What changed in this filing

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Item 1. Business

2024-03-18 compared with 2023-03-01 · 219 added, 211 removed, 386 unchanged (53% of the section changed)

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in July 2019, the Company recognized its first commercial sale of IsoPet®.

A veterinarian from

Alaska brought his cat with a re-occurrent spindle cell sarcoma tumor on his face.

The cat had previously received external beam therapy,

but now the tumor was growing rapidly.

A veterinarian from Alaska brought his cat with a re-occurrent

spindle cell sarcoma tumor on his face.

The cat had previously received external beam therapy, but now the tumor was growing rapidly.

He was given a high dose of 400Gy with heavy therapy at the margins.

This sale met the revenue

recognition requirements under ASC 606 as the performance obligation was satisfied.

The Company completed sales for an additional four

animals that received the IsoPet® during 2019.

This sale met the revenue recognition requirements under the Financial Accounting Standards Board (“ FASB ”) Accounting Standards Codification (“ ASC ”)

as the performance obligation was satisfied.

The Company completed sales for an additional four animals that received the IsoPet®

plan is to incorporate the data assembled from our work with Isopet ® in animal therapy to support the Company’s

efforts in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell

RadioGel™ as a Class II medical device.

RadioGel™ is an injectable particle-gel for brachytherapy radiation treatment of

cancerous tumors in people and animals.

RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature

and then gels when reaching body temperature after injection into a tumor.

In the gel are small, less than two microns, Y-90 phosphate

Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation

The radiation is beta, consisting of high-speed electrons.

These electrons only travel a short distance so the device can deliver

high radiation to the tumor with minimal dose to the surrounding tissue.

Optimally, patients can go home immediately following treatment

without the risk of radiation exposure to family members.

Since Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its

original value after ten days.

the Company modified its Indication for Use from skin cancel to cancerous tissue or solid tumors pathologically associated with locoregional

efforts in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell RadioGel™

as a Class II medical device.

RadioGel™ is an injectable particle-gel for brachytherapy radiation treatment of cancerous tumors

in people and animals.

RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature and then gels when

reaching body temperature after injection into a tumor.

In the gel are small, less than two microns, Y-90 phosphate particles.

Once injected,

these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation dose.

The radiation is

beta, consisting of high-speed electrons.

These electrons only travel a short distance so the device can deliver high radiation to the

tumor with minimal dose to the surrounding tissue.

Optimally, patients can go home immediately following treatment without the risk of

radiation exposure to family members.

Since Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its original value after

Company modified its Indication for Use from skin cancer to cancerous tissue or solid tumors pathologically associated with locoregional

papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic lymph nodes

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Board felt that demonstrating efficacy in clinical trials was much easier with this new indication.

original license with Battelle National Laboratory reached its end of life in 2022.

During the past several years, in anticipation of

this we have expanded our proprietary knowledge, our trademark and patent protection.

Our original license with Battelle National Laboratory (the “ Battelle

License ”) reached its end of life in 2022.

During the past several years, we have expanded our proprietary knowledge, as well

as our trademark and patent protection, in anticipation of the Battelle License reaching the end of its term.

RadioGel trademark protection is in 17 countries.

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the International Certificate of Registration for ISOPET, which is the first step to file in several countries .

filed for trademark protection for the term Precision Radionuclide Therapy TM.

We believe this term will be increasingly important.

Company received the Patent Cooperation Treaty (“ PCT ”) International Search Report on our patent application (No.1811.191).

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extend for many years the patent protection for our proprietary Yttrium-90 phosphate particles utilized in Isopet ® and

patent team filed our particle patent in more than ten patent offices that collectively cover 63 countries throughout the world.

a continuation-in-part applications number 1774054 in the USA to expand the claims on our

particle patent.

T he US Patent office recently gave us the Notice of Allowance for our patent

to produce our yttrium phosphate microparticles, US Patent Application Serial No:

We also filed an amendment to correct the wording on our claims at make them consistent with the

Our patent team filed our particle patent in more than ten patent offices

that collectively cover 63 countries throughout the world.

We filed a continuation-in-part applications number 1774054 in the United States

of America (“ USA ”, or “ U.S.” ) to expand the claims on our particle patent.

