journey.

Both Lucid-sponsored

observational/registry studies expect to have preliminary results and/or interim analysis before the end of 2023.

previously disclosed, consequently, we have decided to delay for the time being the two previously commenced clinical trials, the “EsoGuard

screening study” (“BE-1”) and the “EsoGuard case-control study” (“BE-2”), as we are devoting

our clinical resources to the studies cited above, which we expect will more efficiently generate the clinical data we are currently

prioritizing to drive EsoGuard commercialization.

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.

continues to expand the EsoGuard and EsoCheck evidence portfolio with additional clinical utility, clinical validity, and analytical

validity data from a range of ongoing studies and those that have recently completed or will be completed in the upcoming year.

efforts include planned publication of the results from the previously discussed “Multi-center, Single-arm EsoGuard clinical validation

study” (“BE-1”) which will also be presented at Digestive Disease Week (DDW) 2024;

this third clinical validation study

evaluated EsoGuard performance in the intended-use population.

Publication of real-world experience of EsoCheck as a nonendoscopic cell

collection device is also planned (previously presented as a poster at DDW 2023), in addition to results from EsoGuard analytical validation

studies performed by LucidDx Labs, and a summary of real-world outcomes from several hundred patients who tested positive with EsoGuard

and underwent confirmatory endoscopic evaluation.

These four manuscripts will be submitted for peer review in the first half of 2024.

Lucid-sponsored multi-center, prospective, observational CL inical U tility of E soGuard study ( CLUE ) with >500

subjects completed enrollment in late 2023, and full results are expected to be published in mid-2024;

results from an additional data

snapshot of the Lucid-sponsored PREVENT and PREVENT - F ire f ighter ( FF ) registries with a combined enrollment

of >1,000 subjects are expected to be published in a similar timeframe.

Both studies 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.

results for the Lucid-sponsored virtual-patient study are expected to be ready for analysis in mid-2024.

the “EsoGuard case-control study” (“BE-2”), a Lucid-sponsored clinical validation study, resumed enrollment in

2023 and is expected to continue through 2024.

This data will further supplement what has previously been produced by the two NCI-funded

studies (Moinova, et al.

Sci Transl Med.

Manufacturing

is currently manufactured for us by our partners Coastline International, a high-volume device manufacturer, and Sage Product

Through mid-2023, we expect to further transition from Sage to Coastline as the manufacturing process is further

Our current line capacity can produce up to 25,000 units per year.

With Coastline’s improvement and expansion,

there is capacity to scale exponentially.

Our EsoGuard Specimen Kits are currently manufactured for us by our partner Path-Tec.

warehousing, logistics, fulfillment and customer support of our products is managed for us by our partners HealthLink International

is currently manufactured for us by our partners Coastline International (“Coastline”), a high-volume device manufacturer,

and Sage Product Development.

Our 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.

Our EsoGuard Specimen Kits are currently manufactured for us by our partner

The warehousing, logistics, fulfillment and customer support of our products is managed for us by our partners HealthLink International

(a leading third-party logistics company) and Path-Tec.

the terms of Lucid’s license agreement with Case Western Reserve University (“CWRU”), 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;

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

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;

$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.

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.

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.

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

government agency, whichever comes later.

The EsoCheck patents, which are currently the last

to expire, begin to expire in May 2035.

June 2019, we received FDA 510(k) clearance to market EsoCheck in the U.S.

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In December 2019, our CLIA-certified then-laboratory partner, completed documentation of EsoGuard analytical

validity allowing us to commercialize it as a Laboratory Developed Test (LDT).

validity allowing us to commercialize it as a LDT.

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

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be marketed in CE Mark European countries.

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

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

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

If finalized, FDA believes

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

of safety and effectiveness.

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

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

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

the final rule.

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

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

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

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

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

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

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

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

Once the final policy is released, we will implement

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

for EsoGuard premarket submission.

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

per the timeframe defined in the final policy.

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

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

QS requirements, if and when required by the FDA.

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 screening system must be cleared

or approved by the FDA as an IVD device.

This use of EsoGuard together with EsoCheck as a testing system must be cleared or

approved by the FDA as an IVD device.

February 25, 2022, our new, wholly owned subsidiary, LucidDx Labs Inc.

(“LucidDx Labs”), acquired from 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, we have conducted EsoGuard testing at our own laboratory with, until recently, the assistance of

RDx, which had continued to provide certain testing and related services for the laboratory in accordance with the terms of a management

services agreement (“MSA-RDx”), dated and effective February 25, 2022.

Recently, however, the Company accelerated the development

of internal resources necessary to operate the laboratory entirely on its own.

Accordingly, Lucid’s subsidiary LucidDx Labs and

RDx agreed terminate the MSA-RDx effective as of February 10, 2023, such that LucidDx Labs now operates the laboratory itself, which

the Company believes will improve the efficiency of the performance of the EsoGuard assay.

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

more than 30 million at-risk individuals over the age of 50.

Given the large market for pre-cancer screening, we likely will face numerous

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

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

multi-cancer early detection products.

Our EsoCheck device faces competition from other manufactures with devices designed to collect

cell samples from targeted regions of the esophagus.

For example, Cytosponge is a small mesh sponge within a soluble gelatin capsule

that dissolves 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 contamination.

(“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, we have conducted EsoGuard testing at our own

laboratory with, until February 10, 2023, the assistance of RDx, which had continued to provide certain testing and related services

for the laboratory in accordance with the terms of a management services agreement (“MSA RDx”).

LucidDx Labs and RDx

agreed to terminate the MSA RDx effective as of February 10, 2023, such that LucidDx Labs now operates the laboratory itself, which

the Company believes has improved the efficiency of the performance of the EsoGuard assay.

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

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.

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, we likely will face numerous competitors,

some of which possess significantly greater financial and other resources and development capabilities than us.

Our EsoGuard test faces

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

early detection products.

Our EsoCheck device faces competition from other manufactures with devices designed to collect cell samples

from targeted regions of the esophagus.

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

before it, is a small mesh sponge within a soluble gelatin capsule that needs to reside in the stomach 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.

Our competitors may also be developing additional methods of detecting

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

the market for our products is highly competitive and is characterized by extensive research and clinical efforts and rapid technological

In order to compete effectively, EsoGuard and EsoCheck will have to achieve market acceptance, receive adequate insurance coverage

and reimbursement, be cost effective and be simultaneously safe and effective.

