Item 1A. Risk Factors
The following risk factors and
other information included in this Annual Report on Form 10-K should be carefully considered. The risks and uncertainties described below
are not the only ones we face. Additional risks and uncertainties not presently known to us or we presently deem less significant may
also impair our business operations. If any of the following risks occur, our business, financial condition, results of operations and
future growth prospects could be materially and adversely affected.
Risks Factor Summary
Our business is subject to numerous
risks and uncertainties that you should consider before investing in our common stock. These risks are described more fully below and
include, but are not limited to, risks relating to the following:
Risks Associated with Our Financial Condition
Risks Associated with Our Business
● Our products may never achieve market acceptance.
● Our business may suffer if we are unable to manage our growth.
Risks Associated with Healthcare Regulation, Billing and Reimbursement,
and Product Safety and Effectiveness.
Risks Associated with Our Intellectual Property
and Technology Infrastructure
Risks Associated with Our Relationship with PAVmed
Risks Associated with Ownership of Our Common
Stock
● We do not intend to pay any dividends on our common stock at this time.
Risks Associated with Our Financial Condition
We have incurred operating losses since our
inception and may not be able to achieve profitability.
We have incurred net losses since
our inception. For the years ended December 31, 2024 and 2023, we had a net loss of $45.5 million and $52.7 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 future.
We 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 trials.
We
have concluded there is substantial doubt of our ability to continue as a going concern and our independent registered public accounting
firm’s report on our financial statements contains an explanatory paragraph describing our ability to continue as a going concern.
In
our December 31, 2024 consolidated financial statements, we have concluded and stated our recurring losses from operations, recurring
cash flows used in operations and the requirement we raise additional capital in order to fund our ongoing operations beyond March 2026
raise substantial doubt regarding our ability to continue as a going concern. Additionally, our independent registered public accounting
firm’s report on our consolidated financial statements includes an explanatory paragraph expressing substantial doubt about our ability
to continue as a going concern. Our plans to address this going concern risk include pursuing further financings in addition to the recently
completed offering of our Registered Direct Offering (in which we realized net proceeds of approximately $14.5 million) and pursuing
additional offerings of debt and/or equity securities. The consolidated financial statements do not include any adjustments that might
result from our inability to consummate such offerings or our ability to continue as a going concern. Moreover, there is no assurance
if we consummate additional offerings, we will raise sufficient proceeds in such offerings to pay our financial obligations as they become
due. These factors raise substantial doubt about our ability to continue as a going concern.
To raise capital, we have issued a significant
amount of convertible securities under which we expect to issue a correspondingly significant amount of shares of our common stock upon
conversion thereof. In addition, we may issue shares of our capital stock or debt securities in the future in order to raise capital
to fund our operations. All of the foregoing would dilute the equity interest of our stockholders and might cause a change in control
of our ownership.
Our certificate of incorporation
authorizes the issuance of up to 300,000,000 shares of common stock, par value $.001 per share, and 20,000,000 shares of preferred stock,
par value $.001 per share. There are 209,246,149 authorized but unissued shares of our common stock available for issuance as of March
20, 2025 (inclusive of granted but unvested restricted stock awards granted as of each such date under the Lucid Diagnostics 2018
Long-Term Incentive Equity Plan).
In 2024, we issued shares of
Series B Preferred Stock and Series B-1 Preferred Stock that, in accordance with the terms thereof, as of March 20, 2025 could be
converted into, in the aggregate, up to 62,332,498 shares of our common stock (which amount includes all future dividends that may
be potentially payable in shares of our common stock).
As of March 20, 2025, 21,975,000 shares of our common stock were issuable under the 2024 Convertible Notes, assuming the noteholders elected to convert the
notes in full on such date at the fixed conversion price of $1.00 per share (based on $21.975 million in aggregate principal amount
outstanding as of such date and no accrued and unpaid interest thereon). The number of shares of our common stock to be issued under
the 2024 Convertible Notes may be substantially greater than this amount because (i) in the event of certain issuances
of additional securities by the Company at a price per share less than the then applicable conversion price, such conversion price may
be adjusted to such lower price per share, and (ii) the holders may elect that we make interest payments in shares
of our common stock, and in such event the number of shares to be issued will be determined based on the then current market price.
