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Item 1A. Risk Factors

2022-03-07 compared with 2021-03-24 · 432 added, 466 removed, 76 unchanged (92% of the section changed)

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in our common stock involves a high degree of risk.

You should carefully consider the risks described below, as well as the other

information in this Annual Report, including our financial statements and the related notes and “Management’s Discussion

and Analysis of Financial Condition and Results of Operations,”

before deciding whether to invest in our securities.

occurrence of any of the events or developments described below could harm our business, financial condition, operating results,

and growth prospects.

In such an event, the market price of our common stock could decline, and you may lose all or part of your

Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair

our business operations.

ASSOCIATED WITH THE COMPANY’S BUSINESS

independent registered public accounting firms’

reports on its financial statements questions the Company’s ability

to continue as a going concern.

Company’s independent registered public accounting firms’

reports on the Company’s financial statements for

the years ended December 31, 2020 and 2019 express substantial doubt about the Company’s ability to continue as a going

The reports include an explanatory paragraph stating that the Company has suffered recurring losses, used significant

cash in support of its operating activities and, based on its current operating levels, require additional capital or significant

restructuring to sustain its operation for the foreseeable future.

There is no assurance that the Company will be able to obtain

sufficient additional capital to continue its operations and to alleviate doubt about its ability to continue as a going concern.

If the Company obtains additional financing, such funds may not be available on favorable terms and likely would entail considerable

dilution to existing shareholders.

Any debt financing, if available, may involve restrictive covenants that restrict its ability

to conduct its business.

It is extremely remote that the Company could obtain any financing on any basis that did not result in

considerable dilution for shareholders.

Inclusion of a “going concern qualification”

in the report of its independent

accountants or in any future report may have a negative impact on its ability to obtain debt or equity financing and may adversely

impact its stock price.

combination of our current financial condition and the FDA’s determinations to date regarding our brachytherapy products

raise material concerns about ability to continue as a going concern.

You should carefully consider the risks described below, as well as the other information

in this Annual Report, including our financial statements and the related notes and “Management’s Discussion and Analysis

of Financial Condition and Results of Operations,” before deciding whether to invest in our securities.

The occurrence of any of

the events or developments described below could harm our business, financial condition, operating results, and growth prospects.

such an event, the market price of our common stock could decline, and you may lose all or part of your investment.

Additional risks

and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

ASSOCIATED WITH THE COMPANY’S BUSINESS

independent registered public accounting firms’ reports on its financial statements questions the Company’s ability to continue

as a going concern.

Company’s independent registered public accounting firms’ reports on the Company’s financial statements for the years

ended December 31, 2021 and 2020 express substantial doubt about the Company’s ability to continue as a going concern.

include an explanatory paragraph stating that the Company has suffered recurring losses, used significant cash in support of its operating

activities and based on its current operating levels, require additional capital or restructuring to sustain its operation for the foreseeable

There is no assurance that the Company will be able to obtain sufficient additional capital to continue its operations and to

alleviate doubt about its ability to continue as a going concern.

If the Company obtains additional financing, such funds may not be

available on favorable terms and likely would entail considerable dilution to existing shareholders.

Any debt financing, if available,

may involve restrictive covenants that restrict its ability to conduct its business.

It is extremely remote that the Company could obtain

any financing on any basis that did not result in considerable dilution for shareholders.

Inclusion of a “going concern qualification”

in the report of its independent accountants or in any future report may have a negative impact on its ability to obtain debt or equity

financing and may adversely impact its stock price.

combination of our current financial condition and the FDA’s determinations to date regarding our brachytherapy products raise

material concerns about ability to continue as a going concern.

Company will not be able to continue as a going concern unless the Company obtains financing.

Depending upon the amount of financing,

if any, the Company is able to obtain, the Company may not receive adequate funds to continue the approval process for RadioGel™

or other brachytherapy products with the FDA.

Company has generated operating losses since inception, which are expected to continue, and has increasing cash requirements,

which it may be unable to satisfy .

Company has generated operating losses since inception, which are expected to continue, and has increasing cash requirements, which it

may be unable to satisfy .

Company has generated material operating losses since inception.

The Company has had recurring net losses since inception which

has resulted in an accumulated deficit of $74,558,101 and $73,601,109 as of December 31, 2020 and 2019, respectively including

net losses of $956,992 and $1,610,097 for the years ended December 31, 2020 and 2019.

Historically, the Company has relied

upon investor funds to maintain its operations and develop its business.

The Company needs to raise additional capital within

the next quarter from investors for working capital as well as business expansion, and there is no assurance that additional investor

funds will be available on terms acceptable to the Company, or at all.

If the Company is unable to unable to obtain additional

financing to meet its working capital requirements, the Company likely would cease operations.

The Company has had recurring net losses since inception which has resulted

in an accumulated deficit of $77,085,867 and $74,558,101 as of December 31, 2021 and 2020, respectively including net losses of $2,527,766

and $956,992 for the years ended December 31, 2021 and 2020.

Historically, the Company has relied upon investor funds to maintain its

operations and develop its business.

The Company needs to raise additional capital from investors for working capital as well as business

expansion, and there is no assurance that additional investor funds will be available on terms acceptable to the Company, or at all.

If the Company is unable to unable to obtain additional financing to meet its working capital requirements, the Company likely would

cease operations.

Company requires funding of at least $5 million per year to maintain current operating activities.

Over the next 24 months,

the Company believes it will cost approximately $9 million to fund:

(1) fund the FDA approval process to conduct human clinical

trials, (2) conduct Phase I, pilot, clinical trials, (3) activate several regional clinics to administer IsoPet ®

the county, (4) create an independent production center within the current production site to create a template for future international

manufacturing, and (5) initiate regulatory approval processes outside of the United States.

principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the

FDA’s classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise) and any

requirements for additional studies, which may possibly include clinical studies.

Thereafter, the principal variables in the amount

of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s

arrangements with third parties for manufacturing, sales, distribution and licensing of those products and the products’

success in the U.S.

and elsewhere.

The Company intends to fund its activities through strategic transactions such as licensing

and partnership agreements or additional capital raises.

Over the next 24 months, the Company

believes it will cost approximately $9 million to fund:

(1) fund the FDA approval process to conduct human clinical trials, (2) conduct

Phase I, pilot, clinical trials, (3) activate several regional clinics to administer IsoPet ® across the county, (4) create

an independent production center within the current production site to create a template for future international manufacturing, and

(5) initiate regulatory approval processes outside of the United States.

principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the FDA’s

classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise) and any requirements for

additional studies, which may possibly include clinical studies.

Thereafter, the principal variables in the amount of the Company’s

spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with

third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the U.S.

The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements or

additional capital raises.

economic events, including the COVID-19 pandemic, the inherent instability in global capital markets, as well as the lack of liquidity

in the capital markets, could adversely impact the Company’s ability to obtain financing and its ability to execute its

business plan.

in the capital markets, could adversely impact the Company’s ability to obtain financing and its ability to execute its business

Company has a limited operating history, which may make it difficult to evaluate its business and prospects.

Company has a limited operating history upon which one can base an evaluation of its business and prospects.