We believe that the principal competitive factors in our

diagnostic accuracy and the quality of outcomes for medical conditions;

acceptance by physicians and the medical device market generally;

ease of use and reliability;

technical leadership and superiority;

effective marketing and distribution;

speed to market;

product price and qualification for coverage and reimbursement.

of our existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing and technological

We may be unable to compete effectively against our competitors either because their products and services are superior or

more cost efficient, or because of they have access to greater resources than us.

more cost efficient, or because they have access to greater resources than us.

These competitors may have greater name recognition

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to respond to such technical advances.

Cancer Care Platform

May 2021, we formed Veris Health, a majority-owned subsidiary, focused on digital health technology.

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patient monitoring.

Oncodisc’s core technologies include 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.

was founded in 2018 experienced physician entrepreneurs, James Mitchell, M.D., who joined Veris Health as its full-time Chief Medical

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.

was founded in 2018 by experienced physician entrepreneurs, James Mitchell, M.D., who joined Veris Health as its full-time Chief Medical

Officer, and Andrew Thoreson, M.D., who serves as a Veris Health consultant.

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the MedTech Innovator Accelerator and UCSF Rosenman Institute Accelerator programs.

Veris Cancer Care Platform (“CCP”) is a digital cancer care platform with physiologic data collection, symptom reporting

and telehealth functions, designed to improve personalized cancer care through remote patient monitoring.

Cancer patients enrolled in

the Veris CCP receive a VerisBox™ with Veris-branded Bluetooth enabled connected health care devices.

The devices transmit clinical

data to cancer care teams to detect early signs of common cancer-related complications, provide longitudinal trends of physiologic and

clinical data, and offer data-driven risk management tools for precision oncology.

Veris CCP integrates directly with practices’

and systems’ Electronic Health Record (“EHR”) systems, allowing care teams to easily view and interact with this data.

We are also currently developing a groundbreaking implantable physiologic monitor containing biologic sensors capable of generating continuous

data on key physiologic parameters known to predict adverse outcomes in cancer patients undergoing treatment.

The implantable will seamlessly

interact with the Veris CCP.

These technologies are the subject of multiple patent applications and one issued patent.

Health leverages a business-to-business sales model.

Its software-as-a-service recurring-revenue business model seeks to generate 100%

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 drive revenues from remote physiologic monitoring (and, in the future, device implantation)

under existing CPT codes, as well as through the upcoming CMS Enhancing Oncology Model (EOM) bonuses and incentives.

Veris also plans

to build a commercialization model around the oncology data it is collecting.

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.

addition to targeting the oncology market, Veris plans to expand into the hospital-at-home market, cardiovascular diseases, end-stage

renal disease, and lung disorders like COPD.

We have already initiated R&D efforts around an enhanced implantable cardiac monitor

capable of detecting cardiac arrhythmias and other physiologic parameters critical for high-risk cardiac patients.

Future devices will

combine novel sensing technology with seamless communication, engaging user interface design, and data analytics driving actionable clinical

insights for patients with congestive heart failure.

These technologies will then be expanded for high-risk kidney disease and pulmonary

Veris Platform is a digital cancer care platform with physiologic data collection, symptom reporting and telehealth functions, designed

to improve personalized cancer care through remote patient monitoring.

Cancer patients enrolled in the Veris Platform receive a VerisBox™

with Veris-branded Bluetooth enabled connected health care devices.

The devices transmit clinical data to cancer care teams to detect

early signs of common cancer-related complications, provide longitudinal trends of physiologic and clinical data, and offer data-driven

risk management tools for precision oncology.

The Veris Platform integrates directly with practices’ and systems’ Electronic

Health Record (“EHR”) systems, allowing care teams to easily view and interact with this data.

We have also been developing

a groundbreaking implantable physiologic monitor containing biologic sensors capable of generating continuous data on key physiologic

parameters known to predict adverse outcomes in cancer patients undergoing treatment and as resources permit, we will resume further

development activities for the implantable to bring it to market.

The implantable will seamlessly interact with the Veris Platform.

technologies are the subject of multiple patent applications and one issued patent.

2023, approximately 1.9 million people in the U.S.

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Commercialization/Sales

Veris commercialization efforts have targeted the full spectrum of oncology care providers, with a focus on independent oncology practices,

participants in CMS’s Oncology Care Model (OCM) and EOM, and innovative, progressive health systems.

The growing adoption of value-based

models has provided a strong tailwind, as the Veris CCP addresses many requirements of these programs, including electronic Patient Reported

Outcomes (“ePROs”) and the use of data for quality improvement.

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

solution for these institutions’ oncology departments.

More broadly, in terms of our commercialization strategy, we have a software-as-a-service

recurring-revenue business model where we seek 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

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

components comprising the Veris 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 Impilo, a partner with TransTek and Mio Labs.

The customer support is currently managed internally, while partnering with Zendesk

for customer service management.

Veris CCP software is considered a non-device Medical Device Data System (“MDDS”) that is excluded from the statutory definition

of a medical device under the FDC Act and as confirmed in the FDA’s MDDS Guidance:

Medical Device Data Systems, Medical Image Storage

Devices, and Medical Image Communications Devices.

Therefore, Veris CCP is not subject to the FDA’s regulatory requirements for

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

Veris Platform software is considered a non-device Medical Device Data System (“MDDS”) that is excluded from the statutory

definition of a medical device under the FDC Act and as confirmed in the FDA’s MDDS Guidance:

Medical Device Data Systems, Medical

Image Storage Devices, and Medical Image Communications Devices.

Therefore, the Veris Platform is not subject to the FDA’s regulatory

requirements for devices.

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 current plan to make our 510(k) submission

for the implantable monitor in late 2023.

Veris Health is currently sourcing the devices included in the VerisBox™ from the third-party 510(k) holders for those products,

such holders are responsible for any losses, damages, claims or other liabilities that may arise with respect to those devices used with

the Veris CCP software, notwithstanding Veris Health commercial branding being added to the devices or the devices’ packaging.

We plan to make our 510(k) submission for the

implantable monitor, which could happen as early as late 2024, if and to the extent resources permit us to do so.

market for cancer patient care is large.

There are many existing competitors in the remote patient monitoring space, some of which

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

Our Veris CCP faces competition from

other digital care platforms providing many of the same features, including EHR integration and remote patient monitoring capabilities.

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 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.

is a summary of certain of the other leading products within our development pipeline.

While we currently are devoting substantially

all of our resources to the acceleration of EsoGuard and Veris Cancer Care Platform commercialization, as resources permit, we will continue

to explore innovative technologies, such as our EsoCure, CarpX and NextFlo products as more fully described below, that fulfill our project

selection criteria without limiting ourselves to any target specialty or condition.

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

On March 21, 2024, the Company announced

that it has launched a wholly owned incubator, PMX, to complete development and commercialization of existing portfolio technologies,

including PortIO, EsoCure and CarpX.