Patent office

recently gave us the Notice of Allowance for our patent to produce our yttrium phosphate microparticles, U.S.

Patent Application Serial

We also filed an amendment to correct the wording on our claims at make them consistent with the USE claims.

European Patent Application NO.

20 834 229.5;

filed a hydrogel utility patent in the USA (16309:17/943,311) and internationally (16389:PCT/US22/4374) based on the last eighteen months

filed a hydrogel utility patent in the USA (16309:17/943,311) and internationally (16389:PCT/US22/4374) based on the last 18 months

of development work to optimize our hydrogel component.

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These devices will be preferentially used at Mayo Clinics for human clinical studies at and our IsoPet regional treatment centers.

anticipate that Precison Radionuclide Therapy will become increasingly important in the future and expand to other isotope and other

filed a utility patent in our fourth quarter of 2023 for this therapy support equipment.

anticipate that Precision Radionuclide Therapy will become increasingly important in the future and expand to other isotope and other

indications for use.

Therefore, we filed an alternate particle utility patent (Serial number 18/152,137).

Vivos Inc will focus its near-term

The Company will focus its near-term

effort on the Yttrium-90 therapy, which we believe is the best beta emitter;

however, we leveraged

our hydrogel utility patent to incorporate other promising isotopes and compounds for a range of future applications.

This includes gamma

and alpha particle emitters.

however, we leveraged our hydrogel utility patent to incorporate

other promising isotopes and compounds for a range of future applications.

This includes gamma and alpha particle emitters.

Regional Clinics

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England Equine Practice – Patterson, NY

Equine Clinic

Indian Creek Veterinary Hospital

Animal Hospital - Weare NH

Veterinary Hospital (“ Vista ”) was selected as the pilot private clinic to initiate commercial sales of IsoPet ® .

It is good management practice to implement and learn from a pilot program before spreading to regional clinics across the country.

is located in the Tri-Cities Washington area which is convenient for interactions with key personnel of the Company.

The pilot is being

the Memorandum of Understanding to define all the germane interfaces, roles and liabilities between Vista Inc and the private clinics,

including the pilot responsivity to document and share the key aspects of all therapies with the Company;

and implement proprietary certification training packages;

the production center radioactive material license at IsoTherapeutics, the Company’s IsoPet ® production center,

to allow distribution for commercial applications;

with the pilot program to obtain a radioactive material licensing in an NRC agreement state;

equipment and supplies list;

and post regulatory signage;

different IsoPet ® pricing options;

different approaches to obtain patients;

patient scheduling practices to reduce cost to the pet owners;

communication material and a liability document for the pet owners;

refine the therapy techniques for advanced cancers.

Veterinary Hospital has done well on two audits by the Washington State Department of Health.

The Company is working closely with the

Washington State Department of Health to refine and improve the radioactive material license.

The Company has added several detailed

procedures, which will benefit future regional clinics.

In addition, a second veterinarian has completed all the preliminary requirements

to become certified.

All that remains is to demonstrate proficiency in three therapies.

testing at the universities and at Vista Veterinary Hospital have demonstrated that IsoPet ® is effective on killing cancer

tissue near the injections.

is in the Tri-Cities Washington area which is convenient for interactions with key personnel of the Company.

has done well on two audits by the Washington State Department of Health.

The Company is working closely with the Washington State Department

of Health to refine and improve the radioactive material license.

The Company has added several detailed procedures, which will benefit

future regional clinics.

In addition, a second veterinarian has completed all the preliminary requirements to become certified.

remains is to demonstrate proficiency in three therapies.

testing at the universities and at Vista have demonstrated that IsoPet ® is effective on killing cancer tissue near the

It is most effective in early cases before the cancer has begun to spread.

Later stage cancers are more difficult

to treat since the tendrils from the primary cancer site are not well defined and therefore can lead to recurrence.

have been 115 expressions of interest in IsoPet ® therapy from across the United States, but only about 10% of these were

treated and they were very advanced cases.

The reasons are instructive.

Most of the cases were for so advanced that the pet parents found

out about IsoPet ® on the Internet as a last hope.

