Item 1A Risk Factors 17

Item 1B. Unresolved Staff Comments 33

Item 2. Property 33

Item 3. Legal Proceedings 34

Item 4. Mine Safety Disclosures 34

PART II

Item 6. [Reserved] 35

Item 7A. Quantitative and Qualitative Disclosure About Market Risk 46

Item 8. Financial Statements and Supplementary Data 46

Item 9A. Controls and Procedures 47

Item 9B. Other Information 47

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 47

PART III

Item 10. Directors, Executive Officers, and Corporate Governance 48

Item 11. Executive Compensation 48

Item 14. Principal Accountant Fees and Services 48

PART IV

Item 15. Exhibits and Financial Statement Schedules 49

FORWARD-LOOKING

STATEMENTS

This

Annual Report on Form 10-K (this “Form 10-K”) of PAVmed Inc. (“we”, “us”, “our” or “PAVmed”

or the “Company”), contains forward-looking statements that involve substantial risks and uncertainties. All statements,

other than statements of historical facts, contained in this Form 10-K, including statements regarding our future results of operations

and financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements.

The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,”

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

“estimates,” “predicts,” “potential” or “continue” or the negative of these terms or

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

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

significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are

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

herein by reference.

Important

factors that may affect our actual results include:

● our limited operating history;

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

● the ability of our products to achieve market acceptance;

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

● our ability to protect our intellectual property;

● our ability to complete strategic acquisitions;

● our ability to manage growth and integrate acquired operations;

● the potential liquidity and trading of our securities;

● our regulatory and operational risks;

● cybersecurity risks;

● risks related to the COVID-19 pandemic; and

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

joint ventures or investments we may make.

may not actually achieve the plans, intentions, and/or expectations disclosed in our forward-looking statements, and you should not place

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

exhibits to this Annual Report on Form 10-K completely and with the understanding our actual future results may be materially different

from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information,

future events or otherwise, except as required by applicable law.

PART

Item

1. Business

Background

and Overview

PAVmed

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.

Our

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.

The

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.

EsoGuard

and EsoCheck

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

EsoGuard

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

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

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

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

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

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

testing and analyses using our proprietary EsoGuard NGS DNA assay.

EsoCheck

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

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

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

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

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

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

EsoGuard

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

EsoCheck have been developed to provide 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”).

Market

Opportunity

2023, approximately 20,000 U.S. GERD patients are projected to be diagnosed with EAC and approximately 16,000 will die from it. Over

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

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

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

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

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

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

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

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

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

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

GBA and its MolDx Program on CMS payment and coverage. In October 2020, CMS granted EsoGuard final Medicare payment determination of

$1,938.01, effective January 1, 2021.)

Unfortunately,

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

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

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

Since

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

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

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

Clinical

Guidelines for At-Risk Population

The

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

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

endoscopy in patients with chronic GERD symptoms and 3 or more additional risk factors for BE, including male sex, age greater than 50

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

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

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

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

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

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

for BE.” The clinical guideline specifically mentions EsoCheck, along with Lucid’s EsophaCap® device, as such swallowable,

nonendoscopic esophageal cell collection devices, as well as methylated DNA biomarkers such as EsoGuard. The summary of evidence for

this recommendation includes a reference to the seminal NIH-funded, multicenter, case-control study published in 2018 in Science Translational

Medicine, which demonstrated that EsoGuard is highly accurate at detecting esophageal precancer and cancer, including on samples

collected with EsoCheck.

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.

Commercialization

Our

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

laboratory.

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

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

Reimbursement

and Market Access

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

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

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

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”)

website by MAC Palmetto GBA. The proposed LCD is a further step in Lucid’s efforts to secure Medicare coverage and payment for

EsoGuard. 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. Although

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

comments.

While

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.

Clinical

Utility and Clinical Trials

Demonstrating

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

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

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

the EsoGuard test, when ordered by physicians, provides information that can be used to

identify or exclude patients who would benefit from additional management and/or treatment. Clinical utility studies are also important

for general EsoGuard commercialization by facilitating physician understanding of test indications and potential benefit to the patients.