In August 2024, we entered into
an ninth amendment to the management services agreement with PAVmed (the “MSA”), pursuant to which PAVmed may elect to receive
payment of the monthly fee under the management services agreement in cash or in shares of our common stock valued at a price based on
the current market price, subject to a floor price and a maximum number of shares. Under the amendment, the monthly fee due from the
Company to PAVmed was increased from $0.83 million to $1.05 million. In accordance with the MSA and the PBERA, on January 26, 2024, PAVmed
elected to receive payment of $4.675 million of fees and reimbursements accrued under the MSA and the PBERA through the issuance of 3,331,771
shares of the Company’s common stock. To the extent PAVmed elects for us to satisfy our obligations under the MSA and PBERA in
shares of our common stock in the future, the interest of other shareholders of the Company would be diluted. Currently, under the terms
of its outstanding convertible debt, PAVmed is required to elect to receive such payments in cash.
Furthermore, we have issued and
expect to continue to issue equity awards, including stock options, under our 2018 Long-Term Incentive Equity Plan (the “Lucid
Diagnostics Inc. 2018 Equity Plan”) and our Employee Stock Purchase Plan (the “Lucid Diagnostics Inc. ESPP”). In addition,
in March 2022, we entered into a committed equity facility with an affiliate of Cantor. Under the terms of the facility, Cantor has committed
to purchase up to $50 million in shares of our common shares stock from time to time at the our request (although this facility terminates
on August 1, 2025, which is the first of the month following the 36-month anniversary of the effective date of the registration statement
for the same). In November 2022, we also entered into an “at-the-market offering” for up to $6.5 million of our common stock
that may be offered and sold under a Controlled Equity Offering Agreement between us and Cantor (although effective as of March 4, 2025,
the Company terminated the prospectus supplement for this offering and as a result, the Company will not make any sales of common stock
in this offering unless and until a new prospectus or prospectus supplement is filed). Also in November 2022, we entered into the PBERA
with PAVmed, pursuant to which PAVmed will continue to pay certain payroll and benefit-related expenses on our behalf and we will reimburse
PAVmed, in cash or, subject to approval by each of our boards of directors, in shares of our common stock valued at a price based on
the current market price, subject to a floor price and a maximum number of shares.
In addition, we may issue a substantial
number of additional shares of our common stock or preferred stock or incur indebtedness, or issue or incur a combination of common and
preferred stock and indebtedness, to raise additional funds or in connection with any strategic acquisition or as compensation to our
officers, directors, employees and consultants or to fund investments in our current operations.
The issuance of additional shares
of our common stock or any number of shares of our preferred stock, and the availability for sale of such shares in the public markets:
● may significantly dilute the equity interest of our current investors;
● may adversely affect prevailing market prices for our common stock.
Similarly, if we incur indebtedness,
it could result in:
We expect to need additional capital funding,
which may be compounded by our obligations to our parent company, PAVmed, which requires its own additional capital funding.
Our future capital
requirements depend on many factors, including our research, development, and sales and marketing activities. We intend to continue
to make investments to support our business growth. Because we have not generated significant revenue or cash flow to date, and
despite our recently having raised net proceeds of approximately $14.5 million in connection with our consummation in February 2025
of a registered direct offering, and $18.3 million in connection with the issuance in November 2024 of the 2024 Convertible Notes,
we may require additional funds to:
● fund our operations;
● manufacture and distribute our products; and
● promote market acceptance of our products.