As a company in the

development stage, there are substantial risks, uncertainties, expenses and difficulties to which its business is subject.

address these risks and uncertainties, the Company must do the following:

As a company in the development

stage, there are substantial risks, uncertainties, expenses and difficulties to which its business is subject.

To address these risks

and uncertainties, the Company must do the following:

develop and execute the business strategy;

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developed and implemented or that the Company will successfully address the risks that face its business.

In the event that the

Company does not successfully address these risks, its business, prospects, financial condition, and results of operations could

be materially and adversely affected.

Company’s products are regulated and require appropriate clearances and approvals to be marketed in the U.S.

In the event that the Company

does not successfully address these risks, its business, prospects, financial condition, and results of operations could be materially

and adversely affected.

Company’s products are regulated and require appropriate clearances and approvals to be marketed in the U.S.

and globally.

is no assurance the FDA or other global regulatory authorities will grant the Company permission to market the Company’s

brachytherapy Y-90 RadioGel™

is no assurance the FDA or other global regulatory authorities will grant the Company permission to market the Company’s brachytherapy

Y-90 RadioGel™ device.

Company has been working with the FDA to obtain clearance for its brachytherapy Y-90 RadioGel TM device, but no assurances

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for its patented Y-90 RadioGel TM device pursuant to Section 513(f)(2) of the U.S.

Food, Drug and Cosmetic Act (the

Act ”).

Food, Drug and Cosmetic Act (the “ Act ”).

In June 2015, the FDA notified the Company the de novo was not granted.

In February 2014, the

FDA found the same device under Section 510(k) of the Act not substantially equivalent and concluded that the device is classified

by statute as a Class III medical device, unless the device is reclassified.

The Company is seeking reclassification of the product

If the Company is successful in seeking reconsideration of the Company’s de novo application, as a regulatory

matter, the device could be on an easier and faster path to market in the United States.

However, there would still be the requirements

to complete the in vitro and in vivo testing, and then some human clinical trials.

That testing date is submitted in a de novo

pre-market application and if accepted we could then go to market.

As a practical matter, the Company would still need to secure

funding and commercial arrangements before marketing could commence.

If the de novo is declined and if the Company obtains

funding to permit it to continue operations, the Company will explore steps toward seeking approval for the device as a Class

III medical device.

Generally, the time period and cost of seeking approval as a Class III medical device is materially greater

than the time period and cost of seeking approval as a Class II medical device.

If the Company seeks approval as a Class III device,

human clinical trials will be necessary.

Generally, human trials for Class III products are larger, of longer duration and costlier

than those for Class II devices.

In February 2014, the FDA found the same device under

Section 510(k) of the Act not substantially equivalent and concluded that the device is classified by statute as a Class III medical

device, unless the device is reclassified.

The Company is seeking reclassification of the product to Class II.

If the Company is successful

in seeking reconsideration of the Company’s de novo application, as a regulatory matter, the device could be on an easier

and faster path to market in the United States.

However, there would still be the requirements to complete the in vitro and in vivo testing,

and then some human clinical trials.

That testing date is submitted in a de novo pre-market application and if accepted we could then

go to market.

As a practical matter, the Company would still need to secure funding and commercial arrangements before marketing could

If the de novo is declined and if the Company obtains funding to permit it to continue operations, the Company will

explore steps toward seeking approval for the device as a Class III medical device.

Generally, the time period and cost of seeking approval

as a Class III medical device is materially greater than the time period and cost of seeking approval as a Class II medical device.

the Company seeks approval as a Class III device, human clinical trials will be necessary.

Generally, human trials for Class III products

are larger, of longer duration and costlier than those for Class II devices.

human clinical trials are necessary, there will be additional cost and time to reach marketing clearance or approval.

Company obtains sufficient funding, it will be unable to do the foregoing activities.

There can be no assurance that the product

will be approved as either a Class II or Class III device by the FDA even if additional data is provided.

In August 2017, the

Company met again with the FDA in a pre-submission meeting to once again go through the requirements for pre-clinical testing

and to answer the previous FDA questions submitted years before.

There can be no assurance that the Company will receive FDA approval,

or if it does, the timing thereof.

Unless the Company

obtains sufficient funding, it will be unable to do the foregoing activities.

There can be no assurance that the product will be approved

as either a Class II or Class III device by the FDA even if additional data is provided.

In August 2017, the Company met again with the

FDA in a pre-submission meeting to once again go through the requirements for pre-clinical testing and to answer the previous FDA questions

submitted years before.

There can be no assurance that the Company will receive FDA approval, or if it does, the timing thereof.

the Company is successful in increasing the size of its organization, the Company may experience difficulties in managing growth.

Company is a small organization with a minimal number of employees.

If the Company is successful, it may experience a period of

significant expansion in headcount, facilities, infrastructure and overhead and further expansion may be required to address potential

growth and market opportunities.

Any such future growth will impose significant added responsibilities on members of management,

including the need to improve the Company’s operational and financial systems and to identify, recruit, maintain and integrate

additional managers.

The Company’s future financial performance and its ability to compete effectively will depend, in part,

on the ability to manage any future growth effectively.

Company’s business is dependent upon the continued services of the Company’s Chief Executive Officer, Michael Korenko.

Should the Company lose the services of Dr.

Korenko, the Company’s operations will be negatively impacted.

Company’s business is dependent upon the expertise of its Chief Executive Officer, Michael Korenko.

Korenko is essential

to the Company’s operations.

If the Company is successful, it may experience a period of significant

expansion in headcount, facilities, infrastructure and overhead and further expansion may be required to address potential growth and

market opportunities.

Any such future growth will impose significant added responsibilities on members of management, including the need

to improve the Company’s operational and financial systems and to identify, recruit, maintain and integrate additional managers.

The Company’s future financial performance and its ability to compete effectively will depend, in part, on the ability to manage

any future growth effectively.

Company’s business is dependent upon the continued services of the Company’s Chief Executive Officer, Michael Korenko.

the Company lose the services of Dr.

Korenko, the Company’s operations will be negatively impacted.

Company’s business is dependent upon the expertise of its Chief Executive Officer, Michael Korenko.

Korenko is essential to

the Company’s operations.

Accordingly, an investor must rely on Dr.

Korenko’s management decisions that will continue

to control the Company’s business affairs.

Korenko’s management decisions that will continue to

control the Company’s business affairs.

The Company does not maintain key man insurance on Dr.

Korenko’s life.

The loss of the services of Dr.

Korenko would have a material adverse effect upon the Company’s business.

To mitigate this

risk, David Swanberg has been groomed as a replacement candidate.

He has extensive experience as a co-founder of IsoRay and has

been actively working with Dr.

Korenko’s life.

the services of Dr.

Korenko would have a material adverse effect upon the Company’s business.

To mitigate this risk, David Swanberg

has been groomed as a replacement candidate.

He has extensive experience as a co-founder of IsoRay and has been actively working with

Korenko as a consultant for the last two years.

Company is heavily dependent on consultants for many of the services necessary to continue operations.

The loss of any of these

consultants could have a material adverse effect on the Company’s business, results of operations and financial condition.

