What changed in this filing

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Item 1. Business

2025-03-24 compared with 2024-03-18 · 333 added, 393 removed, 212 unchanged (77% of the section changed)

is a radiation oncology medical device company engaged in the development of its yttrium-90 (“ Y-90 ”) based brachytherapy

device, RadioGel™, for the treatment of non-resectable tumors.

A prominent team of radiochemists, scientists, and engineers, collaborating

with strategic partners, including national laboratories, universities, and private corporations, lead the Company’s development

The Company’s overall vision is to globally empower physicians, medical researchers, and patients by providing them with

new isotope technologies that offer safe and effective treatments for cancer.

2013, the FDA issued the determination that RadioGel™ is a device for human therapy for non-resectable cancers in humans.

result in a faster path than a drug for final approval.

(the “ Company ,” “ we ,” “ us ,” “ our ”) is a radiation oncology

medical device company engaged in the development of its yttrium-90 (“ Y-90 ”) based precision radionuclide therapy

device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide Therapy TM .

A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories,

universities, and private corporations, lead the Company’s development efforts.

The Company’s overall vision is to globally

empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments

2013, the United States Food and Drug Administration (“ FDA ”) issued the determination that RadioGel™ is a device

for human therapy for non-resectable cancers in humans.

This should result in a faster path than a drug for final approval.

January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel TM should be classified as

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Additionally, after a legal review, the Company believes

that the device classification obtained from the Food and Drug Administration (“ FDA ”) Center for Veterinary Medicine

is not limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers, including

all or most solid tumors in animals.

We expect the result of such classification and label review will be that no additional regulatory

approvals are necessary for the use of IsoPet ® for the treatment of solid tumors in animals.

The FDA does not have premarket

authority over devices with a veterinary classification, and the manufacturers are responsible for assuring that the product is safe,

effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.

on the FDA’s recommendation, RadioGel TM will be marketed as “IsoPet ® ” for use by veterinarians

that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but

rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals.

We expect the

result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet ®

for the treatment of solid tumors in animals.

The FDA does not have premarket authority over devices with a veterinary classification,

and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance

with all applicable laws and regulations.

on the FDA’s recommendation, RadioGel TM is being marketed as “IsoPet ® ” for use by veterinarians

to avoid any confusion between animal and human therapy.

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and reserve “RadioGel TM” for human therapy.

Based on these developments, the Company has shifted its primary focus

to the development and marketing of Isopet ® for animal therapy, through the Company’s IsoPet ® Solutions

Historically, the Company’s primary focus was on the development

and marketing of Isopet ® for animal therapy, through the Company’s IsoPet ® Solutions division.

the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device

Exemption and to obtain approval for clinical trials in India.

Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement of

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in private clinics.

The Company has worked with three different university veterinarian hospitals on IsoPet ® testing and

Washington State University treated five cats for feline sarcoma and served to develop the procedures which are incorporated

in our label.

In January 2025 the Company restructured and aligned its internal resources and focused effort to align with animal

therapy, human therapy, and recently other applications of its patented technologies.

Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet ® /RadioGel TM

testing and therapy.

Washington State University treated five cats for feline sarcoma and served to develop the procedures which

are incorporated in our label.

They concluded that the product was safe and effective in killing cancer cells.

Colorado State University demonstrated

the CT and PET-CT imaging of IsoPet ® .

A contract was signed with University of Missouri to treat canine sarcomas and equine

sarcoids starting in November 2017.

dogs were treated for canine soft tissue sarcoma.

Response evaluation criteria in solid tumors (“ RECIST ”) is a set

of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during

The criteria were published by an international collaboration including the European Organisation for Research and Treatment

of Cancer (“ EORTC ”), National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical

Trials Group.

testing at the University of Missouri met its objective to demonstrate the safety of IsoPet®.

Using its advanced CT and PET equipment

it was able to demonstrate that the dose calculations were accurate and that the injections perfused into the cell interstices and did

not stay concentrated in a bolus.

This results in a more homogeneous dose distribution.

There was insignificant spread of Y-90 outside

the points of injection demonstrating the effectiveness of the particles and the gel to localize the radiation with no spreading to the

blood or other organs nor to urine or fecal material.

This confirms that IsoPet® is safe for same day therapy.

effectiveness of IsoPet® for life extension was not the prime objective, but it resulted in valuable insights.