PMX and Hatch Medical, L.L.C.

(“Hatch Medical”), a medical device incubator and technology

brokerage firm, have executed a joint venture agreement to advance the technologies.

Pursuant to the joint venture agreement,

PAVmed will assign PortIO, EsoCure and CarpX to its wholly owned incubator, PMX.

Starting with PortIO, the Company will seek to independently

finance a separate subsidiary of the incubator to develop and commercialize each technology.

Hatch Medical will provide strategic advisory

and brokerage services to the subsidiary to advance the technology through key milestones and, subsequently, seek to engage a strategic

partner to acquire, license or distribute the commercial product.

Although the incubator, PMX, may seek to expand its portfolio

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

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.

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,

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continue to pursue that project, as resources permit.

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.

of Lucid Clinical Trials

is currently seeking to accelerate our collection of clinical utility data through a range of trials that can be efficiently executed.

These efforts include a planned investigator-initiated, retrospective analysis of prospectively collected data on the approximately 400

San Antonio fire fighters who underwent testing as part of a community-sponsored cancer awareness event (in

respect of which we expect to publish results in the first half of 2023) ;

an ongoing investigator-initiated, retrospective, single-center,

study with 500 patients (in respect of which we expect to publish results mid-2023), a virtual-patient randomized controlled trial with

intended recruitment of 100-200 physician participants (in respect of which we expect to publish

results this year) ;

a Lucid-sponsored multi-center, prospective, observational study with 500 patients;

and a Lucid-sponsored

registry at existing Lucid Test Centers, whereby all patients undergoing EsoCheck testing will be given the opportunity to provide informed

consent and contribute data about their risk factors, EsoGuard results, and subsequent diagnostic and/or therapeutic journey.

Both Lucid-sponsored

observational/registry studies expect to have preliminary results and/or interim analysis before the end of 2023.

previously disclosed, consequently, Lucid has decided to delay for the time being the two previously commenced clinical trials, the “EsoGuard

screening study” (“BE-1”) and the “EsoGuard case-control study” (“BE-2”), as Lucid is devoting

our clinical resources to the studies cited above, which we expect will more efficiently generate the clinical data Lucid is currently

prioritizing to drive EsoGuard commercialization.

Labs Laboratory Operations Update

February 14, 2023, Lucid Diagnostics and LucidDx Labs Inc.

entered into an agreement (the “MSA Termination Agreement ”)

with RDx, pursuant to which the parties mutually agreed to terminate the MSA-RDx without cause.

The termination was effective as February

Until the termination of the MSA-RDx, RDx had continued to provide certain testing and related services for the Laboratory

in accordance with the terms of the MSA-RDx.

Recently, however, Lucid accelerated the development of internal resources necessary to

operate the Laboratory entirely on its own.

Accordingly, the Company believes that termination of the MSA-RDx will improve the efficiency

of the performance of the EsoGuard assay.

other things, the MSA Termination Agreement reduces the remaining amounts of the earnout payments and management fees due under the APA-RDx

and the MSA-RDx to $725,000 (from the $3,450,000 that would otherwise have been payable under the APA and MSA if the MSA had remained

in effect through the balance of its stated term), resulting in a net savings to Lucid Diagnostics of $2,725,000.

The payment was satisfied

through the issuance of 553,436 shares of Lucid Diagnostics’ common stock on February 25, 2023.

Lucid Diagnostics was not required

to make any cash payments in connection with the termination.

#CheckYourFoodTube

January 2023, Lucid successfully completed its first #CheckYourFoodTube Precancer Testing Event, in partnership with Rachelle Hamblin,

M.D., M.P.H., and the San Antonio Fire Department (SAFD), to detect esophageal precancer in at-risk members of the department.

testing event was held over two weekends in January, which has been designated as Firefighter Cancer Awareness Month by the International

Association of Fire Fighters (IAFF).

A total of 391 members, nearly one-quarter of the department, who were deemed by Dr.

be at-risk for esophageal precancer, underwent a brief, on-site, noninvasive cell collection procedure, performed by Lucid clinical personnel

using its EsoCheck ® Esophageal Cell Collection Device.

Firefighters with suspected esophageal precancer based on a positive

EsoGuard result were identified, including some less than forty years of age, and will undergo appropriate monitoring and treatment,

as indicated by clinical practice guidelines, to prevent progression to esophageal cancer.

These events, which Lucid looks to expand

across the country, are an extension of Lucid’s recently introduced and expanding satellite Lucid Test Center (sLTC) program, which

brings our precancer testing directly to patients—at their physician’s office and now at large testing day events.

demonstrated that its nurse practitioners can each perform up to fifty EsoCheck procedures in a day, and its laboratory team handled

over two hundred incoming samples in a day, while maintaining turnaround times at target.

These successes provide an excellent foundation

for future testing events as we continue to drive EsoGuard commercialization using all the tools at our disposal.

Health Commercialization Update

December 2022, Veris Health signed a license agreement for the Veris CCP software with its first customer, New Jersey Cancer Care.

Veris Health onboarded the first cohort of patients of that practice onto the Veris CCP as well, and has signed license agreements with

two additional cancer centers.

These successes lay the groundwork for Veris Health’s expansion plans with respect to the Veris

CCP software as it seeks to onboard cancer centers and patients across the country.

December 29, 2022, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30

consecutive business days (through December 28, 2022), the closing bid price of the Company’s common stock had been below the minimum

of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).

The notification letter

stated that the Company would be afforded 180 calendar days (until June 27, 2023) to regain compliance.

In order to regain compliance,

the closing bid price of the Company’s common stock must be at least $1 for a minimum of ten consecutive business days.

2023, the Company distributed a proxy statement for a special meeting of shareholders to be held on March 31, 2023 (the “Special

Meeting”), at which the Company will be seeking approval of an amendment to the Company’s Certificate of Incorporation, to

effect, at any time prior to the one-year anniversary date of the Special Meeting, (i) a reverse split of the Company’s outstanding

shares of common stock at a specific ratio, ranging from 1-for-5 to 1-for-15, to be determined by the board of directors of the Company

in its sole discretion, and (ii) an associated reduction in the number of shares of common stock the Company is authorized to issue,

from 250,000,000 shares to 50,000,000 shares.

If the proposed reverse stock split is approved, the Company anticipates it will regain

compliance with the Nasdaq requirements for continued listing.

Payroll and Benefit Expense Reimbursement Agreement

November 30, 2022, PAVmed and Lucid entered into a payroll and benefit expense reimbursement agreement (the “PBERA”).