Our need for additional funds
may be affected by:
● the effect of competing technological and market developments; and
Under our existing management
services agreement and payroll and benefit expense reimbursement agreement with PAVmed, PAVmed may determine the form and timing of our
satisfaction of our obligations under such agreements. To the extent PAVmed elects for this obligation to be paid in cash (which it is
currently required to do under the terms of its convertible debt), that would increase our need to raise additional capital. In this
regard, because of the challenges PAVmed has faced in terms of raising capital itself, PAVmed has become highly dependent on us to fund
its operations, primarily through electing for the payment in cash by us of our obligations under our management services agreement with
PAVmed.
Debt 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.
Our quarterly operating results could be subject
to significant fluctuation, which could increase the volatility of our stock price and cause losses to our stockholders.
Our 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:
Servicing our indebtedness may require a significant
amount of cash, and the restrictive covenants contained in our indebtedness could adversely affect our business plan, liquidity, financial
condition, and results of operations.
We may be required to repay
or redeem at maturity in 2029 (or sooner, upon the occurrence of certain change of control transactions or an event of default), or
to pay interest on, the 2024 Convertible Notes or any future permitted indebtedness incurred by us or our subsidiaries, in cash.
Our 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 2024 Convertible Notes 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:
The 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.
If 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.
If 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, or at all. Our ability
to refinance our indebtedness will depend on the capital markets and our financial condition at such time. A failure 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.
Risks Associated with Our Business
Since we have a limited operating history,
and have not generated any significant revenues to date, you will have little basis upon which to evaluate our ability to achieve our
business objective.
Since we have a limited operating
history, and have not generated any significant revenues, you will have little basis upon which to evaluate our ability to achieve our
business objective. We are subject to all of the problems, expenses, delays and other risks inherent in any new business, as well as
problems inherent in establishing name recognition and business reputation.
The markets in which we operate are attractive
and other companies or institutions may develop and market novel or improved technologies, which may make the EsoGuard or EsoCheck technologies
less competitive or obsolete.
Given the large market opportunity
for esophageal precancer testing we may face multiple competitors in the future, some of which possess significantly greater financial
and other resources and development capabilities than us. Our EsoGuard test may face competition from new biomarkers also designed to
detect esophageal precancer and conditions along the BE-EAC spectrum.
Cyted, a UK-based medical technology
firm with a diagnostic platform to detect BE has announced that it is seeking capital to fund expansion into the U.S. market. The Mayo
Clinic and Exact Sciences Inc. (Nasdaq: EXAS) have published preliminary data on biomarkers designed to detect esophageal precancer and
have publicly expressed a commitment to advancing them to commercialization. Investigators at Johns Hopkins University associated with
a privately held firm called Previse have published limited data on methylation biomarkers for BE. Of note, both groups used the EsophaCap
“sponge-on-a-string” cell collection device.
Other manufacturers have developed
noninvasive esophageal cell collection devices most notably “sponge-on-a-string” devices which may compete with EsoCheck.
One such device, Cytosponge, previously marketed by in the U.S. by Medtronic Inc. (NYSE: 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. EndoSign, commercialized by Cyted, and much like Cytosponge and our own EsophaCap before it, is a small mesh sponge within
a soluble gelatin capsule that needs to reside in the stomach for some time until it fully dissolves and then is pulled thru the targeted
region brushing the lining of the esophagus and then later 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. 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.
Several well-capitalized companies
are developing “liquid biopsy” tests for early cancer detection based on circulating tumor DNA. Although none of these tests
yet purport to detect early precancer in the bloodstream, technological advances could result in sufficient sensitivity to do so generally
and for conditions along the BE-EAC spectrum. Such advances could put EsoGuard and EsoCheck at a significant competitive disadvantage
in the esophageal precancer testing market as it would be logistically simpler to send the patient for a routine blood draw instead of
a specialized office procedure like EsoCheck, and patients may prefer such a blood draw over even a noninvasive procedure such as EsoCheck.
Additional, still unproven, technologies
with the potential to compete with EsoGuard and EsoCheck in the future, include breath tests and oral tests which may be capable of identifying
the presence of BE. For example, there is early data to suggest that an “electric nose” device which measures volatile organic
compounds (VOCs) developed by The eNose Company, based in the Netherlands, may be able to identify patients with BE. Preliminary published
data from Columbia University School of Medicine found that differences in the oral bacterial microbiome, obtained with a simple saliva
sample or oral swab, may correlate with the presence of BE.
