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United States securities and exchange commission logo





                              October 15, 2021

       Mark White
       Chief Executive Officer
       Nexalin Technology, Inc.
       1776 Yorktown, Suite 550
       Houston, TX 77056

                                                        Re: Nexalin Technology,
Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted September
17, 2021
                                                            CIK No. 0001527352

       Dear Mr. White:

              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 September 17, 2021

       Prospectus Summary
       Overview, page 6

   1.                                                   We note your disclosure
that you provide an FDA-cleared, easy-to-administer treatment
                                                        that utilizes
bioelectronic medical technology to safely and successfully treat various
                                                        mental health
disorders. Please revise to clearly disclose the indications for use from the
                                                        device clearance.
Please also clarify which device version has been cleared.
   2.                                                   Please revise to
provide the basis for your statements that your proprietary waveform
                                                        "distinguishes [y]our
devices from all comparable neurostimulation technologies currently
                                                        available," and that
"[t]he stigma of expensive psychotherapy or pharmaceutical
 Mark White
Nexalin Technology, Inc.
October 15, 2021
Page 2
         medication with side effects and dependency issues will be replaced
with clinically
         proven, safe and cost-effective technology that is undetectable to the
patient during
         treatment."
3.       We note your disclosure that prior to a regulatory change, your Gen-1
device was also
         used to treat depression. Please revise to clarify, if true, that your
device was subject to a
         reclassification by the FDA and that in order to receive approval for
the treatment of
         depression, a new pre-market application is required for this
indication. With respect to
         your insomnia and anxiety indications, please also revise to clarify
whether you have
         completed the required special control trials and the new 510(k)
filing that you
         reference on page 14.
4.       We note your statements that you develop products "to uniquely and
effectively help
         combat the ongoing global mental health epidemic;" that your waveform
is "proven to be
         highly effective in stimulating a positive response from the mid-brain
structures;" that
         your advanced waveform "is safely administered to the human brain,"
that your Gen-2
         device "will generate enhanced patient response," and that you are
able to "preserve
         product safety and integrity" with respect to your Gen-3 device.
Although we note your
         disclosure that the FDA has cleared your Gen-1 device, it is premature
for you to suggest
         that all of your products, including your Gen-2 and Gen-3 devices,
will be determined to
         be safe and effective. Please revise these statements throughout the
prospectus to
         eliminate conclusions or predictions that such devices are safe and
effective as
         determinations of safety and efficacy are solely within the authority
of the FDA. You may
         provide a summary of the data that you used to draw these conclusions,
and such
         discussion is more appropriate in the Business section where full and
proper context can
         be provided.
Chinese Market, page 7

5.       Please revise to describe the material steps you must complete in
order to form the joint
         venture. Please also file the joint venture agreement as an exhibit to
your registration
         statement pursuant to Item 601(b)(10). Alternatively, please explain
to us why such
         disclosure is not required. Please also remove statements that
treatment clearance by the
         China National Medical Products Administration (NMPA) for the 15
milliamps power
         parameters is expected in the next six months, as this statement
appears to be speculative.
Risks Associated
FirstName         with Our Business,
           LastNameMark     White     page 7
Comapany
6.         NameNexalin
       Please              Technology,
              revise to highlight       Inc.
                                  your auditor's explanatory paragraph
regarding your ability to
       continue as a going
October 15, 2021 Page 2     concern.
FirstName LastName
 Mark White
FirstName LastNameMark
Nexalin Technology, Inc. White
Comapany
October 15,NameNexalin
            2021        Technology, Inc.
October
Page 3 15, 2021 Page 3
FirstName LastName
Risk Factors
We may require substantial additional funding to meet our financial needs and
to pursue our
business objectives, page 13

7.       We note your disclosure that you are currently not cash flow positive
and do not expect to
         be cash flow positive until 2023. Please revise to provide the basis
for your statements that
         you expect to be cash flow positive in 2023.
We rely on collaborations with third parties for the development of our
products, page 15

