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Vivos Inc. - FORM correspondence

January
24, 2018

VIA EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

100 F
Street, N.E.

Washington,
D.C. 20549

Attention:
Pamela Long, Assistant Director

RE:

Vivos Inc (formerly Advanced Medical Isotope
Corporation)

Registration Statement on Form S-1

Filed March 10, 2017

File No. 333-216588

Form 10-K for Fiscal Year Ended December 31, 2016

File No. 000-53497

Dear
Ms. Long:

This
letter is submitted on behalf of Vivos Inc., formerly Advanced
Medical Isotope Corporation (the “Company”), in response to
comments of the staff of the Office of Manufacturing and
Construction (the “Staff”) of the Securities and
Exchange Commission (the “Commission”) with respect to the
Company’s Registration Statement on Form S-1 (the
“Registration
Statement”), filed on March 10, 2017, and the
Company’s Form 10-K for the fiscal year ended December 31,
2016 (the “10-K”), as set forth in your
letter, dated April 6, 2017 (the “Comment Letter”) addressed to Dr.
Michael Korenko, Acting Chief Executive Officer of the Company.
Contemporaneously herewith, the Company is filing Amendment No. 1
to the 10-K (the “10-K/A”) in response to the
Staff’s comments raised in the Comment Letter. The Company
intends to file Pre-Effective Amendment No. 1 to the Registration
Statement (the “S-1/A”) in the near future to
address the issues raised by the Staff in the Comment Letter, as
more particularly set forth below.

For
reference purposes, the Staff’s numbered comments have been
reproduced in bold herein, with responses immediately following
such comment. Where the Staff’s comments are applicable to
both the 10-K and the Registration Statement, the Company has
amended the 10-K in response to such comments, and intends to amend
the Registration Statement consistent with such revisions to the
10-K, which, as discussed with the Staff, the Company intends to
file in the near future. The responses provided herein are based
upon information provided to Disclosure Law Group, a Professional
Corporation, by the Company.

General

1.

You
appear to be offering Units since you are registering the offer and
sale of shares of common stock and warrants to purchase common
stock which you state can only be purchased together. If you are
offering Units, please revise your prospectus cover page,
description of securities and otherwise throughout your
registration statement to describe the Units. In addition, your fee
table should cover the Units, common stock, warrants and the shares
underlying the warrants. For additional guidance on the fee table,
please refer to our Compliance and Disclosure Interpretations,
Securities Act Rules, Questions 240.05 and 240.06, available on our
website.

Response

Although
the Company is offering shares of common stock together with common
stock purchase warrants in the offering, the shares of common stock
and warrants are immediately seperable and are not intended to
remain together as a single unit once the securities are in the
possession of the purchaser. The Company intends to add disclosure
noting this distinction to the cover page of the S-1/A, and where
applicable throughout the prospectus contained within the
S-1/A.

2.

Please
clarify whether this is a best efforts offering with no minimum or
a firm underwritten offering. To the extent that this is an
underwritten offering, then please identify your lead
underwriter(s) in your next amendment. We intend to defer further
review of the filing until the registration statement is amended to
include the name of the lead underwriter(s).

Response

This
is a best efforts offering with no minimum, and the Company intends
to revise the applicable disclosure in the S-1/A accordingly, in
response to the Staff’s comment.

-1-

3.

It
appears that you may be contemplating an at-the-market offering.
You are not eligible under Rule 415 of the Securities Act of 1933
to conduct an at-the-market offering. Please revise your offering
to sell shares at a fixed price for the duration of the offering,
or advise. Similarly, you discuss increasing or decreasing the
number of shares that you are offering. Please note that you may
not increase the number of securities you are publicly offering
without filing to register those additional securities, and revise
accordingly.

Response

In
response to Staff’s comment, the Company intends to remove
all disclosure from the S-1/A indicating that it is conducting an
at-the-market offering. Instead, the Company intends to add
disclosure to the S-1/A indicating that the offering of shares will
be conducted at a fixed price. The Company also intends to remove
all discussion of increasing or decreasing the number of shares
that it is offering.

4.

If
you intend to conduct this offering on a best-efforts basis, then
please revise your use of proceeds and dilution sections to provide
the information assuming the sale of 25%, 50%, 75% and 100% of the
offering.

Response

As
noted in our response to comment 1 above, the Company intends to
conduct a best efforts offering. The Company therefore intends to
revise the Use of Proceeds and Dilution sections in the S-1/A to
provide the additional disclosure requested by the
Staff.

5.

Please
provide disclosure requirements pursuant to Item 505 of Regulation
S-K.