Of the cases one is

still cancer-free but the others eventually recurred since there was not a strong focus on treating the margins.

The University of Missouri

has agreed to become a regional center to administer IsoPet® therapy and will incorporate the improvements suggested by the testing

Company anticipates that future profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet ® )

and related services, and from licensing to private medical and veterinary clinics in the U.S.

and internationally.

The Company intends

to report the results from the IsoPet ® Solutions division as a separate operating segment in accordance with GAAP.

Colorado State University

demonstrated the CT and PET-CT imaging of IsoPet ® .

The University of Missouri conducted an animal study to treat canine

Johns Hopkins University completed a study on VX2 Tumors in Rabbits.

Every study confirmed that the Y-90 stayed at the injection

site with insignificant distribution outside that boundary.

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

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

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®

Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet ® )

and related services, and from certifying veterinary clinics to administer IsoPet Therapy.

Until recently the Company certified clinics

at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its first clinic for the certification

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

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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

or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical

RadioGel™ is an injectable particle-gel for Precision Radionuclide Therapy 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.

2021 the 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 or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical

remnant ablation (for example, after prior incomplete radioiodine therapy).

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The Company’s Medical Advisory

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

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.

We have expanded our trademark protection from RadioGel to now include IsoPet.

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).

Seven of our claims were immediately ruled as having novelty, inventive step and industrial applicability.

This gives us the basis to

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

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 18 months

of development work to optimize our hydrogel component.

These include reducing the polymer production time and increasing the output

by a factor of three.

We have also further reduced the level of trace contaminants to be well below the FDA guidelines.

filed a provisional patent (Serial Number 63436562) to protect our innovative improvements in our shipping container, our vial shield,

our syringe shield, and our Peltier chiller.

Our objectives were to reduce shipping costs, decrease radiation exposure, and enhance sterility.

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

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).

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.

Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance.

December 2023, the Food and Drug Administration granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device

pursuant to the FDA’s Breakthrough Devices Program.

This gave the company access to the “sprint” rapid review process

for IDE comments.

For the last several months the company has been taking advantage of that program to resoled detailed FDA questions

on a variety of topics.

early 2025 the Company began actively pursuing human clinical trials in India.

This involved successful step-by-step implementation of

several requirements, including location of a respected lead investigator at a respected hospital;

regulatory approvals (securing clearances

from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health

& Family Welfare, and the Company was issued the Clinical Trial Registry-India (CTRI) number required for publishing results);

coordination (acquired liability insurance, expanded the treatment institution’s radioactive material license to include RadioGel ® ,

and established robust international shipping protocols and an alternate contingency shipping path for the Yttrium-90 (Y-90)-based product);

protocol development (finalized the Clinical Trial Protocol, incorporating Mayo Clinic study designs and feedback from FDA pre-submission

discussions);

operational readiness (re-validated RadioGel ® manufacturing at IsoTherapeutics to ensure compliance with

Quality Management System standards and FDA sterility and validation recommendations);

administrative preparations (signed agreements

with the Ethics Committee and treatment institution while confirming trademark and patent protections in the region);

and training and

certification (conducted comprehensive certification training for the treatment team).

Failure on any step would have terminated the effort.

December 2024 the Company conducted an important offset strategic meeting to ensure that its entire key internal and external team was

alighted to its strategic plans.

Attendees included all our current internal team members, our senior health physics volunteer, the members

of the Medical Advisory Board and the Veterinary Medicine Advisory Board, lead Investigator for the proposed Mayo Clinic clinical trial,

lead investigator for the clinical trial in India, and our patent attorney.

The primary objective was to re-assess our business direction,

to select the next target series of indications for Use, to ensure that we have developed the optimum precision Radionuclide Therapy TM

approach for each cancer type, including the isotope, the delivery technique, and the dose, and to ensure that our current and

future patents protect these directions.

It also discussed the domestic and internation plans.

Company decided to explore the viability of harvesting its technology for other business opportunities as a separate “division.”

The Company is working with Akina, on these initiatives.

The current efforts are on the Peltier Chiller technology and the hydrogel.

To prevent the Company from being distracted from its primary focus of treating cancer, if viable, Akina would probably also be the principal

Alternatively, each business sector can be spun off as separate business activities to an interested party.

Laboratory Chilling - As Akina explained, it is easy to purchase many laboratory devices to control heating, but there are limited or

no options for controlled cooling, which is a common laboratory requirement usually involving ice baths.

