What changed in this filing

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Item 1A. Risk Factors

2023-03-14 compared with 2022-04-06 · 823 added, 1045 removed, 1220 unchanged (60% of the section changed)

10 unchanged sentences

described more fully below and include, but are not limited to, risks relating to the following:

Associated with Our Financial Condition

have incurred operating losses since our inception and may not be able to achieve profitability.

quarterly operating results could be subject to significant fluctuation, which could increase

the volatility of our stock price and cause losses to our stockholders.

● The March 2023 Senior Convertible Note has not been issued, and it may not be issued, including if certain closing conditions

to the issuance of such note are not satisfied.

our indebtedness may require a significant amount of cash, and the restrictive covenants

contained in our indebtedness could adversely affect our business plan, liquidity, financial

condition, and results of operations.

Associated with Our Business

we have a limited operating history, you will have little basis upon which to evaluate our ability to achieve our business objective.

business may be adversely affected by health epidemics and or pandemics, including the COVID-19 pandemic.

markets in which we operate are attractive and other companies or institutions may develop and market novel or improved technologies,

which may make the EsoGuard or EsoCheck technologies less competitive or obsolete.

we have a limited operating history, and have not generated any significant revenues to date,

you will have little basis upon which to evaluate our ability to achieve our business objective.

markets in which we operate are attractive and other companies or institutions may develop

and market novel or improved technologies, which may make the EsoGuard or EsoCheck technologies

less competitive or obsolete.

expect to derive substantially all of our revenues from the EsoGuard and EsoCheck products.

are highly dependent on the License Agreement, the termination of which would prevent us from commercializing our products, and which

imposes significant obligations on us.

are highly dependent on the License Agreement, the termination of which would prevent us

from commercializing our products, and which imposes significant obligations on us.

products may never achieve market acceptance.

sizes of the markets for our current and future products have not been established with precision, and may be smaller than we estimate.

sizes of the markets for our current and future products have not been established with precision,

and may be smaller than we estimate.

● Recommendations

in published clinical practice guidelines issued by various organizations, including professional societies and federal agencies

may significantly affect payors’ willingness to cover, and physicians’ willingness to prescribe, our products and services.

expect to be dependent on third-party manufacturers since we do not expect to directly manufacture our products in the foreseeable

third-party manufacturers may not have the manufacturing and processing capacity to meet the production requirements of consumer

demand or clinical testing in a timely manner.

EsoGuard test is performed in a single laboratory facility.

may remain dependent on the sales and marketing efforts of third parties if we are unable to or choose not to develop an extensive

sales and marketing staff and other resources.

results of operations can be adversely affected by labor shortages, turnover, and labor cost increases.

heavily rely upon certain suppliers, including suppliers that are the sole source of certain products.

The loss or interruption of

supply from our suppliers could have a disruptive effect on our business.

expect to rely on courier delivery services to transport EsoCheck devices and EsoGuard Specimen Kits to physicians and other medical

professionals and samples back to laboratory facilities for analysis.

we attempt to bring any other products or services to market in addition to the EsoGuard test and EsoCheck device, we likely will

be required to make significant investments in research and development, which ultimately may prove unsuccessful.

officers may allocate their time to other businesses thereby potentially limiting the amount of time they devote to our affairs.

This conflict of interest could have a negative impact on our operations.

are party to agreements pursuant to which we may be required to make payments to certain of our affiliates, which may reduce our

cash flow and profits.

ability to be successful is dependent upon the efforts of our key personnel.

in published clinical practice guidelines issued by various organizations, including professional

societies and federal agencies may significantly affect payors’ willingness to cover,

and physicians’ willingness to prescribe, our products and services.

or our third-party manufacturers may not have the manufacturing and processing capacity to

meet the production requirements of consumer demand or clinical testing in a timely manner.

EsoGuard test is performed in a single commercial clinical laboratory facility.

for our EsoGuard test grows, we may lack adequate facility space and capabilities to meet

increased processing requirements.

Moreover, if these or any future facilities or their equipment

were damaged or destroyed, or if we experience a significant disruption in our commercial

clinical laboratory operations for any reason, our ability to continue to operate our business

could be materially harmed.

may remain dependent on the sales and marketing efforts of third parties if we are unable

to or choose not to develop an extensive sales and marketing staff and other resources.

results of operations can be adversely affected by labor shortages, turnover, and labor cost

expect to rely on courier delivery services to transport EsoCheck devices and EsoGuard Specimen

Kits to physicians and other medical professionals and samples back to laboratory facilities

for analysis.

If these delivery services are disrupted or become prohibitively expensive,

customer satisfaction and our business could be negatively impacted.

we attempt to bring any other products or services to market in addition to the EsoGuard

test and EsoCheck device, we likely will be required to make significant investments in research

and development, which ultimately may prove unsuccessful.

Our future performance may be affected

by the success of products we have not yet developed, licensed, acquired.

officers may allocate their time to other businesses thereby potentially limiting the amount

of time they devote to our affairs.

This conflict of interest could have a negative impact

on our operations.

ability to be successful will be totally dependent upon the efforts of our key personnel.

officers and directors have fiduciary obligations to other companies and, accordingly, may

have conflicts of interest in determining to which entity a particular business opportunity

should be presented.

business may suffer if we are unable to manage our growth.

may conduct business internationally, in which case our business, financial condition and results of operations could be adversely

affected by the political and economic conditions of countries other than the U.S.

may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce

our financial resources.

business, financial condition and results of operations could be adversely affected by the

political and economic conditions of the countries in which we conduct business.

business may be adversely affected by health epidemics and or pandemics, including the COVID-19

may engage in acquisitions that are not successful and which could disrupt our business,

cause dilution to our stockholders and reduce our financial resources.

results in material litigation matters could have a material adverse effect upon our business.

Associated with Healthcare Regulation, Billing and Reimbursement, and Product Safety and Effectiveness.

ability to market EsoGuard, or any other IVD that we may develop, license, or acquire, as LDTs without FDA approval, is entirely

dependent on FDA continuing to exercise enforcement discretion with regard to requiring premarket review of LDTs.

our commercial clinical laboratory fails to maintain CLIA-certification or otherwise meet the applicable requirements

of federal or state law regulating clinical laboratories, that failure could limit or prevent its ability to perform our EsoGuard

or any other IVD without FDA approval we may develop, license, or acquire and market as an LDT, may not be jointly marketed as a

combined product with EsoCheck without first securing FDA approval of the combined product as an IVD.

FDA approval of EsoGuard, or any other IVD we may develop, license, or acquire, as an IVD, separately or as a combined product with

EsoCheck, is a complex process requiring substantial time, commitment of resources and expense without any assurance that FDA will

ability to market EsoGuard, or any other IVD product that we may develop, license, or acquire,

as LDTs without FDA approval, is entirely dependent on FDA continuing to exercise enforcement

discretion with regard to requiring premarket review of LDTs.

If FDA ceases to exercise,

or modifies how it exercises, this discretion through guidance documents, formal rulemaking,

departmental directive, executive order or pursuant to legislation, we may be abruptly forced

to halt commercialization of these diagnostic tests until we are able satisfy FDA’s

modified enforcement regime, or until we secure FDA approval for these IVD products.

we fail to maintain CLIA-certification or otherwise meet the applicable requirements of federal

or state law regulating commercial clinical laboratories, such failure could limit or prevent

our ability to perform our EsoGuard test, or any other tests which we may develop, license

or acquire, affect any payor consideration of such tests, prevent their clearance or approval

entirely, and/or interrupt the commercial sale and/or marketing of any such tests, cause

us to incur significant expense to remedy this failure and otherwise negatively impact our

or any other IVD product without FDA approval we may develop, license, or acquire and market

as an LDT, may not be jointly marketed as a combined product with EsoCheck without first

securing FDA approval of the combined product as an IVD device.

If FDA deems that we are

jointly marketing such an IVD product with EsoCheck without FDA approval of the combined

product as an IVD device, we would be subject to FDA enforcement action which could limit

or halt commercialization of our products, and result in FDA sanctions which could severely

impact our business.

FDA approval of EsoGuard, or any other IVD product we may develop, license, or acquire, as

an IVD device, separately or as a combined product with EsoCheck, is a complex process requiring

substantial time, commitment of resources and expense without any assurance that FDA will

grant such approval.

to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.

to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our

products internationally.

● Modifications

to our cleared or approved products may require new clearances or premarket approvals, or may require us to cease marketing or recall

the modified products until clearances are obtained.

trials necessary to support regulatory submission will be expensive and will require the enrollment of large numbers of patients,

and suitable patients may be difficult to identify and recruit.

results of our clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects.

our clinical studies do not satisfy providers, payors, patients and others as to the reliability and performance of our EsoGuard

test and the EsoCheck device, or any other product or service we may develop and seek to commercialize, we may experience reluctance

or refusal on the part of physicians to order, and third-party payors to pay for, such test.

the validity of an informed consent for a clinical trial of one of our products was challenged, we could be subject to fines, penalties,

litigation, or regulatory sanctions, or other adverse consequences.

business and reputation will suffer if we are unable to establish and comply with, stringent quality standards to assure that the

highest level of quality is observed in the performance of our tests.

and any other products we develop that receive regulatory clearance or approval will be subject to ongoing regulatory obligations

and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply

with applicable regulatory requirements.

we are found to be promoting the use of our devices for unapproved or “off-label” uses or engaging in other noncompliant

activities, we may be subject to recalls, seizures, fines, penalties, injunctions, adverse publicity, prosecution, or other adverse

actions, resulting in damage to our reputation and business.

laboratories and medical diagnostic companies are subject to extensive and frequently changing federal, state, and local laws.

service centers, where prescribing physicians can send patients for EsoGuard testing, including undergoing specimen collection using

EsoCheck, are subject to federal and state regulations which may be burdensome, costly or difficult to comply with.

to our cleared or approved products may require new clearances or premarket approvals, or

may require us to cease marketing or recall the modified products until clearances are obtained.

trials necessary to support regulatory submission will be expensive and will require the

enrollment of large numbers of patients, and suitable patients may be difficult to identify

Delays or failures in our clinical trials will prevent us from expanding our

commercial efforts and will adversely affect our business, operating results and prospects.

results of our clinical trials may not support our product candidate claims or may result

in the discovery of adverse side effects.

our clinical studies do not satisfy providers, payors, patients and others as to the reliability

and performance of our EsoGuard test and the EsoCheck device, or any other product or service

we may develop and seek to commercialize, we may experience reluctance or refusal on the

part of physicians to order, and third-party payors to pay for, such test.

the validity of an informed consent for a clinical trial of one of our products was challenged,

we could be subject to fines, penalties, litigation, or regulatory sanctions, or other adverse

consequences, including invalidating or requiring us to repeat clinical trials which could

negatively affect our business and results of operations.

and any other products we develop that receive regulatory clearance or approval will be subject

to ongoing regulatory obligations and continued regulatory review, which may result in significant

additional expense and subject us to penalties if we fail to comply with applicable regulatory

requirements.

we are found to be promoting the use of our devices for unapproved or “off-label”

uses or engaging in other noncompliant activities, we may be subject to recalls, seizures,

fines, penalties, injunctions, adverse publicity, prosecution, or other adverse actions,

resulting in damage to our reputation and business.

laboratories and medical diagnostic companies are subject to extensive and frequently changing

federal, state, and local laws.

We could be subject to significant fines and penalties if

we fail (or if our prior unrelated third-party laboratory partner previously failed) to comply

with these laws and regulations.

operate patient service centers where prescribing physicians can send patients for EsoGuard

testing, including undergoing specimen collection using EsoCheck.

These patient service centers

are subject to federal and state regulations which may be burdensome, costly or difficult

to comply with.

Failure to comply with these regulations could result in sanctions, fines

or other enforcement actions which may be costly, time-consuming and limit our ability to

utilize them and adversely impact our business.

intend to engage with one or more third-party telemedicine companies to provide physicians

to evaluate patients who respond to our direct-to-consumer (“DTC”) marketing

activities seeking EsoGuard testing and, if clinically indicated, refer the patient to our

patient service centers to undergo EsoCheck specimen collection for EsoGuard testing.

Telemedicine,

and its specific use in conjunction with DTC, is subject to numerous federal and state regulations and faces particularly intense

scrutiny by these regulators.

aspects of our business, beyond the specific elements described above are subject to complex, intertwined, costly and/or burdensome

federal health care laws and regulations which may open to interpretation and be subject to varying levels of discretionary enforcement.

private or governmental third-party payors do not maintain reimbursement for our products at adequate reimbursement rates, we may

be unable to successfully commercialize our products which would limit or slow our revenue generation and likely have a material

adverse effect on our business.

regulations that govern pricing and reimbursement for new products vary widely from country to country, and may adversely affect

the pricing, coverage and reimbursement rates of our products in other countries.

to billing complexities in the diagnostic and laboratory service industry, we may not be able to collect payment for the EsoGuard

tests we perform.

and its specific use in conjunction with DTC, is subject to numerous federal and state regulations

and faces particularly intense scrutiny by these regulators.