Historically,

PAVmed has paid for certain payroll and benefit-related expenses in respect of Lucid’’s personnel on behalf of Lucid, and

Lucid has reimbursed PAVmed for the same.

Pursuant to the PBERA, PAVmed will continue to pay such expenses, and Lucid will continue to

reimburse PAVmed for the same.

The PBERA now provides that the expenses will be reimbursed on a quarterly basis or at such other frequency

as the parties may determine, in cash or, subject to approval by the board of directors of each of PAVmed and Lucid, in shares of Lucid’s

common stock, with such shares valued at the volume weighted average price of such stock during the final ten trading days preceding

the later of the two dates on which such stock issuance is approved by the board of directors of each of PAVmed and Lucid (subject to

a floor price of $0.40 per share), or in a combination of cash and shares.

However, in no event shall Lucid issue any shares of its common

stock to PAVmed in satisfaction of all or any portion of the expenses if the issuance of such shares of its common stock would exceed

the maximum number of shares of common stock that the Issuer may issue under the rules or regulations of The Nasdaq Stock Market LLC

(“Nasdaq”), unless Lucid obtains the approval of its stockholders as required by the applicable rules of the Nasdaq for issuances

of shares of its common stock in excess of such amount.

Z Warrant Modification

December 4, 2023, the Company announced the extension of the Company’s Series Z Warrants, by 12 months, to April 30, 2025.

In addition, as a

result of the reverse stock split, described below, the Series Z Warrants became exercisable to purchase one whole share of common

stock of the Company at an exercise price of $24.00, which exercise price per whole share was further reduced to $23.48 as described

below under the heading “ PAVmed Distribution of Lucid Diagnostics Common Stock to Shareholders ”.

recognized the incremental value associated with the Series Z Warrants modification for the term extension as a deemed dividend

charge of $1.8 million and as an increase of net loss available to common stockholders on the consolidated statements of operations

December 7, 2023, the Company implemented a 1-for-15 reverse stock split of its common stock and reduced its authorized shares from 250,000,000

to 50,000,000, each in accordance with shareholder approval granted at a March 31, 2023 special meeting of the Company’s stockholders.

The Company filed an amended Certificate of Incorporation reflecting the reduction in authorized shares.

purpose of the reverse stock split was to regain compliance with the $1 minimum bid price requirement for continued listing on the Nasdaq

Capital Market.

Indeed, on January 7, 2024, the Company received a letter from the Listing Qualifications Department of Nasdaq, stating

the Company had regained compliance with such requirement.

Services Agreement/Payroll Benefits and Expense Reimbursement Agreement with Lucid Diagnostics

On March 22, 2024, PAVmed and Lucid

entered into an eighth amendment to the management services agreement between PAVmed and Lucid (“MSA”) to increase the monthly

fee thereunder from $0.75 million per month to $0.83 million per month, effective as of January 1, 2024.

The amendment also reset the

maximum number of shares issuable under the agreement to 19.99% of the shares outstanding as of the date of the amendment.

January 26, 2024, in accordance with the MSA and the payroll, benefits and expense reimbursement agreement between PAVmed and Lucid (“PBERA”),

PAVmed elected to receive payment of approximately $4.7 million of fees and reimbursements accrued under the MSA and the PBERA through the issuance of 3,331,771 shares of Lucid’s common stock.

Distribution of Lucid Diagnostics Common Stock to Shareholders

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

stock held by the Company.

On such date, each PAVmed shareholder as of the January 15,

2024 record date received a stock dividend of approximately 38 shares of Lucid common stock for every 100 shares of PAVmed common stock

they held as of such date.

The shares distributed were approximately equal to the number of shares of common stock that Lucid issued

to PAVmed on or about January 26, 2024 in satisfaction of certain intercompany obligations due to Lucid from PAVmed, as discussed above.

distribution constituted an “Extraordinary Dividend” as defined in the warrant agreement that governs the Company’s

Series Z Warrants.

As a result, pursuant to the warrant agreement, the exercise price under the Series Z Warrants per full share of PAVmed

common stock was automatically decreased by $0.52 (the fair market value of 0.37709668 of a share of Lucid Diagnostics’ common

stock) to $23.48 per share.

March 7, 2024, the Company received a notice from the Nasdaq Listing Qualifications Department stating that, for the preceding 30 consecutive

business days (through March 6, 2024), the market value of the Company’s listed securities (“MVLS”) had been below

the minimum of $35 million required for continued inclusion on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2).

The notification

letter stated that the Company would be afforded 180 calendar days (until September 3, 2024) to regain compliance.

In order to regain

compliance, the Company’s MVLS must close at $35 million or more for a minimum of ten consecutive business days.

The notification

letter also states that in the event the Company does not regain compliance prior to the expiration of the 180-day period, the Company

will receive written notification that its securities are subject to delisting.

The Nasdaq notification has no effect at this time on

the listing of the Company’s common stock or Series Z warrants, and the stock and warrants will continue to trade uninterrupted

under the symbol “PAVM” and “PAVMZ”, respectively.

Incubator Program

On March 21, 2024, the Company announced

that it has launched a wholly owned incubator, PMX, to complete development and commercialization of existing portfolio technologies,

including PortIO, EsoCure and CarpX.

PMX and Hatch Medical, L.L.C.

(“Hatch Medical”), a medical device incubator and technology

brokerage firm, have executed a joint venture agreement to advance the technologies.

Pursuant to the joint venture agreement,

PAVmed will assign PortIO, EsoCure and CarpX to its wholly owned incubator, PMX.

Starting with PortIO, the Company will seek to independently

finance a separate subsidiary of the incubator to develop and commercialize each technology.

Hatch Medical will provide strategic advisory

and brokerage services to the subsidiary to advance the technology through key milestones and, subsequently, seek to engage a strategic

partner to acquire, license or distribute the commercial product.

Purchase Agreement - March 31, 2022 - Senior Secured Convertible Note - April 4, 2022 and Senior Secured Convertible Note - September

as of March 31, 2022, we entered into a Securities Purchase Agreement (“SPA”) with an accredited institutional investor (“Investor”,

“Lender”, and /or “Holder”), pursuant to which we agreed to sell, and the Investor agreed to purchase an aggregate

of $50.0 million face value principal of Senior Secured Convertible Notes.

The SPA provided for the sale to the Investor of an initial

Senior Secured Convertible Note with a face value principal of $27.5 million, which closed on April 4, 2022 (the “April 2022 Senior

Convertible Note”).

The SPA also provided for sales of additional Senior Secured Convertible Notes in one or more additional closings

(upon the satisfaction of certain conditions), with an aggregate face value principal of up to an additional $22.5 million.