Company’s success is heavily dependent on the continued active participation of certain consultants and collaborating scientists.

The loss of any of these consultants

could have a material adverse effect on the Company’s business, results of operations and financial condition.

Company’s success is heavily dependent on the continued active participation of certain consultants and collaborating scientists.

Certain key employees and consultants have no written employment contracts.

Loss of the services of any one or more of its consultants

could have a material adverse effect upon the Company’s business, results of operations and financial condition.

the Company is unable to hire and retain additional qualified personnel, the business and financial condition may suffer.

Company’s success and achievement of its growth plans depend on its ability to recruit, hire, train and retain highly qualified

technical, scientific, regulatory and managerial employees, consultants and advisors.

Competition for qualified personnel among

pharmaceutical and biotechnology companies is intense, and an inability to attract and motivate additional highly skilled personnel

required for the expansion of the Company’s activities, or the loss of any such persons, could have a material adverse effect

on its business, results of operations and financial condition.

Company’s revenues have historically been derived from sales made to a small number of customers.

Competition for qualified personnel among pharmaceutical

and biotechnology companies is intense, and an inability to attract and motivate additional highly skilled personnel required for the

expansion of the Company’s activities, or the loss of any such persons, could have a material adverse effect on its business, results

of operations and financial condition.

Company’s revenues have historically been derived from sales made to a small number of customers.

The Company has discontinued

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of only consulting revenue, and our revenues for the year ended December 31, 2018 consisted of only $17,583 of grant revenue.

The Company’s consulting revenues for the year ended December 31, 2017 were made to one customer, and those sales constituted

100% of total revenues for that years.

At such time as the Company recommences active operations, no assurances can be given that

the Company will be successful in commercializing its products or expanding the number of customers purchasing its products and

The Company had $7,000 and $9,500 in operating revenues, net of discounts for the years ended December 31, 2020 and

2019, respectively as they have commenced sales of IsoPet ®

of the Company’s competitors have greater resources and experience than the Company has.

of the Company’s competitors have greater financial resources, longer history, broader experience, greater name recognition,

and more substantial operations than the Company has, and they represent substantial long-term competition for us.

The Company’s

competitors may be able to devote more financial and human resources than the Company can to research, new product development,

regulatory approvals, and marketing and sales.

The Company’s competitors may develop or market products that are viewed

by customers as more effective or more economical than the Company’s products.

There is no assurance that the Company will

be able to compete effectively against current and future competitors, and such competitive pressures may adversely affect the

Company’s business and results of operations.

Company’s future revenues depend upon acceptance of its current and future products in the markets in which they compete.

Company’s future revenues depend upon receipt of financing, regulatory approval and the successful production, marketing,

and sales of the various isotopes the Company might market in the future.

The rate and level of market acceptance of each of these

products, if any, may vary depending on the perception by physicians and other members of the healthcare community of its safety

and efficacy as compared to that of any competing products;

The Company’s

consulting revenues for the year ended December 31, 2017 were made to one customer, and those sales constituted 100% of total revenues

for that years.

At such time as the Company recommences active operations, no assurances can be given that the Company will be successful

in commercializing its products or expanding the number of customers purchasing its products and services.

The Company had $14,887 and

$7,000 in operating revenues, net of discounts for the years ended December 31, 2021 and 2020, respectively as they have commenced sales

of IsoPet ® .

of the Company’s competitors have greater resources and experience than the Company has.

of the Company’s competitors have greater financial resources, longer history, broader experience, greater name recognition, and

more substantial operations than the Company has, and they represent substantial long-term competition for us.

The Company’s competitors

may be able to devote more financial and human resources than the Company can to research, new product development, regulatory approvals,

and marketing and sales.

The Company’s competitors may develop or market products that are viewed by customers as more effective

or more economical than the Company’s products.

There is no assurance that the Company will be able to compete effectively against

current and future competitors, and such competitive pressures may adversely affect the Company’s business and results of operations.

Company’s future revenues depend upon acceptance of its current and future products in the markets in which they compete.

Company’s future revenues depend upon receipt of financing, regulatory approval and the successful production, marketing, and sales

of the various isotopes the Company might market in the future.

The rate and level of market acceptance of each of these products, if

any, may vary depending on the perception by physicians and other members of the healthcare community of its safety and efficacy as compared

to that of any competing products;

the clinical outcomes of any patients treated;

the effectiveness of

its sales and marketing efforts in the United States, Europe, Far East, Middle East, and Russia;

any unfavorable publicity concerning

its products or similar products;

the price of the Company’s products relative to other products or competing treatments;

any decrease in current reimbursement rates from the Centers for Medicare and Medicaid Services or third-party payers;

developments related to the manufacture or continued use of its products;

availability of sufficient supplies to either purchase

or manufacture its products;

its ability to produce sufficient quantities of its products;

and the ability of physicians to properly

utilize its products and avoid excessive levels of radiation to patients.

Any material adverse developments with respect to the

commercialization of any such products may adversely affect revenues and may cause the Company to continue to incur losses in

the effectiveness of its sales and marketing efforts

in the United States, Europe, Far East, Middle East, and Russia;

any unfavorable publicity concerning its products or similar products;

the price of the Company’s products relative to other products or competing treatments;

any decrease in current reimbursement rates

from the Centers for Medicare and Medicaid Services or third-party payers;

regulatory developments related to the manufacture or continued

use of its products;

availability of sufficient supplies to either purchase or manufacture its products;

its ability to produce sufficient

quantities of its products;

and the ability of physicians to properly utilize its products and avoid excessive levels of radiation to

Any material adverse developments with respect to the commercialization of any such products may adversely affect revenues

and may cause the Company to continue to incur losses in the future.

Company currently relies on a single supplier for Y-90 particles, and that supplier is the only supplier in the United States.

An inability to procure Y-90 particles will harm the Company’s business.

is only one supplier of Y-90 particles in the United States, requiring us to rely entirely on this supplier to provide the Y-90

particles needed to produce RadioGel TM .

If we are unable to obtain a sufficient supply of Y-90 particles, we will not

be able to proceed with our development of RadioGel TM and our business may be materially harmed.

to procure Y-90 particles will harm the Company’s business.

is only one supplier of Y-90 particles in the United States, requiring us to rely entirely on this supplier to provide the Y-90 particles

needed to produce RadioGel TM .

If we are unable to obtain a sufficient supply of Y-90 particles, we will not be able to proceed

with our development of RadioGel TM and our business may be materially harmed.

Company currently subcontracts the manufacturing of RadioGel TM to IsoTherapeutics.

PerkinElmer Inc.

is the sole supplier

of the Y-90 particles used by IsoTherapeutics and is the only supplier of Y-90 particles in the United States.

is the sole supplier of

the Y-90 particles used by IsoTherapeutics and is the only supplier of Y-90 particles in the United States.

In the event PerkinElmer

is unable to satisfy our supply requirements or stope producing Y-90 particles, we will be unable to continue with development

of RadioGel™

is unable to satisfy our supply requirements or stope producing Y-90 particles, we will be unable to continue with development of RadioGel™

and our business would be materially harmed.

