December 11, 2019
Matthew Wolfson
Chief Executive Officer
Electromedical Technologies, Inc.
16561 N. 92nd Street, Suite 101
Scottsdale, AZ 85260
Re: Electromedical Technologies, Inc.
Registration Statement of Form S-1
Filed November 12, 2019
File No. 333-234623
Dear Mr. Wolfson:
We have reviewed your 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 amending your registration statement
and providing the
requested information. 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 any amendment to your registration statement and the
information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1
Cover Page
1. Because you are not eligible to conduct a primary at-the-market
offering, please revise
your prospectus throughout to clarify that the shares in the Primary
Direct Offering will be
made at a fixed price for the duration of the offering. In addition, we
note that selling
stockholders may sell the shares of common stock described in the
prospectus in a number
of different ways and at varying prices. Please note that the OTC
Markets Pink is not an
established public trading market into which the selling stockholder may
offer and sell its
shares of common stock at other than a fixed price. Given the absence of
an existing
trading market for your common stock, please disclose the fixed price at
which the selling
stockholders will sell the shares for the duration of the offering.
Refer to Item 501(b)(3) of
Regulation S-K.
Matthew Wolfson
FirstName LastNameMatthew Inc.
Electromedical Technologies, Wolfson
Comapany11, 2019
December NameElectromedical Technologies, Inc.
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2. Since you do not meet the requirements in General Instruction VII to
Form S-1, please
delete the statement that your subsequently filed periodic and current
reports are
incorporated by reference into the prospectus.
Our Business and Corporate History, page 6
3. Please quantify the amount of common shares that were sold and
proceeds that were
received in the Regulation A offering. Please also disclose when that
offering was
terminated.
4. To the extent that you highlight in the Summary a product that has not
yet received FDA
clearance/approval, please clarify the current lack of FDA regulatory
approval. In this
regard, it does not appear that you have FDA clearance/approval for
the new POD devices
that you intend to offer to military veterans.
5. Please provide the basis for the market statistics cited in the sixth
paragraph of this
section. Please also clarify what portion of the 22 million military
veterans have
conditions that would be addressed by your products.
Summary Financial Information, page 7
6. Please reconcile the net loss disclosed here for the year ended
December 31, 2017 of
$(53,707) with the financial statements on page 47 which disclose a
net loss of
$(510,412).
Risks Factors, page 9
7. Please add a risk factor to disclose that there is substantial doubt
about your ability to
continue as a going concern. In this risk factor, please describe this
going concern opinion
and how it impacts your business operations. Additionally, please
disclose your working
capital deficit and net losses to date.
8. With reference to your disclosures on pages 19-20, please add a risk
factor highlighting
that the primary offering does not require that a minimum number of
shares be sold and as
such you may not receive sufficient funding to achieve the $4.85
million in gross proceeds
necessary to "implement your minimum business plan." Also, disclose,
if true,
that investor funds are at risk to be utilized solely for offering and
routine administrative
expenses if you do not raise sufficient funds in the offering.
Plan of Distribution, page 24
9. Please explain why potential investors must confirm that they are
purchasing shares in a
state providing for an exemption from registration.
Certain Relationships and Related Transactions, page 26
10. For each transaction described in this section, please name the
related person and the basis
on which the person is a related person.
Matthew Wolfson
FirstName LastNameMatthew Inc.
Electromedical Technologies, Wolfson
Comapany11, 2019
December NameElectromedical Technologies, Inc.
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11. Please describe how the estimated number of conversion shares issuable
pursuant to the
KISS agreement is calculated. Discuss, as applicable, whether the
current default impacts
the terms of the note.
Principal Products and Services, page 30
12. Please identify clearly each product that is FDA cleared/approved for
marketing in the
United States and also identify any other material market(s) where the
product is sold.
With respect to FDA cleared/approved products, please disclose:
when you received FDA clearance/approval and the indicated use(s)
for the device;
whether the product is a Class I, II, or III device; and
whether it received 510(k) clearance or premarket approval.
13. In this section and elsewhere in the prospectus you refer to your
WellnessPro POD device
as a "clinical-grade" device. Please explain what you mean by
clinical-grade. Please also
disclose the status of FDA approval for the WellnessPro POD and the
Wellness ION Pen.
Strategy, page 31
14. Please revise to provide support for your claim concerning your
"product's ability to
deliver uncommon levels of pain relief (and) better quality of life
and wellness for
thousands of customers."
Intellectual Property, page 33
15. Please disclose the duration of your material patents and indicate
whether you directly
own or license the patents.
Regulation, page 33
16. Please expand the disclosure on page 33 to more fully describe the FDA
approval process
and the nature of regulatory oversight. For example, include in your
disclosure the
duration of the process, post-market reporting and record keeping
requirements and
remedies for noncompliance.
Description of Property, page 34
17. Please revise to expand your disclosure in this section to cover the
production facility to
which you refer in the Manufacturing section on page 33.
Alternatively, please revise
your disclosure on page 33 to clarify that all production, including
product assembly, is
conducted at third-party facilities.
Management's Discussion and Analysis
Going Concern, page 35
18. We note the statement in this section that management is endeavoring
to commence
revenue-generating operations, which appears inconsistent with the
reported results in the
Matthew Wolfson
FirstName LastNameMatthew Inc.
Electromedical Technologies, Wolfson
Comapany11, 2019
December NameElectromedical Technologies, Inc.