If we fail to comply with federal

healthcare regulations, we could face substantial penalties, sanctions, fines or prosecution

and our business, operations and financial condition could be adversely affected.

aspects of our business, beyond the specific elements described above, are subject to complex,

intertwined, costly and/or burdensome federal health care laws and regulations which may

open to interpretation and be subject to varying levels of discretionary enforcement.

we fail to comply with these laws and regulations, we could face substantial penalties and

our business, operations and financial condition could be adversely affected.

private or governmental third-party payors do not maintain reimbursement for our products

at adequate reimbursement rates, we may be unable to successfully commercialize our products

which would limit or slow our revenue generation and likely have a material adverse effect

on our business.

regulations that govern pricing and reimbursement for new products vary widely from country

to country, and may adversely affect the pricing, coverage and reimbursement rates of our

products in other countries.

to billing complexities in the diagnostic and laboratory service industry, we may not be

able to collect payment for the EsoGuard tests we perform.

reform measures could hinder or prevent our products’ commercial success.

face uncertainty related to healthcare reform, pricing, coverage and reimbursement, which could reduce our revenue.

products may cause serious adverse side effects or even death or have other properties that could delay or prevent their regulatory

clearance or approval, limit the commercial desirability of an approved label or result in significant negative consequences following

any marketing clearance or approval.

intend to market our products in Europe, however major changes in the EU regulation of medical devices and IVDs may make it burdensome,

costly and impossible to successfully do so, which could adversely impact our business.

medical products may in the future be subject to product recalls that could harm our reputation, business, and financial results.

our medical products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical

device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.

liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our products.

medical products may in the future be subject to product recalls that could harm our reputation,

business, and financial results.

our medical products cause or contribute to a death or a serious injury, or malfunction in

certain ways, we will be subject to medical device reporting regulations, which can result

in voluntary corrective actions or agency enforcement actions.

liability lawsuits against us could cause us to incur substantial liabilities and to limit

commercialization of our products.

with the HIPAA security, privacy and breach notification regulations may increase our costs.

employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities,

including noncompliance with regulatory standards and requirements.

Associated with Our Intellectual Property and Technology Infrastructure

may not be able to protect or enforce the intellectual property rights for the technology used in, or expected to be used in, our

products, which could impair our competitive position.

may be subject to intellectual property infringement claims by third parties which could be costly to defend, divert management’s

attention and resources, and may result in liability.

may violate the intellectual property rights for the technology used in, or expected to be used in, our products, and we may bring

litigation to protect and enforce our intellectual property rights, which may result in substantial expense and may divert our attention

from implementing our business strategy.

in our information technology, storage systems or our clinical laboratory equipment could significantly disrupt our operations and

our research and development efforts, which could adversely impact our revenues, as well as our research, development and commercialization

internal computer systems, or those used by our third-party research institution collaborators, vendors or other contractors or consultants,

may suffer security breaches.

Associated with Our Financial Condition

have incurred operating losses since our inception and may not be able to achieve sustainable profitability.

have incurred recurring losses to date, which raised substantial doubt about our ability to continue as a going concern, although

such doubt has been alleviated by PAVmed’s agreement to continue to fund our operations.

may need substantial additional funding and may be unable to raise capital when needed, which could force us to delay, reduce, eliminate

or abandon growth initiatives or product development programs.

quarterly operating results could be subject to significant fluctuation, which could increase the volatility of our stock price and

cause losses to our stockholders.

may not be able to protect or enforce the intellectual property rights for the technology

used in, or expected to be used in, our products, which could impair our competitive position.

may be subject to intellectual property infringement claims by third parties which could

be costly to defend, divert management’s attention and resources, and may result in

● Competitors

may violate the intellectual property rights for the technology used in, or expected to be

used in, our products, and we may bring litigation to protect and enforce our intellectual

property rights, which may result in substantial expense and may divert our attention from

implementing our business strategy.

in our information technology systems could significantly disrupt our operations and our

research and development efforts, which could adversely impact our revenues, as well as our

research, development and commercialization efforts.

internal computer systems, or those used by our third-party research institution collaborators,

vendors or other contractors or consultants, may suffer security breaches.

Associated with Our Relationship with PAVmed

our management, our initial stockholders and their respective affiliates control a substantial interest in us and thus may influence

certain actions requiring a stockholder vote.

conflicts of interest may arise between us and our officers, directors, and affiliated companies, including PAVmed, and in some cases

we have waived certain rights with respect thereto.

historical financial information as a subsidiary of PAVmed may not be representative of our results as an independent public company.

ability to operate our business effectively may suffer if the management services agreement with PAVmed is insufficient to meet our

needs or if, upon the termination of the management services agreement, we do not cost-effectively establish our own fully functional

financial, administrative, operational and other support systems in order to operate as a stand-alone company.

order to preserve the ability for PAVmed to distribute its shares of our common stock on a tax-free basis for U.S.

federal income

tax purposes, we may be prevented from pursuing opportunities to raise capital, to effectuate acquisitions or to provide equity incentives

owns a majority of our voting stock and thus may control certain actions requiring a stockholder

conflicts of interest may arise between us and our affiliated companies, including PAVmed,

and in some cases we have waived certain rights with respect thereto.

ability to operate our business effectively may suffer if the MSA with PAVmed is insufficient

to meet our needs or if, upon the termination of the MSA, we do not cost-effectively establish

our own fully functional financial, administrative, operational and other support systems

in order to operate as a stand-alone company.

order to preserve the ability for PAVmed to distribute its shares of our common stock on

a tax-free basis for U.S.

federal income tax purposes, we may be prevented from pursuing

opportunities to raise capital, to effectuate acquisitions or to provide equity incentives

to our employees, which could hurt our ability to grow.

parties may seek to hold us responsible for liabilities of PAVmed, which could result in a decrease in our income.

disputes that arise between us and PAVmed with respect to our past and ongoing relationships could harm our business operations.

ability to control our board of directors and company may make it difficult for us to recruit high-quality independent directors

and employees.

disputes that arise between us and PAVmed with respect to our past and ongoing relationships

could harm our business operations.

Associated with Ownership of Our Common Stock

may issue shares of our capital stock or debt securities in the future which could reduce the equity interest of our stockholders

and might cause a change in control of our ownership.

active trading market may not develop for our common stock, and you may not be able to sell your shares at or above the initial public

offering price.

securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock

price and trading volume could decline.

may in the future delist our common stock, which could limit investors’ ability to make transactions in our securities and

subject us to additional trading restrictions.

may issue shares of our capital stock or debt securities in the future which could reduce

the equity interest of our stockholders and might cause a change in control of our ownership.

securities or industry analysts do not publish research, or publish inaccurate or unfavorable

research, about our business, our stock price and trading volume could decline.

may in the future delist our common stock, which could limit investors’ ability to

make transactions in our securities and subject us to additional trading restrictions.

stock price may be volatile, and purchasers of our common stock could incur substantial losses.

do not intend to pay any dividends on our common stock at this time.

will incur significantly increased costs as a result of operating as a public company, and our management will be required to devote

substantial time to new compliance initiatives.

we fail to establish and maintain proper and effective internal control over financial reporting, investors may lose confidence in

the accuracy and completeness of our financial reports and the market price of our common stock could decline significantly.

disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

are subject to evolving corporate governance and public disclosure expectations and regulations that impact compliance costs and

risks of noncompliance.

are an “emerging growth company,” and we cannot be certain if the reduced reporting requirements applicable to emerging

growth companies will make our common stock less attractive to investors.

in our corporate charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts

by our stockholders to replace or remove our current management.

charter provides, subject to limited exceptions, that the Court of Chancery of the State of Delaware is the sole and exclusive forum

for certain stockholder litigation matters, which limits our stockholders’ ability to obtain a favorable judicial forum for

will incur significantly increased costs as a result of operating as a public company, and

our management will be required to devote substantial time to compliance initiatives.

we fail to establish and maintain proper and effective internal control over financial reporting,

investors may lose confidence in the accuracy and completeness of our financial reports and

the market price of our common stock could decline significantly.

are subject to evolving corporate governance and public disclosure expectations and regulations

that impact compliance costs and risks of noncompliance.

are an “emerging growth company,” and we cannot be certain if the reduced reporting

requirements applicable to emerging growth companies will make our common stock less attractive

to investors.

in our corporate charter documents and under Delaware law could make an acquisition of us

more difficult and may prevent attempts by our stockholders to replace or remove our current

charter provides, subject to limited exceptions, that the Court of Chancery of the State

of Delaware will be the sole and exclusive forum for certain stockholder litigation matters,

which could limit our stockholders’ ability to obtain a favorable judicial forum for

disputes with us or our directors, officers, employees or stockholders.

Associated with Our Financial Condition

have incurred operating losses since our inception and may not be able to achieve profitability.

have incurred net losses since our inception.

For the years ended December 31, 2022 and December 31, 2021, we had a net loss of $56.2

million and $28.1 million, respectively.

Our ability to generate sufficient revenue from any of our products in development, and to transition

to profitability and generate consistent positive cash flows is dependent upon factors that may be outside of our control.

that our operating expenses will continue to increase as we continue to develop, pursue regulatory clearance or approval for and commercialize

our products, build our manufacturing, sales and other commercial infrastructure, and incur additional operational and reporting costs

associated with being a public company.

As a result, we expect to continue to incur operating losses for the foreseeable future.

are subject to all of the risks and uncertainties typically faced by a medical device and diagnostic company devoting substantially all

its efforts to the commercialization of its initial products and services and ongoing research and development activities and clinical

may need substantial additional funding and may be unable to raise capital when needed, which could force us to delay, reduce, eliminate

or abandon growth initiatives or product development programs.

intend to continue to make investments to support our business growth, and we may require additional funds to:

our research and development including existing and new clinical trials;

additional regulatory clearances and approvals for our products;

our intellectual property rights or defend, in litigation or otherwise, any claims that we

infringe third-party patents or other intellectual property rights;

our operations;

● manufacture

and distribute our products;

market acceptance of our products.

need for additional funds may be affected by:

cost and timing of expanding our sales, marketing and distribution capabilities;

effect of competing technological and market developments;

extent to which we acquire or invest in businesses, products and technologies, although we

currently have no commitments or agreements relating to any of these types of transactions.

or preferred stock financing, if available, may involve covenants restricting our operations or our ability to incur additional debt

or issue additional preferred stock, and may contain other terms that are not favorable to us or our stockholders.

Additional equity

financing may result in substantial dilution to our existing stockholders.

If we do not have, or are not able to obtain, sufficient funds,

we may have to delay product development initiatives or license to third parties the rights to commercialize products or technologies

that we would otherwise seek to market.

We also may have to reduce manufacturing, distribution, marketing, customer support or other

resources devoted to our products.

quarterly operating results could be subject to significant fluctuation, which could increase the volatility of our stock price and cause

losses to our stockholders.

results of operations, including our revenue and profits, assuming we are able to successfully commercialize the EsoGuard and EsoCheck

products, may fluctuate significantly, depending on a variety of factors, including the following:

success in marketing and selling, and changes in demand for, our products, and the level

of reimbursement and collection obtained for our products;

variations affecting physician recommendations for esophageal precancer and cancer screenings

and patient compliance with physician recommendations, including without limitation holidays,

weather events, and circumstances such as the outbreak of COVID-19, influenza or other disease

that may limit patient access to medical practices for preventive services such as esophageal

precancer and cancer screening;

success in collecting payments from third-party payors, patients and collaborative partners,

variation in the timing of these payments and recognition of these payments as revenues;

pricing of our products, including potential changes in CMS reimbursement rates or other

reimbursement rates;

● circumstances

affecting our ability to provide our products, including weather events, supply shortages,

or regulatory or other circumstances that adversely affect our ability to manufacture our

products or process tests in our clinical laboratory;

● fluctuations

in the amount and timing of our selling and marketing costs and our ability to manage costs

and expenses and effectively implement our business;

research and development activities, including the timing of costly clinical trials.

March 2023 Senior Convertible Note has not been issued, and it may not be issued, including if certain closing conditions to the issuance

of such note are not satisfied.

March 13, 2023, we entered into the SPA, pursuant to which we anticipate issuing the March 2023 Senior Convertible Note.

However, such

issuance is subject to certain closing conditions, some of which are outside of our control.

If any of the closing conditions to the

issuance of the March 2023 Senior Convertible Note are not met, or if the Investor fails to purchase the March 2023 Senior Convertible

Note when required to do so under the SPA, the note may not be issued.

our indebtedness may require a significant amount of cash, and the restrictive covenants contained in our indebtedness could adversely

affect our business plan, liquidity, financial condition, and results of operations.

may be required to repay or redeem, or to pay interest on, the March 2023 Senior Convertible Note (if issued) or any future

permitted indebtedness incurred by us or our subsidiaries, in cash.

Despite our right to pay the interest and principal balance of

the March 2023 Senior Convertible Note (if issued) by issuing shares of our common stock, we may be required to repay such

indebtedness in cash, if we do not meet certain customary equity conditions (including minimum price and volume thresholds) or in

certain other circumstances.

For example, we may be required to repay the outstanding principal balance and accrued but unpaid

interest, along with a premium, upon the occurrence of certain changes of control or an event of default.

ability to make payments of the principal of, to pay interest on, or to redeem our indebtedness in cash, depends on our future performance,

which is subject to economic, financial, competitive and other factors beyond our control.

We have not generated material revenue from

operations to date, and our business may not generate cash flow from operations in the future sufficient to service our indebtedness

and make necessary capital expenditures.

In addition, the March 2023 Senior Convertible Note (if issued) would contain, and any future indebtedness may

contain, restrictive covenants, including financial covenants.

These payment obligations and covenants could have important consequences

on our business.