Company will rely heavily on a limited number of suppliers for the foreseeable future.

of the products the Company might market, and components thereof are currently available only from a limited number of suppliers,

several of which are international suppliers.

Failure to obtain deliveries from these sources could have a material adverse effect

on the Company’s ability to operate.

of the products the Company might market, and components thereof are currently available only from a limited number of suppliers, several

of which are international suppliers.

Failure to obtain deliveries from these sources could have a material adverse effect on the Company’s

ability to operate.

Company may incur material losses and costs as a result of product liability claims that may be brought against it.

Company faces an inherent business risk of exposure to product liability claims in the event that products supplied by the Company

fail to perform as expected or such products result, or is alleged to result, in bodily injury.

Any such claims may also result

in adverse publicity, which could damage the Company’s reputation by raising questions about the safety and efficacy of

its products and could interfere with its efforts to market its products.

A successful product liability claim against the Company

in excess of its available insurance coverage or established reserves may have a material adverse effect on its business.

the Company currently maintains liability insurance in amounts it believes are commercially reasonable, any product liability

the Company may incur may exceed its insurance coverage.

Company is subject to the risk that certain third parties may mishandle the Company’s products.

the Company markets products, the Company likely will rely on third parties, such as commercial air courier companies, to deliver

the products, and on other third parties to package the products in certain specialized packaging forms requested by customers.

The Company thus would be subject to the risk that these third parties may mishandle its product, which could result in material

adverse effects, particularly given the radioactive nature of some of the products.

Company faces an inherent business risk of exposure to product liability claims in the event that products supplied by the Company fail

to perform as expected or such products result, or is alleged to result, in bodily injury.

Any such claims may also result in adverse

publicity, which could damage the Company’s reputation by raising questions about the safety and efficacy of its products and could

interfere with its efforts to market its products.

A successful product liability claim against the Company in excess of its available

insurance coverage or established reserves may have a material adverse effect on its business.

Although the Company currently maintains

liability insurance in amounts it believes are commercially reasonable, any product liability the Company may incur may exceed its insurance

Company is subject to the risk that certain third parties may mishandle the Company’s products.

the Company markets products, the Company likely will rely on third parties, such as commercial air courier companies, to deliver the

products, and on other third parties to package the products in certain specialized packaging forms requested by customers.

thus would be subject to the risk that these third parties may mishandle its product, which could result in material adverse effects,

particularly given the radioactive nature of some of the products.

Company is subject to uncertainties regarding reimbursement for use of its products.

and freestanding clinics may be less likely to purchase the Company’s products if they cannot be assured of receiving favorable

reimbursement for treatments using its products from third-party payers, such as Medicare and private health insurance plans.

Third-party payers are increasingly challenging the pricing of certain medical services or devices, and there is no assurance

that they will reimburse the Company’s customers at levels sufficient for it to maintain favorable sales and price levels

for the Company’s products.

There is no uniform policy on reimbursement among third-party payers, and there is no assurance

that the Company’s products will continue to qualify for reimbursement from all third-party payers or that reimbursement

rates will not be reduced.

A reduction in or elimination of third-party reimbursement for treatments using the Company’s

products would likely have a material adverse effect on the Company’s revenues.

Company’s future growth is largely dependent upon its ability to develop new technologies that achieve market acceptance

with appropriate margins.

Company’s business operates in global markets that are characterized by rapidly changing technologies and evolving industry

Accordingly, future growth rates depend upon a number of factors, including the Company’s ability to (i) identify

emerging technological trends in the Company’s target end-markets, (ii) develop and maintain competitive products, (iii)

enhance the Company’s products by adding innovative features that differentiate the Company’s products from those

of its competitors, and (iv) develop, manufacture and bring products to market quickly and cost-effectively.

The Company’s

ability to develop new products based on technological innovation can affect the Company’s competitive position and requires

the investment of significant resources.

These development efforts divert resources from other potential investments in the Company’s

business, and they may not lead to the development of new technologies or products on a timely basis or that meet the needs of

the Company’s customers as fully as competitive offerings.

In addition, the markets for the Company’s products may

not develop or grow as it currently anticipates.

The failure of the Company’s technologies or products to gain market acceptance

due to more attractive offerings by the Company’s competitors could significantly reduce the Company’s revenues and

adversely affect the Company’s competitive standing and prospects.

Company may rely on third parties to represent it locally in the marketing and sales of its products in international markets

and its revenue may depend on the efforts and results of those third parties.

Company’s future success may depend, in part, on its ability to enter into and maintain collaborative relationships with

one or more third parties, the collaborator’s strategic interest in the Company’s products and the Company’s

products under development, and the collaborator’s ability to successfully market and sell any such products.

payers are increasingly challenging the pricing of certain medical services or devices, and there is no assurance that they will reimburse

the Company’s customers at levels sufficient for it to maintain favorable sales and price levels for the Company’s products.

There is no uniform policy on reimbursement among third-party payers, and there is no assurance that the Company’s products will

continue to qualify for reimbursement from all third-party payers or that reimbursement rates will not be reduced.

A reduction in or

elimination of third-party reimbursement for treatments using the Company’s products would likely have a material adverse effect

on the Company’s revenues.

Company’s future growth is largely dependent upon its ability to develop new technologies that achieve market acceptance with appropriate

Company’s business operates in global markets that are characterized by rapidly changing technologies and evolving industry standards.

Accordingly, future growth rates depend upon a number of factors, including the Company’s ability to (i) identify emerging technological

trends in the Company’s target end-markets, (ii) develop and maintain competitive products, (iii) enhance the Company’s products

by adding innovative features that differentiate the Company’s products from those of its competitors, and (iv) develop, manufacture

and bring products to market quickly and cost-effectively.

The Company’s ability to develop new products based on technological

innovation can affect the Company’s competitive position and requires the investment of significant resources.

These development

efforts divert resources from other potential investments in the Company’s business, and they may not lead to the development of

new technologies or products on a timely basis or that meet the needs of the Company’s customers as fully as competitive offerings.

In addition, the markets for the Company’s products may not develop or grow as it currently anticipates.

The failure of the Company’s

technologies or products to gain market acceptance due to more attractive offerings by the Company’s competitors could significantly

reduce the Company’s revenues and adversely affect the Company’s competitive standing and prospects.

Company may rely on third parties to represent it locally in the marketing and sales of its products in international markets and its

revenue may depend on the efforts and results of those third parties.

Company’s future success may depend, in part, on its ability to enter into and maintain collaborative relationships with one or

more third parties, the collaborator’s strategic interest in the Company’s products and the Company’s products under

development, and the collaborator’s ability to successfully market and sell any such products.

Company intends to pursue collaborative arrangements regarding the marketing and sales of its products;

however, it may not be

able to establish or maintain such collaborative arrangements, or if it is able to do so, the Company’s collaborators may

not be effective in marketing and selling its products.

To the extent that the Company decides not to, or is unable to, enter

into collaborative arrangements with respect to the sales and marketing of its products, significant capital expenditures, management

resources and time will be required to establish and develop an in-house marketing and sales force with technical expertise.

the extent that the Company depends on third parties for marketing and distribution, any revenues received by the Company will

depend upon the efforts and results of such third parties, which may or may not be successful.

however, it may not be able to

establish or maintain such collaborative arrangements, or if it is able to do so, the Company’s collaborators may not be effective

in marketing and selling its products.

