What changed in this filing

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Item 1. Business

2022-03-07 compared with 2021-03-24 · 516 added, 542 removed, 102 unchanged (91% 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 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 for cancer.

2013 the 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 a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.

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.

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

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.

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

a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.

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

to avoid any confusion between animal and human therapy.

The Company already has trademark protection for the “IsoPet ®

and RadioGel TM are used synonymously throughout this document.

The only distinction between

and RadioGel TM is the FDA’s recommendation that we use “IsoPet®”

for veterinarian

usage, 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 division.

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

of university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the

technology in private clinics.

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

The Company already has trademark protection for the “IsoPet ® ”

IsoPet ® and RadioGel TM are used synonymously throughout this document.

The only distinction between IsoPet ®

and RadioGel TM is the FDA’s recommendation that we use “IsoPet ® ” for veterinarian usage,

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

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

university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the technology

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

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Colorado State University demonstrated

the CT and PET-CT imaging of IsoPet®.

the CT and PET-CT imaging of IsoPet ® .

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

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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 treatment.

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.

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

effectiveness of IsoPet®

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

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 program.

Company anticipates that future profits, if any, will be derived from direct sales of RadioGel™

(under the name IsoPet®)

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.

intends to report the results from the IsoPet®

Solutions division as a separate operating segment in accordance with GAAP.

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.

The Company intends

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

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.

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

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®

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

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.

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 particles.

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

very high local radiation dose.

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 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).

Papillary thyroid carcinoma belongs

to the general class of head and neck tumors for which tumors are accessible by intraoperative direct needle injection.

The Company’s

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

Company’s lead brachytherapy products, including RadioGel™, incorporate patented technology developed for Battelle

Memorial Institute (“

Battelle ”) at Pacific Northwest National Laboratory, a leading research institute for

government and commercial customers.

Battelle has granted the Company an exclusive license to patents covering the manufacturing,

processing and applications of RadioGel™

Battelle License ”).

This exclusive license is to terminate

upon the expiration of the last patent included in this agreement (May 2022).

Other intellectual property protection includes

proprietary production processes and trademark protection in 17 countries.

The Company plans to continue efforts to develop new

refinements on the production process, and the product and application hardware, as a basis for future patents.

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 Radiogel™.

As part of the normal review process, we have also

submitted the technical justification for seven additional claims.

We are in the process of filing patent claims in Canada, UK

(Great Britain, Scotland, Wales and Ireland), Japan, Germany, Italy, France, Australia, Brazil, China, India, North Countries

(Sweden, Norway, Finland, and Denmark).

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

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).

Papillary thyroid carcinoma belongs to the general class

of head and neck tumors for which tumors are accessible by intraoperative direct needle injection.

The Company’s Medical Advisory

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

Company’s lead brachytherapy products, including RadioGel™, incorporate patented technology developed for Battelle Memorial

Institute (“ Battelle ”) at Pacific Northwest National Laboratory, a leading research institute for government and commercial

Battelle has granted the Company an exclusive license to patents covering the manufacturing, processing and applications of

RadioGel™ (the “ Battelle License ”).

This exclusive license is to terminate upon the expiration of the last patent

included in this agreement (May 2022).

Other intellectual property protection includes proprietary production processes and trademark

protection in 17 countries.

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

During the past several years, in anticipation

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

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

We obtained the International Certificate of Registration

for ISOPET, which is the first step to file in several countries .

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 Radiogel™.

filed its particle patent in several countries and in parallel is

pursuing amendments to increase the number of claims.

addition to the United States of America, our new patent team filed in Canada, the European Union, Japan, Australia, Brazil, China, India,

South Korea, and the Russian Eurasian (Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan,

Tajikistan, and Turkmenistan) .

have just filed a new provisional patent to protect our current and planned developments.