In particular, they could:

us to dedicate a substantial portion of our cash flow from operations to payments on our

indebtedness;

among other things, our ability to borrow additional funds and otherwise raise additional

capital, and our ability to conduct acquisitions, joint, ventures or similar arrangements,

as a result of our obligations to make such payments and comply with the restrictive covenants

in the indebtedness;

our flexibility in planning for, or reacting to, changes in our businesses and the industries

in which we operate;

our vulnerability to general adverse economic and industry conditions;

us at a competitive disadvantage compared to our competitors that have lower fixed costs.

debt service requirements of any other permitted indebtedness we incur or issue in the future, as well as the restrictive covenants contained

in the governing documents for any such indebtedness, could intensify these risks.

we are unable to make the required cash payments, there could be a default under one or more of the instruments governing our indebtedness.

Any such default or acceleration may further result in an event of default and acceleration of our other indebtedness.

In such event,

or if a default otherwise occurs under our indebtedness, including as a result of our failure to comply with the financial or other covenants

contained therein, the holders of our indebtedness could require us to immediately repay the outstanding principal and interest on such

indebtedness in cash, in some cases subject to a premium.

Furthermore, the holders of our secured indebtedness could foreclose on their

security interests in our assets.

we are required to make payments under our indebtedness in cash and are unable to generate sufficient cash flow from operations, we may

be required to sell assets, or we may seek to refinance the remaining balance, by either refinancing with the holder of the indebtedness,

by raising sufficient funds through a sale of equity or debt securities or by obtaining a credit facility.

No assurances can be given

that we will be successful in making the required payments under our indebtedness, or in refinancing our obligations on favorable terms,

Our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such time.

to refinance could have a material adverse effect on our liquidity, financial position, and results of operations.

Should we refinance,

it could be dilutive to shareholders or impose onerous terms on us.

Associated with Our Business

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new business, as well as problems inherent in establishing name recognition and business reputation.

business may be adversely affected by health epidemics and or pandemics, including the COVID-19 pandemic.

2019, an outbreak of a novel strain of a coronavirus occurred, which spread on a global basis to other countries, including the U.S.

On March 11, 2020, the World Health Organization declared a pandemic resulting from the coronavirus, with such pandemic commonly referred

to as the “COVID-19 pandemic” after the related illness.

The COVID-19 pandemic is ongoing, and we continue to monitor the

ongoing impact of the COVID-19 pandemic on the United States national economy, the global economy, and our business.

COVID-19 pandemic may have an adverse impact on our operations, supply chains, and distribution systems and/or those of our contractors,

and may increase our expenses, including because of preventive and precautionary

measures being taken, restrictions on travel, quarantine polices, and social distancing.

Such adverse impacts may include, for example,

the inability of our employees and/or those of our contractors to perform their work or curtail their services

provided to us.

We expect the significance of the COVID-19 pandemic, including the extent of its effect on our consolidated financial

condition and consolidated operational results and cash flows, to be dictated by the success of U.S.

and global efforts to mitigate and/or

to contain the spread of the coronavirus, as well as the impact of those efforts.

spread of the coronavirus also has disrupted the United States’ healthcare and healthcare regulatory systems which could divert

healthcare resources away from, or materially delay FDA approval with respect to our products.

In addition, our clinical trials have

been, and may be further, affected by the COVID-19 pandemic, as site initiation and patient enrollment may be delayed, for example, due

to prioritization of hospital resources toward the virus and/or illness response, as well as travel restrictions imposed by governments,

the inability to access clinical test sites for initiation and monitoring, and the inability of our investigators to perform EGDs required

by our clinical trials.

Furthermore, the COVID-19 pandemic may have an adverse impact on the economies and financial markets of many

countries, including the U.S., resulting in an economic downturn that could adversely affect demand for our products and services and/or

our product candidates.

we are continuing to monitor and assess the effects of the COVID-19 pandemic on our business, the ultimate impact of the COVID-19 pandemic

(or any similar health epidemic) is highly uncertain and subject to change, and therefore, its impact on our consolidated financial condition,

consolidated results of operations, and/or consolidated cash flows, the adverse impact could be material.

markets in which we operate are attractive and other companies or institutions may develop and market novel or improved technologies,

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may compete with EsoCheck.

Two such devices, Cytosponge, previously marketed by in the U.S.

One such device, Cytosponge, previously marketed by in the U.S.

by Medtronic Inc.

MDT), and EsophaCap,

manufactured by CapNostics, LLC and utilized almost exclusively for clinical research, are spherical mesh sponges encapsulated

in soluble gelatin that dissolve in the stomach.

The expanded sponge brushes the lining of the esophagus as it is withdrawn and retrieved.

Although, unlike EsoCheck, these devices do not provide anatomic targeting nor protect their sample from dilution and contamination during

device withdrawal, future biomarkers may have sufficient sensitivity to detect BE-EAC despite such dilution and contamination.

or other manufacturers may also be developing new tools that have not yet been announced that provide noninvasive esophageal cell sampling

with the same or better protection from dilution and contamination as EsoCheck.

MDT), which is similar

to EsophaCap, the device we acquired in our acquisition of CapNostics LLC and is utilized almost exclusively for clinical research, is

a spherical mesh sponge encapsulated in soluble gelatin that dissolves in the stomach.

The expanded sponge brushes the lining of the

esophagus as it is withdrawn and retrieved.

Although, unlike EsoCheck, this device does not provide anatomic targeting nor protect their

sample from dilution and contamination during device withdrawal, future biomarkers may have sufficient sensitivity to detect BE-EAC despite

such dilution and contamination.

Manufacturers may also be developing new tools that have not yet been announced that provide noninvasive

esophageal cell sampling with the same or better protection from dilution and contamination as EsoCheck.

well-capitalized companies are developing “liquid biopsy” tests for early cancer detection based on circulating tumor DNA.

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issues, intellectual property rights issues, market acceptance, product competition, performance and reliability, reputation, price competition

and economic and market conditions, and the other factors discussed in this prospectus, could adversely affect our business prospects,

financial condition and results of operations, and could threaten the viability of our business.

and economic and market conditions, and the other factors discussed in this filing, could adversely affect our business prospects, financial

condition and results of operations, and could threaten the viability of our business.

are highly dependent on the License Agreement, the termination of which would prevent us from commercializing our products, and which

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Accordingly, any such termination or dispute could threaten the viability of our business.

the License Agreement imposes significant obligations on us.

We will be required to pay CWRU a minimum yearly royalty commencing the

year after the first commercial sale of a product utilizing the EsoGuard or EsoCheck technology, with the minimum amount rising based

on prior years’ net sales of the product.

The License Agreement also is subject to certain regulatory and commercialization milestones,

with a payment due from us to CWRU upon the achievement of certain of the milestones.

The remaining milestone is the submission of a

PMA application to FDA for a product using the licensed technology.

Accordingly, we could be obligated to pay royalties or other amounts

to CWRU even though we have generated no or limited revenue.

Such payments could materially and adversely affect our profitability and

could limit our investment in our business.

products may never achieve market acceptance.

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publicity concerning our products or similar products;

the case of FDA PMA approval of the EsoGuard combined with EsoCheck as an IVD device,

and in the case of any other products or services we may develop in the future, the timing

of regulatory approvals of our products and market entry compared to competitive products.

the case of FDA PMA approval of the EsoGuard combined with EsoCheck as an IVD device, and

in the case of any other products or services we may develop in the future, the timing of

regulatory approvals of our products and market entry compared to competitive products.

sizes of the markets for our current and future products have not been established with precision, and may be smaller than we estimate.

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Human Services’ AHRQ, makes influential recommendations on clinical preventative services.

We intend to seek a USPSTF recommendation

We may seek a USPSTF recommendation

in the future.

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recommendation, and the outcome of any USPSTF process is uncertain.

expect to be dependent on third-party manufacturers since we do not expect to directly manufacture our products in the foreseeable future.

do not expect to directly manufacture our products and expect to rely on third parties to do so for us for the foreseeable future.

our manufacturing agreements are not satisfactory, we may not be able to develop or commercialize products as planned.

In addition, we

may not be able to contract with third parties to manufacture our products in an economical manner.

Furthermore, third-party manufacturers

may not adequately perform their obligations, which may delay distribution of our products, clinical development or submission of products

for regulatory clearance or approval or otherwise may impair our competitive position.

We may not be able to enter into or maintain relationships

with manufacturers that comply with good manufacturing practices.

If a product manufacturer fails to comply with good manufacturing practices,

we could experience significant delays, or we may be unable to commercialize or continue to market the products.

Changes in our manufacturers

could require costly new product testing and facility compliance inspections.

In the United States, failure to comply with good manufacturing

practices or other applicable legal requirements can lead to federal seizure of violative products, injunctive actions brought by the

federal government, and potential criminal and civil liability on the part of a company and its officers and employees.

Because of these

and other factors, we may not be able to replace our manufacturing capacity quickly or efficiently if our manufacturers are unable to

manufacture our products at one or more of their facilities.

As a result, the sale and marketing of our products could be delayed or

we could be forced to develop our own manufacturing capacity, which could require substantial additional funds and personnel and compliance

with extensive regulations.

third-party manufacturers may not have the manufacturing and processing capacity to meet the production requirements of consumer demand

or clinical testing in a timely manner.

capacity to commercialize our products and conduct any clinical trials required for additional regulatory clearances or approvals will

depend in part on our ability to manufacture or provide our products on a large scale, at a competitive cost and in accordance with regulatory

requirements.

We must establish and maintain a commercial scale manufacturing process for all our products in order to meet customer

demand and to complete the clinical trials required for certain regulatory clearance or approval pathways.

have no direct experience in large-scale product manufacturing, nor do we currently have the internal resources or facilities to manufacture

most of our products on a commercial scale.

Accordingly, we expect to rely on third party manufacturers.

We cannot guarantee that our

third-party manufacturers will be able to establish or increase production and processing capacity in a timely or cost-effective manner,

Our third-party manufacturers may encounter delays or other difficulties in establishing or in increasing production or processing

capacity at any time that could result in delays in the commercialization of our products, in the distribution of our products, in the

clinical trials for our products or in the submissions for additional regulatory clearances or approvals for our products.

Any such delays

could have an adverse effect on our ability to obtain regulatory clearance or approval for, commercialize and secure sales of our products.

or our third-party manufacturers may not have the manufacturing and processing capacity to meet the production requirements of consumer

demand or clinical testing in a timely manner.

capacity to conduct clinical trials and commercialize our products will depend in part on our ability to manufacture or provide our products

on a large scale, at a competitive cost and in accordance with regulatory requirements.

We must establish and maintain a commercial scale

manufacturing process for all of our products to complete clinical trials.

We or our third-party manufacturers may encounter difficulties

with these processes at any time that could result in delays in clinical trials, regulatory submissions or the commercialization of products.

some of our products, we or our third-party manufacturers will need to have sufficient production and processing capacity in order to

conduct human clinical trials, to produce products for commercial sale at an acceptable cost.

We have limited experience in large-scale

product manufacturing, nor do we have the resources or facilities to manufacture most of our products on a commercial scale.

guarantee that we or our third-party manufacturers will be able to increase capacity in a timely or cost-effective manner, or at all.

we will not directly manufacture our products and will rely on third parties to do so for us.

If our manufacturing and distribution agreements

are not satisfactory, we may not be able to develop or commercialize products as planned.

In addition, we may not be able to contract

with third parties to manufacture our products in an economical manner.

Furthermore, third-party manufacturers may not adequately perform

their obligations, may delay clinical development or submission of products for regulatory approval or otherwise may impair our competitive

We may not be able to enter into or maintain relationships with manufacturers that comply with good manufacturing practices.

If a product manufacturer fails to comply with good manufacturing practices, we could experience significant time delays or we may be

unable to commercialize or continue to market the products.

Changes in our manufacturers could require costly new product testing and

facility compliance inspections.

In the United States, failure to comply with good manufacturing practices or other applicable legal

requirements can lead to federal seizure of violative products, injunctive actions brought by the federal government, and potential criminal

and civil liability on the part of a company and its officers and employees.

Because of these and other factors, we may not be able to

replace our manufacturing capacity quickly or efficiently in the event that our manufacturers are unable to manufacture our products

at one or more of their facilities.

As a result, the sales and marketing of our products could be delayed or we could be forced to develop

our own manufacturing capacity, which could require substantial additional funds and personnel and compliance with extensive regulations.

manufacturing processes for our products have not yet been tested at commercial levels, and it may not be possible to manufacture or

process these materials in a cost-effective manner.

EsoGuard test is performed in a single commercial clinical laboratory facility.

If demand for our EsoGuard test grows,

we may lack adequate facility space and capabilities to meet increased processing requirements.

Moreover, if these or any future

facilities or their equipment were damaged or destroyed, or if we experience a significant disruption in our commercial clinical

laboratory operations for any reason, our ability to continue to operate our business could be materially harmed.

Further, our CLIA-certified

laboratory is partially managed through a laboratory management services agreement with our previous laboratory partner who

may terminate its contract with us which may interrupt our ability to perform our tests and potentially materially

harm our business.

EsoGuard test is performed in a single commercial clinical laboratory facility located in Lake Forest, California.

Our commercial clinical laboratory is partially managed by RDx under a laboratory

management services agreement, under which RDx may terminate on short notice for any or no reason.

This may interrupt our

ability to perform our tests until we are able to transition to fully staff our laboratory with qualified personnel which may

take substantial resources and time to fully operate our own laboratory.

This may materially harm our business for a

substantial period of time.