Although there can be no assurance
that we will pursue the development of any products other than EsoGuard and EsoCheck, if we seek to develop other products, we may need
to compete with a broad range of organizations in the U.S. and other countries that are engaged in the development, production and commercialization
of diagnostic products and services. These competitors include biotechnology, diagnostic and other life science companies; academic and
scientific institutions, governmental agencies, and public and private research organizations.
We may be unable to compete effectively
against our competitors either because their products and services are superior or more cost efficient, or because they have access to
greater resources than us. Our potential competitors may have substantially greater financial, marketing, sales, distribution, manufacturing,
and technological resources. These competitors may also have broader product lines and greater name recognition than we do. Many of these
competitors will have obtained FDA or other regulatory clearances or approvals, and patent protection, for their products, or are in
the process of seeking such clearances, approvals, and protection. Certain of our potential competitors may commercialize their products
in advance of our products. In addition, our competitors may make technical advances that render our products obsolete. We may be unable
to respond to such technical advances, especially given our focus on the EsoGuard and EsoCheck technology. Although there can be no assurance
that we will pursue the development of any products other than EsoGuard and EsoCheck, even if we do develop new marketable products or
services, our current and future competitors may develop products and services that are more commercially attractive than ours, and they
may bring those products and services to market earlier or more effectively than us.
We expect to derive substantially all of our
revenues from the EsoGuard and EsoCheck products.
Although we may develop additional
products based on the technology underlying our EsoGuard and EsoCheck products, or other related technologies we develop, license, or
acquire, we presently expect to derive substantially all of our revenues from sales of our EsoGuard and EsoCheck products. As such, any
factor adversely affecting sales of our products, including the product development and release cycles, regulatory 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 filing, could adversely affect our business prospects, financial condition
and results of operations, and could threaten the viability of our business.
We are highly dependent on our license agreement
with CWRU, the termination of which would prevent us from commercializing our products, and which imposes significant obligations on
us.
We are highly dependent on the
intellectual property licensed from CWRU, pursuant to which we license the technology underlying our EsoGuard and EsoCheck products.
Other products or services we may develop also may rely on the same technology. In the event that we default in the payment of any amount
when due under the License Agreement, and such amount is not paid within 30 days of notice of nonpayment, CWRU may terminate the exclusivity
of the license or terminate the License Agreement in full. Furthermore, if we breach the agreement, and we do not cure such breach within
the applicable time period, in addition to seeking damages, CWRU could terminate the License Agreement. Any termination of the License
Agreement resulting in the loss of the licensed rights would prevent us from marketing and selling the EsoGuard and EsoCheck products
and any other products or services we may develop based on the same underlying technology. Any termination of the exclusivity of the
license could damage our competitive position within the marketplace. In addition, disputes may also arise between us and CWRU regarding
the License Agreement. If any such dispute results in an impairment of our ability to use the intellectual property, we may be unable
to commercialize the EsoGuard and EsoCheck products and any other product or service we may develop based on the same underlying technology.
Accordingly, any such termination or dispute could threaten the viability of our business.
Our products may never achieve market acceptance.
To date, we have not generated
any significant revenues. Our ability to generate revenues from product sales and to achieve profitability will depend upon our ability
to successfully commercialize the EsoGuard and EsoCheck products and any other products, tests or services we develop. Because we have
just begun to offer our products, tests or services for sale, we have no basis to predict whether any of our products will achieve market
acceptance. A number of factors may limit the market acceptance of any of our products, including:
● unfavorable publicity concerning our products or similar products; and
The sizes of the markets for our current and
future products have not been established with precision, and may be smaller than we estimate.