It includes a summary of our improved hydrogel

formulation and production process, the use of other particles incorporating other isotopes beyond Y-90, and the anti-circumvention techniques

we discovered that would make it more difficult for competitors to engineer around our proprietary hydrogel with other hydrogels from

our defensive effort we call our “knock-off red team exercise”.

the provisional patent, we will file for utility patents on our polymer/hydrogel improvements.

These include reducing

the polymer production time and increasing the output by a factor of three.

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

currently are developing a micro-injection system for

small tumor therapy.

This will provide more precise controls for treating cancerous thyroid lymph nodes.

It will also be valuable if

the company pursues other future indications for use that will require precise micro-injections, e.g.

ocular melanoma, spinal tumors

and brain cancers.

Veterinary Hospital

Veterinary Hospital (“

Vista ”) was selected as the pilot private clinic to initiate commercial sales of IsoPet ®

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.

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

The pilot is being used to

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;

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 ®

center, to allow distribution for commercial applications;

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;

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and post regulatory signage;

different IsoPet ®

pricing options;

different IsoPet ® pricing options;

different approaches to obtain patients;

3 unchanged sentences

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.

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 in close proximity to the injections.

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

tissue in close proximity to the injections.

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 63 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.

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 84 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”

Those patients would have been treated by regional

clinics once we implement that strategy.

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

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 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.

One animal, 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.

For the first time a second therapy was administered and the tumor

has continued to decrease in size.

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.

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.

RadioGel™

has a long regulatory history with the Food and Drug Administration (“

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™

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™

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 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.

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

should be considered a Class III device and therefore subject to pre-market approval.

On December 29, 2014, the Company submitted

a de novo petition for RadioGel™

The de novo petition was denied by the FDA on June 1, 2015,

with the FDA providing numerous comments and questions.

On September 29, 2015, the Company submitted a follow-up pre-submission

informational meeting request with the FDA (Q151569).

This meeting took place on November 9, 2015, at which time the FDA indicated

acceptance of the Company’s applied dosimetry methods and clarified the FDA’s outstanding questions regarding RadioGel™.

Following the November 2015 pre-submission meeting, the Company prepared a new pre-submission package to obtain FDA feedback on

the proposed testing methods, intended to address the concerns raised by the FDA staff and to address the suitability of RadioGel™

for de novo reclassification.

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

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.

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.

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.

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

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.

currently are working with the NY Surgical Center on Long Island to become a new IsoPet Regional Center.

They have completed their certification

training and have submitted their Radioactive Material Handling License application to the NY regulators.

Aside from the normal solid

tumor therapy they are interested in treating the margins for resected tumors and to use their surgical techniques to treat tumors deep

within the body, such as bladder cancers.

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

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

be considered a Class III device and therefore subject to pre-market approval.

On December 29, 2014, the Company submitted a de novo

petition for RadioGel™ (DEN140043).

The de novo petition was denied by the FDA on June 1, 2015, with the FDA providing

numerous comments and questions.

On September 29, 2015, the Company submitted a follow-up pre-submission informational meeting request

with the FDA (Q151569).

This meeting took place on November 9, 2015, at which time the FDA indicated acceptance of the Company’s

applied dosimetry methods and clarified the FDA’s outstanding questions regarding RadioGel™.

Following the November 2015

pre-submission meeting, the Company prepared a new pre-submission package to obtain FDA feedback on the proposed testing methods, intended

to address the concerns raised by the FDA staff and to address the suitability of RadioGel™ for de novo reclassification.

This pre-submission package was presented to the FDA in a meeting on August 29, 2017.

the August 2017 meeting, the FDA clarified their position on the remaining pre-clinical testing needed for RadioGel™.

Specifically,

the FDA addressed proposed dosimetry calculating techniques, dosimetry distribution between injections, hydrogel viscoelastic

properties, and the details of the Company’s proposed animal testing.

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

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™

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.

During the August 2017 meeting, the FDA clarified

their position on the remaining pre-clinical testing needed for RadioGel™.

Specifically, the FDA addressed proposed dosimetry calculating

techniques, dosimetry distribution between injections, hydrogel viscoelastic properties, and the details of the Company’s proposed

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.