2022 Senior Convertible Note proceeds were $24.4 million after deducting a $2.5 million lender fee and the Company’s offering costs

of approximately $0.6 million, inclusive primarily of $0.5 million placement agent fees.

September 8, 2022, we completed an additional closing under the SPA, in which we sold to the Investor an additional Senior Secured Convertible

Note with a face value principal of $11.25 million (the “September 2022 Senior Convertible Note”).

The September 2022 Senior

Convertible Note proceeds were $10.0 million after deducting a $1.0 million lender fee and the Company’s offering costs of approximately

$0.2 million, inclusive primarily of placement agent fees.

Effective as of March 12, 2024,

the Company entered into an amendment and waiver (the “Note Amendment and Waiver”) with the holder of the April 2022 Senior

Convertible Note and the September 2022 Senior Convertible Note (each such term as defined below).

Pursuant to the Note Amendment and

Waiver, the maturity date of the April 2022 Senior Convertible Note was extended to April 4, 2025 and the maturity date of the September

2022 Senior Convertible Note was extended to September 8, 2025, in each case subject to further extension in certain circumstances.

holder of the such note also waived, for the period commencing on December 1, 2023 and ending on August 31, 2024, the financial covenant

contained in such notes requiring that the ratio of (a) the outstanding principal amount of the notes, accrued and unpaid interest thereon

and accrued and unpaid late charges to (b) the Company’s average market capitalization over the prior ten trading days, not exceed

30%, and that the Company’s market capitalization not be less than $75 million.

In consideration of the Note Amendment and Waiver,

the Company agreed to pay the holder of the notes $2,000,000 in cash (or in such other form as may be mutually agreed in writing) by April

our accompanying consolidated financial statements Note 13, Debt , for further discussion of the SPA dated March 31, 2022 and the

senior convertible notes.

Diagnostics Inc.

- Committed Equity Facility and ATM Facility

March 2022, our majority-owned subsidiary, Lucid Diagnostics, entered into a committed equity facility with an affiliate of Cantor Fitzgerald

Under the terms of the facility, Cantor committed to purchase up to $50 million of Lucid Diagnostics common stock

from time to time upon the request of Lucid Diagnostics.

While there are distinct differences, the facility is structured similarly to

a traditional at-the-market equity facility, insofar as it allows Lucid Diagnostics to raise primary capital on a periodic basis at prices

based on the existing market price.

Through December 31, 2022, 680,263 shares of common stock of Lucid Diagnostics were issued under

this facility for total proceeds of approximately $1.8 million.

November 2022, Lucid Diagnostics also entered into an “at-the-market offering” for up to $6.5 million of its common stock

that may be offered and sold under a Controlled Equity Offering Agreement between Lucid Diagnostics and Cantor Fitzgerald & Co.

the year ended December 31, 2022, there were no Lucid Diagnostics shares sold through their at-the-market equity facility.

to December 31, 2022, through March 9, 2023, Lucid Diagnostics sold 230,068 shares through its at-the-market equity facility for approximately

$0.3 million.

Diagnostics - Series A Preferred Stock Offering

March 7, 2023, Lucid entered into subscription agreements for the sale of 13,625 shares (the “ Lucid Series A

Preferred Stock ”).

Each share of the Lucid Series A Preferred Stock has a stated value of $1,000 and a conversion price of

The terms of the Lucid Series A Preferred Stock also include a one times preference on liquidation and a right to receive

dividends equal to 20% of the number of shares of Lucid common stock into which such Lucid Series A Preferred Stock is convertible,

payable on the one-year and two-year anniversary of the issuance date.

The Lucid Series A Preferred Stock is a non-voting security,

other than with respect to limited matters related to changes in terms of the Lucid Series A Preferred Stock.

Lucid Diagnostics - Preferred Stock Offerings

On March 13, 2024, Lucid entered

into subscription agreements (each, a “Series B Subscription Agreement”) and exchange agreements (each, an “Exchange

Agreement”) with certain accredited investors (collectively, the “Series B Investors”), which agreements provided for

(i) the sale to the Series B Investors of 12,495 shares of Lucid’s newly designated Series B Convertible Preferred Stock, par value

$0.001 per share (the “Lucid Series B Preferred Stock”), at a purchase price of $1,000 per share, and (ii) the exchange by

the Series B Investors of 13,625 shares of Lucid’s Series A Convertible Preferred Stock, par value $0.001 per share (the “Lucid

Series A Preferred Stock”), and 10,670 shares of Lucid’s Series A-1 Convertible Preferred Stock, par value $0.001 per share

(the “Lucid Series A-1 Preferred Stock”), held by them for 31,790 shares of Lucid Series B Preferred Stock (collectively,

the “Lucid Series B Offering and Exchange”).

Prior to the execution of the Series B Subscription Agreements and the Exchange

Agreements, Lucid entered into subscription agreements with certain of the Series B Investors providing for the sale to such investors

of 5,670 shares of Lucid Series A-1 Preferred Stock, at a purchase price of $1,000 per share, which shares the investors immediately agreed

to exchange for shares of Lucid Series B Preferred Stock pursuant to the Exchange Agreements (and are included in the 10,670 shares of

Lucid Series A-1 Preferred Stock set forth above).

Each share of the Lucid Series B Preferred Stock has a stated value of $1,000 and a

conversion price of $1.2444.

The terms of the Lucid Series B Preferred Stock also include a one times preference on liquidation and a

right to receive dividends equal to 20% of the number of shares of Lucid common stock into which such Lucid Series B Preferred Stock is

convertible, payable on the one-year and two-year anniversary of the issuance date.

The Lucid Series B Preferred Stock is a voting security.

The aggregate gross proceeds to Lucid of these transactions was $18.16 million (inclusive of $5.67 million of aggregate gross proceeds

from the sale of the Lucid Series A-1 Preferred Stock that was immediately exchanged for Lucid Series B Preferred Stock in the transactions).

As a result of 100% of the then-outstanding

shares of Lucid Series A Preferred Stock and Lucid Series A-1 Preferred Stock being exchanged for shares of Lucid Series B Preferred Stock

in the Lucid Series B Offering and Exchange, no shares of Lucid Series A Preferred Stock or Lucid Series A-1 Preferred Stock remain outstanding.

On October 17, 2023, Lucid sold

5,000 shares of Lucid Series A-1 Preferred Stock, solely to accredited investors (all of which were including in the 10,670 shares of

Lucid Series A-1 Preferred exchanged for Lucid Series B Preferred Stock in the Lucid Series B Offering and Exchange).

