United States securities and exchange commission logo
January 19, 2022
Mark White
Chief Executive Officer
Nexalin Technology, Inc.
1776 Yorktown, Suite 550
Houston, TX 77056
Re: Nexalin Technology,
Inc.
Registration
Statement on Form S-1
Filed on January 4,
2022
File No. 333-261989
Dear Mr. White:
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.
Unless we note
otherwise, our references to prior comments are to comments in our
December 21, 2021 letter.
Registration Statement on Form S-1 filed on January 4, 2022
Overview, page 3
1. We note your response
to prior comment 6 and your disclosure throughout the registration
statement stating that
"[w]hile [the Gen-1] device had been cleared by the FDA to treat
anxiety and insomnia .
.. . [you] have voluntarily suspended marketing efforts on the Gen-1
device for treatment of
anxiety or insomnia until a 510(k) application is approved by the
FDA." Given that the
FDA has not approved your 510(k) application and your
disclosure on page 4
that "[a]nxiety and insomnia were reclassified as Class II devices and
required a new
application in the form of a special control trial, a summary version of a
PMA, requiring safety
data and mild efficacy response," please revise your disclosure here
and throughout the
registration statement to clarify that your decision to suspend
Mark White
Nexalin Technology, Inc.
January 19, 2022
Page 2
marketing efforts on the Gen-1 device for the treatment of anxiety or
insomnia is not
currently voluntary or advise.
Intellectual Property Matrix, page 83
2. We note your response to prior comment 7 and your revised disclosure on
pages 82-85.
Please revise further to explain why the expected expiration dates for
the remaining
pending applications are currently unknown.
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 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 Joshua Gorsky at 202-551-7836 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
January 19, 2022 Page 2
cc: Martin Siegel, Esq.
FirstName LastName