CLIA-certified commercial clinical laboratory facility, without purchasing additional lab equipment applicable

to our test, is expected to have an annual capacity of approximately 100,000 tests per year.

If demand for the EsoGuard test outstrips

this capacity, and the laboratory fails to add additional equipment and staff, or complete, or timely complete, an expansion of its available

laboratory facilities, it may significantly delay EsoGuard processing times and limit the volume of EsoGuard tests it can process, which

may adversely affect our business, financial condition, and results of operation.

In addition, our financial condition may be adversely

affected if they are unable to complete these expansion projects on budget and otherwise on terms and conditions acceptable to us.

cannot guarantee our CLIA-certified commercial clinical laboratory will be able to maintain or increase processing capacity in

a timely or cost-effective manner, or at all.

Our CLIA-certified commercial clinical laboratory may encounter delays or

other difficulties in maintaining or in increasing processing capacity at any time that could result in delays in the commercialization

of our products, in the distribution of our products, in the clinical trials for our products or in the submissions for additional regulatory

clearances or approvals for our products.

Any such delays could have an adverse effect on our ability to obtain regulatory clearance

or approval for, commercialize and secure sales of our products.

the present, or any future, laboratory facilities we utilize were to be damaged, destroyed or otherwise unable to operate, whether due

to fire, floods, storms, tornadoes, other inclement weather events or natural disasters, employee malfeasance, terrorist acts, power

outages, or otherwise, our business could be severely disrupted.

We may not be able

to perform our EsoGuard test or generate test reports as promptly as patients and healthcare providers require or expect, or possibly

If we are unable to perform our EsoGuard test or generate test reports

within a timeframe that meets patient and healthcare provider expectations, our business, financial results and reputation could be materially

If demand for our EsoGuard test grows, we may lack adequate

facility space and capabilities to meet increased processing requirements.

Moreover, if these or any future facilities or their equipment

were damaged or destroyed, or if we experience a significant disruption in our commercial clinical laboratory operations for any reason,

our ability to continue to operate our business could be materially harmed.

currently perform the EsoGuard test in a single laboratory facility in Lake Forest, CA.

The laboratory facility, without purchasing additional

lab equipment applicable to our test, is expected to have an annual capacity of approximately 50,000 tests per year.

If demand for the

EsoGuard test outstrips this capacity, and we fail to add additional equipment and staff, or complete, or timely complete, an expansion

of its available laboratory facilities, it may significantly delay our EsoGuard processing times and limit the volume of EsoGuard tests

we can process, which may adversely affect our business, financial condition and results of operation.

In addition, our financial condition

may be adversely affected if they are unable to complete these expansion projects on budget and otherwise on terms and conditions acceptable

Finally, our financial condition will be adversely affected if demand for our products and services does not materialize in line

with our current expectations and if, as a result, we end up building excess capacity that does not yield a reasonable return on our

our present, or any future, laboratory facilities were to be damaged, destroyed or otherwise unable to operate, whether due to fire,

floods, storms, tornadoes, other inclement weather events or natural disasters, employee malfeasance, terrorist acts, power outages,

or otherwise, our business could be severely disrupted.

We may not be able to perform our EsoGuard test or generate test reports as promptly

as patients and healthcare providers require or expect, or possibly not at all.

If we are unable to perform our EsoGuard test or generate

test reports within a timeframe that meets patient and healthcare provider expectations, our business, financial results and reputation

could be materially harmed.

currently maintain insurance against damage to our property and equipment and against business interruption, subject to deductibles and

other limitations.

If we have underestimated our insurance needs with respect to an interruption, or if an interruption is not subject

to coverage under our insurance policies, we may not be able to cover our losses.

may remain dependent on the sales and marketing efforts of third parties if we are unable to or choose not to develop an extensive sales

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A number of factors may adversely affect the labor force available to us or increase

labor costs, including high employment levels, federal unemployment subsidies, including unemployment benefits offered in response to

the COVID-19 pandemic, increased wages offered by other employers, vaccine mandates and other government regulations and our responses

As more employers offer remote work, we may have more difficulty recruiting for jobs that require on-site attendance, such as

certain clinical laboratory and sales roles.

Although we have not experienced any material labor shortage to date, we have recently observed

an overall tightening and increasingly competitive labor market.

A sustained labor shortage or increased turnover rates within our employee

base, caused by COVID-19 or as a result of general macroeconomic factors, could lead to increased costs, such as increased overtime or

financial incentives to meet demand and increased wage rates to attract and retain employees, and could negatively affect our ability

to efficiently operate our clinical laboratories and overall business.

If we are unable to hire and retain employees capable of performing

at a high level, or if mitigation measures we may take to respond to a decrease in labor availability have unintended negative effects,

our business could be adversely affected.

labor costs, including high employment levels, federal unemployment subsidies, increased wages offered by other employers, vaccine mandates

and other government regulations and our responses thereto.

As more employers offer remote work, we may have more difficulty recruiting

for jobs that require on-site attendance, such as certain clinical laboratory and sales roles.

Although we have not experienced any material

labor shortage to date, we have recently observed an overall tightening and increasingly competitive labor market.

A sustained labor

shortage or increased turnover rates within our employee base could lead to increased costs, such as increased overtime or financial

incentives to meet demand and increased wage rates to attract and retain employees, and could negatively affect our ability to efficiently

operate our clinical laboratories and overall business.

If we are unable to hire and retain employees capable of performing at a high

level, or if mitigation measures we may take to respond to a decrease in labor availability have unintended negative effects, our business

could be adversely affected.

Additionally,

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our operations.

heavily rely upon certain suppliers, including suppliers that are the sole source of certain products.

The loss or interruption of supply

from our suppliers could have a disruptive effect on our business .

purchase certain supplies from third-party suppliers and manufacturers.

In some cases, due to the unique attributes of products that

are incorporated into our tests, we may maintain either a single-source supplier relationship or a very limited set of supplier relationships.

Certain of our third-party suppliers may possess exclusive intellectual property or otherwise may be the only party with the rights or

expertise to provide us critical supplies.

These third parties are independent entities subject to their own unique operational, regulatory

compliance, and financial risks that are outside our control.

These third parties may not be willing to enter or renew long-term supply

arrangements with us or continue to supply us at all.

Additionally, they may not perform their obligations in a timely and cost-effective

manner and they may be unwilling to increase production capacity commensurate with demand for our tests or future products or services.

Our relationships with suppliers may also be negatively affected by general supply chain material shortages worldwide, as suppliers struggle

to keep pace with demand and manage their own supply chains.

may become dependent on additional single- or limited-source suppliers, or become increasingly dependent on existing suppliers, as we

expand and develop our product and service pipeline.

The loss of a critical supplier, the failure to perform by a critical supplier,

the deterioration of our relationship with a critical supplier or any unilateral modification to the contractual terms under which we

are supplied materials could have a disruptive effect on our business, and could adversely affect our results of operations for an extended

period of time, particularly if we are required to validate an alternative supplier.

expect to rely on courier delivery services to transport EsoCheck devices and EsoGuard Specimen Kits to physicians and other medical

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by air express courier delivery service to our CLIA-certified laboratory for EsoGuard testing.

Disruptions in delivery

service, whether due to bad weather, natural disaster, labor disruptions, terrorist acts or threats, or for other reasons, can adversely

affect customer satisfaction, specimen quality and our ability to provide our services on a timely basis.

If the courier delivery services

that transport EsoCheck devices or EsoGuard Specimen Kits institute significant price increases, our profitability would be negatively

affected and we may need to identify alternative delivery methods, if possible, modify our service model, or attempt to raise our pricing,

which may not be possible with regard to Medicare claims or commercially practicable with regard to commercial claims.

Disruptions in delivery service, whether

due to bad weather, natural disaster, labor disruptions, terrorist acts or threats, or for other reasons, can adversely affect customer

satisfaction, specimen quality and our ability to provide our services on a timely basis.

If the courier delivery services that transport

EsoCheck devices or EsoGuard Specimen Kits institute significant price increases, our profitability would be negatively affected and

we may need to identify alternative delivery methods, if possible, modify our service model, or attempt to raise our pricing, which may

not be possible with regard to Medicare claims or commercially practicable with regard to commercial claims.

we attempt to bring any other products or services to market in addition to the EsoGuard test and EsoCheck device, we likely will be

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We cannot assure you these conflicts will be resolved in our favor.

are party to agreements pursuant to which we may be required to make payments to certain of our affiliates, which may reduce our cash

flow and profits.

are party to agreements pursuant to which we may be required to make payments to certain of our affiliates.

For instance, under

the License Agreement, we are required to make royalty and other payments to CWRU, which presently owns more than 5% of our outstanding

common stock.

In addition, we are required to make payments to PAVmed, our majority shareholder, under the MSA.

While we believe

that the agreements reflect arms’-length negotiations, we cannot assure you that such services are not available at lower cost

from third parties.

Any payments made to affiliates will reduce our cash flow and profits.

ability to be successful will be dependent upon the efforts of our key personnel.

ability to successfully carry out our business plan is dependent upon the efforts of our key personnel.

We cannot assure you that any

of our key personnel will remain with us for the immediate or foreseeable future.

The unexpected loss of the services of our key personnel

could have a detrimental effect on us.

We may also be unable to attract and retain additional key personnel in the future.

to do so may impact our ability to continue and grow our operations.

ability to be successful will be totally dependent upon the efforts of our key personnel.

Our ability to successfully carry out our business plan is dependent upon

the efforts of our key personnel.

We cannot assure you that any of our key personnel will remain with us for the immediate or foreseeable

The unexpected loss of the services of our key personnel could have a detrimental effect on us.

We may also be unable to attract

and retain additional key personnel in the future.

As of March 9, 2023, we only have only 3,725,723 shares available for issuance under

our long-term incentive plan, which could limit our ability to attract and retain key personnel, until such amount is increased.

to attract and retain key personnel may impact our ability to continue and grow our operations.

officers and directors have fiduciary obligations to other companies and, accordingly, may have conflicts of interest in determining

to which entity a particular business opportunity should be presented.

of our officers and directors have fiduciary obligations to other companies engaged in medical device business activities.

they may participate in transactions and have obligations that may be in conflict or competition with our business.

As a result, a potential

business opportunity may be presented by certain members of our board or management team to another entity prior to its presentation

to us and we may not be afforded the opportunity to engage in such a transaction.

business may suffer if we are unable to manage our growth.

we fail to effectively manage our growth, our ability to execute our business strategy could be impaired.

The anticipated rapid growth

Any unanticipated rapid growth

of our business may place a strain on our management, operations and financial systems.

We may need to improve existing systems and controls

or implement new systems and controls in response to anticipated growth.

may conduct business internationally, in which case our business, financial condition and results of operations could be adversely affected

by the political and economic conditions of countries other than the U.S.

business, financial condition and results of operations could be adversely affected by the political and economic conditions of countries

other than the U.S.

We need to ensure our existing systems and controls

are adequate to support our business and its anticipated growth.

business, financial condition and results of operations could be adversely affected by the political and economic conditions of the countries

in which we conduct business.

business, financial condition and results of operations could be adversely affected by the political and economic conditions of the countries

in which we conduct business.

These factors include:

associated with cultural differences, languages and distance;

● differences

in clinical practices, needs, products, modalities and preferences;

● differences

in legal and regulatory requirements and approvals, permits and licenses for our products,

and difficulties in complying with unclear product regulations in various jurisdictions,

including the changing regulation in Europe with regard to medical device and IVD regulations;

● complexities

associated with managing multiple payer reimbursement regimes, public payers or patient self-pay

systems, and the complexity of compliance with local standard contractual requirements to

access public customers and payers;

and regulations associated with shipping tissue samples or complying with local regulations

concerning the analysis of tissue, including infrastructure conditions and transportation

in our ability to access or penetrate international markets if we are not able to process

tests locally;

payment cycles in some countries;

risks of many kinds;

and regulatory differences and restrictions;

exchange fluctuations;

exchange controls that might prevent us from repatriating cash earned in certain countries;

and economic instability and export restrictions;

● variability

in sterilization requirements for medical devices;

in sterilization requirements for multi-usage surgical devices;

adverse tax consequences;

cost associated with doing business internationally;

in implementing educational programs required by our approach to doing business;

● competition

from local and regional product offerings;

risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact

of local and regional financial crises on demand and payment for our tests, and exposure

to foreign currency exchange rate fluctuations;

exchange controls that might prevent us from repatriating cash earned in certain countries;

or export licensing requirements or restrictions imposed by governments;

● potentially

burdensome taxation and adverse changes in foreign tax;

changes in laws and governmental policies, especially those affecting healthcare, trade and

economic developments in economies around the world and the instability of governments, including

the threat of war, terrorist attacks, epidemic or civil unrest;

changes in laws and governmental policies, especially those affecting trade and investment;

epidemics and /or pandemics, such as the epidemics resulting from the Ebola virus, or the

enterovirus, or the avian influenza virus, or the pandemic resulting from a novel strain

of a coronavirus designated “Severe Acute Respiratory Syndrome Coronavirus 2”

- or “SARS-CoV-2”, which may adversely affect our workforce as well as our local

suppliers and customers;

or export licensing requirements imposed by governments;

labor standards;

levels of protection of intellectual property;

threat that our operations or property could be subject to nationalization and expropriation;

practices of the regulatory, tax, judicial and administrative bodies in the jurisdictions

where we operate;

threat that our operations or property could be subject to nationalization and expropriation;

and economic instability, including the threat of war, terrorist attacks, epidemic or civil

such as the coronavirus, the Ebola virus, the enterovirus and the avian flu, which may adversely

affect our workforce as well as our local suppliers and customers;

associated with cultural differences, languages and distance;

labor standards and employment laws;

levels of protection of intellectual property;

data protection laws and restrictions or prohibitions of transmitting personal data, including

patient data, from foreign jurisdictions to our centralized laboratories in the U.S.;

and compliance risks that relate to maintaining accurate information and control over the

activities of our salesforce and distributors that may fall within the purview of the U.S.