Several others were internal cancers that could not be reached, for

example deep in the throat.

Several cases were treatable, but the pets weighed more than 20 pounds and the pet parents were not willing

to fly them in the “Safe Cargo” holds.

Those patients would have been treated by regional clinics once we implement that

Several cases were mast cell cancers.

The Company is confident that those tumors could have been treated, but once killed they

release mast cells in a process called granulation.

This could cause a shock to the animal’s system.

The Company will focus one

of our clinical studies on the optimum approach for those therapies.

Veterinary Hospital accepted advanced cancer cases and has gained experience to extend the animal’s lives.

The first cat was terminally

ill and had previously had external beam, surgery and chemotherapy.

The facial tumor was treated with 400 Gy and the biopsy confirmed

that the cancer was killed.

In about seven months the cancer returned in the throat and could not be treated so the cat had to be put

Later stage cancers are more difficult to treat

since the tendrils from the primary cancer site are not well defined and therefore can lead to recurrence.

accepted advanced cancer cases and has gained experience to extend the animal’s lives.

The first cat was terminally ill and had

previously had external beam, surgery and chemotherapy.

The facial tumor was treated with 400 Gray and the biopsy confirmed that the

cancer was killed.

In about seven months the cancer returned in the throat and could not be treated so the cat had to be put down.

Bauder, the veterinarian pet parent, was still elated about the life extension and is asking us to use him as a reference.

The other cases were also very advanced with multiple tumors and they recurred since they had already spread before therapy.

Yukon had a large tumor on his leg that was recommended for amputation.

The tumor size decreased 50% after the first treatment, but then

stopped decreasing.

cases were also very advanced with multiple tumors and they recurred since they had already spread before therapy.

One animal, Yukon,

had a large tumor on her leg that was recommended for amputation.

The tumor size decreased 50% after the first treatment, but then stopped

For the first time, a second therapy was administered and the tumor has continued to decrease in size.

life was extended for more than a year until she finally succumbed to metastatic cancer in another location.

was extended for more than a year until she finally succumbed to metastatic cancer in another location.

IsoPet ® has shown to be effective in killing cancer at the site of injection the current focus is in optimizing the techniques

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This approach is very cost effective.

Hopkins University VCTN, Veterinary Clinical Trials Network, is now an Isopet ® regional clinic.

Additionally, Johns Hopkins

will also perform new Isopet® animal studies on various specific cancers.

They have the required radioactive material license and

have completed their training certification for Isopet®.

This important relationship will also help meet our objective of obtaining

high quality data on a range of cancers that can be published in leading journals.

These publications are the optimal way to increase

awareness of Isopet® and to gain broader acceptance from the veterinarian/oncology community.

objective is to open several regional clinics by the end of 2023 and to participate in a minimum of four conferences to spread the word

about IsoPet in the veterinarian community for treating tumors in small animals and horses.

We created a Marketing Steering Board to

provide advice on obtaining new pet patients.

has a long regulatory history with the Food and Drug Administration (“ FDA ”).

Hopkins University Veterinary Clinical Trials Network (“ Johns Hopkins ”), is now an Isopet ® regional

Additionally, Johns Hopkins will also perform new Isopet® animal studies on various specific cancers.

They have the

required radioactive material license and have completed their training certification for Isopet®.

This important relationship

will also help meet our objective of obtaining high quality data on a range of cancers that can be published in leading journals.

These publications are the optimal way to increase awareness of Isopet®, and to gain broader acceptance from the

veterinarian/oncology community.

Johns Hopkins just completed the VX2 Tumor therapy animal study in rabbits and is writing a report

on the study.

The study further demonstrated the safety of RadioGel TM , generating the activity decay curves that show

that the hydrogel remains at the injection site.

This study also:

(1) demonstrated the validity of the Instructions for Use;

validity of the Injection Guidance Table;

and (3) provided a basis for refining the techniques for treating small human cancerous

objectives are to open several more regional clinics over the next three years, and to participate in a minimum of four conferences annually

to spread the word about IsoPet ® in the veterinarian community for treating tumors in small animals and horses.

Our Veterinary

Medicine Steering Board provides advice on obtaining new pet patients.