The Company is now testing a

prototype universal laboratory cooling device.

– the Company spent years on refining the development of its hydrogel, in which gelation initiates just above room temperature

and is completed as it warms to body temperature.

It is currently investing in quantifying and controlling the hydrogel resorption characteristics.

There has been sufficient spontaneous interest in this component to warrant a serious business case assessment.

The Company just trademarked

the name Precision Gel TM and, in addition to its current hydrogel patent, has filed a new provisional patent in January 2025

to cover retention, transport, and release of a broad range of agents.

These agents include radioactive and non-radioactive materials,

solid particles, including nano-particles, large molecules, small molecules, including liquids, cells, and viruses.

A MOU has been drafted

to interface with potential clients including licensing and exclusive material contracting.

Initial meetings are scheduled in the first

quarter of 2025 with potential clients to assess the business viability.

original license agreement with Battelle National Laboratory (the “ Battelle License ”) reached its end of life in 2022.

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 during the past several years.

trademark protection, which usually is extended to 17 countries, has been expanding continuously as summarized below:

own applications/registrations for the following and should mark as noted below:

RADIONUCLIDE THERAPY TM

PRECISIONGEL TM

we have systematically filed provisional and utility patents that cover our key components, hydrogel and the yttrium phosphate

particles, and our injection system in the US office and more than ten others covering approximately 63 counties.

January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel.

Regional Clinics

currently have four regional therapy clinics:

Veterinary Hospital – Kennewick, WA

of Missouri – Columbia, MO

Hopkins University – Baltimore, MD

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 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.

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

has done well in several audits by the Washington State Department of Health.

The Company worked closely with the Washington State Department

of Health to refine and improve the radioactive material license by adding several detailed procedures, which will benefit future regional

In addition, a second veterinarian has been certified.

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

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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.

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.

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

to help the pet resorb the necrotic tissue rapidly.

In addition, IsoPet ® was used to treat a mast cell tumor.

cancers are destroyed, they release their mast cell.

The animal was treated with a steroid to counter this effect, and to date, is doing

Company’s efforts are now to obtain more early-stage cancer patients.

The biggest obstacle is to convince the veterinarians of

the pet parents to agree with IsoPet ® therapy rather than using a more traditional method such as surgery.

This is a slow

process due to the conservative nature of the veterinarian professions.

This is the prime motivation to continue with additional clinical

trials and to publish the results.

Company worked closely with FX Masse to develop nine certification training modules for use in potential regional clinics.

These modules

are necessary to satisfy the radioactive material handling licenses.

This approach is very cost effective.

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

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.

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 for publication.

The study further demonstrated the safety of RadioGel ® , 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;

the validity of the Injection Guidance Table;

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

classification as a breakthrough device was positively influenced by the safety and effectiveness of many animal therapies.

expanded the number of IsoPet Certified clinic from 4 in 2023 to 13 by the end of 2024:

Veterinary Hospital – Kennewick, WA

of Missouri – Columbia, MO

Hopkins University – Baltimore, MD

England Equine Practice – Patterson, NY

Equine Clinic, Rochester, NH

of Wisconsin School of Veterinary Medicine, Madison, W

Valley Equine Hospital, Navasota, TX

Creek Veterinary Hospital, Fort Wayne, IN

Animal Hospital - Hopkinton, N

VETS Veterinary Emergency Trauma & Specialty Center, Robbinsville, NJ

Emergency & Specialty Center of Knoxville, Knoxville, TN

Veterinary Hospital, Sumner, WA

University of Illinois College of Veterinary Medicine, Urbana, IL

now treat feline, canine, equine, and exotic animals.

are targeting to open approximately ten more clinics in 2025.

Company worked closely with FX Masse to assist the clinics with licensing.

They developed nine certification training modules for use

in potential regional clinics.

These modules are necessary to satisfy the radioactive material handling licenses.

2024, the Company saw the development of three new websites to elevate the online presence and brand identity.

These included a corporate

website and dedicated sites for its two divisions, RadioGel ® and IsoPet ® , tailored to their unique audiences.

Each site featured user-friendly designs, informative content, and engaging blogs to educate visitors and build industry authority.

Materials were created that effectively communicated our innovative cancer treatment Precision Radionuclide Therapy™.

team managed a booth at six conferences.