The aggregate gross

proceeds from the sale of shares in such offering were $13.625

Diagnostics - Private Placement - Securities Purchase Agreement

as of March 13, 2023, Lucid entered into a Securities Purchase Agreement (“Lucid SPA”) with an accredited

institutional investor (“Lucid Investor”, “Lucid Lender”, and /or “Lucid Holder”), pursuant to

which Lucid agreed to sell, and the Lucid Investor agreed to purchase a Senior Secured Convertible Note with a face value principal

of up to $11.1 million (the “March 2023 Lucid Senior Convertible Note”).

The issuance of the March 2023 Lucid Senior

Convertible Note is subject to customary closing conditions.

March 2023 Lucid Senior Secured Convertible Note would have a 7.875% annual stated interest rate, a contractual conversion price of $5.00

per share of Lucid’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination,

recapitalization or other similar transaction), and a contractual maturity date of the two-year anniversary of the date of issuance.

The March 2023 Lucid Senior Convertible Note would be convertible into or otherwise paid in shares of Lucid’s common stock.

the March 2023 Lucid Senior Convertible Note, Lucid is and would be subject to certain customary affirmative and

negative covenants regarding the incurrence of indebtedness, the existence of liens, the repayment of indebtedness and the making of

investments, the payment of cash in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of

other indebtedness, and transactions with affiliates, among other customary matters.

Under the March 2023 Lucid Senior Convertible Note, Lucid would also be subject to financial

covenants requiring that (i) the amount of Lucid’s available cash equal or exceed $5.0 million at all times, (ii) the ratio of (a) the

outstanding principal amount of the notes issued under the Lucid SPA, accrued and unpaid interest thereon and accrued and unpaid

late charges to (b) Lucid’s average market capitalization over the prior ten trading days, not exceed 30%, and (iii) that

Lucid’s market capitalization shall at no time be less than an amount to be agreed upon.

business depends on our ability to create or acquire proprietary medical device and diagnostics technologies to commercialize.

or have the right to use intellectual property rights, such as patents, trademarks, copyrights, trade secrets and know-how, pertaining

to our EsoCheck and EsoGuard technology, our Veris technology and our EsoCure, CarpX and PortIO products, among other technologies and

proceeds to Lucid of this offering was $5.0 million.

December 2021, we entered into an “at-the-market offering” for up to $50 million of our common stock that may be offered

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

In March 2023, the “at-the-market offering”

became subject to General Instruction I.B.6 of Form S-3, which limits sales of our securities under this instruction in any 12-month

period to one-third of the aggregate market value of our public float (unless our public float rises to $75 million or more, in which

case the instruction will cease to apply).

As a result of this limitation and our then-current public float, in May 2023, we amended

our “at-the-market offering” to cover up to an additional $18 million of our common stock.

In the year ended December 31,

2023, the Company sold 321,288 shares through its at-the-market equity facility for net proceeds of approximately $1.8 million, after

payment of 3% commissions.

business will depend proprietary medical device and diagnostic technologies to commercialize.

We own or have the right to use intellectual

property rights, such as patents, trademarks, copyrights, trade secrets and know-how, pertaining to our EsoCheck and EsoGuard technology,

our Veris technology and our EsoCure, CarpX and PortIO products, among other technologies and products.

intend to vigorously protect our proprietary technologies’ intellectual property rights in patents, trademarks and copyrights,

as available through registration in the United States and internationally.

We currently have applied for, license or own 55 domestic

and foreign patents across 11 families of products, including patents protecting our EsoCheck, EsoGuard and Veris technology.

the patents protecting certain of our owned and licensed technology will first begin to expire is as set forth in the table below (although

currently pending patent applications, both foreign and domestic, are positioned to provide protection beyond such date in each instance).

protection and other proprietary rights are thus essential to our business.

Patent protection and other proprietary rights are thus essential

to our business.

We currently have applied for, license or own 55 domestic and foreign patents across 11 families of products, including

patents protecting our EsoCheck, EsoGuard and Veris technology.

Each of the technologies noted below is protected by multiple families,

and only the earliest expiration for the first of the families is listed.

The date the patents protecting certain of our owned and licensed

technology will first begin to expire is as set forth in the table below (although currently pending patent applications, both foreign

and domestic, are positioned to provide protection beyond such date in each instance).

For EsoGuard, families are pending that, when

granted, will offer additional protections until at least 2037.

Our policy is to aggressively file patent applications to

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delays by the U.S.

Patent and Trademark Office in granting a patent, or patent term extension, which restores time lost due to regulatory

Patent and Trademark Office (“USPTO”) in granting a patent, or patent term extension, which restores time

lost due to regulatory delays.

intend to continuously reassess and fine-tune our intellectual property strategy in order to fortify our position in the United States

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our ability to adequately obtain and protect these rights and the likelihood or possibility of infringement upon competing rights of

also rely upon trade secrets, know-how, continuing technological innovation, and upon licensing opportunities, to develop and

maintain our competitive position.

We intend to protect our proprietary rights through a variety of methods, including

confidentiality agreements and/or proprietary information agreements with suppliers, employees, consultants, independent contractors

and other entities who may have access to proprietary information.

We will generally require employees to assign patents and other

intellectual property to us as a condition of employment with us.

All of our consulting agreements will pre-emptively assign to us

all new and improved intellectual property that arise during the term of the agreement.

also rely upon trade secrets, know-how, continuing technological innovation, and upon licensing opportunities, to develop and maintain

our competitive position.

We intend to protect our proprietary rights through a variety of methods, including confidentiality agreements

and/or proprietary information agreements with suppliers, employees, consultants, independent contractors and other entities who may

have access to proprietary information.

We will generally require employees to assign patents and other intellectual property to us as

a condition of employment with us.

All of our consulting agreements will pre-emptively assign to us all new and improved intellectual

property that arise during the term of the agreement.

also has (directly or through its subsidiaries) proprietary rights to a range of trademarks, including, among others, PAVmed™,

Lucid Diagnostics™, LUCID™, VERIS™, Oncodisc™, CarpX®, EsoCheck®, EsoGuard®, EsoCheck Cell Collection

Device®, Collect + Protect®, EsoCure Esophageal Ablation Device™, NextFlo™, and PortIO™.

(Solely as a matter

of convenience, trademarks and trade names referred to herein may or may not be accompanied with the requisite marks of “™”

Device®, Collect + Protect®, EsoCure Esophageal Ablation Device™, and PortIO™.

(Solely as a matter of convenience,

trademarks and trade names referred to herein may or may not be accompanied with the requisite marks of “™” or “®”.