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:

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 IDE and saved the Company much time in the review of that future application.

MAB selected eighteen 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, and the testing for many of the subsequent applications could be conducted

in parallel, depending on available resources.

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

The Company requires funding of approximately $2 million annually to maintain current operating activities.

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.

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

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

requirements for additional studies which may possibly include clinical studies.

Thereafter, the principal variables in the amount

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

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

success in the U.S.

and elsewhere.

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

and partnership agreements or additional capital raises.

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.

Company received $497,880 which were deposited into the Company’s accounts between April and June 2020.

Following the clearance

of the Regulation A+ offering by the SEC on June 3, 2020, the common shares for these proceeds were issued.

In addition, the Company

exchanged their outstanding convertible notes payable of $525,000, $27,536 in accrued interest and $98,508 in an exchange premium

stipulated in the note agreements into shares of common stock, and repaid $50,000 in promissory notes payable.

In addition, the

Company raised $1,138,800 in the Regulation A+ from November 30, 2020 through December 3, 2020 and issued 42,177,778 shares of

common stock and sold 19,200,000 warrants for $19,200 in these offerings.

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

on June 3, 2020 and have issued the first tranche of shares under the Regulation A+ on June 10, 2020, and amended on February

The intent is to raise up to an additional $1,800,000 over the next 12 months, which may be completed in separate closings.

Company intends to use the proceeds generated from the sale of shares under Regulation A+ as follows:

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 IDE 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.

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.

parallel the Company 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.

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, and the testing for many of the subsequent applications could be conducted in parallel, depending on

available resources.

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.

Company’s initial Regulation A+ raised approximately $4,000,000 from the sale of shares under Regulation A+, and intends to use

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.

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.

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

a new regional clinic with their license and certification training.

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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

on the Company’s financial history since inception, its auditor has expressed substantial doubt as to the Company’s

ability to continue as a going concern.

The Company has limited revenue, nominal cash, and has accumulated deficits since inception.

If the Company cannot obtain sufficient additional capital, the Company will be required to delay the execution of its business

strategy and may not be able to continue operations.

Although management believes that it will be able to secure necessary working

capital to fund its development programs and execute its business strategy, no assurances can be given.

Company’s RadioGel™

device has the following product features:

particles only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the nearby

normal tissues.

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.

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 recent qualified Regulation A+.

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 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.

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

substantial doubt as to the Company’s ability to continue as a going concern.

The Company has limited revenue, nominal cash, and

has accumulated deficits since inception.

If the Company cannot obtain sufficient additional capital, the Company will be required to

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 initial epicenter of the COVID-19 outbreak in

the United States.

The Company has started to in recent weeks to continue their marketing to the animal therapy market and attempt to

increase the exposure to their product and generate revenue accordingly.

of December 31, 2021, the Company has $1,606,123 cash on hand.

There are currently commitments to vendors for products and services purchased.

To continue the development of the Company’s products, the current level of cash may not be enough to cover the fixed and variable

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.

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

particles only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the nearby normal

In medical terms Y-90 beta emitter has a high efficacy rate;

from the short penetration distance, the patient can go home immediately with no fear of exposure to family members, and there

is a greatly reduced radiation risk to the doctor.

A simple plastic tube around the syringe, gloves and safety glasses are

all that is required.

from the short penetration distance, the patient can go home immediately with no fear of exposure to family members, and there is

a greatly reduced radiation risk to the doctor.

A simple plastic tube around the syringe, gloves and safety glasses are all that

Other gamma emitting products require much more protection;

2.7-day half-life means that only 5% of the radiation remains after ten days.

This is in contrast to the industry-standard

gamma irradiation product, which has a half-life of 17 days;

This is in contrast to the industry-standard gamma

irradiation product, which has a half-life of 17 days;

short half-life also means that any medical waste can be stored for thirty days then disposed as normal hospital waste;

RadioGel™

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 is in contrast to

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 presence of metal seeds.