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.

Manufacturing

EsoCheck

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

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

optimized. 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. 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.

License

Agreement

Under

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; and 8% of net sales greater than $100 million per year. Lucid is also required to pay CWRU minimum annual

royalty payments as follows: $50,000 per year, beginning January 1 following the first anniversary of a commercial sale of a licensed

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

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

yearly royalty amounts are subject to increase based on the percentage change in the CPI-W Consumer Price Index and are credited against

the royalties otherwise due. The license agreement was subject to four regulatory and commercialization milestones, of which one remains

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

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

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

that have been granted by FDA or other U.S. government agency, whichever comes later. The EsoCheck patents, which are currently the last

to expire, begin to expire in May 2035.

Regulatory

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

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

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

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

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

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

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

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

more favorable pre/post market data collection balance. The Centers for Medicare and Medicaid Services and the United States Congress

continue to work to provide an expedited coverage pathway for emerging technologies.

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

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

be marketed in CE Mark European countries.

Our

longer-term strategy is to secure a specific indication, based on published guidelines, for BE screening 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.

Laboratory

Operations

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.

Competition

The

U.S. 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. Our EsoGuard

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. Our competitors may also be developing additional methods of detecting

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

Accordingly,

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

change. 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

markets are:

● 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; and

● product price and qualification for coverage and reimbursement.

Most

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

resources. 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. These competitors may have greater name recognition

than we do. Many of these competitors have obtained all desirable FDA or other regulatory approvals, and superior patent protection,

for their products. Certain of our competitors have already commercialized their products, and others may commercialize their products

in advance of our products. In addition, our competitors may make technical advances that render our products obsolete. We may be unable

to respond to such technical advances.

Veris

Cancer Care Platform

Overview

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

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

patient monitoring. Oncodisc’s core technologies include 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.

Oncodisc

was founded in 2018 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. They previously co-founded Redsmith, Inc., an interventional

catheter company whose technology was acquired by C.R. Bard Inc., now BD Inc. (NYSE: BDX). Oncodisc received a National Science Foundation

(“NSF”) Small Business Innovation Research (“SBIR”) grant award to support its early work and completed both

the MedTech Innovator Accelerator and UCSF Rosenman Institute Accelerator programs.

The

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 VerisBoxTM 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.

Veris

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

patients.

Market

Opportunity

2022, approximately 1.9 million people in the U.S. were newly diagnosed with cancer, and cancer incidence in the U.S. is expected to

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

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

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

Based

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

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

monitor, data commercialization, and the expansion into other markets aside from oncology.

Commercialization/Sales

Our

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.

Manufacturing

The

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

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

by Impilo, a partner with TransTek and Mio Labs. The customer support is currently managed internally, while partnering with Zendesk

for customer service management.

Regulatory

The

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

devices.

Veris

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

agreement on regulatory strategy and required testing to seek clearance of the monitor. We 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 VerisBoxTM 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.

Competition

The

U.S. 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.

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.

Product

Pipeline

Below

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.

Esocure

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

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

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

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

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

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

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

CarpX

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

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

or other imaging equipment, and therefore will be significantly less invasive than existing treatments. To use CarpX, the operator first

advances a guidewire through the carpal tunnel under the ligament, and then advanced over the wire and positioned in the carpal tunnel

under ultrasonic and/or fluoroscopic guidance. When the CarpX balloon is inflated it creates tension in the ligament positioning the

cutting electrodes underneath it and creates space within the tunnel, providing anatomic separation between the target ligament and critical

structures such as the median nerve. Radiofrequency energy is briefly delivered to the electrodes, rapidly cutting the ligament, and

relieving the pressure on the nerve. We believe CarpX will be significantly less invasive than existing treatments.

CarpX

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

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

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

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

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

continue to pursue that project, as resources permit.

PortIO

Our

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

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

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

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

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

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

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

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

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

or radiographic confirmation.

Recent

Developments

Business

Status

of Lucid Clinical Trials

Lucid

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