F.C.P.A., its books and records provisions or its anti-bribery provisions, or similar anti-bribery

or anti-corruption laws or regulations, such as the U.K.

Anti-bribery Act and the U.K.

Finances Act.

● potentially

burdensome taxation and changes in foreign tax.

business may be adversely affected by health epidemics and or pandemics, including the COVID-19 pandemic.

COVID-19 pandemic may have an adverse impact on our operations, supply chains, and distribution systems and /or those of our contractors

of our laboratory partner, and increase our expenses, including as a result of impacts associated with preventive and precautionary measures

being taken, restrictions on travel, quarantine polices.

Such adverse impact may include, for example, the inability of our employees

and /or those of our contractors or laboratory partner to perform their work or curtail their services provided to us.

addition, the COVID-19 pandemic has disrupted the United States’ healthcare and healthcare regulatory systems which could divert

healthcare resources away from, or materially delay United States Food and Drug Administration (“FDA”) approval with respect

to our products.

our clinical trials have been and may be further affected by the COVID-19 pandemic, as site initiation and patient enrollment may be

delayed, for example, due to prioritization of hospital resources toward the virus and /or illness response, as well as travel restrictions

imposed by governments, and the inability to access clinical test sites for initiation and monitoring.

COVID-19 pandemic may have an adverse impact on the economies and financial markets of many countries, including the United States, resulting

in an economic downturn that could adversely affect demand for our products and services and /or our product candidates.

we are continuing to monitor and assess the effects of the COVID-19 pandemic on our business, the ultimate impact of the COVID-19 pandemic

(or a similar health epidemic) is highly uncertain and subject to change, and therefore, its impact on our consolidated financial condition,

consolidated results of operations, and /or consolidated cash flows, the adverse impact could be material.

may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce

our financial resources.

have entered into, and may in the future enter into

transactions to acquire other businesses, products, services or technologies.

While we recently completed several small acquisitions,

because we have not made any major acquisitions to date, our ability to do so successfully is unproven.

If we do identify

suitable candidates, we may not be able to make such acquisitions on favorable terms or at all.

In addition, an insufficient amount

of time has passed to evaluate whether the acquisitions we completed were cost effective and otherwise beneficial to our business.

acquisitions we have completed and any acquisitions we make in the future may not strengthen our products, technologies or

businesses or otherwise improve our competitive position, and these transactions may be viewed negatively by investors, healthcare providers,

patients and others.

have entered into, and may in the future enter into transactions to acquire other businesses, products, services or technologies.

we recently completed several small acquisitions, because we have not made any major acquisitions to date, our ability to do so successfully

If we do identify suitable candidates, we may not be able to make such acquisitions on favorable terms or at all.

an insufficient amount of time has passed to evaluate whether the acquisitions we completed were cost effective and otherwise beneficial

to our business.

The acquisitions we have completed and any acquisitions we make in the future may not strengthen our products, technologies

or businesses or otherwise improve our competitive position, and these transactions may be viewed negatively by investors, healthcare

providers, patients and others.

For examples, we may be unable to timely and effectively integrate the acquired businesses into our business;

may lose key employees;

we may encounter potential unknown liabilities and unforeseen risks, including liabilities associated with contracts

containing consent and/or other provisions that may be triggered by the acquisitions;

we may be unable to realize the anticipated benefits

of the acquisitions or do so within the anticipated timeframe;

we may lose key employees;

we may encounter potential unknown liabilities and unforeseen risks, including liabilities associated with

contracts containing consent and/or other provisions that may be triggered by the acquisitions;

we may be unable to realize the anticipated

benefits of the acquisitions or do so within the anticipated timeframe;

or we may be unable to effectively manage our expanded operations.

addition to the risks outlined above, we may decide to incur debt in connection with an acquisition or issue our common stock or other

In addition to the risks outlined above, we may decide to incur debt in connection with an acquisition or issue our common stock or other

securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders.

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and requests for information from governmental agencies and bodies, including CMS or private payors, requesting comment and/or information

on allegations of billing irregularities, billing and pricing arrangements, or privacy practices that are brought to our attention

through audits or third parties.

Legal actions could result in substantial monetary damages, as well as damage to our reputation with

customers and diversion of the attention of our management, which could have a material adverse effect upon its business.

on allegations of billing irregularities, billing and pricing arrangements, or privacy practices that are brought to our attention through

audits or third parties.

Legal actions could result in substantial monetary damages, as well as damage to our reputation with customers

and diversion of the attention of our management, which could have a material adverse effect upon its business.

Associated with Healthcare Regulation, Billing and Reimbursement, and Product Safety and Effectiveness

ability to market EsoGuard, or any other IVD product that we may develop, license, or acquire, as LDTs without FDA approval, is

entirely dependent on FDA continuing to exercise enforcement discretion with regard to requiring premarket review of LDTs.

If FDA ceases

to exercise, or modifies how it exercises, this discretion through guidance documents, formal rulemaking, departmental directive, executive

order or pursuant to legislation, we may be abruptly forced to halt commercialization of these diagnostic tests until we are able satisfy

FDA’s modified enforcement regime, or until we secure FDA approval for these IVD products.

ability to market EsoGuard, or any other IVD product that we may develop, license, or acquire, as LDTs without FDA approval, is entirely

dependent on FDA continuing to exercise enforcement discretion with regard to requiring premarket review of LDTs.

If FDA ceases to exercise,

or modifies how it exercises, this discretion through guidance documents, formal rulemaking, departmental directive, executive order

or pursuant to legislation, we may be abruptly forced to halt commercialization of these diagnostic tests until we are able satisfy FDA’s

modified enforcement regime, or until we secure FDA approval for these IVD products.

is currently being marketed as an LDT and has not received FDA approval to be marketed as an IVD.

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market as LDTs, at least initially, any other IVD product without FDA approval that we may develop, license, or acquire.

defines an LDT as “an IVD product that is intended for clinical use and designed, manufactured and used within a single

laboratory.” Thus, LDTs are considered “devices”, specifically IVD devices, as defined by the FDCA.

long maintained that it has clear regulatory authority over LDTs and could, therefore, require them to fully comply with the regulatory

requirements governing device safety and effectiveness.

FDA, however, has generally not enforced these regulatory requirements for LDTs

and has generally not required LDTs to undergo FDA premarket review of analytical validity and clinical validity, as other IVD products

For over a decade, FDA has expressed the opinion that its enforcement discretion was based on the fact that, historically,

most LDTs were low-risk, and that it has become concerned about insufficient regulatory oversight over increasingly high-risk LDTs.

has also exercised enforcement discretion of elements of its “single laboratory” definition of LDTs which by strict interpretation

would require the LDT to have been “designed” at the “single laboratory” and not transferred from another research

or commercial laboratory.

FDA has demonstrated its position that it has regulatory authority over all IVD products, by choosing

to fully exercise its authority for certain classes of “single laboratory” IVD products which would satisfy its definition

of an LDT, such as direct-to-consumer tests that do not involve a health care provider.

defines an LDT as “an IVD product that is intended for clinical use and designed, manufactured and used within a single laboratory.”

Thus, LDTs are considered “devices”, specifically IVD products, as defined by the FDCA.

FDA has long maintained that it has

clear regulatory authority over LDTs and could, therefore, require them to fully comply with the regulatory requirements governing device

safety and effectiveness.

FDA, however, has generally not enforced these regulatory requirements for LDTs and has generally not required

LDTs to undergo FDA premarket review of analytical validity and clinical validity, as other IVD products must.

For over a decade, FDA

has expressed the opinion that its enforcement discretion was based on the fact that, historically, most LDTs were low-risk, and that

it has become concerned about insufficient regulatory oversight over increasingly high-risk LDTs.

FDA has also exercised enforcement

discretion of elements of its “single laboratory” definition of LDTs which by strict interpretation would require the LDT

to have been “designed” at the “single laboratory” and not transferred from another research or commercial laboratory.

FDA has demonstrated its position that it has regulatory authority over all IVD products, by choosing to fully exercise its authority

for certain classes of “single laboratory” IVD products which would satisfy its definition of an LDT, such as direct-to-consumer

tests that do not involve a health care provider.

July 2010, FDA announced its intent to reconsider its long-standing policy of enforcement discretion with respect to LDTs after identifying

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to our third-party CLIA-certified laboratory partner and then to our own CLIA-certified commercial clinical laboratory.

also be materially affected if FDA is granted broader authority and a mandate to regulate LDTs, through pending legislation such as the

If any of these were to occur, we may be required to change business plans regarding the development and commercialization

of EsoGuard and any other LDTs we develop, license or acquire.

They may significantly slow the time it would take us to bring LDTs to

market, may materially increase the costs of developing, and decrease the profitability of providing, EsoGuard and any other LDTs we

may develop, license or acquire, and may prevent us from commercializing certain products or services.

We cannot provide any assurance

that FDA clearance or approval will not be required in the future for EsoGuard or any other LDTs we develop, license or acquire, whether

as a result of additional guidance or regulations issued by FDA, new enforcement policies adopted by FDA or new legislation adopted by

It is possible that legislation will be enacted into law, regulations could be promulgated or guidance could be issued by FDA

that may result in increased regulatory burdens for us to continue to offer diagnostic tests or to develop and introduce new tests.

if pre-market review is required by FDA or if we decide to voluntarily pursue FDA’s pre-market review for any of our IVD products,

there can be no assurance that they will be approved, or timely approved, nor can there be assurance that labeling claims will be

consistent with our current claims or adequate to support continued adoption of and reimbursement for our tests.

If pre-market review

is required, our business could be negatively impacted as a result of commercial delay that may be caused by any new requirements.

we fail to maintain CLIA-certification or otherwise meet the applicable requirements of federal or state law regulating commercial

clinical laboratories, such failure could limit or prevent our ability to perform our EsoGuard test, or any other tests

which we may develop, license or acquire, affect any payor consideration of such tests, prevent their clearance or approval entirely,

It could also

be materially affected if FDA is granted broader authority and a mandate to regulate LDTs, through pending legislation such as the VALID

If any of these were to occur, we may be required to change business plans regarding the development and commercialization of EsoGuard

and any other LDTs we develop, license or acquire.

They may significantly slow the time it would take us to bring LDTs to market, may

materially increase the costs of developing, and decrease the profitability of providing, EsoGuard and any other LDTs we may develop,

license or acquire, and may prevent us from commercializing certain products or services.

We cannot provide any assurance that FDA clearance

or approval will not be required in the future for EsoGuard or any other LDTs we develop, license or acquire, whether as a result of

additional guidance or regulations issued by FDA, new enforcement policies adopted by FDA or new legislation adopted by Congress.

is possible that legislation will be enacted into law, regulations could be promulgated or guidance could be issued by FDA that may result

in increased regulatory burdens for us to continue to offer diagnostic tests or to develop and introduce new tests.

Moreover, if pre-market

review is required by FDA or if we decide to voluntarily pursue FDA’s pre-market review for any of our IVD products, there can

be no assurance that they will be approved, or timely approved, nor can there be assurance that labeling claims will be consistent with

our current claims or adequate to support continued adoption of and reimbursement for our tests.

If pre-market review is required, our

business could be negatively impacted as a result of commercial delay that may be caused by any new requirements.

we fail to maintain CLIA-certification or otherwise meet the applicable requirements of federal or state law regulating commercial clinical

laboratories, such failure could limit or prevent our ability to perform our EsoGuard test, or any other tests which we may develop,

license or acquire, affect any payor consideration of such tests, prevent their clearance or approval entirely, and/or interrupt the

commercial sale and/or marketing of any such tests, cause us to incur significant expense to remedy this failure and otherwise negatively

impact our business.

perform the EsoGuard test in our own CLIA-certified commercial clinical laboratory, and like all clinical laboratories which perform

non-research laboratory testing on human samples in the U.S., it is regulated by CMS through CLIA and associated federal regulations

set forth in 42 CFR § 493, as well as through other federal and state laws and regulations.

Federal CLIA requirements and laws of

certain states impose certification requirements for clinical laboratories, establish standards for quality assurance and quality control,

among other things.

Some state laws restrict laboratory marketing activities, which may adversely affect our ability to market our laboratory

Clinical laboratories are subject to inspection by regulators, and to sanctions for failing to comply with applicable requirements.

Sanctions available under CLIA include prohibiting a laboratory from running tests, requiring a laboratory to implement a corrective

plan, and imposing civil monetary penalties.

If we fail to maintain CLIA-certification or otherwise meet the applicable requirements

of federal or state law, that failure could adversely limit or prevent its ability to perform our EsoGuard test, or any other diagnostic

tests which we may develop, license or acquire, affect any payor consideration of such tests, prevent their clearance or approval entirely,

and/or interrupt the commercial sale and/or marketing of any such tests, cause us to incur significant expense to remedy this failure

and otherwise negatively impact our business.

Previously, our

unrelated third-party CLIA-certified commercial clinical laboratory partner performed the EsoGuard test.