Our estimates of the annual total
addressable markets for our current products are based on a number of internal and third-party estimates, including, without limitation,
the number of patients with esophageal cancer and precancer, the number of individuals who are at a higher risk for developing cancer,
and the assumed prices at which we can sell tests for markets that have not been established. While we believe our assumptions and the
data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions
or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors. As a result, our estimates
of the annual total addressable market for our current or future products may prove to be incorrect. If the actual number of patients
who would benefit from our products, the price at which we can sell our products, or the annual total addressable market for our products
is smaller than we have estimated, it may impair our sales growth and have an adverse impact on our business.
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.
Long-term adoption of our products
as well as payment and coverage for them may depend on their recommendation in clinical practice guidelines. These include professional
society guidelines published by gastroenterology specialty societies, such as the American College of Gastroenterology (ACG), the American
Gastroenterological Association (AGA), and the American Society for Gastrointestinal Endoscopy (ASGE), internal medicine and family practice
societies such as the American College of Physicians (ACP) and American Academy of Family Physicians (AAFP), and oncology societies such
as the American Cancer Society (ACS). These also include federal agencies and federally funded affiliates such as the U.S. Preventative
Services Task Force (“USPSTF”) and the Agency for Healthcare Research & Quality (“AHRQ”). The recommendations
in these clinical practice guidelines may shape payors’ coverage decisions.
The USPSTF, a panel of primary
care physicians and epidemiologists and other national experts funded by the U.S. Department of Health and Human Services’ AHRQ,
makes influential recommendations on clinical preventative services. We may seek a USPSTF recommendation in the future. The process of
USPSTF recommendation development is lengthy, requires high quality supporting evidence for a positive recommendation, and the outcome
of any USPSTF process is uncertain.
We or our third-party manufacturers may not
have the manufacturing and processing capacity to meet the production requirements of consumer demand or clinical testing in a timely
manner.
Our 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.
For 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. We cannot guarantee that we or our third-party
manufacturers will be able to increase capacity in a timely or cost-effective manner, or at all.
Initially, 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 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 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.
The 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.
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.
We currently have adequate capacity
to process EsoGuard tests, based on current test volumes. 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 our 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 to us. 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 investment.
If 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.
We 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.
Our results of operations can be adversely
affected by labor shortages, turnover, and labor cost increases.
Labor is a significant component
of operating our business. A number of factors may adversely affect the labor force available to us or increase 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, 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 mitigating measures we may take to respond to a decrease in labor availability have unintended negative
effects, our business could be adversely affected.
Additionally, the operations
of our vendors and partners could also suffer from labor shortages, turnover, and labor cost increases which could result in supply chain
disruptions and increases in the costs of the products and services we purchase, each of which could adversely affect our operations.
We expect to rely on courier delivery services
to transport EsoCheck devices and EsoGuard specimen kits to physicians and other medical professionals and samples back to laboratory
facilities for analysis. If these delivery services are disrupted or become prohibitively expensive, customer satisfaction and our business
could be negatively impacted.
In most cases, we expect to
ship EsoCheck devices and EsoGuard specimen kits to physicians and have the physician’s office ship samples 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.
If we attempt to bring any other products or
services to market in addition to the EsoGuard test and EsoCheck device, we likely will be required to make significant investments in
research and development, which ultimately may prove unsuccessful. Our future performance may be affected by the success of products
we have not yet developed, licensed, acquired.
Although there can be no assurance
that we will pursue the development of any products or services other than the EsoGuard test and EsoCheck device, we may develop additional
products or services based on the same underlying technologies or other technologies we develop, license, or acquire. If we attempt to
bring any other such products or services to market, we likely will incur significant expenses on research and development efforts, which
ultimately may prove unsuccessful.
Our 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 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. We are limited in shares available for issuance
under our long-term incentive plan,even taking into account the shareholder-approved annual increases, which could limit our ability
to attract and retain key personnel. An inability to attract and retain key personnel may impact our ability to continue and grow our
operations.
Our officers and directors have fiduciary obligations
to other companies and, accordingly, may have conflicts of interest in determining to which entity a particular business opportunity
should be presented.