RadioGel™ has a long regulatory history with the FDA.

Initially, the Company submitted a presubmission

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process resulted in a rapid review of our existing data and approach.

It led to a redirection of our efforts on writing the IDE and saved

It led to a redirection of our efforts on writing the Investigational Device Exemptions (“ IDEs ”) and saved

the Company much time in the review of that future application.

on advice from the FDA the Company has scheduled a Pre-Submission meeting on November 30, 2021 to discuss a draft of an Investigational

Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.

this process results in more rapid feedback to prepare the final IDE.

Based on advice from the FDA the Company has scheduled a Pre-Submission

meeting on November 30, 2021 to discuss a draft of an IDE for Early Feasibility Medical Device Clinical Studies, including certain First

in Human (“ FIH ”) Studies.

Using this process results in more rapid feedback to prepare the final IDE.

FDA was very supportive and had suggested this Q-Submission path for rapid turnaround and dialog.

The Mayo Clinic physicians did an excellent

job presenting the need for Radiogel ™ to treat recurrent thyroid cancer and to answer a range of questions from the

new FDA review team.

The FDA provided many helpful suggestions on a range of subjects from labeling to dosimetry to the Mayo protocol

for clinical testing, and the need for some additional specific testing.

They suggested having another Q-Sub Review and conference call

dedicated to the details of the dosimetry calculations.

May of 2022 the Company held another Pre-Sub meeting with the FDA.

They concurred with our dosimetry techniques and requested one more

animal test to confirm that the Y-90 stays at the injection site.

We will be proposed a Pre-Sub meeting to discuss this new animal test

of VX-2 tumors in rabbits at Johns Hopkins University.

We have a meeting scheduled with the FDA in October to obtain their feedback on

our new animal test plan.

In the meantime, the Company is working to complete all the other required pre-clinical testing, such as biocompatibility

since they are required for the submittal of the IDE.

held another Pre-Sub meeting with the FDA on October 17, 2022 to obtain detailed feedback on the proposed VX-2/Rabbit Animal Test Plan

and to submit the Risk Management Report.

The Mayo Clinic physicians did an

excellent job presenting the need for Radiogel ™ to treat recurrent thyroid cancer and to answer a range of

questions from the new FDA review team.

The FDA provided many helpful suggestions on a range of subjects from labeling to dosimetry

to the Mayo Clinic protocol for clinical testing, and the need for some additional specific testing.

They suggested having another

Q-Sub Review and conference call dedicated to the details of the dosimetry calculations.

In May of 2022 the Company held another pre-submission meeting with

They concurred with our dosimetry techniques and requested one more animal test to confirm that the Y-90 stays at the injection

We will be proposing a pre-submission meeting to discuss this new animal test of VX-2 tumors in rabbits at Johns Hopkins.

a meeting scheduled with the FDA in October to obtain their feedback on our new animal test plan.

In the meantime, the Company is working

to complete all the other required pre-clinical testing, such as biocompatibility since they are required for the submittal of the IDE.

We held another pre-submission meeting with the FDA on October 17,

2022 to obtain detailed feedback on the proposed VX-2/Rabbit Animal Test Plan and to submit the Risk Management Report (“ RMR ”).

The RMR analyzed all hypothetical scenarios and concluded that RadioGel is inherently safe.

We participated in pre-submission meetings with the FDA on April 10,

2023, and September 29, 2023, to discuss the preliminary results of the VX2 tumor animal study and to obtain feedback on the genotoxicity

After providing addition information to the FDA on December 18, 2023,

the FDA classified us as a Breakthrough device to our proposed Indication for Use.

parallel the Company is working with the Mayo Clinic’s principal investigators to improve the clinical trial protocol for their

Institutional Review Board.

MAB selected eighteen applications for RadioGel™, each of which meet the criteria described above.

MAB selected 18 applications for RadioGel™, each of which meet the criteria described above.

This large number confirms the

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and recurrent papillary thyroid carcinoma.

anticipate that this initial application will facilitate each subsequent application for additional s Indications for Use.

second indication for use we intend to applied for a broad indication for use, which would target to obtain approval to treat all solid

Company’s stock offering under Regulation A+ was qualified by the Securities and Exchange Commission (“SEC”) on June

A second Regulation A+ was qualified by the SEC on September 15, 2021 to raise capital for 50,000,000 shares at a price of $0.10

for a maximum of $5,000,000.