March 2022, we started to perform the EsoGuard test in our own CLIA-certified commercial clinical laboratory, and like all

clinical laboratories which perform non-research laboratory testing on human samples in the U.S., it is regulated by CMS

through CLIA and associated federal regulations set forth in 42 CFR § 493, as well as through other federal and state laws and

Federal CLIA requirements and laws of certain states impose certification requirements for clinical laboratories,

establish standards for quality assurance and quality control, among other things.

Some state laws restrict laboratory marketing

activities, which may adversely affect our ability to market our laboratory services.

Clinical laboratories are subject to

inspection by regulators, and to sanctions for failing to comply with applicable requirements.

Sanctions available under CLIA

include prohibiting a laboratory from running tests, requiring a laboratory to implement a corrective plan, and imposing civil

monetary penalties.

If we fail to maintain CLIA-certification or otherwise meet the applicable requirements of federal or

state law, that failure could adversely limit or prevent its ability to perform our EsoGuard test, or any other diagnostic tests

which we may develop, license or acquire, affect any payor consideration of such tests, prevent their clearance or approval

entirely, and/or interrupt the commercial sale and/or marketing of any such tests, cause us to incur significant expense to remedy

this failure and otherwise negatively impact our business.

or any other IVD product without FDA approval we may develop, license, or acquire and market as an LDT, may not be jointly marketed

as a combined product with EsoCheck without first securing FDA approval of the combined product as an IVD device.

that we are jointly marketing such an IVD product with EsoCheck without FDA approval of the combined product as an IVD device,

we would be subject to FDA enforcement action which could limit or halt commercialization of our products, and result in FDA sanctions

which could severely impact our business.

or any other IVD product without FDA approval we may develop, license, or acquire and market as an LDT, may not be jointly marketed as

a combined product with EsoCheck without first securing FDA approval of the combined product as an IVD device.

If FDA deems that we are

jointly marketing such an IVD product with EsoCheck without FDA approval of the combined product as an IVD device, we would be subject

to FDA enforcement action which could limit or halt commercialization of our products, and result in FDA sanctions which could severely

impact our business.

has received FDA 510(k) clearance permitting us to market it in the U.S.

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and EsoCheck as separate products.

Jointly marketing EsoGuard, or any other IVD product that we develop, license or acquire, as

a combined product with EsoCheck would require us to secure FDA approval of the combined product as an IVD device.

to jointly market such products, even inadvertently, without such FDA approval we would be subject to FDA enforcement actions which could

result in fines, unanticipated compliance expenditures, recall or seizures of our products, total or partial suspension of production

or distribution, restrictions on labeling and promotion, termination of ongoing research, disqualification of data for submission to

regulatory authorities, enforcement actions, injunctions and criminal prosecution.

Responding to such actions could cause us to incur

significant expense, limit or halt commercialization of our products and severely impact our business.

FDA approval of EsoGuard, or any other IVD product we may develop, license, or acquire, as an IVD device, separately or

as a combined product with EsoCheck, is a complex process requiring substantial time, commitment of resources and expense without any

assurance that FDA will grant such approval.

has indicated to us through its pre-submission process that jointly marketing EsoGuard combined with EsoCheck as an IVD device

would be subject to PMA premarket approval, the most stringent FDA premarket medical device scientific and regulatory review process,

which requires sufficient valid scientific evidence in addition to general and special controls to assure that it is safe and effective

for its intended use(s).

Any other IVD product we may develop, license, or acquire, would likely also require PMA premarket approval

to be marketed with EsoCheck as an IVD device.

If we choose, or are required, as a result of changes in LDT regulation, to secure

FDA approval of EsoGuard, or any other IVD product we may develop, license or acquire, as an IVD device, even if not combined

with EsoCheck, we expect we would this require FDA PMA approval.

Jointly marketing EsoGuard, or any other IVD product that we develop, license or acquire, as a combined

product with EsoCheck would require us to secure FDA approval of the combined product as an IVD device.

If we were to jointly market

such products, even inadvertently, without such FDA approval we would be subject to FDA enforcement actions which could result in fines,

unanticipated compliance expenditures, recall or seizures of our products, total or partial suspension of production or distribution,

restrictions on labeling and promotion, termination of ongoing research, disqualification of data for submission to regulatory authorities,

enforcement actions, injunctions and criminal prosecution.

Responding to such actions could cause us to incur significant expense, limit

or halt commercialization of our products and severely impact our business.

FDA approval of EsoGuard, or any other IVD product we may develop, license, or acquire, as an IVD device, separately or as a combined

product with EsoCheck, is a complex process requiring substantial time, commitment of resources and expense without any assurance that

FDA will grant such approval.

has indicated to us through its pre-submission process that jointly marketing EsoGuard combined with EsoCheck as an IVD device would

be subject to PMA premarket approval, the most stringent FDA premarket medical device scientific and regulatory review process, which

requires sufficient valid scientific evidence in addition to general and special controls to assure that it is safe and effective for

its intended use(s).

Any other IVD product we may develop, license, or acquire, would likely also require PMA premarket approval to be

marketed with EsoCheck as an IVD device.

If we choose, or are required, as a result of changes in LDT regulation, to secure FDA approval

of EsoGuard, or any other IVD product we may develop, license or acquire, as an IVD device, even if not combined with EsoCheck, we expect

we would this require FDA PMA approval.

process of securing FDA PMA approval is complex and requires substantial time, commitment of resources and expense.

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to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.

intend to seek distribution and marketing partners for one or more of the products we are developing in foreign countries.

procedures vary among countries and can involve additional clinical testing, and the time required to obtain approval may differ from

that required to obtain FDA approval.

Moreover, clinical studies or manufacturing processes conducted in one country may not be accepted

by regulatory authorities in other countries.

Approval by FDA does not ensure approval by regulatory authorities in other countries,

and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign countries

However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process

The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval.

We may not obtain

foreign regulatory approvals on a timely basis, if at all.

We may not be able to file for regulatory approvals and even if we file, we

may not receive necessary approvals to commercialize our products in any market.

intend to seek, as resources permit, distribution and marketing partners for one or more of the products we are developing in foreign

The approval procedures vary among countries and can involve additional clinical testing, and the time required to obtain

approval may differ from that required to obtain FDA approval.

Moreover, clinical studies or manufacturing processes conducted in one

country may not be accepted by regulatory authorities in other countries.

Approval by FDA does not ensure approval by regulatory authorities

in other countries, and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in

other foreign countries or by FDA.

However, a failure or delay in obtaining regulatory approval in one country may have a negative effect

on the regulatory process in others.

The foreign regulatory approval process may include all of the risks associated with obtaining FDA

We may not obtain foreign regulatory approvals on a timely basis, if at all.

We may not be able to file for regulatory approvals

and even if we file, we may not receive necessary approvals to commercialize our products in any market.

Modifications

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The clinical trial process may fail to demonstrate that our product candidates

are safe and effective for the proposed indicated uses, which could cause us to abandon a product candidate and may delay development

Any delay or termination of our clinical trials will delay the filing of our product submissions and, ultimately, our ability

to commercialize our product candidates and generate revenues.

It is also possible that patients enrolled in clinical trials will experience

adverse side effects that are not currently part of the product candidate’s profile.

are safe and effective for the proposed indicated uses or otherwise influence medical decisions in the manner we need to show to evidence

the clinical utility of our product candidates, which could cause us to abandon a product candidate and may delay development of others.

Any delay or termination of our clinical trials will delay the filing of our product submissions and, ultimately, our ability to commercialize

our product candidates and generate revenues (in particular where evidence of clinical utility is a critical factor to payor’s

decisions around reimbursement).

It is also possible that patients enrolled in clinical trials will experience adverse side effects that

are not currently part of the product candidate’s profile.

our clinical studies do not satisfy providers, payors, patients and others as to the reliability and performance of our EsoGuard test

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on the part of physicians to order, and third-party payors to pay for, such test.

we have received FDA 510(k) clearance to market EsoCheck, and EsoGuard may be performed in our own CLIA-certified commercial

clinical laboratory and marketed as an LDT, if the results of any research and clinical studies conducted by us, including those

conducted for the purpose of obtaining FDA approval of the combined EsoGuard and EsoCheck product as an IVD device, and our sales

and marketing activities relating to communication of these results, do not convince guidelines organizations, physicians and other healthcare

providers, third-party payors and patients that EsoGuard and EsoCheck are safe and effective, we may experience reluctance or refusal

on the part of physicians to order, and third-party payors to pay for, EsoGuard or EsoCheck, which could adversely affect our business

Likewise, if the results of our research and clinical studies and our sales and marketing activities relating to new products

or services we may develop and seek to commercialize in the future do not convince FDA and other regulators, guidelines organizations,

physicians and other healthcare providers, third-party payors and patients that such other products and services are safe and reliable,

those tests may not receive or sustain necessary regulatory clearances or approvals and we may experience reluctance or refusal on the

part of physicians to order, and third-party payors to pay for, those tests, which could adversely affect our business prospects.

we have received FDA 510(k) clearance to market EsoCheck, and EsoGuard may be performed in our own CLIA-certified commercial clinical

laboratory and marketed as an LDT, if the results of any research and clinical studies conducted by us, including those conducted for

the purpose of obtaining FDA approval of the combined EsoGuard and EsoCheck product as an IVD device, and our sales and marketing activities

relating to communication of these results, do not convince guidelines organizations, physicians and other healthcare providers, third-party

payors and patients that EsoGuard and EsoCheck are safe and effective, we may experience reluctance or refusal on the part of physicians

to order, and third-party payors to pay for, EsoGuard or EsoCheck, which could adversely affect our business prospects.

the results of our research and clinical studies and our sales and marketing activities relating to new products or services we may develop

and seek to commercialize in the future do not convince FDA and other regulators, guidelines organizations, physicians and other healthcare

providers, third-party payors and patients that such other products and services are safe and reliable, those tests may not receive or

sustain necessary regulatory clearances or approvals and we may experience reluctance or refusal on the part of physicians to order,

and third-party payors to pay for, those tests, which could adversely affect our business prospects.

this regard, we have been unable to successfully complete our clinical trials related to the EsoGuard test to generate clinical utility

data showing that the results of the test influence’s provider decision making in providing medical care.

As such clinical utility

is important to decisions by payor’s to provide reimbursement for the test, continued delays in such trials will adversely impact

our ability to commercialize the EsoGuard test and generate revenues from sales of the same.

the validity of an informed consent for a clinical trial of one of our products was challenged, we could be subject to fines, penalties,

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We seek to receive

approval from an ethical review board, or institutional review board (“IRB”) for projects that meet the definition

of “human subjects research,” which includes review and approval of processes for subject informed consent and authorization

for use of personal information or waivers thereof.

approval from an ethical review board, or institutional review board (“IRB”) for projects that meet the definition of “human

subjects research,” which includes review and approval of processes for subject informed consent and authorization for use of personal

information or waivers thereof.

We could conduct clinical trials in a number of different countries.

When we utilize

clinical research contractor or partner with other third parties, we rely upon them to comply with the requirements to obtain the subject’s

informed consent and to comply with applicable laws and regulations.

The collection of data and samples in many different countries results

in complex legal questions regarding the adequacy of informed consent and the status of genetic material under a large number of different

When we utilize clinical research

contractor or partner with other third parties, we rely upon them to comply with the requirements to obtain the subject’s informed

consent and to comply with applicable laws and regulations.

The collection of data and samples in many different countries results in

complex legal questions regarding the adequacy of informed consent and the status of genetic material under a large number of different

legal systems.

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and financial resources.

business and reputation will suffer if we are unable to establish and comply with, stringent quality standards to assure that the highest

level of quality is observed in the performance of our tests.

risks are involved in providing and marketing cancer tests and related services.

Patients and healthcare providers rely on us to provide

accurate clinical and diagnostic information that may be used to make critical healthcare decisions.

As such, users of our tests may

have a greater sensitivity to errors than users of some other types of products and services.

must maintain top service standards and FDA-mandated and other quality controls.

Past or future performance or accuracy defects, incomplete

or improper process controls, excessively slow turnaround times, unanticipated uses of our tests or mishandling of samples or test results

(whether by us, patients, healthcare providers, courier delivery services or others) can lead to adverse outcomes for patients and interruptions

to our services.

These events could lead to voluntary or legally mandated safety alerts relating to our tests or our laboratory facilities

and could result in the removal of our products and services from the market or the suspension of our laboratories’ operations.

Insufficient quality controls and any resulting negative outcomes could result in significant costs and litigation, as well as negative

publicity that could reduce demand for our tests and payers’ willingness to cover our tests.

Even if we maintain adequate controls

and procedures, damaging and costly errors may occur.

and any other products we develop that receive regulatory clearance or approval will be subject to ongoing regulatory obligations and

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We and our contract manufacturers also will be required to comply with current good manufacturing practice (“cGMP”)

regulations regarding the manufacture of our products, which include requirements related to quality control and quality assurance

as well as the corresponding maintenance of records and documentation.

regulations regarding the manufacture of our products, which include requirements related to quality control and quality assurance as

well as the corresponding maintenance of records and documentation.

Further, regulatory authorities must approve these manufacturing

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a provider of clinical diagnostic products and services, we are subject (and our prior third-party laboratory partner previously was

subject) to extensive and frequently changing federal, state, and local laws and regulations governing various other aspects of our

In particular, the clinical laboratory industry is subject to significant governmental certification and licensing regulations,

as well as federal and state laws regarding:

subject) to extensive and frequently changing federal, state, and local laws and regulations governing various other aspects of our business.