However, the absence of such marks is not intended to indicate, in any way, PAVmed Inc.

or its subsidiaries will

not assert, to the fullest extent possible under applicable law, their respective rights to such trademarks and trade names.)

or its subsidiaries will not assert, to the fullest

extent possible under applicable law, their respective rights to such trademarks and trade names.)

Insurance Coverage and Reimbursement

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for a fuller discussion of the competitive environment for our key products, EsoCheck, EsoGuard and the Veris Cancer Care Platform.

products we develop must be cleared by the FDA before they are marketed in the United States.

Before and after approval or clearance

in the United States, our products are subject to extensive regulation by the FDA under the FDCA and/or the Public Health Service Act,

as well as by other regulatory bodies.

FDA regulations govern, among other things, the development, testing, manufacturing, labeling,

safety, storage, recordkeeping, market clearance or approval, advertising and promotion, import and export, marketing and sales, and

distribution of medical devices and products.

and after approval or clearance in the United States, our products are subject to extensive regulation by the FDA under the FDCA and/or

the Public Health Service Act, as well as by other regulatory bodies.

FDA regulations govern, among other things, the development, testing,

manufacturing, labeling, safety, storage, recordkeeping, market clearance or approval, advertising and promotion, import and export,

marketing and sales, and distribution of medical devices and products.

the United States, medical devices are subject to varying degrees of regulatory control and are classified in one of three classes depending

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general controls, such as labeling and adherence to quality system regulations;

special controls, pre-market notification (often referred to as a 510(k) application),

specific controls such as performance standards, patient registries, post-market surveillance,

additional controls such as labeling and adherence to quality system regulations;

special controls and approval of a PMA application.

special controls, pre-market notification (often referred to as a 510(k) application), specific controls such as performance

standards, patient registries, post-market surveillance, additional controls such as labeling and adherence to quality system regulations;

special controls and approval of a de novo request or PMA application, likely with clinical data requirements.

general, the higher the classification, the greater the time and cost to obtain approval to market.

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requirements for approval, even within each class.

For example, the FDA could grant 510(k) status, but require a human clinical trial,

a typical requirement of a PMA.

They could also initially assign a device Class III status but end up approving a device as a 510(k)

device if certain requirements are met.

The range of the number and expense of the various requirements is significant.

and least expensive pathway would be 510(k) approval with just a review of existing data.

The longest and most expensive path would be

a PMA with extensive randomized human clinical trials.

We cannot predict how the FDA will classify our products, nor predict what requirements

will be placed upon us to obtain market approval, or even if they will approve our products at all.

For example, FDA could grant 510(k) status, but require a human clinical trial, a

typical requirement of a PMA.

They could also initially assign a device Class III status but end up clearing a device as a 510(k) device

or under a de novo classification pathway if certain requirements are met.

The range of the number and expense of the various requirements

is significant.

The quickest and least expensive pathway would be 510(k) clearance with a review of existing bench and animal data.

de novo classification pathway would have a similar cost to seeking 510(k) clearance, but with a slightly longer review timeline.

longest and most expensive path would be a PMA with extensive randomized human clinical trials.

We cannot predict fully how FDA will

classify our products, nor predict what requirements will be placed upon us to obtain market clearance or approve our products at all.

request marketing authorization by means of a 510(k) clearance, we must submit a pre-market notification demonstrating the proposed device

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1997, the Food and Drug Administration Modernization Act (FDAMA) added the de novo classification pathway under section 513(f)(2) of

the FD&C Act, establishing an alternate pathway to classify new devices into Class I or II that had automatically been placed in

the FDCA, establishing an alternate pathway to classify new devices into Class I or II that had automatically been placed in

Class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission.

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classification of the device under section 513(a)(1) of the Act.

2012, section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act

2012, section 513(f)(2) of the FDCA was amended by section 607 of the Food and Drug Administration Safety and Innovation Act

(FDASIA), to provide a second option for de novo classification.

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We cannot foresee what effect, if any, such changes may have on us.

Regulations will continue to change and evolve including the 2016-21st Century Cures Act which mandated the creation and revision of

policies and processes intended to speed patient access to new medical devices and codifying into law the FDA’s expedited review

program for breakthrough devices for which EsoGuard was so designated.

In 2017, the Food and Drug Administration Reauthorization Act

(FDARA) which included improvements to premarket review times and investments in strategic initiatives like the National Evaluation System

for health Technology (NEST) and patient input and decoupling accessory classification from classification of the parent device.

continue to be aware of these changes that possibly impact our development and commercialization work.

The Company has a network of professionals

with extensive experience in these matters that advise us on both the pre-approval/clearance requirements as well as the post market

surveillance compliance obligations.

Trials of Medical Technology

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Post-Approval

Regulation of Medical Devices

a device is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply.

Regulation of Medical Devices and Diagnostic Tests

a device is cleared or approved for marketing, numerous regulatory requirements continue to apply.

These include:

FDA Quality Systems Regulation (QSR), which governs, among other things, how manufacturers

design, test manufacture, exercise quality control over, and document manufacturing of their

and claims regulations, which prohibit the promotion of products for unapproved or “off-label”

uses and impose other restrictions on labeling;

Medical Device Reporting regulation, which requires reporting to the FDA of certain adverse

experience associated with use of the product.

will continue to be subject to inspection by the FDA to determine our compliance with regulatory requirements.

FDA Quality Systems Regulation (QSR), which governs, among other things, how manufacturers design, test manufacture, exercise quality

control over, and document manufacturing of their products;

and claims regulations, which prohibit the promotion of products for unapproved or “off-label” uses and impose other

restrictions on labeling;

Medical Device Reporting regulation, which requires reporting to FDA of certain adverse experience associated with use of the product.

will continue to be subject to inspection by FDA to determine our compliance with regulatory requirements.

Manufacturing

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and otherwise cause Lucid to incur significant expense.

Healthcare Regulation

addition to FDA restrictions on marketing and promotion of drugs and devices, other federal and state laws restrict our business practices.

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laws regarding payments or other items of value provided to healthcare providers.

of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available under such laws, it is

possible that some of our business activities, including certain sales and marketing practices and the provision of certain items

and services to our customers, could be subject to challenge under one or more of such laws.

If our operations are found to be in

violation of any of the health regulatory laws described above or any other laws that apply to us, we may be subject to penalties,

including potentially significant criminal and civil and administrative penalties, damages, fines, disgorgement, imprisonment,

exclusion from participation in government healthcare programs, contractual damages, reputational harm, administrative burdens,

diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect

our ability to operate our business and our results of operations.