Certain of our officers and directors
have fiduciary obligations to other companies engaged in medical device business activities. Accordingly, 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.
Our business may suffer if we are unable to
manage our growth.
If we fail to effectively manage
our growth, our ability to execute our business strategy could be impaired. Any unanticipated rapid growth of our business may place
a strain on our management, operations and financial systems. We need to ensure our existing systems and controls are adequate to support
our business and its anticipated growth.
Our business, financial condition and results
of operations could be adversely affected by the political and economic conditions of the U.S. and the other countries in which we conduct
business.
Our business, financial condition
and results of operations could be adversely affected by the political and economic conditions of the U.S. and the other countries in
which we conduct business (although our near-term focus is on our U.S. operations). These factors include:
● potentially burdensome taxation and changes in domestic and foreign tariffs;
● challenges associated with cultural differences, languages and distance;
● longer payment cycles in some countries;
● credit risks of many kinds;
● legal and regulatory differences and restrictions;
● currency exchange fluctuations;
● political and economic instability and export restrictions;
● variability in sterilization requirements for multi-usage surgical devices;
● potential adverse tax consequences;
● higher cost associated with doing business internationally;
● import or export licensing requirements imposed by governments;
● differing labor standards;
● differing levels of protection of intellectual property; and
We may engage in acquisitions that are not
successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.
We may in the future enter into
transactions to acquire other businesses, products, services or technologies. 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. 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 example, we may be unable to timely and effectively integrate the acquired businesses into our business; 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. 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. We cannot predict the number, timing
or size of future acquisitions or the effect that any such transactions might have on our operating results. For the foregoing reasons,
the market price of our common stock may decline as a result of any acquisitions.
Adverse results in material litigation matters
could have a material adverse effect upon our business.
We may become subject in the
ordinary course of business to material legal actions related to, among other things, intellectual property disputes, contract disputes,
data and privacy issues, professional liability and employee-related matters. We may also receive inquiries 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.
Risks Associated with Healthcare Regulation, Billing
and Reimbursement, and Product Safety and Effectiveness
If private or governmental third-party payors
do not maintain reimbursement for our products at adequate reimbursement rates, we may be unable to successfully commercialize our products
which would limit or slow our revenue generation and likely have a material adverse effect on our business.
Despite our initiative to establish
a robust cash-pay program, successful commercialization of our EsoGuard test and EsoCheck device, and of any other product or service
we develop, license or acquire depends, in large part, on the availability of adequate reimbursement from private or governmental third-party
payors.
EsoGuard’s 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. Although CMS granted EsoGuard final Medicare payment determination
of $1,938.01, effective January 1, 2021, we have not received a final Medicare local coverage determination from MolDx. Most recently,
in May 2023, a final Local Coverage Determination (“LCD”) L39256, entitled “Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia” became effective on the CMS website by MAC Palmetto GBA. (A substantially
identical LCD was published by Noridian Healthcare Solutions, the MAC whose geographic jurisdiction covers our CLIA laboratory in Lake
Forest, CA.) The LCD outlines criteria for future coverage that MolDX expects upper gastrointestinal precancer and cancer molecular diagnostic
tests to meet. These criteria include active GERD with at least two risk factors, as well as evidence of analytic validity, clinical
validity, and clinical utility. Although the LCD indicated that it found that no currently existing test has fulfilled all these criteria,
it indicated that it will “monitor the evidence and may revise this determination based on the pertinent literature and society
recommendations.” In November 2024, we announced that we submitted to MolDx our complete clinical evidence package in support of
a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard. However, there can be
no assurance that MolDx will determine that we meet the criteria for coverage as specified in the LCD. If we are not granted coverage,
or if a determination is substantially delayed, that could have a material adverse effect on our ability to commercialize EsoGuard.
Commercial third-party payors
often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. Third-party payors are
increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new healthcare products.