This is in contrast to permanent

presence of metal seeds.

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

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.

of the Hydrogel

RadioGel™

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

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

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

When the product is ready to ship, a small quantity

of the gel is dissolved in a sterile saline solution.

When the product is ready to ship, a small quantity of

the gel is dissolved in a sterile saline solution.

It is then passed through an ultra-fine filter to ensure sterility.

1 unchanged sentence

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

then mixed into a phosphate-buffered saline solution.

They are then mixed

into a phosphate-buffered saline solution.

They can be produced in large batches for several shipments.

of particles per shipment is determined by the dose prescribed by the doctor.

RadioGel™

The number of particles per shipment

is determined by the dose prescribed by the doctor.

is shipped in two containers, one with a solution of the gel and the other with a solution of the particles.

Before shipment they

are subjected to sterility testing, again by strict procedures.

The vial with the Y-90 is put through a special radiation calibrator,

which measures beta particles.

Before shipment they are

subjected to sterility testing, again by strict procedures.

The vial with the Y-90 is put through a special radiation calibrator, which

measures beta particles.

The vials can be shipped via FedEx or UPS by following the proper protocols.

user receives the two vials.

The solution containing the RadioGel™

is mixed with the solution containing the Y-90 particles.

The solution containing the RadioGel ™ is mixed with the solution containing the Y-90 particles.

This is then shaken to ensure homogeneity and withdrawn into a syringe.

The quantities that are mixed are calculated from the

information on the product label.

The quantities that are mixed are calculated from 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 syringes.

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

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

RadioGel™

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

The Company has been seeking FDA approval

of RadioGel™

for almost five years.

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.

on the FDA’s ruling of RadioGel™

as a device, the Company is currently developing test plans to address issues raised

in the Company’s prior FDA submittal regarding RadioGel™.

The Company intends to request FDA approval to submit RadioGel™

for de novo classification, which would reclassify the device from a Class III device to a Class II device and accelerate

the regulatory approval path.

analyzing the Company’s data and the last five years of communication from the FDA, the Company has taken the following

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.

on the FDA’s ruling of RadioGel ™ as a device, the Company is currently developing test plans to address issues

raised in the Company’s prior FDA submittal regarding RadioGel ™ .

The Company intends to request FDA approval to

submit RadioGel™ for de novo classification, which would reclassify the device from a Class III device to a Class II device

and accelerate the regulatory approval path.

analyzing the Company’s data and the last five years of communication from the FDA, the Company has taken the following steps:

new leadership, the Company is implementing all past recommendations from the FDA.

1 unchanged sentence

for Use, will provide test plans for FDA review to respond to answer all previous FDA questions, and will request a pre-submission

a pre-submission request document and FDA meeting request to obtain feedback on the test plans in order to initiate testing,

to present the proposed content for the final application and to request permission to submit a de novo;

an Investigational Device Exemption (“

IDE ”) to obtain permission to conduct human clinical studies;

a pre-submission request document and FDA meeting request to obtain feedback on the test plans in order to initiate testing, to present

the proposed content for the final application and to request permission to submit a de novo;

an Investigational Device Exemption (“ IDE ”) to obtain permission to conduct human clinical studies;

a de novo or Pre-Market Approval application.

critical path is the required testing –

in vitro, animal testing, human clinical studies –

all of which is resource

previous submittals, the Company proposed applying a very broad range of cancer therapies, referred to as Indications for Use,

to RadioGel™.

critical path is the required testing – in vitro, animal testing, human clinical studies – all of which is resource dependent.

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

The FDA has strongly advised the Company to reduce its Indications for Use.

To comply with that request, the

Company has expanded its MAB, consisting of Drs.

To comply with that request, the Company has expanded its

MAB, consisting of Drs.

Pressman (Chairman), Albert DeNittis, and Howard Sandler.

1 unchanged sentence

(i) the potential for FDA approval and successful therapy;

(ii) notable advantages of RadioGel™

over current therapies;

and (iii) the likelihood that RadioGel™

can be widely

accepted by the medical community and profitably commercialized.