To the extent that the Company decides not to, or is unable to, enter into collaborative arrangements

with respect to the sales and marketing of its products, significant capital expenditures, management resources and time will be required

to establish and develop an in-house marketing and sales force with technical expertise.

To the extent that the Company depends on third

parties for marketing and distribution, any revenues received by the Company will depend upon the efforts and results of such third parties,

which may or may not be successful.

Company may pursue strategic acquisitions that may have an adverse impact on its business.

the Company’s business strategy may involve pursuing and consummating strategic transactions to acquire complementary businesses

or technologies.

In pursuing these strategic transactions, even if the Company does not consummate them, or in consummating such

transactions and integrating the acquired business or technology, the Company may expend significant financial and management

resources and incur other significant costs and expenses.

There is no assurance that any strategic transactions will result in

additional revenues or other strategic benefits for the Company’s business.

The Company may issue the Company’s stock

as consideration for acquisitions, joint ventures or other strategic transactions, and the use of stock as purchase consideration

could dilute the interests of its current stockholders.

In addition, the Company may obtain debt financing in connection with

an acquisition.

Any such debt financing may involve restrictive covenants relating to capital-raising activities and other financial

and operational matters, which may make it more difficult for the Company to obtain additional capital and pursue business opportunities,

including potential acquisitions.

In addition, such debt financing may impair the Company’s ability to obtain future additional

financing for working capital, capital expenditures, acquisitions, general corporate or other purposes, and a substantial portion

of cash flows, if any, from the Company’s operations may be dedicated to interest payments and debt repayment, thereby reducing

the funds available to the Company for other purposes.

Company will need to hire additional qualified accounting personnel in order to remediate a material weakness in its internal

control over financial accounting, and the Company will need to expend any additional resources and efforts that may be necessary

to establish and to maintain the effectiveness of its internal control over financial reporting and its disclosure controls and

a public company, the Company is subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, and

the Sarbanes-Oxley Act of 2002.

The Company’s management is required to evaluate and disclose its assessment of the effectiveness

of the Company’s internal control over financial reporting as of each year-end, including disclosing any “material

weakness”

in the Company’s internal control over financial reporting.

A material weakness is a control deficiency,

or combination of control deficiencies, that results in more than a remote likelihood that a material misstatement of the annual

or interim financial statements will not be prevented or detected.

As a result of its assessment, management has determined that

there is a material weakness due to the lack of segregation of duties and, due to this material weakness, management concluded

that, as of December 31, 2020 and 2019, the Company’s internal control over financial reporting was ineffective.

This material

weakness has the potential of adversely impacting the Company’s financial reporting process and the Company’s financial

Because of this material weakness, management also concluded that the Company’s disclosure controls and procedures

were ineffective as of December 31, 2020 and 2019.

The Company needs to hire additional qualified accounting personnel in order

to resolve this material weakness.

The Company also will need to expend any additional resources and efforts that may be necessary

to establish and to maintain the effectiveness of the Company’s internal control over financial reporting and disclosure

controls and procedures.

In pursuing these strategic transactions, even if the Company does not consummate them, or in consummating such transactions

and integrating the acquired business or technology, the Company may expend significant financial and management resources and incur

other significant costs and expenses.

There is no assurance that any strategic transactions will result in additional revenues or other

strategic benefits for the Company’s business.

The Company may issue the Company’s stock as consideration for acquisitions,

joint ventures or other strategic transactions, and the use of stock as purchase consideration could dilute the interests of its current

stockholders.

In addition, the Company may obtain debt financing in connection with an acquisition.

Any such debt financing may involve

restrictive covenants relating to capital-raising activities and other financial and operational matters, which may make it more difficult

for the Company to obtain additional capital and pursue business opportunities, including potential acquisitions.

In addition, such debt

financing may impair the Company’s ability to obtain future additional financing for working capital, capital expenditures, acquisitions,

general corporate or other purposes, and a substantial portion of cash flows, if any, from the Company’s operations may be dedicated

to interest payments and debt repayment, thereby reducing the funds available to the Company for other purposes.

Company will need to hire additional qualified accounting personnel in order to remediate a material weakness in its internal control

over financial accounting, and the Company will need to expend any additional resources and efforts that may be necessary to establish

and to maintain the effectiveness of its internal control over financial reporting and its disclosure controls and procedures.

a public company, the Company is subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, and the Sarbanes-Oxley

The Company’s management is required to evaluate and disclose its assessment of the effectiveness of the Company’s

internal control over financial reporting as of each year-end, including disclosing any “material weakness” in the Company’s

internal control over financial reporting.

A material weakness is a control deficiency, or combination of control deficiencies, that

results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented

As a result of its assessment, management has determined that there is a material weakness due to the lack of segregation

of duties and, due to this material weakness, management concluded that, as of December 31, 2021 and 2020, the Company’s

internal control over financial reporting was ineffective.

This material weakness has the potential of adversely impacting the Company’s

financial reporting process and the Company’s financial reports.

Because of this material weakness, management also concluded that

the Company’s disclosure controls and procedures were ineffective as of December 31, 2021 and 2020.

The Company needs to hire additional

qualified accounting personnel in order to resolve this material weakness.

The Company also will need to expend any additional resources

and efforts that may be necessary to establish and to maintain the effectiveness of the Company’s internal control over financial

reporting and disclosure controls and procedures.

Company may be unable to make timely license and patent payments

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however, the licensing contract with Battelle Pacific Northwest

Laboratory (“

Battelle ”) was re-negotiated to significantly reduce these costs.

Existing patent and license

fees must be paid for the Company to maintain rights to its technologies.

The Company would forfeit its exclusive rights to licensed

technologies in the event it fails to pay patent and rights fees in a timely fashion.

No assurance can be given that the Company

will be able to continue to pay license fees in the event it is unable to secure adequate working capital.

Battelle has advised

the Company that if we did not make a payment they would not attempt to relicense but would allow the patents to lapse.

has decided to pursue additional patents outside the Battelle contract based on exclusive proprietary manufacturing techniques

developed by the Company.

Company’s patented or other technologies may infringe on other patents, which may expose it to costly litigation.

is possible that the Company’s patented or other technologies may infringe on patents or other rights owned by others.

Company may have to alter its products or processes, pay licensing fees, defend infringement actions or challenge the validity

of the patents in court, or cease activities altogether because of patent rights of third parties, thereby causing additional

unexpected costs and delays to the Company.

Patent litigation is costly and time consuming, and the Company may not have sufficient

resources to pursue such litigation.

If the Company does not obtain a license under such patents, if it is found liable for infringement,

or if it is not able to have such patents declared invalid, the Company may be liable for significant money damages, may encounter

significant delays in bringing products to market or may be precluded from participating in the manufacture, use or sale of products

or methods of treatment requiring such licenses.

the Company’s intellectual property is critical to its innovation efforts.

Laboratory (“ Battelle ”) was re-negotiated to significantly reduce these costs.