The Company amended this and was able to raise $1,200,000 in July 2022 at $0.08 per share (15,000,0000 shares)

and sold 20,000,000 warrants for $20,000.

An amended Regulation A+ was filed in October 2022 to raise the remaining $3,800,000 of the

Company’s Regulation A+’s raised approximately $5,200,000 from the sale of shares and is using the proceeds generated as

We anticipate that this initial application will facilitate each subsequent

application for additional Indications for Use.

After the second Indication for Use, we intend to apply for a broad Indication for Use

which we would target to obtain approval to treat all solid tumors.

The Company’s stock offering under Regulation A+ was qualified

by the Securities and Exchange Commission (“ SEC ”) on June 3, 2020.

A second Regulation A+ offering was qualified by

the SEC on September 15, 2021, pursuant to the Company’s offering statement on Form 1-A (File No.

024-11627) (the “ Offering

Statement ”) to raise capital by selling 50,000,000 shares at a price of $0.10 per share, for a maximum offering of $5,000,000

(the “ Regulation A+ Offering ”).

In July 2022, the Company amended the Offering Statement, which the Company raised

$1,200,000 at $0.08 per share (15,000,000 shares) and sold 20,000,000 warrants for $20,000.

An amendment to the Offering Statement was

filed and qualified in October 2022, to raise the remaining $3,800,000 of the original offering amount of $5,000,000 at a price of $0.08

A further amendment to the Offering Statement was filed and qualified in December 2023, as supplemented, to raise the remaining

$3,200,000 at an offering price of $0.064 per share.

During 2023, $1,179,245 was raised through the sale of 16,132,000 shares of common

stock and 18,797,000 warrants.

The Company’s offerings pursuant to Regulation A+ have raised

approximately $6,000,000 from the sale of shares and is using the proceeds generated as follows:

the animal therapy market:

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Report the results to the FDA in a pre-submission meeting.

the feedback from that meeting to write the IDE (Investigational Device Exemption), which is required to initiate clinical trials.

and development of the Company’s brachytherapy product line has been funded with proceeds from the sale of equity and debt securities.

The Company may require additional funding of approximately $2 million annually to maintain current operating activities.

Over the next

12 to 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, 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 proceeds to be raised from the recent qualified Regulation

A+ will be used to continue to fund this development.

the feedback from that meeting to write the IDE, which is required to initiate clinical trials.

Research and development of the Company’s brachytherapy product

line has been funded with proceeds from the sale of equity and debt securities.

The Company may require additional funding of approximately

$2 million annually to maintain current operating activities.

Over the next 12 to 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, clinical trials;

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

The proceeds to be raised from the recent qualified Regulation A+ Offering will be used to continue to fund this development.

continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources and personnel.

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

from proceeds to be raised from the recent qualified Regulation A+.

from proceeds to be raised from the recently qualified Regulation A+ Offering.

receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing,

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its global commercialization strategy.

the longer-term, subject to the Company receiving adequate funding, regulatory approval for RadioGel™ and other brachytherapy products,

and thereafter being able to successfully commercialize its brachytherapy products, the Company intends to consider resuming research

efforts with respect to other products and technologies intended to help improve the diagnosis and treatment of cancer and other illnesses.

the Company intends to consider resuming research efforts with respect to other products and technologies intended to help improve the

diagnosis and treatment of cancer and other illnesses.

These long-term goals are subject to the Company:

(1) receiving adequate funding;

(2) receiving regulatory approval for RadioGel TM and other brachytherapy products;

and (3) being able to successfully commercialize

its brachytherapy products.

on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed

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delay the implementation of its business strategy and may not be able to continue operations.

Company has been impacted from the effects of COVID-19.

The Company’s headquarters are in Northeast Washington however there focus

of the animal therapy market has been the Northwestern sector of the United States.

The Company continues their marketing to the animal

therapy market and attempt to increase the exposure to their product and generate revenue accordingly.