MAB selected eighteen Indications for Use for RadioGel™, each of which meets the above-mentioned criteria.

notable advantages of RadioGel ™ over current therapies;

and (iii) the likelihood that RadioGel ™ can

be widely accepted by the medical community and profitably commercialized.

MAB selected eighteen Indications for Use for RadioGel ™ , each of which meets the above-mentioned criteria.

These eighteen

Indications for Use are listed below.

This large number confirms the wide applicability of the device and defines the path for

future growth.

The Company intends to apply to the FDA for a single Indication for Use, followed by subsequent applications for

additional Indications for Use.

The initial application should facilitate each subsequent application, and the testing for many

of the subsequent applications could be conducted in parallel, depending on available resources.

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

The Company intends to apply to the FDA for a single Indication for Use, followed by subsequent applications for additional Indications

The initial application should facilitate each subsequent application, and the testing for many of the subsequent applications

could be conducted in parallel, depending on available resources.

Non-dendritic

cancers –

several types

cancers – several types

Gynecological

1 unchanged sentence

cancer resection cavity

thorough review to prioritize indications, the MAB has selected basal cell and squamous cell carcinoma (skin cancers) as the first

Indication for Use to be presented to the FDA.

According to American Cancer Society, one out of every three new cancers diagnosed

is a cancerous skin lesion of this type, representing 5.5 million tumors annually.

The MAB believes RadioGel™

will be the preferred treatment in a reasonable number of cases in a very large market.

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

Nearly one-half of dogs and one-third of cats are diagnosed

with cancer at some point in their lifetime.

The Veterinary Oncology & Hematology Center in Norwalk, Connecticut, reports

that cancer is the number one natural cause of death in older cats and dogs, accounting for nearly 50 percent of pet deaths each

The American Veterinary Medical Association reports that half of the dogs ten years or older will die because of cancer.

The National Cancer Institute 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.

Nearly one-half of dogs and one-third of cats are diagnosed with

cancer at some point in their lifetime.

The Veterinary Oncology & Hematology Center in Norwalk, Connecticut, reports that cancer

is the number one natural cause of death in older cats and dogs, accounting for nearly 50 percent of pet deaths each year.

Veterinary Medical Association reports that half of the dogs ten years or older will die because of cancer.

The National Cancer Institute

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.

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.

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

Commercial sales of RadioGel TM

for animals requires confirmation by the FDA Center for Veterinary Medicine (“

CVM ”).

In January 2018,

the Center for Veterinary Medicine Product Classification Group, the entity within the CVM that is responsible for determining

the classification of a product, ruled that RadioGel TM should be classified as a device for animal therapy of feline

sarcomas and canine soft tissue sarcomas.

Commercial sales of RadioGel TM for

animals requires confirmation by the FDA Center for Veterinary Medicine (“ CVM ”).

In January 2018, the Center for Veterinary

Medicine Product Classification Group, the entity within the CVM that is responsible for determining the classification of a product,

ruled that RadioGel TM should be classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.

Additionally,

after a legal review, the Company believes 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 all solid tumors in animals.

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

regulatory approvals are necessary for the use of RadioGel TM for the treatment of solid tumors in animals.

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.

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.

to the terms of the grant with Washington State University, it was responsible for conducting studies regarding in vivo dosimetry

and toxicity of intralesional Y-90 phosphate nanoparticles for the treatment of spontaneous feline and canine sarcomas.

of the grant was October 1, 2016 through January 31, 2018.

The Company provided the university with the RadioGel TM

required to complete the studies, as well as technical support for dosimetry calculations.

All payments provided to Washington

State University in relation to the grant were made by Washington State Life Sciences Discovery Fund pursuant to a grant and were

not paid by the Company.