LeeAnna Binder toured the country discussing IsoPet therapy with several clinics in a specially modified IsoPet van.

To amplify visibility, our marketing team managed and maintained an

active presence on social media platforms, including Facebook, Instagram, X, and LinkedIn, with consistent, engaging posts to

connect with our target audience.

This comprehensive approach enhanced brand recognition, drove traffic to our websites, and

supported business growth.

2024, IsoPet Division transitioned from data collection to commercialization, utilizing our extensive data to refine our offerings.

collaborating closely with certified clinics, we have recalibrated our pricing to make our services more affordable for pet patients.

As we enter 2025, with plans to expand our clinic network across strategic US regions, we are excited about enhancing pet care nationwide.

With increasing patient volumes, we are also aligning with our production team to establish a more defined ordering schedule.

This strategy

will help synchronize patient bookings with product availability, ultimately reducing production costs and making IsoPet’s solutions

even more accessible.

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

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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

(Q130140) to obtain FDA feedback about the proposed product.

The FDA requested that the Company file a request for designation with the

Office of Combination Products (RFD130051), which led to the determination that RadioGel™ is a device for human therapy for non-resectable

cancers, which must be reviewed and ultimately regulated by the Center for Devices and Radiological Health (“ CDRH ”).

The Company then submitted a 510(k) notice for RadioGel™ (K133368), which was found Not Substantially Equivalent due to the lack

of a suitable predicate, and RadioGel™ was assigned to the Class III product code NAW (microspheres).

Class III products or devices

are generally the highest risk devices and are therefore subject to the highest level of regulatory review, control, and oversight.

III products or devices must typically be approved by FDA before they are marketed.

Class II devices represent lower risk products or

devices than Class III and require fewer regulatory controls to provide reasonable assurance of the product’s or device’s

safety and effectiveness.

In contrast, Class I products and devices are deemed to be lower risk than Class I or II, and are therefore

subject to the least regulatory controls.

Regulatory Status- Recent Developments

November 2020 the Company submitted a request for a Breakthrough Device Designation.

Ultimately, this was denied, but the FDA acknowledged,

“The FDA does believe that RadioGel™ meets criterion #2a:

Device represents breakthrough technology.

Your device does

meet this criterion because it is a novel application of a precision radionuclide therapy device outside of the liver.” More

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

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 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 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 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.

May of 2022 the Company held another pre-submission 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 participated in another pre-submission meeting to discuss

this new animal test of VX-2 tumors in rabbits at Johns Hopkins.

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

feedback on our new animal test plan.

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.

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 protocol.

providing addition information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication

September 2024 the company has been engaged in the sprint process to discuss several FDA comments in detail.

There will continue through

February 2024, at which time we will re-submit the request for an IDE.

In parallel, the Company is working with the Mayo Clinic’s

principal investigators to improve the clinical trial protocol for their Institutional Review Board.

Medical Advisory Board (“ MAB ”) selected 18 applications for RadioGel™, each of which meet the criteria described

This large number confirms the wide applicability of the device and defines the path for future business growth.

The Company’s

application establishes a single Indication for Use - treatment of cancerous tissue or solid tumors pathologically associated with locoregional

papillary thyroid carcinoma and recurrent papillary thyroid carcinoma.

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

After the second

Indication for Use, our objective is to apply for a broad Indication for Use which we would target to obtain approval to treat all solid

Device Designation:

2014, the Company submitted a presubmission (Q130140) to obtain FDA feedback about the proposed product.

The FDA requested that the Company

file a request for designation with the Office of Combination Products (RFD130051), which led to the determination that RadioGel™

is a device for human therapy for non-resectable cancers, which must be reviewed and ultimately regulated by the Center for Devices and

Radiological Health (“ CDRH ”).

The Company then submitted a 510(k) notice for RadioGel™ (K133368), which was

found Not Substantially Equivalent due to the lack of a suitable predicate, and RadioGel™ was assigned to the Class III product

code NAW (microspheres).

Class III products or devices are generally the highest risk devices and are therefore subject to the highest

level of regulatory review, control, and oversight.

Class III products or devices must typically be approved by FDA before they are marketed.

Class II devices represent lower risk products or devices than Class III and require fewer regulatory controls to provide reasonable

assurance of the device’s safety and effectiveness.

In contrast, Class I products and devices are deemed to be lower risk than

Class I or II, and are therefore subject to the least regulatory controls.

pre-submission meeting (Q140496) was held with the FDA on June 17, 2014, during which the FDA maintained that RadioGel™ should

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animal testing.