8.       We note your disclosure that you rely on collaborations with third
parties for the
         development of your products. Please identify any material strategic
collaboration you
         continue to rely on in this risk factor. In addition, to the extent
you have not done so, in
         your Business section, please describe the material terms of the
collaboration agreements
         you have entered into and also file the agreements as exhibits to your
registration
         statement pursuant to Item 601(b)(10) of Regulation S-K.
Alternatively, please explain to
         us why such disclosure is not required.
Risks Related to Doing Business in China, page 19

9.       We note your risk factor disclosure that a material portion of your
operations and assets
         are located in China. However, we also note that your principal
executive offices are
         located in the United States and that the joint venture with Wider has
not yet been
         completed. Please explain to us in greater detail the operations and
assets of the Company
         that are located in China.
"We are an emerging growth company . . . ", page 29

10.      On the cover page, you have indicated you have elected to use the
extended transition
         period for complying with any new or revised financial accounting
standards provided to
         Section 7(a)(2)(B) of the Securities Act. On page 30, you state you
have irrevocably
         elected not to avail yourselves of this exemption from new or revised
accounting
         standards and, therefore, will be subject to the same new or revised
accounting standards
         as other public companies that are not emerging growth companies.
Please revise these
         conflicting statements here and throughout the filing.
Our amended and restated certificate of incorporation will provide that the
Court of Chancery of
the State of Delaware and the, page 29

11.      We note that your forum selection provision identifies the Court of
Chancery of the State
         of Delaware as the exclusive forum for certain litigation, including
any    derivative
         action,    and the U.S. federal district courts as the exclusive forum
for resolving any
         complaint asserting a cause of action arising under the Securities
Act. Please revise to
         disclose whether this provision applies to actions arising under the
Exchange Act.
         Additionally, please revise your risk factor to disclose that that
there is uncertainty as to
 Mark White
FirstName LastNameMark
Nexalin Technology, Inc. White
Comapany
October 15,NameNexalin
            2021        Technology, Inc.
October
Page 4 15, 2021 Page 4
FirstName LastName
         whether a court would enforce such provision and that there is also a
risk that your
         exclusive forum provision may result in increased costs for investors
to bring a claim.
Use of Proceeds, page 33

12.      We note your disclosure that you intend to use the net proceeds from
the offering to,
         among other things, fund clinical research, trials and development
work for future product
         candidates and for working capital. Please revise your disclosure to
describe how far the
         proceeds are expected to enable you to progress in the clinical
development of your
         product candidates. With respect to the proceeds used for working
capital, please revise to
         provide more meaningful and specific disclosure of the intended use of
proceeds.
Management Discussion and Analysis . . .
Year Ended December 31, 2020 Compared to the Year Ended December 31, 2019, page
38

13.      Your table includes two line items for stock-based compensation
expense and for selling,
         general and administrative expense. Your financial statement
classifies these two line
         items as selling, general and administrative expense and as a loss on
impairment of right
         of use asset, respectively. Please revise your discussion of these
expenses to be consistent
         with the financial statement presentation.
14.      On page 6, you state that you have devoted substantially all your
financial resources and
         efforts to research and development. Please quantify and provide a
discussion of your
         research and development expenses as part of this discussion and
disclose the amount of
         these expenses in your financial statements or the related footnotes
or, otherwise, explain
         to us why such discussion and disclosure is not required. Refer to
Item 303(a) of
         Regulation S-K.
Depression Market , page 45

15.      Please revise to provide the basis for your statement that any decline
in the depression
         medication market will indirectly accelerate the growth of the
neurostimulator market and
         that prior to 2019, your existing Gen-1 medical device had been used
to successfully treat
         depression in the USA.
Substance Use Disorders (Opioid Addiction) Market, page 46