As a result, there is uncertainty surrounding whether EsoGuard or EsoCheck will be eligible for coverage by third-party payors or, if
eligible for coverage, what the reimbursement rates will be. Reimbursement of esophageal precancer and cancer screening by a third-party
payor may depend on a number of factors, including a payor’s determination that tests using our technologies are sufficiently sensitive
and specific for esophageal cancer and precancer; not experimental or investigational; approved or recommended by the major guidelines
organizations; reliable, safe and effective; medically necessary; appropriate for the specific patient; and cost-effective.
Coverage determinations and reimbursement
rates are also subject to the effects of federal and state coverage mandates and other healthcare regulations and reform initiatives
as described below. As noted below, federal and state coverage mandates may be deemed not to apply to EsoGuard and EsoCheck, may be interpreted
in a manner unfavorable to us, may be difficult to enforce and are subject to repeal or modification.
In addition to the risk of adverse
reimbursement decisions, we also may experience material delays in obtaining such reimbursement decisions and payment for our EsoGuard
test and EsoCheck device that are beyond our control. Further, there can be no assurance that CMS and other third-party payors who initially
decide to cover our products will continue to do so. Coverage determinations and reimbursement rates 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.
If we are unable to obtain favorable
decisions from third-party payors, including CMS and managed care organizations, approving reimbursement at adequate levels for our EsoGuard
test and EsoCheck device, and any other product or service we may develop, or if coverage is later revoked or reimbursement levels are
reduced, our commercial success will be compromised, our ability to raise capital may be restricted and our revenues would be significantly
limited.
Even where a third-party payor
agrees to cover EsoGuard and EsoCheck at an adequate reimbursement rate, other factors may have a significant impact on the actual reimbursement
we receive for an EsoGuard test or EsoCheck device from that payor. For example, if we do not have a contract with a given payor, we
may be deemed an “out-of-network” provider by that payor, which could result in the payor allocating a portion of the cost
of the EsoGuard test or EsoCheck device to the patient, notwithstanding any applicable coverage mandate. We may be unsuccessful in our
efforts to enter into, or maintain, a network contract with a given payor, and we expect that our network status with a given payor may
change from time to time for a variety of reasons, many of which may be outside our control. To the extent EsoGuard or EsoCheck is out
of network for a given payor, physicians may be less likely to prescribe EsoGuard and EsoCheck for their patients and their patients
may be less likely to comply with those prescriptions that are written. Also, some payors may require that they give prior authorization
for an EsoGuard test or EsoCheck device before they are willing to pay for it or review claims post-service to ensure the service was
medically appropriate for specific patients. Prior authorization and other medical management practices may require that we, patients
or physicians provide the payor with extensive medical records and other information. Prior authorization and other medical management
practices impose a significant additional cost on us, may be difficult to comply with given our position as a laboratory that generally
does not have direct access to patient medical records, may make physicians less likely to prescribe EsoGuard and EsoCheck for their
patients, and may make patients less likely to comply with physician orders for EsoGuard and EsoCheck, all or any of which may have an
adverse effect on our revenues. Payment rates also may vary according to the use of the product and the clinical setting in which it
is used, may be based on payments allowed for lower cost products that are already reimbursed and may be incorporated into existing payments
for other services.
FDA has proposed a policy under which it would
phase out its general enforcement discretion approach for LDTs so that IVDs manufactured at a laboratory would generally fall under the
same enforcement approach as other IVDs. While we are confident that the proposed policy will not have a material impact on our business,
there can be no assurance that will be the case.
On May 6, 2024, the FDA issued
a final rule aimed at helping to ensure the safety and effectiveness of LDTs. The rule amends the FDA’s regulations to make explicit
that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory.
Along with this amendment, the FDA is finalizing a policy under which the FDA will provide greater oversight of IVDs offered as LDTs
through a phaseout of its general enforcement discretion approach for LDTs over the course of four years, as well as targeted enforcement
discretion policies for certain categories of IVDs manufactured by laboratories.