December 11, 2019 Page 4
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FirstName LastName
financial statements. Please reconcile.
Management's Discussion and Analysis
Operating Results, page 36
19. We note that you present selling, general and administrative expenses,
net loss and
accumulated net losses excluding non-cash items. Please note that
disclosure of GAAP-
based amounts excluding the impact of non-cash items creates non-GAAP
measures under
Item 10(e) of Regulation S-K. Accordingly, please revise to provide
all of the disclosures
required by Item 10(e) of Regulation S- K or revise the discussion to
avoid presentation of
non-GAAP measures.
Executive and Director Compensation, page 41
20. Please revise your prospectus to provide a summary compensation table
and a narrative
description of any material factors necessary to an understanding of
the information
disclosed in the table. Refer to Items 402(n) and (o) of Regulation
S-K. Please also
include a table of outstanding equity awards at fiscal year end. Refer
to Item 402(p) of
Regulation S-K.
Security Ownership of Certain Beneficial Owners and Management, page 42
21. Please tell us why the conversion shares under the KISS agreement are
not included in the
shares owned by Blue Ridge Enterprises LLC. We note that the agreement
is currently in
default and the obligation matured in July 2019.
Legal Matters, page 43
22. Please revise to clarify whether Mailander Law Office will pass upon
the validity of the
shares to be sold by the selling stockholders that are included in the
prospectus.
Financial Statements for the Years Ended December 31, 2018 and 2017
Note 2 - Summary of Significant Accounting Policies
Going Concern, page 50
23. We note that you present here and on page 63 the non-GAAP measure
working capital
deficit excluding customer deposits and related party KISS liability
and on page 63 the
non-GAAP measure accumulated net losses excluding non-cash expenses.
Please note
that under Rule 10(e)(1)(ii)(C) of Regulation S-K, it is not
appropriate to include non-
GAAP measures in the notes to your financial statements. Please revise
the footnotes to
remove these non-GAAP measures.
Matthew Wolfson
Electromedical Technologies, Inc.
December 11, 2019
Page 5
Interim Financial Statements
Note 2 - Summary of Significant Accounting Policies
Revenue Recognition, page 63
24. We note that you adopted ASC 606 effective January 1, 2018 using the
modified
retrospective basis. However, under the modified retrospective basis
prior periods are not
restated. Please revise your disclosure to clarify the date on which
ASC 606 was adopted
and the transition method used.
25. As a related matter, we note that you reference the revenue
recognition criteria from SAB
Topic 13A which was superseded by ASC 606. Please confirm, if true,
that your revenue
recognition was not impacted by the adoption of ASC 606 and revise
your disclosures
accordingly.
Exhibits
26. Please have counsel revise the legal opinion filed as Exhibit 5.1 to
reflect, if true, that the
shares being offered by the selling shareholders are already
outstanding. For guidance,
refer to Section II.B.2.h of Staff Legal Bulletin No. 19.
General
27. 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.
28. We note your disclosure that Mr. Wolfson will offer 10 million shares
on behalf of the
company in the Direct Primary Offering. We further note that the
registration statement
covers the resale of 2 million shares beneficially owned by Mr.
Wolfson. Accordingly,
please tell us whether Mr. Wolfson will offer his shares for resale
during the pendency of
the Direct Primary Offering.
29. Please revise your disclosure throughout to explain whether you will be
registering your
common stock under the Exchange Act in connection with this offering. If
not, then add a
separate risk factor to explain that you will not be subject to the
proxy rules under Section
14 of the Exchange Act, the prohibition of short-swing profits under
Section 16 of the
Exchange Act, the beneficial ownership reporting requirements of
Sections 13(d) and (g)
FirstName LastNameMatthew Wolfson
of the Exchange Act, and that your periodic reporting obligations under
Section 13(a) will
Comapany NameElectromedical Technologies, Inc.
be automatically suspended under Section 15(d) of the Exchange Act to
the extent that
December 11, 2019 Page 5 300 shareholders.
you have fewer than
FirstName LastName
Matthew Wolfson
FirstName LastNameMatthew Inc.
Electromedical Technologies, Wolfson
Comapany11, 2019
December NameElectromedical Technologies, Inc.
Page 6
December 11, 2019 Page 6
FirstName LastName
30. We note that your forum selection provision in Article VII of your
Certificate of
Incorporation identifies the Court of Chancery of the State of
Delaware as the exclusive
forum for certain litigation, including any "derivative action."
Please disclose whether this
provision applies to actions arising under the Securities Act or
Exchange Act. In that
regard, we note that Section 27 of the Exchange Act creates exclusive
federal jurisdiction
over all suits brought to enforce any duty or liability created by the
Exchange Act or the
rules and regulations thereunder, and Section 22 of the Securities Act
creates concurrent
jurisdiction for federal and state courts over all suits brought to
enforce any duty or
liability created by the Securities Act or the rules and regulations
thereunder. If the
provision applies to Securities Act claims, please also revise your
prospectus to state that
there is uncertainty as to whether a court would enforce such
provision and that investors
cannot waive compliance with the federal securities laws and the rules
and regulations
thereunder. If this provision does not apply to actions arising under
the Securities Act or
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
Securities Act or Exchange
Act.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Eric Atallah at (202) 551-3663 or Lynn Dicker at (202)
551-3616 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Chris Edwards at (202) 551-6761 or Joe McCann at (202) 551-6262 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Tad Mailander