Existing patent and license fees must

be paid for the Company to maintain rights to its technologies.

The Company would forfeit its exclusive rights to licensed technologies

in the event it fails to pay patent and rights fees in a timely fashion.

No assurance can be given that the Company will be able to continue

to pay license fees in the event it is unable to secure adequate working capital.

Battelle has advised the Company that if we did not

make a payment they would not attempt to relicense but would allow the patents to lapse.

The Company has decided to pursue additional

patents outside the Battelle contract based on exclusive proprietary manufacturing techniques developed by the Company.

Company’s patented or other technologies may infringe on other patents, which may expose it to costly litigation.

is possible that the Company’s patented or other technologies may infringe on patents or other rights owned by others.

may have to alter its products or processes, pay licensing fees, defend infringement actions or challenge the validity of the patents

in court, or cease activities altogether because of patent rights of third parties, thereby causing additional unexpected costs and delays

to the Company.

Patent litigation is costly and time consuming, and the Company may not have sufficient resources to pursue such litigation.

If the Company does not obtain a license under such patents, if it is found liable for infringement, or if it is not able to have such

patents declared invalid, the Company may be liable for significant money damages, may encounter significant delays in bringing products

to market or may be precluded from participating in the manufacture, use or sale of products or methods of treatment requiring such licenses.

the Company’s intellectual property is critical to its innovation efforts.

Company owns or has a license to use several U.S.

and foreign patents and patent applications, trademarks and copyrights.

Company’s intellectual property rights may be challenged, invalidated or infringed upon by third parties, or it may be unable

to maintain, renew or enter into new licenses of third party proprietary intellectual property on commercially reasonable terms.

The Company’s

intellectual property rights may be challenged, invalidated or infringed upon by third parties, or it may be unable to maintain, renew

or enter into new licenses of third party proprietary intellectual property on commercially reasonable terms.

In some non-U.S.

countries, laws affecting intellectual property are uncertain in their application, which can adversely affect

the scope or enforceability of the Company’s patents and other intellectual property rights.

Any of these events or factors

could diminish or cause the Company to lose the competitive advantages associated with the Company’s intellectual property,

subject the Company to judgments, penalties and significant litigation costs, or temporarily or permanently disrupt its sales

and marketing of the affected products or services.

Company may not be able to protect its trade secrets and other unpatented proprietary technology, which could give competitors

an advantage.

laws affecting intellectual property are uncertain in their application, which can adversely affect the scope or enforceability of the

Company’s patents and other intellectual property rights.

Any of these events or factors could diminish or cause the Company to

lose the competitive advantages associated with the Company’s intellectual property, subject the Company to judgments, penalties

and significant litigation costs, or temporarily or permanently disrupt its sales and marketing of the affected products or services.

Company may not be able to protect its trade secrets and other unpatented proprietary technology, which could give competitors an advantage.

Company relies upon trade secrets and other unpatented proprietary technology.

The Company may not be able to adequately protect

its rights with regard to such unpatented proprietary technology, or competitors may independently develop substantially equivalent

The Company seeks to protect trade secrets and proprietary knowledge, in part through confidentiality agreements with

its employees, consultants, advisors and collaborators.

Nevertheless, these agreements may not effectively prevent disclosure

of the Company’s confidential information and may not provide the Company with an adequate remedy in the event of unauthorized

disclosure of such information, and as result the Company’s competitors could gain a competitive advantage.

The Company may not be able to adequately protect its

rights with regard to such unpatented proprietary technology, or competitors may independently develop substantially equivalent technology.

The Company seeks to protect trade secrets and proprietary knowledge, in part through confidentiality agreements with its employees,

consultants, advisors and collaborators.

Nevertheless, these agreements may not effectively prevent disclosure of the Company’s

confidential information and may not provide the Company with an adequate remedy in the event of unauthorized disclosure of such information,

and as result the Company’s competitors could gain a competitive advantage.

Company is subject to extensive government regulation in jurisdictions around the world in which it does business.

address, among other things, environmental compliance, import/export restrictions, healthcare services, taxes and financial reporting,

and those regulations can significantly increase the cost of doing business, which in turn can negatively impact operations, financial

results and cash flow.

the Company is successful in developing manufacturing capability, the Company will be subject to extensive government regulation

and intervention both in the U.S.

Regulations address,

among other things, environmental compliance, import/export restrictions, healthcare services, taxes and financial reporting, and those

regulations can significantly increase the cost of doing business, which in turn can negatively impact operations, financial results

and cash flow.

the Company is successful in developing manufacturing capability, the Company will be subject to extensive government regulation and

intervention both in the U.S.

and in all foreign jurisdictions in which it conducts business.

Compliance with applicable laws

and regulations will result in higher capital expenditures and operating costs, and changes to current regulations with which

the Company complies can necessitate further capital expenditures and increases in operating costs to enable continued compliance.

Additionally, from time to time, the Company may be involved in proceedings under certain of these laws and regulations.

operations are subject to political instabilities, restrictions on funds transfers, import/export restrictions, and currency fluctuation.

RELATED TO THE COMPANY’S COMMON STOCK

Company’s common stock is currently quoted on the OTCQB Marketplace.

Failure to develop or maintain a more active trading

market may negatively affect the value of the Company’s common stock, may deter some potential investors from purchasing

the Company’s common stock or other equity securities, and may make it difficult or impossible for stockholders to sell

their shares of common stock.

Company’s average daily volume of shares traded for the years ended December 31, 2020 and 2019 was 32,815 and 681,623, respectively.

Failure to develop or maintain an active trading market may negatively affect the value of the Company’s common stock, may

make some potential investors unwilling to purchase the Company’s common stock or equity securities that are convertible

into or exercisable for the Company’s common stock, and may make it difficult or impossible for the Company’s stockholders

to sell their shares of common stock and recover any part of their investment.

Company’s outstanding securities, the stock or other securities that it may become obligated to issue under existing agreements,

and certain provisions of those securities, may cause immediate and substantial dilution to existing stockholders and may make

it more difficult to raise additional equity capital.

Compliance with applicable laws and regulations

will result in higher capital expenditures and operating costs, and changes to current regulations with which the Company complies can

necessitate further capital expenditures and increases in operating costs to enable continued compliance.

Additionally, from time to

time, the Company may be involved in proceedings under certain of these laws and regulations.

Foreign operations are subject to political

instabilities, restrictions on funds transfers, import/export restrictions, and currency fluctuation.

RELATED TO THE COMPANY’S COMMON STOCK

Company’s common stock is currently quoted on the OTCQB Marketplace.

Failure to develop or maintain a more active trading market

may negatively affect the value of the Company’s common stock, may deter some potential investors from purchasing the Company’s

common stock or other equity securities, and may make it difficult or impossible for stockholders to sell their shares of common stock.

Company’s average daily volume of shares traded for the years ended December 31, 2021 and 2020 was 2,074,138 and 32,815, respectively.

Failure to develop or maintain an active trading market may negatively affect the value of the Company’s common stock, may make

some potential investors unwilling to purchase the Company’s common stock or equity securities that are convertible into or exercisable

for the Company’s common stock, and may make it difficult or impossible for the Company’s stockholders to sell their shares

of common stock and recover any part of their investment.