The phaseout policy contains
the following five stages:
The FDA also intends to exercise
enforcement discretion and generally not enforce some or all applicable requirements for certain categories of IVDs manufactured by a
laboratory. The categories of enforcement discretion that are applicable to EsoGuard are summarized in the table below.
Category of IVD Stage 1 Stage 2 Stage 3 Stages 4 & 5 (Premarket Review)
As EsoGuard was marketed
prior to rule publication and is also NYS CLEP approved, hence, enforcement discretion is applicable for compliance with Stages 4
and 5. We will be implementing compliance with MDR requirements, correction and removal reporting requirements, and quality system
(QS) requirements regarding complaint files by March 31, 2025, well before the deadline of May 6, 2025. Gap analysis has been
completed and we are expecting our compliance activities to be completed for Stages 2 and 3 before the FDA’s expected timeframes in 2026 and 2027, respectively. We are confident that the proposed
final rule will not have a commercial impact as the Company already has a robust QS management platform for medical devices and
EsoGuard will be able to easily transition to the platform to fulfill the QS requirements, as required by the FDA. However, there
can be no assurance that we will be able to successfully transition the platform to fulfill the QS requirements, as required by FDA,
and our failure to do so could have a material impact on our ability to commercialize EsoGuard and on our business as a whole.
If we fail to maintain CLIA-certification or
otherwise meet the applicable requirements of federal or state law regulating commercial clinical laboratories, such failure could limit
or prevent our ability to perform our EsoGuard test, or any other tests which we may develop, license or acquire, affect any payor consideration
of such tests, prevent their clearance or approval entirely, and/or interrupt the commercial sale and/or marketing of any such tests,
cause us to incur significant expense to remedy this failure and otherwise negatively impact our business.
We 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 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.
EsoGuard may not be jointly marketed as a combined
product with EsoCheck without first securing FDA approval of the combined product as an IVD device. If FDA deems that we are jointly
marketing such an IVD product with EsoCheck without FDA approval of the combined product as an IVD device, we would be subject to FDA
enforcement action which could limit or halt commercialization of our products, and result in FDA sanctions which could severely impact
our business.
EsoCheck has received FDA 510(k)
clearance permitting us to market it in the U.S. as a cell collection device indicated for use in the collection and retrieval of surface
cells of the esophagus in the general population of adults, 22 years of age and older. EsoGuard, on the other hand, has not received
FDA approval to be marketed as an IVD device and is being marketed as an LDT. As such we must market EsoGuard and EsoCheck as separate
products. Jointly marketing EsoGuard 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.
Securing FDA approval of EsoGuard as an IVD
device, separately or as a combined product with EsoCheck, is a complex process requiring substantial time, commitment of resources and
expense without any assurance that FDA will grant such approval.
FDA 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). If we choose, or
are required, as a result of changes in LDT regulation, to secure FDA approval of EsoGuard as an IVD device, even if not combined with
EsoCheck, we expect we would this require FDA PMA approval.
The process of securing FDA PMA
approval is complex and requires substantial time, commitment of resources and expense. The process may take many years to complete,
and approval may never be obtained. It requires us to demonstrate with substantial evidence, gathered in preclinical and large, complex
well-controlled clinical trials, that the planned product is safe and effective for use for as intended. We may not conduct such a trial
or may not successfully enroll or complete any such trial, if required.
There can be no assurance that
FDA will ever permit us to market EsoGuard, used with EsoCheck, as a combined product. Also, any regulatory clearance or approval of
a product, once obtained, may be withdrawn.
Failure to obtain regulatory approvals in foreign
jurisdictions will prevent us from marketing our products internationally.
We intend to seek, as resources
permit, distribution and marketing partners for one or more of the products we are developing in foreign countries. 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 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.
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.
For any product approved pursuant
to a PMA, we are required to seek supplemental approval for many types of changes to the approved product, for which we will need to
determine whether a PMA supplement or other regulatory filing is needed or whether the change may be reported via the PMA Annual Report.
Similarly, any modification to a 510(k)-cleared device that could significantly affect its safety or effectiveness, or that would constitute