<SEC-DOCUMENT>0000000000-20-009066.txt : 20210111
<SEC-HEADER>0000000000-20-009066.hdr.sgml : 20210111
<ACCEPTANCE-DATETIME>20200925165828
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-20-009066
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20200925

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Vivos Therapeutics, Inc.
		CENTRAL INDEX KEY:			0001716166
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				813224056
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		9137 RIDGELINE BOULEVARD
		STREET 2:		SUITE 135
		CITY:			HIGHLANDS RANCH
		STATE:			CO
		ZIP:			80129
		BUSINESS PHONE:		(866)908-4867

	MAIL ADDRESS:	
		STREET 1:		9137 RIDGELINE BOULEVARD
		STREET 2:		SUITE 135
		CITY:			HIGHLANDS RANCH
		STATE:			CO
		ZIP:			80129

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Vivos BioTechnologies, Inc.
		DATE OF NAME CHANGE:	20170901
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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<TEXT>
United States securities and exchange commission logo





                              September 25, 2020

       R. Kirk Huntsman
       Chief Executive Officer
       Vivos Therapeutics, Inc.
       9137 Ridgeline Boulevard, Suite 135
       Highlands Ranch, Colorado 80129

                                                        Re: Vivos Therapeutics,
Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted August
31, 2020
                                                            CIK 0001716166

       Dear Mr. Huntsman:

              We have reviewed your draft registration statement and have the
following comments. In
       some of our comments, we may ask you to provide us with information so
we may better
       understand your disclosure.

              Please respond to this letter by providing the requested
information and either submitting
       an amended draft registration statement or publicly filing your
registration statement on
       EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
       believe an amendment is appropriate, please tell us why in your
response.

             After reviewing the information you provide in response to these
comments and your
       amended draft registration statement or filed registration statement, we
may have additional
       comments.

       Draft Registration Statement on Form S-1 submitted August 31, 2020

       Overview, page 2

   1.                                                   We note your disclosure
that published studies have shown that the patented and
                                                        proprietary
technologies and protocols incorporated into the Vivos System alter the size,
                                                        shape and position of
the tissues that comprise the human airway, leading to lower mean
                                                        AHI scores by up to
65.9% in patients with mild-to-moderate OSA. In an appropriate
                                                        location in your
prospectus, please revise your disclosure to indicate the studies where this
                                                        effect was observed and
clarify whether the Vivos System was actually used in those
                                                        studies.
   2.                                                   We note your disclosure
that your DNA appliance is currently registered with the FDA for
                                                        palatal expansion, that
the DNA appliance also currently has a pending 510(k) application
 R. Kirk Huntsman
FirstName LastNameR.
Vivos Therapeutics, Inc.Kirk Huntsman
Comapany 25,
September NameVivos
              2020     Therapeutics, Inc.
September
Page 2    25, 2020 Page 2
FirstName LastName
         to include additional indications of use for the treatment of
mild-to-moderate OSA,
         snoring, and SDB in adults, and that your dentists regularly prescribe
the DNA appliance
         to treat conditions associated with OSA. Please update your disclosure
to clarify if the
         OSA uses or prescriptions would be considered off-label at this time.
Our Market Opportunity, page 3

3.       Your disclosure on page 21 indicates that a majority of patients being
treated today for
         SDB or OSA are initially referred to pulmonologists, who may not
currently use your
         system. Please update your estimates of market size here and on page
69 to address that
         pulmonologists do not currently recommend your system.
Our Competitive Strengths, page 6

4.       We note your disclosure here and in other locations in your prospectus
that your system
         can be a "potentially life-saving treatment." Please provide us with
support for this
         disclosure or revise as appropriate.
Emerging Growth Company under the JOBS Act, page 13

5.       Please supplementally provide us with copies of all written
communications, as defined in
         Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
         present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
         not they retain copies of the communications.
Liquidity and Capital Resources, page 56

6.       We note that you have entered into a loan under the Paycheck
Protection Program,
         pursuant to which the company borrowed $1,265,067. Please revise your
risk factor
         section to disclose any associated risks with the loan, including, but
not limited to the risk
         that all or parts of the loan may not be forgiven. In addition, please
disclose the following:
         (i) the material terms of the loan; (ii) how you intend to use the
loan proceeds; and (iii)
         whether you expect the loan to be forgiven.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies Involving Management Estimates and Assumptions
Stock-Based Compensation , page 63

7.       Please revise your filing to explain in more detail the methodologies
and underlying
         assumptions that your board of directors utilized in determining the
fair value of your
         common stock underlying your equity instruments granted during the
periods presented.
         Additionally, progressively bridge to the current estimated IPO price
the fair value per
         share determinations used for any option grant since June 30, 2020. We
will delay our
         assessment of your response pending inclusion of the estimated IPO
price in the
         filing. Please discuss with the staff how to submit your response.
 R. Kirk Huntsman
Vivos Therapeutics, Inc.
September 25, 2020
Page 3
Current Treatments for OSA and their Limitations, page 69

8.    We note your disclosure that CPAP "was generally" the "gold standard" of
care for
      treatment of Obstructive Sleep Apnea by the medical community, and your
disclosure on
      page 69 that CPAP therapy is the mainstay of therapy for adults with OSA.
If you believe
      CPAP is no longer the "gold standard" for treatment, please revise to
clarify the basis of
      your belief. We also note your statement that 29 to 83 percent of
patients are nonadherent
      to CPAP therapy, although 60% or more find they are intolerant, refuse
treatment or fail to
      continue their CPAP treatment. Please update your disclosure to clarify
whether the 60%
      figure is a subset of the initial 29 to 83 percent range or is taken from
a different study.
Our Solution for OSA     the Vivos System, page 70

9.    We note your statement that you believe that the Vivos system is the
first truly effective
      solution for mild-to-moderate OSA, snoring and SDB. Please explain to us
why your
      solution is "truly effective" as compared to CPAP, MADs and surgical
options.
Choice of Forum, page 115

10.   We note that your forum selection provision identifies a state court
located within the
      State of Delaware (or, if the Court of Chancery does not have
jurisdiction, the federal
      district court for the District of Delaware) as the exclusive forum for
certain litigation,
      including any "derivative action." Please disclose whether this provision
applies to actions
      arising under the Exchange Act. If so, please also state that there is
uncertainty as to
      whether a court would enforce such provision. If this provision does not
apply to actions
      arising under the Exchange Act, please also ensure that the exclusive
forum provision in
      the governing documents states this clearly, or tell us how you will
inform investors in
      future filings that the provision does not apply to any actions arising
under the Exchange
      Act.
       You may contact Michael Fay at 202-551-3812 or Kevin Kuhar at
202-551-3662 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Alan Campbell at 202-551-4224 or Tim Buchmiller at 202-551-3635 with
any other
questions.



                                                            Sincerely,
FirstName LastNameR. Kirk Huntsman
                                                            Division of
Corporation Finance
Comapany NameVivos Therapeutics, Inc.
                                                            Office of Life
Sciences
September 25, 2020 Page 3
cc:       Lawrence A. Rosenbloom, Esq.
FirstName LastName
</TEXT>
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