To compliment the grant, additional scope was added to explore the option of pre-mixing the vials prior

to shipment and the Company was reimbursed $17,583 as a separate contract to the grant.

to the terms of the contract with the University of Missouri, it was responsible for conducting studies regarding in vivo dosimetry

and toxicity of intralesional Y-90 phosphate nanoparticles for the treatment of soft tissue carcinoma and equine sarcoids.

term of the contract was initially from November 1, 2017 through October 31, 2018, but it has recently been working to extend

this contract through testing completion on canine soft tissue sarcoma and equine sarcoids, plus additional tumors of interest

defined by the University of Missouri principal investigators.

This extension is dependent upon keeping current with paying for

the expenses of the ongoing therapies.

after a legal review, the Company believes 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 all solid tumors in animals.

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

approvals are necessary for the use of RadioGel TM 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.

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.

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.

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

that our products target.

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

products or their possible effect on our sales.

Certain potentially competitive products to our products may be in various stages

of development.

Also, there may be many ongoing studies with currently marketed products and other developmental products, which

may yield new data that could adversely impact the use of our products in their current and potential future Indications for Use.

The introduction of competitive products could significantly reduce our sales, which, in turn would adversely impact our financial

and operating results.

of 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

effect on our sales.

Certain potentially competitive products to our products may be in various stages of development.

Also, there may

be many ongoing studies with currently marketed products and other developmental products, which may yield new data that could adversely

impact the use of our products in their current and potential future Indications for Use.

The introduction of competitive products could

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.

and globally.

General categories of treatment include

surgery, chemotherapy, radiation therapy and immunotherapy.

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.

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.

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.

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.

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.

Eckert and Ziegler the only supplier

of Y-90 in the United States, is the sole supplier of the Y-90 used by IsoTherapeutics to manufacture the Company’s RadioGel™.

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

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

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.

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

including RadioGel™, are subject to extensive laws, regulations, regulatory approvals and guidelines.

Within the United

States, the Company’s therapeutic radiological devices must comply with the U.S.

Federal Food, Drug and Cosmetic Act, which

is enforced by FDA.

The Company is also required to adhere to applicable FDA Quality System Regulations, also known as the Good

Manufacturing Practices, which include extensive record keeping and periodic inspections of manufacturing facilities.

the United States, the FDA regulates, among other things, new product clearances and approvals to establish the safety and efficacy

of these products.

We are also subject to other federal and state laws and regulations, including the Occupational Safety and

Health Act and the Environmental Protection Act.

2021, utilized Akina, Inc.

as an alternate supplier of its hydrogel polymer component.

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.

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

RadioGel ™ , are subject to extensive laws, regulations, regulatory approvals and guidelines.

Within the United States,

the Company’s therapeutic radiological devices must comply with the U.S.

Federal Food, Drug and Cosmetic Act, which is enforced

The Company is also required to adhere to applicable FDA Quality System Regulations, also known as the Good Manufacturing Practices,

which include extensive record keeping and periodic inspections of manufacturing facilities.

the United States, the FDA regulates, among other things, new product clearances and approvals to establish the safety and efficacy of

these products.

We are also subject to other federal and state laws and regulations, including the Occupational Safety and Health Act

and the Environmental Protection Act.

Federal Food, Drug, and Cosmetic Act and other federal statutes and regulations govern or influence the research, testing, manufacture,

safety, labeling, storage, record keeping, approval, distribution, use, reporting, advertising and promotion of such products.

Noncompliance with applicable requirements can result in civil penalties, recall, injunction or seizure of products, refusal of

the government to approve 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.

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

of regulation:

Noncompliance

with applicable requirements can result in civil penalties, recall, injunction or seizure of products, refusal of the government to approve

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.

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

Class I, Class II, and Class III.

Most Class I devices are exempt from premarket notification 510(k);

II devices require premarket notification 510(k);

most Class II devices require premarket

notification 510(k);

and most Class III devices require premarket approval.

RadioGel™

classified as a Class III device.

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

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.

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.

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.

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

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 .

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

Good Manufacturing Practices, or cGMP.