Response

In
response to Staff’s comment, the Company intends to add a
section entitled “Determination of Offering Price” to
the S-1/A and include the disclosure required by Item 505 of
Regulation S-K.

Outside Front Cover Page, page i

6.

Please
limit the prospectus cover page to one page. See Item 50l (b) of
Regulation S-K. Prospectus Summary, page 2

Response

The
Company intends to update the prospectus cover page to the S-1/A in
response to the Staff’s comment.

7.

Please
revise to disclose that you have received a going concern opinion
from your auditor.

Response

In
response to Staff’s comment, the Company intends to add
disclosure stating that it has received a going concern opinion
from its auditor on the outside front cover page of the prospectus
contained within the S-1/A.

8.

We
note your disclosure that the FDA classified RadioGel as a medical
device. Please revise to clarify whether the FDA classified your
RadioGel as a Class III medical device. Please briefly discuss the
process and implications of being classified as Class I, Class II,
and Class III.

Response

RadioGel
has been classified as a Class III medical device. In response to
Staff’s comment, the Company revised the Business, as well as
the Business Overview sections in the 10-K/A, and intends to amend
the Registration Statement consistent with the disclosure in the
10-K/A.

9.

We
note that you repeatedly indicate that you intend to seek de novo
review of your RadioGel. However, on page 8 you disclose that in
2015 the FDA notified you that your 2014 de novo application was
not granted. Please reconcile. Please disclose what the
company’s plans are given that the 2014 de novo application
was not granted.

-2-

Response

In
response to Staff’s comment, the Company has revised the
disclosure throughout the 10-K/A to reconcile the inconsistent
disclosure and to reflect the Company’s intentions as of
December 31, 2016.

The Company also intends to revise the disclosure
throughout the S-1/A to reconcile the inconsistent disclosure. As
will be disclosed in the revised prospectus, the Company is
currently developing test plans to address the issues raised by the
FDA in connection with the Company’s previous submissions,
that resulted in the denial of its 2014 de novo application.

Risk Factors, page 7

The Company’s new products..., page 8

10.

We
note here, and throughout your registration statement, that you
discuss the Company’s product Y-90 RadioGel. We note that you
mention Y-90 fast-Resorbable Polymer Seeds and Y-90 Polymer Topical
Paste products in your risk factor section. Please clarify whether
these products are currently in production and whether you are
seeking FDA approval for these products. Please revise your
business section as appropriate.

Response

Our
Y-90 fast-Resorbable Polymer Seeds and our Y-90 Polymer Topical
Paste products are no longer in production, and the Company is
therefore not seeking FDA approval for either product, nor was it
doing so as of December 31, 2016. As a result, the Company revised
the relevant risk factor in the 10-K/A to remove reference to each
of these products in response to the Staff’s comment, and
intends to amend the
Registration Statement consistent with the disclosure in the
10-K/A.

The Company’s common stock is listed on the OTC Bulletin
Board ..., page 14

11.

Please
revise here and elsewhere to clarify that your stock is quoted on
the OTC Pink.

Response

The
Company has revised the applicable disclosure in the 10-K/A in in
response to the Staff’s comment, and intends to amend
the
Registration Statement consistent with the disclosure in the
10-K/A.

Use of Proceeds, page 17

12.

You
list the discharge of outstanding debt as a probable use of the
proceeds of this offering. Please indicate the interest rate and
maturity of the indebtedness to which you may apply these proceeds
to and any other information required by Instruction 4 to Item 504
of Regulation S-K.

Response

The
Company intends to revise the disclosure in the Use of Proceeds
section of the prospectus contained within the S-1/A in response to
the Staff’s comment.

Dilution, page 21

13.

Please
enhance your disclosures to clarify how you determine the net
tangible book value of approximately $3 million as of December 31,
2016.

Response

The
Company intends to revise the applicable disclosure in the
prospectus contained within the S-1/A in response to the
Staff’s comment.

Management’s Discussion and Analysis of Financial Condition
and Results of Operations, page 22

Revenue, page 22

-3-

14.

You
disclose that consulting revenue generated $8,108 and $24,108 for
the years ended December 31, 2016 and December 31, 2015,
respectively, and that consulting revenues consisted of providing
services to your company. Please clarify how providing services to
your company generated revenues rather than resulting in operating
expenses.

Response

The
disclosure set forth in the 10-K and the prospectus contained
within the Registration Statement referenced the provision of
services to the Company in error, as the services were provide by
the Company. The Company revised the disclosure in the 10-K/A in
response to the Staff’s comment to correct the error, and
intends to revise the applicable disclosure in the S-1/A consistent
with the disclosure in the 10-K/A.

