What changed in this filing

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Item 1. Business

2021-03-24 compared with 2020-04-28 · 120 added, 104 removed, 524 unchanged (30% of the section changed)

Company ”

we ”) was incorporated under the laws of Delaware on December 23,

1994 as Savage Mountain Sports Corporation (“

SMSC ”).

On December 28, 2017, the Company changed its name from

Advanced Medical Isotope Corp.

to Vivos Inc.

June 25, 2019, the Company amended their Certificate of Incorporation amending their authorized common shares to 950,000,000 from

2,000,000,000 shares.

In addition, the 1 for 8 reverse stock-split was effective on June 28, 2019.

The reverse stock-split reduced

the number of common shares issued and outstanding from 1,421,687,688 to 177,710,961 shares.

The par value for the common shares

remained $0.001 per share, The Company did not amend their preferred stock which is 20,000,000 shares of preferred stock authorized,

$0.001 par value per share.

principal place of business is located at 719 Jadwin Avenue, Richland, Washington 99352.

Our telephone number is (509) 736-4000.

Our corporate website address is http://www.radiogel.com.

Our common stock is currently listed for quotation on the OTCQB Marketplace

under the symbol “RDGL.”

Company is a radiation oncology medical device company engaged in the development of its yttrium-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.

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

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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.

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®.

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

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

The cat had previously received external beam therapy,

but now the tumor was growing rapidly.

A veterinarian

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

The cat had previously received external

beam therapy, but now the tumor was growing rapidly.

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

This sale met the

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

The Company completed sales for an

additional four animals that received the IsoPet®

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®

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

In the gel are small, one micron, yttrium-90 phosphate

particles (“

Y-90 ”).

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 particles.

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

very high local radiation dose.

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

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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

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This exclusive license is to terminate

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

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

Other intellectual property protection includes

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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).

Veterinary Hospital

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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 Vista Inc.

is being used to

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

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communication material and a liability document for the pet owners;

refine the therapy techniques for advanced cancers.

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

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have been 63 expressions of interest in IsoPet ®

therapy from across the United States, but only four of these were

treated and they were very advanced cases.

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 ®

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.

Four 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.

Three 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.

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.

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 four advanced cancer cases.

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.

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

Buader, the veterinarian

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

Two other cases were also very

advanced with multiple tumor and they recurred since they had already spread before therapy.

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.

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(2) notable advantage over current therapies; and (3) probability of wide-spread acceptance by the medical community.

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

Ultimately, this was denied, but the FDA

acknowledged, “The FDA does believe that RadioGel™

meets criterion #2a:

Device represents breakthrough technology.

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

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

It led to a redirection of our efforts

on writing the 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.

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The Company’s application establishes

a single Indication for Use - treatment of basal cell and squamous cell skin cancers.

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.

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

securities as well as a series of grants.

The Company requires funding of approximately $2.3 million annually to maintain current

operating activities.

Over the next 12 to 24 months, the Company believes it will cost approximately $5.0 million to $10.0 million

(1) fund the FDA approval process and initial deployment of the brachytherapy products, and (2) initiate regulatory approval

processes outside of the United States.

The 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’

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.

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,

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to facilitate its global commercialization strategy.

following recent financing events have supported the Company’s execution of its development strategy:

November 2019, the Company had its Regulation A+ approved by the Securities and Exchange Commission for an offering up to

150 million shares of common stock.

the Company’s second and third fiscal quarters, the Company secured approximately $300,000 in convertible promissory

Company recognized its first few sales of IsoPet ®

Company obtained Regulation A+ approval.

The intent is to obtain up to $3,000,000 in tranches of $250,000 over time.

intends to use these proceeds as follows:

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:

the animal therapy market:

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the pedigree of the Quality Management System.

the pre-clinical testing that has been previously defined and report the bulk of the results to the FDA in a pre-submission

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

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

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

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

The Company has raised

$125,280 in proceeds under this Regulation A+ in March 2020, which was in escrow until April 2020 at which time it was deposited

into the Company’s accounts.

The common shares for these proceeds were issued in April 2020.

In addition, the Company converted

their outstanding convertible notes payable of $415,000, $23,427 in accrued interest and $87,686 in an exchange premium stipulated

in the note agreements into shares of common stock effective March 31, 2020.

These shares were issued in April 2020, however effective

as of March 31, 2020.

Company’s RadioGel™

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Company currently subcontracts the manufacturing of RadioGel TM at IsoTherapeutics.

PerkinElmer Inc., the only supplier

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™.

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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