These regulations require that we and any of our contract manufacturers design, manufacture

and service products, and maintain documents in a prescribed manner with respect to manufacturing, testing, distribution, storage,

design control, and service activities.

Modifications or enhancements that could significantly affect the safety or effectiveness

of a device or that constitute a major change to the intended use of the device require a new 510(k) premarket notification for

any significant product modification.

Medical Device Reporting regulation requires that we provide information to the FDA on deaths or serious injuries alleged to be

associated with the use of our devices, as well as product malfunctions that are likely to cause or contribute to death or serious

injury if the malfunction were to recur.

Labeling and promotional activities are regulated by the FDA and, in some circumstances,

by the Federal Trade Commission.

a medical device manufacturer, we are also subject to laws and regulations administered by governmental entities at the federal,

state and local levels.

For example, our facility is licensed as a medical device manufacturing facility in the State of Washington

and is subject to periodic state regulatory inspections.

Our customers are also subject to a wide variety of laws and regulations

that could affect the nature and scope of their relationships with us.

the United States, as a manufacturer of medical devices and devices utilizing radioactive byproduct material, we are subject to

extensive regulation by not only federal governmental authorities, such as the FDA and FAA, but also by state and local governmental

authorities, such as the Washington State Department of Health, to ensure such devices are safe and effective.

In Washington State,

the Department of Health, by agreement with the federal Nuclear Regulatory Commission (“

NRC ”), regulates the

possession, use, and disposal of radioactive byproduct material as well as the manufacture of radioactive sealed sources to ensure

compliance with state and federal laws and regulations.

RadioGel™

constitutes both medical devices and radioactive sealed

sources and are subject to these regulations.

our use, management, and disposal of certain radioactive substances and wastes are subject to regulation by several federal and

state 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.

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 .

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

Manufacturing Practices, or cGMP.

These regulations require that we and any of our contract manufacturers design, manufacture and service

products, and maintain documents in a prescribed manner with respect to manufacturing, testing, distribution, storage, design control,

and service activities.

Modifications or enhancements that could significantly affect the safety or effectiveness of a device or that

constitute a major change to the intended use of the device require a new 510(k) premarket notification for any significant product modification.

Medical Device Reporting regulation requires that we provide information to the FDA on deaths or serious injuries alleged to be associated

with the use of our devices, as well as product malfunctions that are likely to cause or contribute to death or serious injury if the

malfunction were to recur.

Labeling and promotional activities are regulated by the FDA and, in some circumstances, by the Federal Trade

a medical device manufacturer, we are also subject to laws and regulations administered by governmental entities at the federal, state

and local levels.

For example, our facility is licensed as a medical device manufacturing facility in the State of Washington and is

subject to periodic state regulatory inspections.

Our customers are also subject to a wide variety of laws and regulations that could

affect the nature and scope of their relationships with us.

the United States, as a manufacturer of medical devices and devices utilizing radioactive byproduct material, we are subject to extensive

regulation by not only federal governmental authorities, such as the FDA and FAA, but also by state and local governmental authorities,

such as the Washington State Department of Health, to ensure such devices are safe and effective.

In Washington State, the Department

of Health, by agreement with the federal Nuclear Regulatory Commission (“ NRC ”), regulates the possession, use, and

disposal of radioactive byproduct material as well as the manufacture of radioactive sealed sources to ensure compliance with state and

federal laws and regulations.

RadioGel ™ constitutes both medical devices and radioactive sealed sources and are subject

to these regulations.

our use, management, and disposal of certain radioactive substances and wastes are subject to regulation by several federal and state

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.

Environmental

business does not require us to comply with any extraordinary environmental regulations.

Our RadioGel™

product is manufactured

Our RadioGel ™ product is manufactured

in an independently owned and operated facility.

Any environmental effects or contamination event that could result would be from

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

Any environmental effects or contamination event that could result would be from the

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

of December 31, 2021, the Company had one full-time personnel.

The Company utilizes several independent contractors to assist

with its operations.

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

with its 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

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 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.

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.

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