Company’s headquarters are in Northeast Washington;

however, the focus of the animal therapy market has been the Northwestern sector

of the United States.

The Company continues our marketing efforts to the animal therapy market, attempting to increase the exposure to

our product and generate revenue accordingly.

of December 31, 2023, the Company has $1,592,287 cash on hand.

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can be administered with small diameter needles (27-gauge) so there is minimal damage to the normal tissue.

This is in contrast to

the injection of metal seeds, which does considerable damage;

This contrasts with the

injection of metal seeds, which does considerable damage;

about 120 days the gel resorbs by a normal biological cycle, called the Krebs Cycle.

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are phosphate particles so small in diameter that it requires a high-resolution microscope to find them.

This is in contrast to permanent

This contrasts with permanent

presence of metal seeds.

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is determined by the dose prescribed by the doctor.

– RTU, Ready to Use

Inc now pre-mixes the particle solution and the hydrogel and places the RTU IsoPet in standard size vials.

Pre-Mixing – Ready to Use (“RTU”)

The Company now pre-mixes the particle solution and the hydrogel and places the RTU IsoPet® in standard size vials.

This innovation is cost effective

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training for new regional clinics.

vials are shipped via FedEx or UPS by following the proper protocols.

vials are shipped inside the specially designed plastic shipping pigs via FedEx or UPS, all following the proper protocols.

quantities and activities are in the information on the product label.

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The last remaining

animal test has been designed and has begun the initial scoping phase.

is currently fully developed, requiring only FDA approval before commercialization.

The Company has been seeking FDA approval of

RadioGel™ for almost five years.

Recent progress has been delayed due to a lack of adequate funding.

The principal issue preventing

approval is that the Company attempted to obtain regulatory approval for a broad range of Indications for Use, including all non-resectable

cancers, without sufficient supporting data.

animal test has been designed, and the Company has begun the initial scoping phase.

Company has been seeking FDA approval of RadioGel™ for almost five years.

Recent progress has been delayed due to a lack of adequate

The principal issue preventing approval is that the Company attempted to obtain regulatory approval for a broad range of Indications

for Use, including all non-resectable cancers, without sufficient supporting data.

are approximately 150 million pet dogs and cats in the United States.

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be treated, and have provided business contact information to the private clinics.

Villalobos has retired.

Richard Weller DVM, DACVIM,

is now the Chairman of the Veterinary Medicine Advisory Board.

In addition, John E.

Hendrich, PhD, DVM is a new member.

of the product and application techniques and animal testing is allowed under FDA regulation.

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Company currently intends to utilize university veterinary hospitals for therapy development, given that veterinary hospitals offer superior

and plentiful veterinarians and students, a large number of animal patients, radioactive material handling licenses, and are respected

by private veterinary centers and hospitals.

and plentiful veterinarians and students, many animal patients, radioactive material handling licenses, and are respected by private

veterinary centers and hospitals.

Company competes in a market characterized by technological innovation, extensive research efforts, and significant competition.

pharmaceutical and biotechnology industries are intensely competitive and subject to rapid and significant technological changes.

of companies are pursuing the development of pharmaceuticals and products that target the same diseases and conditions that our products

companies are pursuing the development of pharmaceuticals and products that target the same diseases and conditions that our products

We cannot predict with accuracy the timing or impact of the introduction of potentially competitive products or their possible

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significantly reduce our sales, which, in turn would adversely impact our financial and operating results.

are a wide variety of cancer treatments approved and marketed in the U.S.

There are a wide variety of cancer treatments approved and marketed

and globally.

General categories of treatment include surgery,

chemotherapy, radiation therapy and immunotherapy.

These products have a diverse set of success rates and side effects.

The Company’s

products, including RadioGel ™ , fall into the brachytherapy treatment category.

There are a number of brachytherapy devices

currently marketed in the U.S.

General categories of treatment include surgery, chemotherapy, radiation therapy and immunotherapy.

These products

have a diverse set of success rates and side effects.

The Company’s products, including RadioGel ™ , fall into the

brachytherapy treatment category.

There are a number of brachytherapy devices currently marketed in the U.S.

and globally.