Company’s outstanding securities, the stock or other securities that it may become obligated to issue under existing agreements,

and certain provisions of those securities, may cause immediate and substantial dilution to existing stockholders and may make it more

difficult to raise additional equity capital.

Company had 343,530,678 shares of common stock outstanding on March 1, 2022.

The Company also had outstanding on that

date dilutive securities consisting of preferred stock, restricted stock units, options, warrants, and convertible notes (collectively,

Common Stock Equivalents ”) that if they had been exercised and converted in full on March 18, 2021,

would have resulted in the issuance of up to 90,093,648 additional shares of common stock.

The issuance of shares upon

the exercise of the Common Stock Equivalents may result in substantial dilution to each stockholder by reducing that stockholder’s

percentage ownership of the Company’s total outstanding shares of common stock.

The issuance of some or all those warrants

and any exercise of those warrants will have the effect of further diluting the percentage ownership of the Company’s other

stockholders.

sales of the Company’s securities, including sales following exercise or conversion of derivative securities, or the perception

The Company also had outstanding on that date dilutive

securities consisting of preferred stock, restricted stock units, options, and warrants (collectively, “ Common Stock Equivalents ”)

that if they had been exercised and converted in full on March 1, 2022, would have resulted in the issuance of up to 69,287,379

additional shares of common stock.

The issuance of shares upon the exercise of the Common Stock Equivalents may result in substantial

dilution to each stockholder by reducing that stockholder’s percentage ownership of the Company’s total outstanding shares

of common stock.

The issuance of some or all those warrants and any exercise of those warrants will have the effect of further diluting

the percentage ownership of the Company’s other stockholders.

sales of the Company’s securities, including sales following exercise or conversion of derivative securities, or the perception

that such sales may occur, may depress the price of common stock and could encourage short sales.

sale or availability for sale of substantial amounts of the Company’s shares in the public market, including shares issuable

upon exercise of the Common Stock Equivalents, or the perception that such sales may occur, may adversely affect the market price

of the Company’s common stock.

Any decline in the price of the Company’s common stock may encourage short sales, which

could place further downward pressure on the price of the Company’s common stock.

Company’s stock price is likely to be volatile.

the year ended December 31, 2020, the reported low closing price for the Company’s common stock was $0.0135 per share,

and the reported high closing price was $0.245 per share.

For the year ended December 31, 2019, the reported low closing

price for the Company’s common stock was $0.0112 per share, and the reported high closing price was $0.0893 per share.

is generally significant volatility in the market prices, as well as limited liquidity, of securities of early stage companies,

particularly early stage medical product companies.

Contributing to this volatility are various events that can affect the Company’s

stock price in a positive or negative manner.

sale or availability for sale of substantial amounts of the Company’s shares in the public market, including shares issuable upon

exercise of the Common Stock Equivalents, or the perception that such sales may occur, may adversely affect the market price of the Company’s

common stock.

Any decline in the price of the Company’s common stock may encourage short sales, which could place further downward

pressure on the price of the Company’s common stock.

Company’s stock price is likely to be volatile.

the year ended December 31, 2021, the reported low closing price for the Company’s common stock was $0.068 per share, and the reported

high closing price was $0.2592 per share.

For the year ended December 31, 2020, the reported low closing price for the Company’s

common stock was $0.0135 per share, and the reported high closing price was $0.245 per share.

There is generally significant volatility

in the market prices, as well as limited liquidity, of securities of early stage companies, particularly early stage medical product

Contributing to this volatility are various events that can affect the Company’s stock price in a positive or negative

These events include, but are not limited to:

governmental approvals, refusals to

approve, regulations or other actions;

market acceptance and sales growth of the Company’s products;

litigation involving

the Company or the Company’s industry;

developments or disputes concerning the Company’s patents or other proprietary

governmental approvals, refusals to approve, regulations or other actions;

acceptance and sales growth of the Company’s products;

litigation involving the Company or the Company’s industry;

or disputes concerning the Company’s patents or other proprietary rights;

changes in the structure of healthcare payment systems;

1 unchanged sentence

future sales of its securities;

in its financial results or those of companies that are perceived to be similar to us;

investors’

general perception of

fluctuations in its financial results or those of companies that are perceived

to be similar to us;

investors’ general perception of us;

and general economic, industry and market conditions.

If any of these events occur, it could cause the Company’s stock

price to fall, and any of these events may cause the Company’s stock price to be volatile.

Company’s common stock is subject to the “Penny Stock”

rules of the SEC and the trading market in its securities

is limited, which makes transactions in its common stock cumbersome and may reduce the value of an investment in the Company’s

SEC has adopted Rule 3a51-1, which establishes the definition of a “penny stock,”

for the purposes relevant to us,

as any equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share,

subject to certain exceptions.

For any transaction involving a penny stock, unless exempt, Rule 15g-9 requires that a broker or

dealer approve a person’s account for transactions in penny stocks and that the broker or dealer receive from the investor

a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased.

order to approve a person’s account for transactions in penny stocks, the broker or dealer must obtain financial information

and investment experience and objectives of the person and must make a reasonable determination that the transactions in penny

stocks are suitable for that person and that the person has sufficient knowledge and experience in financial matters to be capable

of evaluating the risks of transactions in penny stocks.

broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating

to the penny stock market, which sets forth the basis on which the broker or dealer made the suitability determination, and that

the broker or dealer received a signed, written agreement from the investor prior to the transaction.

brokers may be less willing to execute transactions in securities subject to the “penny stock”

This may make

it more difficult for investors to dispose of the Company’s common stock and may cause a decline in the market value of

also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the

commissions payable to both the broker-dealer and the registered representative, current quotations for the securities and the

rights and remedies available to an investor in cases of fraud in penny stock transactions.

Finally, monthly statements have to

be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny

a result of the Company issuing preferred stock, the rights of holders of the Company’s common stock and the value of the

Company’s common stock may be adversely affected.

Company’s Board of Directors is authorized to issue classes or series of preferred stock, without any action on the part

of the stockholders.

The Company’s Board of Directors also has the power, without stockholder approval, to set the terms

of any such classes or series of preferred stock, including voting rights, dividend rights and preferences over the common stock

with respect to dividends or upon the liquidation, dissolution or winding-up of its business, and other terms.

The Company has

issued preferred stock that has a preference over the common stock with respect to the payment of dividends or upon liquidation,

dissolution or winding-up, and with respect to voting rights.

In accordance with that and with the issuance of preferred stock,

our common stockholders voting rights have been diluted and it is possible that the rights of holders of the common stock or the

value of the common stock have been adversely affected.

If any of these

events occur, it could cause the Company’s stock price to fall, and any of these events may cause the Company’s stock price

to be volatile.

Company’s common stock is subject to the “Penny Stock” rules of the SEC and the trading market in its securities is

limited, which makes transactions in its common stock cumbersome and may reduce the value of an investment in the Company’s stock.

SEC has adopted Rule 3a51-1, which establishes the definition of a “penny stock,” for the purposes relevant to us, as any

equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject

to certain exceptions.

