What changed in this filing

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Item 1A. Risk Factors

2025-03-24 compared with 2024-03-18 · 159 added, 158 removed, 322 unchanged (50% of the section changed)

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Inclusion of a “going concern qualification”

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

impact our 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.

The 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 can obtain, the Company may not receive adequate

funds to continue the approval process for RadioGel™ or other brachytherapy products with the FDA, which would disrupt our business

operations or derail our business strategy, and materially and adversely affect our business, financial condition and results of operations.

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

financing and may adversely impact our stock price.

combination of our current financial condition and the United States Food and Drug Administration’s (“FDA”) determinations

to date regarding Radiogel™ 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 can obtain, the Company may not receive adequate funds to continue the approval process for RadioGel™ or other

precision radionuclide therapy products with the FDA, which would disrupt our business operations or derail our business strategy, and

materially and adversely affect our business, financial condition, and results of operations.

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

may be unable to satisfy .

The 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 $82,450,781 and $79,556,028 as

of December 31, 2023 and 2022, respectively, including net losses of $2,894,753 and $2,470,161 for the years ended December 31, 2023 and

2022, respectively.

Historically, the Company has relied upon investor funds to maintain its operations and develop its business.

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.

The Company requires funding of at least $5 million per year to maintain

current operating activities.

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 $85,361,229 and $82,450,781 as of December 31, 2024 and 2023, respectively, including net losses of $2,910,448

and $2,894,753 for the years ended December 31, 2024 and 2023.

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 approximately $3.5 million per year for Selling and General Administration costs and to fund its ongoing

Over the next 36 months, the Company believes it will cost approximately $10 million to:

(1) fund the FDA

approval process to conduct human clinical trials;

(2) conduct Phase I, pilot, and 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.

(1) conduct human clinical trials;

(2) activate several regional clinics to administer IsoPet ® across the county;

(3) create an alternate manufacturing center

based on a template for future international manufacturing.

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

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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.

third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the United States

of America (“ U.S.

”, or the “ United States ”) and elsewhere.

The Company intends to fund its activities

through strategic transactions such as licensing and partnership agreements or additional capital raises.

geopolitical events, including the inherent instability and volatility in global capital markets, as well as the lack of liquidity in

the capital markets, could also impact the Company’s ability to obtain financing and its ability to execute its business plan.

economic events, 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, which would materially and adversely affect our business and operations.

impact the Company’s ability to obtain financing and its ability to execute its business plan, which would materially and adversely

affect our business and operations.

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

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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.

If 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™ device.

The Company has been working with the FDA to obtain clearance for its

brachytherapy Y-90 RadioGel TM device, but no assurances have been received.

On December 23, 2014, the Company announced that

it submitted a de novo application to the FDA for marketing clearance 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 ”).

In June 2015, the FDA notified the Company

the de novo application 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.

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.

there would still be the requirements to complete the in vitro and in vivo testing, and then some human clinical trials.

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 application 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.

If human clinical trials are necessary, there will be additional cost

and time to reach marketing clearance or approval.

Unless the Company obtains sufficient funding, it will be unable to undertake such

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.

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

radionuclide therapy Y-90 RadioGel™ device.

Company has been working with the FDA to obtain clearance for its precision radionuclide therapy Y-90 RadioGel TM device, but

no assurances have been received.

On December 23, 2014, the Company announced that it submitted a de novo application to the FDA

for marketing clearance 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 ”).

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

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

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 application 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.

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

human trials for Class III products are larger, of longer duration and costlier than those for Class II devices.

will be additional cost and time to reach marketing clearance or approval.

Unless the Company obtains sufficient funding, it will be

unable to undertake such 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.

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.

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control the Company’s business affairs.

The Company does not maintain key man insurance on Dr.

The Company does not maintain life insurance on Dr.

Korenko’s life.

the services of Dr.

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

Korenko as a consultant for the last two years.

mitigate this risk Dr.

Korenko has been working with two internal candidates with the potential to seamlessly assume authority.

David Swanberg and Brad Weeks, current active consultants to the Company with broad responsivities, have been identified as high potential

candidates to succeed Dr.

Korenko or to assume senior positions, although no formal arrangement has been reached.

The Company Board would

make the final appointment.

See “ Directors, Executive Officers and Significant Consultants” on page 29.

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

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

The Company’s success is heavily dependent on the continued active

participation of certain consultants and collaborating scientists.

Certain consultants have no written 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.

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

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.

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The Company had $27,995 and $19,500

in operating revenues, net of discounts for the years ended December 31, 2023 and 2022, respectively, as we have commenced sales of IsoPet ® .

in operating revenues, net of discounts, for the years ended December 31, 2024 and 2023, respectively, as we have commenced sales of

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

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

Company currently subcontracts the manufacturing of RadioGel TM to IsoTherapeutics.

Eckert and Ziegler 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™

and our business would be materially harmed.

and Ziegler is the sole supplier of the Y-90 particles used by IsoTherapeutics and is the only supplier of Y-90 particles in the United

In the event Eckert & Ziegler 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 relies on a sole manufacturing contact with IsoTherapeutics.

IsoTherapeutics

is our sole particle manufacturing contractor.

Vivos now has alternate suppliers for its hydrogel and is actively engaged is selecting

an alternate supplier for the particle production.

Both domestic and internation candidates are being assessed.

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

Some 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 would 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.

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

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 would have a material adverse effect on the Company’s

ability to operate.

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

Company faces an inherent business risk of exposure to product liability claims if 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 more than 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 coverage.

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

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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

Accordingly, future growth rates depend upon several 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

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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’s future success may depend, in part, on its ability to enter 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;

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in marketing and selling its products.

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

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

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

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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 shares of 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.

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 shares of 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

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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.

qualified accounting personnel 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’s patented or other technologies may infringe on other patents, which may expose us to costly litigation.

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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.

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

In some non-U.S.

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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.

rights about such unpatented proprietary technology, or competitors may independently develop substantially equivalent technology.

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.

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difficult to raise additional equity capital.

Company had 389,894,033 shares of common stock outstanding on March 1, 2024.

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, 2024, would have resulted in the issuance of up to 56,746,379 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

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.

Company had 440,873,806 shares of common stock outstanding as of December 31, 2024.

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 December 31, 2024, would have resulted in the

issuance of up to 43,852,379 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

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Company’s stock price is likely to be volatile.

the year ended December 31, 2023, the reported low closing price for the Company’s common stock was $0.0412 per share, and the

reported high closing price was $0.1195 per share.

the year ended December 31, 2024, the reported low closing price for the Company’s common stock was $0.049 per share, and the reported

high closing price was $0.255 per share.

For the year ended December 31, 2023, the reported low closing price for the Company’s

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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.

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

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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

also must 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.

Finally, monthly statements must 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

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

What changed 10-K

Item 1A. Risk Factors