The traditional iodine-125 (I-125) and palladium-103 (Pd-103) technologies for brachytherapy

are well entrenched with powerful market players controlling the market.

The industry-standard I-125-based therapy was developed by Oncura,

which is a unit of General Electric Company.

The traditional

iodine-125 (“ I-125 ”) and palladium-103 (“ Pd-103 ”) technologies for brachytherapy are well entrenched

with powerful market players controlling the market.

The industry-standard I-125-based therapy was developed by Oncura, which is a unit

of General Electric Company.

Additionally, C.R.

Bard, a major industry player competes in the I-125 brachytherapy marketplace.

These market competitors are also involved in the distribution of Pd-103 based products.

competitors are also involved in the distribution of Pd-103 based products.

Cs-131 brachytherapy products are sold by IsoRay.

Several Y-90 therapies have been FDA approved including SIR-Spheres by Sirtex, TheraSphere by Biocompatibles UK and Zevalin by Spectrum

Pharmaceuticals.

Company currently subcontracts the manufacturing of RadioGel TM at IsoTherapeutics.

Prior to 2021, Eckert and Ziegler was the

only supplier of Y-90 in the United States, and was the sole supplier of the Y-90 used by IsoTherapeutics to manufacture the Company’s

Y-90 therapies have been FDA approved including SIR-Spheres by Sirtex, TheraSphere by Biocompatibles UK and Zevalin by Spectrum Pharmaceuticals.

The Company currently subcontracts the manufacturing of RadioGel TM

at IsoTherapeutics.

Eckert and Ziegler is the sole supplier of the Y-90 used by IsoTherapeutics to manufacture the Company’s RadioGel ™ .

The Company obtains supplies, hardware, handling equipment and packaging from several different U.S.

Eckert and Ziegler previously

provided Y-90 to the USA from Germany, but we now receive the material from their Massachusetts operations.

We also spent more than a

year’s effort to prepare Eckert and Ziegler to become a full provider of the particles and hydrogel, and they currently are positioned

to become an alternate supplier should the need arise.

2021, the Company engaged Akina, Inc.

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as another alternate polymer supplier.

the future we will be looking to qualify an alternative particle supplier.

Company anticipates that potential customers for our potential brachytherapy products likely would include those institutions and individuals

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a company can market certain Class II medical devices that can be shown to be substantially equivalent to other legally marketed devices.

Company intends to apply for a de novo with an anticipated expenditure of $10.0 million over the next four years.

This expenditure

estimate includes anticipated costs associated with in vitro and in vivo pre-clinical testing, our application for an Investigational

Device Exemption, Phase I and Phase II clinical trials and our application for a de novo .

The Company intends to apply for a de novo petition with an

anticipated expenditure of $10.0 million over the next four years.

This expenditure estimate includes anticipated costs associated with

in vitro and in vivo pre-clinical testing, our application for an Investigational Device Exemption, Phase I and Phase II clinical trials

and our application for a de novo petition.

a registered medical device manufacturer with the FDA, we are subject to inspection to ensure compliance with FDA’s current Good

38 unchanged sentences

personnel are good.

Company prepares and files annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and certain other

information with the United States Securities and Exchange Commission (the “ SEC ”).

The SEC maintains an Internet site

that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC

at http://www.sec.gov.

Moreover, the Company maintains a website at http://www.RadioGel.com that contains important information about

the Company, including biographies of key management personnel, as well as information about the Company’s business.

This information

is publicly available and is updated regularly.

The content on any website referred to in this Annual Report is not incorporated by reference

into this Annual Report, unless (and only to the extent) expressly so stated herein.

The Company prepares and files annual reports on Form 10-K, quarterly

reports on Form 10-Q, current reports on Form 8-K and certain other information with the SEC.

The SEC maintains an Internet site that

contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov.

Moreover, the Company maintains a website at http://www.RadioGel.com that contains important information about the Company, including

biographies of key management personnel, as well as information about the Company’s business.

This information is publicly available

and is updated regularly.

The content on any website referred to in this Annual Report is not incorporated by reference into this Annual

Report, unless (and only to the extent) expressly so stated herein.

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 1. Business