For any transaction involving a penny stock, unless exempt, Rule 15g-9 requires that a broker or dealer approve

a person’s account for transactions in penny stocks and that the broker or dealer receive from the investor a written agreement

to the transaction, setting forth the identity and quantity of the penny stock to be purchased.

order to approve a person’s account for transactions in penny stocks, the broker or dealer must obtain financial information and

investment experience and objectives of the person and must make a reasonable determination that the transactions in penny stocks are

suitable for that person and that the person has sufficient knowledge and experience in financial matters to be capable of evaluating

the risks of transactions in penny stocks.

broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to

the penny stock market, which sets forth the basis on which the broker or dealer made the suitability determination, and that the broker

or dealer received a signed, written agreement from the investor prior to the transaction.

brokers may be less willing to execute transactions in securities subject to the “penny stock” rules.

This may make it more

difficult for investors to dispose of the Company’s common stock and may cause a decline in the market value of its stock.

also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions

payable to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies

available to an investor in cases of fraud in penny stock transactions.

Finally, monthly statements have to be sent disclosing recent

price information for the penny stock held in the account and information on the limited market in penny stocks.

a result of the Company issuing preferred stock, the rights of holders of the Company’s common stock and the value of the Company’s

common stock may be adversely affected.

Company’s Board of Directors is authorized to issue classes or series of preferred stock, without any action on the part of the

stockholders.

The Company’s Board of Directors also has the power, without stockholder approval, to set the terms of any such classes

or series of preferred stock, including voting rights, dividend rights and preferences over the common stock with respect to dividends

or upon the liquidation, dissolution or winding-up of its business, and other terms.

The Company has issued preferred stock that has

a preference over the common stock with respect to the payment of dividends or upon liquidation, dissolution or winding-up, and with

respect to voting rights.

In accordance with that and with the issuance of preferred stock, our common stockholders voting rights have

been diluted and it is possible that the rights of holders of the common stock or the value of the common stock have been adversely affected.

Company does not expect to pay any dividends on common stock for the foreseeable future.

Company has not paid any cash dividends on its common stock to date and does not anticipate it will pay cash dividends on its

common stock in the foreseeable future.

Accordingly, stockholders must be prepared to rely on sales of their common stock after

price appreciation to earn an investment return, which may never occur.

Any determination to pay dividends in the future will

be made at the discretion of the Company’s board of directors and will depend on the Company’s results of operations,

financial conditions, contractual restrictions, restrictions imposed by applicable law, and other factors that the Company’s

board deems relevant.

Company has not paid any cash dividends on its common stock to date and does not anticipate it will pay cash dividends on its common

stock in the foreseeable future.

Accordingly, stockholders must be prepared to rely on sales of their common stock after price appreciation

to earn an investment return, which may never occur.

Any determination to pay dividends in the future will be made at the discretion

of the Company’s board of directors and will depend on the Company’s results of operations, financial conditions, contractual

restrictions, restrictions imposed by applicable law, and other factors that the Company’s board deems relevant.

including COVID-19 may adversely affect our business.

recent unprecedented events related to COVID-19, the disease caused by the novel coronavirus (SARS-CoV-2), have had significant

health, economic, and market impacts and may have short-term and long-term adverse effects on our business that we cannot predict

as the global pandemic continues to evolve.

The extent and effectiveness of responses by governments and other organizations also

cannot be predicted.

unprecedented events related to COVID-19 and the variants, the disease caused by the novel coronavirus (SARS-CoV-2), have had significant

health, economic, and market impacts and may have short-term and long-term adverse effects on our business that we cannot predict as

the global pandemic continues to evolve.

The extent and effectiveness of responses by governments and other organizations also cannot

be predicted.

ability to access the capital markets is unknown during the COVID-19 pandemic.

Any such limitation on available financing would

adversely affect our business.

Volatility in raw material and energy

costs, interruption in ordinary sources of supply, and an inability to recover from unanticipated increases in energy and raw

material costs could result in lost sales or could increase significantly the cost of doing business.

and economic conditions affecting the costs of raw materials, utilities, energy costs, and infrastructure required to provide

for the delivery of the Company’s products and services are beyond the Company’s control.

Any disruption or halt in

supplies, or rapid escalations in costs, could adversely affect the Company’s ability to manufacture products or to competitively

price the Company’s products in the marketplace.

To date, the ultimate impact of energy costs increases has been mitigated

through price increases or offset through improved process efficiencies;

however, continuing escalation of energy costs could

have a negative impact upon the Company’s business and financial performance.

General economic conditions in markets

in which the Company does business can impact the demand for the Company’s goods and services.

Decreased demand for the

Company’s products and services could have a negative impact on its financial performance and cash flow.

for the Company’s products and services, in part, depends on the general economic conditions affecting the countries and

industries in which the Company does business.

A downturn in economic conditions in a country or industry that the Company serves

may adversely affect the demand for the Company’s products and services, in turn negatively impacting the Company’s

operations and financial results.

Further, changes in demand for the Company’s products and services can magnify the impact

of economic cycles on the Company’s businesses.

Unanticipated contract terminations by customers can negatively impact operations,

financial results and cash flow.

The Company’s earnings, cash flow and financial position are exposed to financial market

risks worldwide, including interest rate and currency exchange rate fluctuations and exchange rate controls.

Fluctuations in domestic

and world financial markets could adversely affect interest rates and impact the Company’s ability to obtain credit or attract

Any such limitation on available financing would adversely

affect our business.

in raw material and energy costs, interruption in ordinary sources of supply, and an inability to recover from unanticipated increases

in energy and raw material costs could result in lost sales or could increase significantly the cost of doing business.

and economic conditions affecting the costs of raw materials, utilities, energy costs, and infrastructure required to provide for the

delivery of the Company’s products and services are beyond the Company’s control.

Any disruption or halt in supplies, or

rapid escalations in costs, could adversely affect the Company’s ability to manufacture products or to competitively price the

Company’s products in the marketplace.

To date, the ultimate impact of energy costs increases has been mitigated through price

increases or offset through improved process efficiencies;

however, continuing escalation of energy costs could have a negative impact

upon the Company’s business and financial performance.

economic conditions in markets in which the Company does business can impact the demand for the Company’s goods and services.

demand for the Company’s products and services could have a negative impact on its financial performance and cash flow.

for the Company’s products and services, in part, depends on the general economic conditions affecting the countries and industries

in which the Company does business.

A downturn in economic conditions in a country or industry that the Company serves may adversely

affect the demand for the Company’s products and services, in turn negatively impacting the Company’s operations and financial

Further, changes in demand for the Company’s products and services can magnify the impact of economic cycles on the Company’s

Unanticipated contract terminations by customers can negatively impact operations, financial results and cash flow.

The Company’s

earnings, cash flow and financial position are exposed to financial market risks worldwide, including interest rate and currency exchange

rate fluctuations and exchange rate controls.

Fluctuations in domestic and world financial markets could adversely affect interest rates

and impact the Company’s ability to obtain credit or attract investors.

UNRESOLVED STAFF COMMENTS.

2 unchanged sentences

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What changed 10-K

Item 1A. Risk Factors