In particular, the clinical laboratory industry is subject to significant governmental certification and licensing regulations, as well

as federal and state laws regarding:

ordering and billing practices;

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In addition, advertising

of our tests is subject to regulation by the Federal Trade Commission (“FTC”) and advertising of laboratory services

is regulated by certain state laws.

of our tests is subject to regulation by the Federal Trade Commission, (“FTC”) and advertising of laboratory services is

regulated by certain state laws.

Violation of any FDA requirement could result in enforcement actions, such as seizures, injunctions,

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which could materially disrupt our business.

intend to operate patient service centers where prescribing physicians can send patients for EsoGuard testing, including undergoing specimen

collection using EsoCheck.

These patient service centers are subject to federal and state regulations which may be burdensome, costly

or difficult to comply with.

Failure to comply with these regulations could result in sanctions, fines or other enforcement actions which

may be costly, time-consuming and limit our ability to utilize them and adversely impact our business.

part of our commercialization efforts for EsoGuard, we are operating patient service centers in jurisdictions where a licensed

health care professional, employed or contracted by us, will perform the esophageal cell collection procedure using EsoCheck and then

package the specimen for transport to our CLIA-certified commercial clinical laboratory.

The patient service centers may be deemed

laboratory draw stations or outpatient centers or clinics, which may be subject to state licensure and operating requirements.

states may require personnel performing the specimen collection procedure to be licensed and may require collaboration with or supervision

by a physician.

operate patient service centers where prescribing physicians can send patients for EsoGuard testing, including undergoing specimen collection

using EsoCheck.

These patient service centers are subject to federal and state regulations which may be burdensome, costly or difficult

to comply with.

Failure to comply with these regulations could result in sanctions, fines or other enforcement actions which may be costly,

time-consuming and limit our ability to utilize them and adversely impact our business.

part of our commercialization efforts for EsoGuard, we are operating patient service centers in jurisdictions where a licensed health

care professional, employed or contracted by us, will perform the esophageal cell collection procedure using EsoCheck and then package

the specimen for transport to our CLIA-certified commercial clinical laboratory.

The patient service centers may be deemed laboratory

draw stations or outpatient centers or clinics, which may be subject to state licensure and operating requirements.

In addition, states

may require personnel performing the specimen collection procedure to be licensed and may require collaboration with or supervision by

The health care professionals may also be subject to malpractice claims.

We will need to purchase insurance policies

to cover such claims but the coverage limits on such policies may be insufficient to cover any monetary awards for damages granted for

We will need to purchase insurance policies to

cover such claims but the coverage limits on such policies may be insufficient to cover any monetary awards for damages granted for such

In certain states, our patient service centers may trigger the corporate practice of medicine doctrine, a general prohibition

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devices, test orders, patient consents, medical necessity requirements and billing regulations.

failure to comply with these regulations in the operation of these patient service centers or in managing the personnel interacting with

patients at these centers could subject us to sanctions, fines or other enforcement actions.

Responding to these actions may be costly

and time-consuming and may require us to cease operations at these centers which may limit our commercialization efforts and adversely

impact our business.

have invested heavily in regulatory and compliance infrastructure in an effort to ensure compliance with this regulatory framework, however,

we cannot guarantee that we will remain in compliance with these rules at all times.

Our failure to comply with these regulations in

the operation of these patient service centers or in managing the personnel interacting with patients at these centers could subject

us to sanctions, fines or other enforcement actions.

Responding to these actions may be costly and time-consuming and may require us

to cease operations at these centers which may limit our commercialization efforts and adversely impact our business.

intend to engage with one or more third-party telemedicine companies to provide physicians to evaluate patients who respond to our direct-to-consumer

(“DTC”) marketing activities seeking EsoGuard testing and, if clinically indicated, refer the patient to our patient

service centers to undergo EsoCheck specimen collection for EsoGuard testing.

Telemedicine, and its specific use in conjunction with

DTC, is subject to numerous federal and state regulations and faces particularly intense scrutiny by these regulators.

If we fail to

comply with federal healthcare regulations, we could face substantial penalties, sanctions, fines or prosecution and our business, operations

and financial condition could be adversely affected.

pillar of our growth strategy is to expand EsoGuard commercialization across multiple channels, including DTC marketing.

Patients with

chronic heartburn who respond to DTC advertising of our products or to consumer-oriented educational material we provide, or who otherwise

become aware of the availability of a simple noninvasive test to screen for esophageal precancer may seek EsoGuard testing.

to facilitate access to EsoGuard testing for such patients by contracting with one or more third-party telemedicine companies who will

provide physicians to evaluate such a patient via video communications, determine whether EsoGuard testing is clinically indicated based

on the patient’s history and condition, and order an EsoGuard test by referring the patient to one of our patient service centers

where the patient would undergo EsoCheck specimen collection for EsoGuard testing by our CLIA-certified commercial clinical laboratory.

The EsoGuard test result would then be sent directly to the prescribing telemedicine physician who, based on the test result, would

refer the patient to a gastroenterologist for further care.

logistics required to manage the patient’s journey through such a DTC/telemedicine program, in a manner which is compliant with

all applicable regulations, are complex and require very careful coordination between us and our third-party telemedicine and laboratory

partners broadly operating within our quality management system.

Our activities and the activities of our third-party partners on our

behalf within this DTC/telemedicine program are subject to numerous federal and state regulations.

The telemedicine provider itself may

be subject to additional state regulations relating to the corporate practice of medicine, test orders, patient consents, medical necessity

requirements and billing regulations.

Telemedicine, and its specific use in conjunction with DTC, faces particularly intense scrutiny

from regulators due to numerous cases of companies failing to operate in this space with a properly functioning regulatory and compliance

infrastructure.

For example, in recent years, the federal government has conducted several major investigations into the use of telemedicine

to generate orders or prescriptions for laboratory tests, pharmaceuticals, durable medical equipment and other ancillary items and services

that are billed to Medicare and other federal health care program (“FHCPs”).

In such cases, the supplier that received

the order or prescription and billed for the ancillary item or service would compensate the telemedicine provider (or management company)

for the patient consultation because the actual telehealth service may not be a covered service or meet the coverage requirements under

the Medicare or other FHCPs (due to lack of provider-patient relationship or audio-only modality).

The Department of Justice has prosecuted

providers on the legal theory that this is akin to a kickback or bribe in the form of remuneration paid to the telemedicine provider

or management company for the order or prescription itself, whether the ancillary item or service was medically necessary.

complexities of these regulations have required us to establish a costly and substantial regulatory and compliance infrastructure for

the DTC/telemedicine program, including retaining multiple legal and regulatory consultants with specific expertise in this space and

a special Quality & Compliance Committee of our board of directors to provide board-level oversight.

Our contracts with our third-party

telemedicine partners are also complex, as are the standard operating procedures that our quality management system requires

all parties to meticulously follow.

Despite these measures, we cannot guarantee that our personnel or those of our third-party partners

will comply with the applicable regulations at all times.

If any such personnel fail to comply with regulations, we could face substantial

penalties, sanctions, fines or prosecution and our business, operations and financial condition could be adversely affected.

aspects of our business, beyond the specific elements described above are subject to complex, intertwined, costly and/or burdensome federal

health care laws and regulations which may open to interpretation and be subject to varying levels of discretionary enforcement.

fail to comply with these laws and regulations, we could face substantial penalties and our business, operations and financial condition

could be adversely affected.

(“DTC”) marketing activities seeking EsoGuard testing and, if clinically indicated, refer the patient to our patient service

centers to undergo EsoCheck specimen collection for EsoGuard testing.

Telemedicine, and its specific use in conjunction with DTC, is

subject to numerous federal and state regulations and faces particularly intense scrutiny by these regulators.

If we fail to comply with

federal healthcare regulations, we could face substantial penalties, sanctions, fines or prosecution and our business, operations and

financial condition could be adversely affected.

element of our growth strategy is to expand EsoGuard commercialization across multiple channels, including DTC marketing.

The logistics

required to manage a patient’s journey through a DTC/telemedicine program, in a manner which is compliant with all applicable regulations,

are complex and require very careful coordination between us and our third-party telemedicine and laboratory partners broadly operating

within our quality management system.

Our activities and the activities of our third-party partners on our behalf within this DTC/telemedicine

program are subject to numerous federal and state regulations.

The telemedicine provider itself may be subject to additional state regulations

relating to the corporate practice of medicine, test orders, patient consents, medical necessity requirements and billing regulations.

Telemedicine, and its specific use in conjunction with DTC, faces particularly intense scrutiny from regulators due to numerous cases

of companies failing to operate in this space with a properly functioning regulatory and compliance infrastructure.

cannot guarantee that our personnel or those of our third-party partners will comply with the applicable regulations at all times.

any such personnel fail to comply with regulations, we could face substantial penalties, sanctions, fines or prosecution and our business,

operations and financial condition could be adversely affected.

aspects of our business, beyond the specific elements described above, are subject to complex, intertwined, costly and/or burdensome

federal health care laws and regulations which may open to interpretation and be subject to varying levels of discretionary enforcement.

If we fail to comply with these laws and regulations, we could face substantial penalties and our business, operations and financial

condition could be adversely affected.

though we do not and do not expect to control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party

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be made under federal healthcare programs, such as the Medicare and Medicaid programs;

Foreign Corrupt Practices Act (“FCPA”) which prohibits payments or

the provision of anything of value to foreign officials for the purpose of obtaining or keeping

federal False Claims Act (“FCA”) which prohibits, among other things,

individuals or entities from knowingly presenting, or causing to be presented, false claims,

or knowingly using false statements, to obtain payment from the federal government, and which

may apply to entities like us which provide coding and billing advice to customers;

Foreign Corrupt Practices Act, or “FCPA,” which prohibits payments or the

provision of anything of value to foreign officials for the purpose of obtaining or keeping

federal False Claims Act, or “FCA,” which prohibits, among other things, individuals

or entities from knowingly presenting, or causing to be presented, false claims, or knowingly

using false statements, to obtain payment from the federal government, and which may apply

to entities like us which provide coding and billing advice to customers;

criminal laws that prohibit executing a scheme to defraud any healthcare benefit program

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Statute constitutes a false or fraudulent claim for purposes of the FCA.

2018, Congress passed Eliminating Kickbacks in Recovery Act (“EKRA”) as part of the Substance Use-Disorder Prevention

that Promotes Opioid Recovery and Treatment for Patients and Communities Act.

2018, Congress passed Eliminating Kickbacks in Recovery Act (“EKRA”) as part of the Substance Use-Disorder Prevention that

Promotes Opioid Recovery and Treatment for Patients and Communities Act.

Similar to the Anti-Kickback Statute, EKRA imposes criminal

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PLA code 0114U has been granted “gapfill” determination through the CMS CLFS process, allowing us to engage directly with

Medicare Administrative Contractor (“MAC”) Palmetto GBA, whose Molecular Diagnostics Program (“MolDx”)

performs technical assessment of molecular diagnostic tests on behalf of itself and other MACs.

We submitted EsoGuard payment and

coverage dossiers to MolDx in 2020.

Although CMS granted EsoGuard final Medicare payment determination of $1,938.01, effective January

1, 2021, we are awaiting Medicare local coverage determination from MolDx, where the Covid-19 pandemic and change of administrations

has resulted in a significant backlog of local coverage reviews.

We have no information on when MolDx will complete its technical assessment

of our dossier, cannot predict whether or not it will grant EsoGuard local coverage determination and whether other MACs will utilize

the MolDx determination.

Medicare Administrative Contractor (“MAC”) Palmetto GBA, whose Molecular Diagnostics Program (“MolDx”) performs

technical assessment of molecular diagnostic tests on behalf of itself and other MACs.

We submitted EsoGuard payment and coverage dossiers

to MolDx in 2020.

Although CMS granted EsoGuard final Medicare payment determination of $1,938.01, effective January 1, 2021, we are

awaiting Medicare local coverage determination from MolDx, where the Covid-19 pandemic and change of administrations has resulted in

a significant backlog of local coverage reviews.

We have no information on when MolDx will complete its technical assessment of our dossier,

cannot predict whether or not it will grant EsoGuard local coverage determination and whether other MACs will utilize the MolDx determination.

third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies.

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and EsoCheck, may be interpreted in a manner unfavorable to us, may be difficult to enforce and are subject to repeal or modification.

For example, the Patient Protection and Affordable Care Act (the “PPACA”) may be repealed or materially modified,

in whole or in part, or replaced with an alternative legal framework governing healthcare matter.

Such repeal, modification or replacement

may eliminate or modify coverage mandates for preventive services, and any such elimination or modification may have an adverse effect

on our business prospects.

For example, the Patient Protection and Affordable Care Act (the “PPACA”) may be repealed or materially modified, in whole

or in part, or replaced with an alternative legal framework governing healthcare matter.

Such repeal, modification or replacement may

eliminate or modify coverage mandates for preventive services, and any such elimination or modification may have an adverse effect on

our business prospects.

addition to the risk of adverse reimbursement decisions, we also may experience material delays in obtaining such reimbursement decisions

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are subject to change, including as a result of reimbursement rate adjustments under the Protecting Access to Medicare Act of 2014, (“PAMA”)

as described below, and we cannot guarantee that even if we initially achieve coverage and adequate reimbursement rates, they will

continue to be applicable to our products in the future.