Business. page 29

Overview, page 29

15.

Please
update your disclosure in this section, in your summary, and
elsewhere in your document as appropriate to disclose (i) the
initial FDA submission and outcome, (ii) your 2014 de novo
submission and outcome; and (iii) the status of any other
submissions. See Item 10 I (h)(4)(iii) of Regulation S-K. Please
revise to state clearly that in the event the FDA denies your
initial 510(k) application and subsequently determines during the
de novo review that your device cannot be classified as a Class I
or Class II device, you will then need to submit a PMA application
to obtain the necessary regulatory approval.

Response

In
response to Staff’s comment, the Company has included a new
section entitled “Regulatory History” in the Business
and Business Overview sections of the 10-K/A, which reflects the
status of the Company’s progress with the FDA as of December
31, 2016. The Company has had further interactions with the FDA
since that date, and intends to amend the
Registration Statement to reflect subsequent events related
to the Staff’s comment.

Veterinary Sector, page 34

16.

Please
disclose the role of the Veterinary Advisory Board in the operation
of your business.

Response

The
Company has provided disclosure in the 10-K/A in response to the
Staff’s comment, and intends to amend the prospectus
contained in the
Registration Statement consistent with the disclosure in the
10-K/A.

17.

Please
disclose the material terms of your engagement with each of the
four university veterinarian hospitals.

Response

The
Company has provided disclosure in the 10-K/A in response to the
Staff’s comment, which reflects the material terms of the
engagements with each of the four universities as of December 31,
2016. Subsequent to that date, the Company’s engagments with
various universities changed, and the Company intends to amend the
prospectus contained in the S-1/A to reflect the Company’s
current engagements with university veterinarian
hospitals.

18.

We
note your disclosure that Dr. Villalobos has agreed that her
private clinic will be the first to implement the company’s
veterinary therapies. Please disclose the material terms of your
arrangement with Dr. Villalobos.

Response

While as of December
31, 2016, the Company believed that Dr. Villalobos would be the
first to utilize RadioGel™ in her private practice, and would
be introducing management to other clinics, the Company has revised
the disclosure in the 10-K/A to delete reference to these
activities, given the concern of the Staff. The Company
intends to amend the prospectus
contained in the S-1/A consistent with the disclosure in the
10-K/A.

Government Regulation, page 35

-4-

19.

Please
significantly expand the disclosure in this section to discuss in
detail the material government regulations that are applicable to
your business, including standard processing times for approval to
test and market your products. In addition, provide an anticipated
timeline for any submissions to the FDA and other anticipated
actions by you before regulatory bodies. We note your disclosure on
page 8 that the company will explore steps toward seeking approval
for the device as a Class III medical device. Please discuss in
detail the processes and anticipated costs associated with seeking
this approval.

Response

As
of December 31, 2016, and as of today’s date, the Company has
been seeking approval for the device as a Class II medical device,
rather than as a Class III medical device. The Company has revised
the Government Regulation section of the 10-K/A in response to the
Staff’s comment, and intends to amend the
Registration Statement consistent with the disclosure in the
10-K/A.

Raw Materials, page 35

20.

Please
expand your disclosure to provide the availability and the names of
your principal suppliers of raw materials. We note your disclosure
that some of your products require purchasing raw materials from a
limited number of suppliers. Sec Item 10l(h)(4)(v) of Regulation
S-K.

Response

The
Company has provided disclosure in 10-K/A in response to the
Staff’s comment, and intends to amend the
Registration Statement consistent with the disclosure in the
10-K/A.

Management, page 37

Identification of Significant Employees and Consultants, page
38

21.

Please
provide for Dr. Alice Villalobos and all other “Veterinarian
Advisory Board” and “Medical Advisory Board”
members the appropriate biographical disclosure required by Item
401 (c) of Regulation S-K.

Response

The
Company has included biographical disclosure for those individuals
who were members of the Veterinarian Advisory Board and Medical
Advisory Board as of December 31, 2016 in the 10-K/A in response to
the Staff’s comment, and intends to amend the prospectus
contained in the S-1/A to include the requested information for the
current members of such Advisory Boards.

Executive Compensation, page 39

22.

Please
revise your Summary Compensation Table to be in the format required
by Item 402(n) of Regulation S-K.

Response

The
Compay has revised the Summary Compensation Table in the 10-K/A in
the format required by Item 402(n) of Regulation S-K, and intends
to amend the Registration
Statement consistent with format included in the
10-K/A.

23.

We
not