Company believes that its submissions to the FDA to date have addressed all the FDA staff’s feedback over the past four years.

Of particular importance, the Company has provided corresponding supporting data for proposed future testing of RadioGel™ to address

any remaining questions raised by the FDA.

We believe, although no assurances can be given, that the clinical testing modifications presented

to the FDA in August 2017 will result in a de novo reclassification for RadioGel™ by the FDA.

In addition, in previous FDA

submittals, the Company proposed applying RadioGel™ for a very broad range of cancer therapies, referred to as Indication for Use.

The FDA requested that the Company reduce its Indications for Use.

To comply with that request, the Company expanded its Medical Advisory

Board (“ MAB ”) and engaged doctors from respected hospitals who have evaluated the candidate cancer therapies based

on three criteria:

(1) potential for FDA approval and successful therapy; (2) notable advantage over current therapies; and

(3) probability of wide-spread acceptance by the medical community.

November 2020 the Company submitted a request for a Breakthrough Device Designation.

Ultimately, this was denied, but the FDA acknowledged,

“The FDA does believe that RadioGel™ meets criterion #2a:

Device represents breakthrough technology.

Your device does

meet this criterion because it is a novel application of a brachytherapy device outside of the liver.” More importantly the

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

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.

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

This large number confirms the

wide applicability of the device and defines the path for future business growth.

The Company’s application establishes a single

Indication for Use - treatment of cancerous tissue or solid tumors pathologically associated with locoregional papillary thyroid carcinoma

and recurrent papillary thyroid carcinoma.

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:

the effort to communicate the benefits of IsoPet ® to the veterinary community and the pet parents.

additional clinical studies to generate more data for the veterinary community.

some IsoPet ® therapies, if necessary, to ensure that all viable candidates are treated.

a new regional clinic with their license and certification training.

the human market:

the pedigree of the Quality Management System.

the previously defined pre-clinical testing and additional testing on an animal model closely aligned with our revised indication

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

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.

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

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

additional studies which may possibly include clinical studies.

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

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

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

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

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,

distribution, sales and marketing.

Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate

its global commercialization strategy.

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.

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) 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 depends on the speed of FDA approval for clinical trials.

The currently approved

1-A Reg A provided a basis for obtaining most of the required investment, assuming there are willing investors.

The Company intends to

reduce its funding requirement via generating income from sales in the animal sector.

of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.

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’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, 2024, the Company has $2,212,548 cash on hand.

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obligations of the Company.

is no guarantee that the Company will be able to raise additional funds or to do so at an advantageous price.

The company has been utilizing the previously authorized Reg A as the principal vehicle to obtain funding

and intends to continue to bring in the funding necessary to support the projected activities through 2027.

There is no guarantee that

the Company will be able to raise additional funds or to do so at an advantageous price.

Company’s RadioGel™ device has the following product features:

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from Production to Therapy

the next two years, the Company intends to outsource material aspects of manufacturing and distribution.

As future product volume increases,

the Company will reassess its make-buy decision on manufacturing and will analyze the cost/benefit of a centrally located facility.

the next two years, the Company intends to continue to outsource material aspects of manufacturing and distribution.

As future product

volume increases, the Company will reassess its make-buy decision on manufacturing and will analyze the cost/benefit of a centrally located

of the Hydrogel

is manufactured with a proprietary process under ventilated sterile hood by following strict Good Laboratory Practices (“ GLP ”)

is manufactured with a proprietary process under ventilated sterile hood by following strict Good Management Practices (“ GMP ”)

It is made in large batches that are frozen for up to three months.

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of the Yttrium-90 Phosphate Particles

Y-90 particles are produced with simple ingredients via a proprietary process, again following strict GLP procedures.

Y-90 particles are produced with simple ingredients via a proprietary process, again following strict GMP procedures.

They are then mixed

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is determined by the dose prescribed by the doctor.

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

and reduces the probability of any accidental spills or biological contamination at the therapy sites.

It also simplified the certification

training for new regional clinics.

– Ready to Use (“RTU”)

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

This innovation is

cost effective and reduces the probability of any accidental spills or biological contamination at the therapy sites.

It also simplified

the certification training for new regional clinics.

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.

specific injection technique depends on the Indication for Use.

