What changed in this filing

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Item 1A. Risk Factors

2024-03-18 compared with 2023-03-01 · 102 added, 108 removed, 378 unchanged (36% of the section changed)

25 unchanged sentences

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.

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.

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.

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.

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 $79,556,028 and $77,085,867 as of December 31, 2022 and 2021, respectively including net losses of $2,470,161

and $2,527,766 for the years ended December 31, 2022 and 2021.

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 ® 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.

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.

Over the next 24 months, the Company believes it will cost approximately $9 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.

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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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

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.

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

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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

have been received.

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

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

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 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 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.

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.

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.

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

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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’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.

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

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larger number of customers.

Company’s consulting revenues relate to their commercializing of its products or expanding the number of customers purchasing its

products and services.

The Company had $36,499 and $14,887 in operating revenues, net of discounts for the years ended December 31, 2022

and 2021, respectively as they have commenced sales of IsoPet ® .

Company’s revenues relate to their commercializing of its products and procedures performed.

The Company had $19,500 and $36,499

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

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

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

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

to procure Y-90 particles will materially 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

1 unchanged sentence

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.

with our development of RadioGel TM and our business would 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.

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

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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.

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.

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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 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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reporting and disclosure controls and procedures.

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

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

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

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Company’s stock price is likely to be volatile.

the year ended December 31, 2022, the reported low closing price for the Company’s common stock was $0.04 per share, and the reported

high closing price was $0.1264 per share.

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.

For the year ended December 31, 2022, the reported low closing price for the Company’s

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

including COVID-19 may adversely affect our business.

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.

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

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

UNRESOLVED STAFF COMMENTS.

item is not applicable to the Company because the Company is a smaller reporting company as defined by Rule 12b-2 under the Securities

Exchange Act of 1934.

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