To the extent any of our products are sold in a foreign country,

we may be subject to similar foreign laws, which may include, for instance, applicable post-marketing requirements, including safety

surveillance, anti-fraud and abuse laws and implementation of corporate compliance programs and reporting of payments or transfers

of value to healthcare professionals.

of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available under such laws, it is possible

that some of our business activities, including certain sales and marketing practices and the provision of certain items and services

to our customers, could be subject to challenge under one or more of such laws.

If our operations are found to be in violation of any

of the health regulatory laws described above or any other laws that apply to us, we may be subject to penalties, including potentially

significant criminal and civil and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation

in government healthcare programs, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings,

and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our

results of operations.

To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws,

which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws and

implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.

In any event, we have established

a substantial regulatory and compliance infrastructure that is designed to ensure compliance with these regulations.

Payment Sunshine Act

has been a recent trend of increased federal and state regulation of payments and transfers of value provided to healthcare professionals

On February 8, 2013, the Centers for Medicare & Medicaid Services, or CMS, released its final rule implementing section

6002 of the Affordable Care Act known as the Physician Payment Sunshine Act that imposes new annual reporting requirements on device

manufacturers for payments and other transfers of value provided by them, directly or indirectly, to physicians and teaching hospitals,

as well as ownership and investment interests held by physicians and their family members.

A manufacturer’s failure to submit timely,

accurately and completely the required information for all payments, transfers of value or ownership or investment interests may result

in civil monetary penalties of up to an aggregate of $150,000 per year, and up to an aggregate of $1 million per year

for “knowing failures.” Manufacturers that produces at least one product reimbursed by Medicare, Medicaid, or Children’s

Health Insurance Program and (i) if the product is a drug or biological, and it requires a prescription (or physician’s authorization)

to administer;

or (ii) if the product is a device or medical supply, and it requires premarket approval or premarket notification by

the FDA are required to comply with the Open Payments (commonly referred to as the Sunshine Act) filing requirements under CMS.

do not have any products covered by Medicare, Medicaid, or Children’s Health Insurance Program as none of our products have premarket

approval or clearance notification.

We expect once our products receive regulatory clearance, we will be required to comply with the

Sunshine Act provisions.

states, such as California and Connecticut, also mandate implementation of commercial compliance programs, and other states, such as

Massachusetts and Vermont, impose restrictions on device manufacturer marketing practices and require tracking and reporting of gifts,

compensation and other remuneration to healthcare professionals and entities.

The shifting commercial compliance environment and the

need to build and maintain robust and expandable systems to comply with different compliance or reporting requirements in multiple jurisdictions

increase the possibility a healthcare company may fail to comply fully with one or more of these requirements.

February 8, 2013, the Centers for Medicare & Medicaid Services, or CMS, released its final rule implementing section 6002 of the

Affordable Care Act known as the Physician Payment Sunshine Act that imposes annual reporting requirements on device manufacturers for

payments and other transfers of value provided by them, directly or indirectly, to physicians and teaching hospitals, as well as ownership

and investment interests held by physicians and their family members.

A manufacturer’s failure to submit timely, accurately and

completely the required information for all payments, transfers of value or ownership or investment interests may result in civil monetary

penalties of up to an aggregate of $150,000 per year, and up to an aggregate of $1 million per year for “knowing failures.”

Manufacturers that produce at least one product reimbursed by Medicare, Medicaid, or Children’s Health Insurance Program and (i)

if the product is a drug or biological, and it requires a prescription (or physician’s authorization) to administer;

the product is a device or medical supply, and it requires premarket approval or premarket notification by the FDA are required to comply

with the Open Payments (commonly referred to as the Sunshine Act) filing requirements under CMS.

We currently do not have any products

covered by Medicare, Medicaid, or Children’s Health Insurance Program as none of our products have premarket approval or clearance

notification.

We expect once our products receive regulatory clearance, we will be required to comply with the Sunshine Act provisions.

states, also mandate implementation of commercial compliance programs, and other states impose restrictions on device manufacturer marketing

practices and require tracking and reporting of gifts, compensation and other remuneration to healthcare professionals and entities.

The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to comply with different

compliance or reporting requirements in multiple jurisdictions increase the possibility a healthcare company may fail to comply fully

with one or more of these requirements.

Anti-Kickback Statute

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Several courts have interpreted the statute’s

intent requirement to mean if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered

business, the Anti-Kickback Statute has been violated.

intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare

covered business, the Anti-Kickback Statute has been violated.

Additionally,

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Several pharmaceutical, device and other healthcare companies have been prosecuted under these laws for, among

other things, allegedly providing free product to customers with the expectation the customers would bill federal programs for the product.

Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of products for

unapproved, and thus non-covered uses.

other things, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the

Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of products

for unapproved, and thus noncovered uses.

government may further prosecute, as a crime, conduct constituting a false claim under the False Claims Act.

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Alternatively, the shift away from fee-for-service agreements to capitated payment

models may support the value of our products which can be shown to decrease resource utilization and lead to cost saving-for both payors

models may support the value of our products which can be shown to decrease resource utilization and lead to cost savings for both payors

and providers.

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International

order to market any product outside of the United States, we would need to comply with numerous and varying regulatory requirements of

other countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing

order to market any of our products outside of the United States, we would need to comply with numerous and varying regulatory requirements

of other countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing

authorization, commercial sales and distribution of our products.

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and jurisdictions.

The time required to obtain clearance required by foreign countries may be longer or shorter than required for FDA

clearance, and requirements for licensing a product in a foreign country may differ significantly from FDA requirements.

European Union or EU will require a CE mark certification or approval in order to market our products in the various countries of the

The time required to obtain clearance required by foreign countries may be longer or shorter than that required for

FDA clearance, and requirements for licensing a product in a foreign country may differ significantly from FDA requirements.

European Union (“EU”) will require a CE mark certification or approval in order to market our products in the various countries of the

European Union or other countries outside the United States.

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the countries of the EU.

The new European Medical Device Regulation (EU MDR 2017/745) which was scheduled to go into effect on May 26,

2020 has been extended by one year to May 26, 2021.

The EU MDR imposes strict new requirements on medical device companies marketing

their products in Europe.

As such, many device companies have been scrambling to renew existing CE certificates granted under the Medical

Devices Directive (MDD 93/42/EEC).

Notified Bodies are now focused on their current customers and those customers’ current devices

making it virtually impossible to submit a new MDD application before May 2020.

Good Manufacturing Practices

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our business.

There were no material capital expenditures for environmental control facilities in the years ended December 31, 2022,

2021 and 2020.

There were no material capital expenditures for environmental control facilities in the years ended December 31, 2023 and

As of March 21, 2024 we had 107 employees (all of whom were full-time employees), inclusive of our executive officers —

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business