For small tumors, one centimeter in diameter or less, the cancer is treated

with a single injection.

For larger tumors, the cancer is treated with a series of small injections from the same syringe or multiple

specific injection technique described on the Instructions for Use.

For small tumors, one centimeter in diameter or less, the cancer

is treated with a single injection.

For larger tumors, the cancer is treated with a series of small injections from the same syringe

or multiple syringes.

Company is currently pursuing two synergistic business sectors, medical and veterinary, each of which are summarized below.

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The last remaining

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.

animal test has been completed, and the Company is engaged in the detailed sprint revie process.

trials have just initiated in India.

It is anticipated that these data will help accelerate FDA approval in the USA.

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

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reports that about six million dogs are diagnosed with cancer each year, translating to more than 16,000 a day.

Company’s IsoPet ® operating division focuses on the veterinary oncology market.

Alice Villalobos, a founding

member of the Veterinary Cancer Society and the Chair of our Veterinary Medicine Advisory Board, has been providing guidance to management

regarding this market.

The Veterinary Medicine Advisory Board gives us recommendations regarding the overall strategy for our animal

business sector.

Specially, they recommended the university veterinary hospitals for demonstration therapies, the specific cancers to

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.

Company’s IsoPet ® operating division focuses on the veterinary oncology market Richard Weller DVM, DACVIM, is now

the Chairman of the Veterinary Medicine Advisory Board.

In addition, John E.

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

There are a wide variety of cancer treatments approved and marketed

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

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

Radiogel™ precision radionuclide therapy product would generally compete with 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 are

well entrenched with powerful market players.

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

Electric Healthcare.

Additionally, C.R.

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

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

Cs-131 brachytherapy products are sold by IsoRay.

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.

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

These market competitors are

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

Cs-131 brachytherapy products are marketed by GT MedTech.

Several Y-90 therapies

have been FDA approved including SIR-Spheres by Sirtex, TheraSphere by Biocompatibles UK.

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.

2024 IsoTherapeutics was acquired by Telix.

That has stimulated Vivos to accelerate its efforts to develop an additional manufacturing

Our objective is to develop more than one alternative to manufacture our components by 2026.

2021, the Company engaged Akina, Inc.

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as another alternate polymer supplier.

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

that currently purchase brachytherapy products or other oncology treatment products.

We are completing the actions to expand Akina’s role to be the supplier of sterilized hydrogel,

PrecisionGel TM .

Company anticipates that potential customers for our potential precision radionuclide therapy products likely would include those

institutions and individuals that currently purchase brachytherapy products or other oncology treatment products.

We anticipate that

the veterinarian and medical communities will recognize the Precision Radionuclide Therapy TM as the best option for

treating many solid tumors.

Company’s present and future intended activities in the development, manufacturing, and sale of cancer therapy products, including

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or clear product approval applications, disqualification from sponsoring or conducting clinical investigations, preventing us from entering

into government supply contracts, withdrawal of previously approved applications, and criminal prosecution.

government supply contracts, withdrawal of previously approved applications, and criminal prosecution.

the United States, medical devices are classified into three different categories over which the FDA applies increasing levels of regulation:

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RadioGel ™ is currently classified as a Class

of new Class III medical devices is a lengthy procedure and can take a number of years and require the expenditure of significant resources.

of new Class III medical devices is a lengthy procedure and can take several years and require the expenditure of significant resources.

There is a shorter FDA review and clearance process for Class II medical devices, the premarket notification or 510(k) process, whereby

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

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

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agencies depending on the nature of the substance or waste material.

We believe that we are in compliance with all federal and state

regulations for this purpose.

We believe that we follow all federal and state regulations for

this purpose.

Environmental

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shipping company during shipment and misuse by the treatment facility upon arrival.

of December 31, 2023, the Company had one full-time personnel.

The Company utilizes several independent contractors to assist with its

The Company does not have a collective bargaining agreement with any of its personnel and believes its relations with its

personnel are good.

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.

2017, the Company has followed the cost-effective model of having had one full-time employee, the CEO.

The Company utilizes several independent

contractors to assist with its operations.

This includes key positions, such as acting CFO and Quality Assurance Manager.

does not have a collective bargaining agreement with any of its personnel and believes its relations with its personnel are good.

enables the Company to operate on very low overhead, for cost-effective utilization of its investment and to manage our work scope like

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 Offering Circular is not incorporated by reference into this Offering Circular, 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