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Item 1. Business

2023-03-01 compared with 2022-03-07 · 102 added, 123 removed, 495 unchanged (31% of the section changed)

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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

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

During the past several years, in anticipation of

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

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 .

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

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

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

particle patent.

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

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

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

European Patent Application NO.

20 834 229.5;

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

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.

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

indications for use.

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

Vivos Inc will focus its near-term

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.

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

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

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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.

tissue near 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.

Later stage cancers are more difficult

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

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

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This approach is very cost effective.

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

regional clinic.

Additionally, Johns Hopkins will also perform new Isopet® animal studies

on various specific cancers.

They have the required radioactive material license and have completed their training certification for

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.

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

Additionally, Johns Hopkins

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

They have the required radioactive material license and

have completed their training certification for Isopet®.

This important relationship will also help meet our objective of obtaining

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

These publications are the optimal way to increase

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

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

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

We created a Marketing Steering Board to

provide advice on obtaining new pet patients.

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

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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.

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

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

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

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

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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.

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

They concurred with our dosimetry techniques and requested one more

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

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

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

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

our new animal test plan.

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

since they are required for the submittal of the IDE.

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

and to submit the Risk Management Report.

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

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

Institutional Review Board.

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

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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.

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

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

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

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

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

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

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

the animal therapy market:

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

The Company continues their marketing to the animal

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

of December 31, 2022, the Company has $1,706,065 cash on hand.

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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.

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.

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.

– RTU, Ready to Use

Inc 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 via FedEx or UPS by following the proper protocols.

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

specific injection technique depends on the Indication for Use.

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

on the FDA’s ruling of RadioGel ™ as a device, the Company incorporated the FDA suggestions and has invested in

the pre-clinical testing required for IDE submittal.

This included two years of effort on biocompatibility testing.

The last remaining

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

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

The Company has been seeking FDA approval of

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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.

The Company intends to narrow the Indications

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 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 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.

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

MAB evaluated the candidate cancer therapies based on three criteria:

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

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

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

Gynecological

and neck (including sino-nasal and oropharyngeal)

cancer resection cavity

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

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

2021, utilized Akina, Inc.

2021, the Company engaged Akina, Inc.

as an alternate supplier of its hydrogel polymer component.

We have now expanded to include SciPoly

as another alternate polymer supplier.

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

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

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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