16.      We note your statements that your pilot study "will provide a source
of validation" for
         your treatment approach, that "initial anecdotal research with [y]our
products in the
         addiction treatment model is promising," that your new advanced
waveform allows you to
         "increase the power of the device exponentially without creating any
safety risks," that
         "deeper penetration also enhances patient response. . ." and that the
new advanced
         waveform at 15 milliamps "has been proven to be safe and highly
effective in the
         treatment mental illness." Please revise these and similar statements
to eliminate
         conclusions or predictions that your device is safe and effective as
determinations of
         safety and efficacy are solely within the authority of the FDA.
 Mark White
FirstName LastNameMark
Nexalin Technology, Inc. White
Comapany
October 15,NameNexalin
            2021        Technology, Inc.
October
Page 5 15, 2021 Page 5
FirstName LastName
Marketing and Growth Strategy, page 48

17.      Please revise to clarify, if true, that the Company is currently in
Phase 1 and indicate if
         any of the Phase 1 activities have been completed. We also note that
in 2020 and 2019, the
         Company generated revenues from licensing and treatment fee agreements
with customers
         and from equipment by selling additional individual nodes to customers
for use with your
         device. Please revise to clarify if the Phase 1 pricing has been
implemented and clearly
         describe the material terms of the licensing and treatment fee
arrangements with your
         customers.
Summary of Current Clinical Trials in the United States, page 49

18.      We note your disclosure that the endpoint of the first UCSD study will
provide pilot data
         to validate your benefits in treating opiate addiction and that a
primary endpoint of the
         second UCSD study is validating your treatment for veterans diagnosed
with mTBI and
         PTSD. Please revise to clearly identify the trial endpoints in each
study. Please also revise
         to clarify if the trials are currently still paused.
19.      Please revise your statements that "providing this type of data will
accelerate [y]our
         acceptance and approval in the regulatory and treatment community" to
remove any
         implication that you will be successful in advancing your product
candidate in a rapid or
         accelerated manner as such statements are speculative.
20.      We note your disclosure that the UPenn pilot data demonstrated that
73% of patients that
         received your treatment had a 50% reduction in depression symptoms in
a 5-day treatment
         window. Please revise to disclose the total number of patients
enrolled in the study.
Summary of Current Clinical Trial Strategy for the Joint Venture, page 50

21.      Please revise statements that your device has been shown in multiple
trials "to be highly
         effective in the treatment of depression" and that trial results
"would further bolster your
         FDA approval process demonstrating both safety and efficacy," to
eliminate conclusions
         or predictions that your product candidates are effective as
determinations of efficacy are
         solely within the authority of the FDA.
Regulatory Strategy, page 52

22.      We note your disclosure that as a result of the pandemic, the deadline
for submitting
         clinical testing data to the FDA was extended. Please revise to
disclose the new
         deadline. Please also revise to clarify whether you are permitted to
continue marketing
         your Gen-1 device for the treatment of anxiety and insomnia before the
amended 510(k)
         application is approved by the FDA.
Intellectual Property Matrix, page 53

23.      Please revise to clarify the patent expiration dates and expected
expiration dates
         for pending patent applications.
 Mark White
Nexalin Technology, Inc.
October 15, 2021
Page 6
Narrative to Summary Compensation Table, page 67

24.   Please file the employment agreement with Mark White and David Owens as
exhibits to
      the Registration Statement pursuant to Item 601(b)(10) of Regulation S-K.
Alternatively,
      please explain to us why such disclosure is not required.
Issuances of Share Capital, page F-21

25.   Please revise your disclosure to provide the information required under
Item 701 of
      Regulation S-K.
General

26.   Please 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.
       You may contact Gary Newberry at 202-551-3761 or Terence O'Brien at
202-551-3355 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Deanna Virginio at 202-551-4530 or Jeffrey Gabor at 202-551-2544 with
any other
questions.



                                                           Sincerely,
FirstName LastNameMark White
                                                           Division of
Corporation Finance
Comapany NameNexalin Technology, Inc.
                                                           Office of Life
Sciences
October 15, 2021 Page 6
cc:       Martin Siegel, Esq.
FirstName LastName
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