Furthermore, it is possible that Medicare or other federal payors that provide

reimbursement for our tests may suspend, revoke or discontinue coverage at any time, may require co-payments from patients, or may reduce

the reimbursement rates payable to us.

may pursue a variety of strategies to increase commercial payor coverage and reimbursement of EsoGuard, used with EsoCheck, and any other

product or service we may develop.

In certain situations, where we believe payors are obligated to cover EsoGuard under federal and state

laws that mandate coverage for certain esophageal precancer and cancer screening tests, we may sue to enforce coverage obligations or

pursue similar tactics.

Such litigation and tactics may be costly, may divert management attention from other responsibilities, may cause

payors, including those not directly involved in any litigation, to resist contracting with us, and may ultimately prove unsuccessful.

as described below, and we cannot guarantee that even if we initially achieve coverage and adequate reimbursement rates, they will continue

to be applicable to our products in the future.

Furthermore, it is possible that Medicare or other federal payors that provide reimbursement

for our tests may suspend, revoke or discontinue coverage at any time, may require co-payments from patients, or may reduce the reimbursement

rates payable to us.

we are unable to obtain favorable decisions from third-party payors, including CMS and managed care organizations, approving reimbursement

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reform measures could hinder or prevent our products’ commercial success.

the U.S., there have been, and we expect there will continue to be, ongoing legislative and regulatory changes to the healthcare system

which could affect our future revenue and profitability.

Federal and state lawmakers regularly propose and, at times, enact legislation

that could result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical

products and services.

For example, one of the most significant healthcare reform measures in decades, the Patient Protection and Affordable

Care Act, as amended by the PPACA was enacted in 2010.

The PPACA contains a number of provisions, including those governing enrollment

in federal healthcare programs, reimbursement changes and fraud and abuse measures, all of which will impact existing government healthcare

The PPACA, among other things, also could result in the imposition of injunctions.

Supreme Court has repeatedly upheld the constitutionality of most elements of the PPACA, other legal challenges are still pending

final adjudication in several jurisdictions.

Although efforts in Congress to repeal the PPACA have repeatedly fallen short, there are

a number of ongoing legislative initiatives to modify it.

At this time, it remains unclear whether there will be any changes made to

We cannot assure you that the PPACA, as currently enacted or as amended in the future, will not adversely affect our business

and financial results and we cannot predict how future federal or state legislative or administrative changes relating to healthcare

reform will affect our business.

addition, other legislative changes have been proposed and adopted since the PPACA was enacted.

There likely will continue to be legislative

and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care.

Medicare reimbursement

for all products and services, including ours, remains highly susceptible to threats of automatic reductions triggered by budgetary shortfalls.

Such payments are subject to recovery of purported overpayment for several years.

We cannot predict the initiatives that may be adopted

in the future or their full impact.

We cannot predict whether any additional legislative changes will affect our business.

continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain

or reduce costs of health care may adversely affect:

likely will be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health

We cannot predict the initiatives that may be adopted in the future or their full impact.

The continuing efforts of the government,

insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of health care may

adversely affect:

ability to set a price that we believe is fair for our products;

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preapproval of promotional materials and restrictions on direct-to-consumer advertising.

face uncertainty related to healthcare reform, pricing, coverage and reimbursement, which could reduce our revenue.

reform laws, including the PPACA and PAMA, are significantly affecting the U.S.

healthcare and medical services industry.

Recently passed

legislation and possible future legal and regulatory changes, including potential repeal or modification of the PPACA, or approval of

health plans that allow lower levels of coverage for preventive services, could substantially change the structure and finances of the

health insurance system and the methodology for reimbursing medical services, drugs and devices, including our current and future products

and services.

Healthcare reforms, which may intend to reduce healthcare costs, may have the effect of discouraging third-party payors

from covering certain kinds of medical products and services, particularly newly developed technologies, such as our EsoGuard test or

EsoCheck device, or any other products or services we develop.

We cannot predict whether future healthcare reform initiatives will be

implemented at the federal or state level or the effect any such future legislation or regulation will have on us.

The taxes imposed

by new legislation, cost reduction measures and the expansion in the government’s role in the U.S.

healthcare industry may result

in decreased profits to us, which may adversely affect our business, financial condition and results of operations.

Medicare currently covers a significant portion of the patients in the current targeted screening population for EsoGuard, any reduction

in the CMS reimbursement rate for EsoGuard would negatively affect our revenues and our business prospects.

There can be no assurance

under PAMA that adequate CMS reimbursement rates will initially be assigned or will continue to be assigned to our tests.

is possible that Medicare or other federal payors that provide reimbursement for our tests in the future may later suspend, revoke or

discontinue coverage at any time, may require co-payments from patients, or may reduce the reimbursement rates payable to us.

action could have a negative impact on our revenues.

products may cause serious adverse side effects or even death or have other properties that could delay or prevent their regulatory clearance

or approval, limit the commercial desirability of an approved label or result in significant negative consequences following any marketing

clearance or approval.

clinical trials have a substantial risk of failing to meet their safety or effectiveness endpoints.

EsoCheck is our only product which

has received FDA marketing clearance in the U.S.

EsoGuard is currently marketed as an LDT without FDA approval as an IVD device.

It is impossible to predict when or if EsoGuard, or any other products we are develop, license or acquire, including EsoGuard, used with

EsoCheck, as a combined IVD product, will prove safe and effective and receive regulatory approval as an IVD device.

side effects caused by any products we are developing could cause us or regulatory authorities to interrupt, delay or halt any required

clinical trials.

They could also result in a more restrictive label or the delay or denial of regulatory clearance or approval by FDA

or other comparable foreign regulatory authority.

Additionally,

after receipt of marketing clearance or approval of any products we may develop, if we or others later identify undesirable side effects

or even deaths caused by such products, a number of potentially significant negative consequences could result, including:

may be forced to recall such product and suspend the marketing of such product;

authorities may withdraw their clearance or approval of such product;

authorities may require additional warnings on the label that could diminish the usage or

otherwise limit the commercial success of such products;

or other regulatory bodies may issue safety alerts, Dear Healthcare Provider letters, press

releases or other communications containing warnings about such product;

may require the establishment or modification of Risk Evaluation Mitigation Strategies, or

a comparable foreign regulatory authority may require the establishment or modification of

a similar strategy that may, for instance, restrict distribution of our products and impose

burdensome implementation requirements on us;

may be required to change the way the product is administered or conduct additional clinical

could be sued and held liable for harm caused to subjects or patients;

may be subject to litigation or product liability claims;

reputation may suffer.

of these events could prevent us from achieving or maintaining market acceptance of the particular product.

intend to market our products in Europe, however major changes in the EU regulation of medical devices and IVDs may make it burdensome,

costly and impossible to successfully do so, which could adversely impact our business.

recently received CE Mark certification for EsoCheck under MDD and completed CE Mark self-certification for EsoGuard, which qualifies

as a General IVD, under IVDD, indicating that both may be marketed in CE Mark European countries, namely the European Economic Area (the

European Union, Norway, Iceland, and Lichtenstein), Switzerland, and, until July 1, 2023, the United Kingdom.

MDD, which refers to Medical

Device Directive 93/42/EEC, has provided the essential requirements and conformity assessment procedure that medical devices must undergo

to be affixed with a CE Mark and sold in CE Mark European countries for nearly three decades but is now obsolete and has been replaced

by MDR, which refers to Regulation (EU) 2017/745 and incorporates several new concepts and registrations, stricter oversight of manufacturers

by notified bodies, universal device identification (UDI) marking, and increased post-market surveillance requirements.

Similarly, IVDD,

which refers to In-Vitro Diagnostic Medical Devices Directive (98/79/EC), has provided the essential requirements and conformity assessment

procedure that in-vitro diagnostic medical devices must undergo to be affixed with a CE Mark and sold in CE Mark European countries for

over twenty years but will become obsolete and replaced in 2022 with IVDR, which refers to Regulation (EU) 2017/746, and has an expanded

scope, risk-based classification, more rigorous clinical evidence and surveillance requirements, and more stringent documentation.

MDR and IVDR have sunset provisions for medical device and IVD certifications under MDD and IVD, respectively.

Both EsoGuard and EsoCheck

will require recertification under their stricter regulations in the coming years.

Failure to secure these recertifications under MDR

and IVDR will halt our ability to commercialize our products in the CE Mark European countries.

In addition, the United Kingdom, which

is a major target market for us, has left the European Union (“Brexit”) and will transition from CE Mark certification to

its own UKCA certification mark.

If we fail to secure UKCA mark certification for our products before CE Mark certification expires in

the UK, we will no longer be able to commercialize our products there, which may adversely impact our business.

medical products may in the future be subject to product recalls that could harm our reputation, business, and financial results.

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information or other private personal information.

employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities,

including noncompliance with regulatory standards and requirements.

are exposed to the risk of fraud, misconduct, or other illegal activity by our employees, independent contractors, consultants, commercial

partners, and vendors.

Misconduct by these parties could include intentional, reckless and negligent conduct that fails to:

the rules and regulations of the CMS, FDA, and other comparable foreign regulatory authorities;

provide true, complete and accurate information

to such regulatory authorities;

comply with manufacturing and clinical laboratory standards;

comply with healthcare fraud and abuse laws

in the United States and similar foreign fraudulent misconduct laws;

or report financial information or data accurately or to disclose

unauthorized activities to us.

In particular, research, sales, marketing, education, and other business arrangements in the healthcare

industry are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing, and other abusive practices, as well as off-label

product promotion.

These laws and regulations may restrict or prohibit a wide range of pricing, discounting, educating, marketing and

promotion, sales and commission, certain customer incentive programs, and other business arrangements generally.

Activities subject to

these laws also involve the improper use of information obtained in the course of participant recruitment for clinical studies, which

could result in regulatory sanctions and cause serious harm to our reputation.

We have adopted a code of business conduct and ethics,

but it is not always possible to identify and deter misconduct by employees and third parties, and the precautions we take to detect

and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental

investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws.

If any such actions are instituted

against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on

our business, including the imposition of significant fines or other sanctions.

Even if it is later determined after an action is instituted

against us that we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending

our actions, and have to divert significant management resources from other matters.

Associated with Our Intellectual Property and Technology Infrastructure

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ability to execute our business strategy depends, in part, on the continued and uninterrupted performance of our information technology

(“IT”) systems that support our operations and our research and development efforts, and those IT systems within the

control of our contract manufacturers.

We are substantially dependent

on those IT systems to receive and process EsoGuard test orders, securely store patient health records and deliver the results of our

EsoGuard tests.

IT systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious

human acts including cyberattacks, and natural disasters.

Despite the precautionary measures we have taken to prevent unanticipated problems

that could affect our IT systems, and the precautionary measures taken by our contract parties, sustained or repeated system failures

that interrupt our ability to generate and maintain data, and in particular to operate our clinical laboratory, could adversely affect

our ability to operate our business.

Any interruption in the operation of IT systems could have an adverse effect on our operations.

(“IT”) systems that support our operations and our research and development efforts, and those IT systems within the control

of our contract manufacturers.

We are substantially dependent on those IT systems to receive and process EsoGuard test orders, securely

store patient health records and deliver the results of our EsoGuard tests.

IT systems are vulnerable to damage from a variety of sources,

including telecommunications or network failures, malicious human acts including cyberattacks, and natural disasters.

Despite the precautionary

measures we have taken to prevent unanticipated problems that could affect our IT systems, and the precautionary measures taken by our

contract parties, sustained or repeated system failures that interrupt our ability to generate and maintain data, and in particular to

operate our clinical laboratory, could adversely affect our ability to operate our business.

Any interruption in the operation of IT

systems could have an adverse effect on our operations.

upgrades, enhancements and replacements, as well as new systems, are required from time to time, and require significant expenditures

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may suffer security breaches.

the ordinary course of our business, we and our contract manufacturers store sensitive data, including intellectual

property, proprietary business information, personally identifiable information of our employees and patient health records, in our data

centers and on our networks.

The integrity and protection of our own data, and that of our customers and employees, is critical to our

The regulatory environment governing information, security and privacy laws is increasingly demanding and continues to evolve.

Despite the implementation of security measures by us and by our contractors, our internal computer systems and those of our contractors

may be vulnerable to security breaches and damage from computer viruses, unauthorized access and ransomware attacks, including the unauthorized

encryption of data stored on our computer network.

Any such breach or attack could materially affect business operations and result in

a loss of data, damage to our IT systems, or inappropriate disclosure of confidential or proprietary information, including protected

health information, which is protected by HIPAA and other laws.

Any such access, disclosure, or other loss of information could result

in legal claims or proceedings, liability under laws that protect the privacy of personal information, damage to our reputation, and

delays in the commercialization of our products.

In addition, we could incur additional cost, expense and the diversion of time and resources

to recover from such an attack, and any such attach could cause our management to conclude that our disclosure controls and procedures

were not effective.

Associated with Our Financial Condition

have incurred operating losses since our inception and may not be able to achieve profitability.

have incurred net losses since our inception.

For the years ended December 31, 2021 and December 31, 2020, we had a net loss of

$28.1 million and $8.3 million, respectively.

Our ability to generate sufficient revenue from any of our products in development,

and to transition to profitability and generate consistent positive cash flows is dependent upon factors that may be outside of our control.

We expect that our operating expenses will continue to increase as we continue to develop, pursue regulatory clearance or approval for

and commercialize our products, build our manufacturing, sales and other commercial infrastructure, and incur additional operational

and reporting costs associated with being a public company.

As a result, we expect to continue to incur operating losses for the foreseeable