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Nexalin Technology, Inc.
Response Received
1 company response(s)
Medium - date proximity
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Nexalin Technology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2025-01-03
Nexalin Technology, Inc.
Summary
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Company responded
2025-01-30
Nexalin Technology, Inc.
Summary
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Nexalin Technology, Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2024-06-05
Nexalin Technology, Inc.
Summary
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Company responded
2024-06-12
Nexalin Technology, Inc.
References: June 5, 2024
Summary
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Company responded
2024-06-24
Nexalin Technology, Inc.
References: June 21, 2024 | June 5, 2024
Summary
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Company responded
2024-06-26
Nexalin Technology, Inc.
Summary
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Company responded
2024-06-26
Nexalin Technology, Inc.
Summary
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Nexalin Technology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-06-21
Nexalin Technology, Inc.
Summary
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Nexalin Technology, Inc.
Response Received
6 company response(s)
High - file number match
SEC wrote to company
2022-01-19
Nexalin Technology, Inc.
Summary
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Company responded
2022-04-08
Nexalin Technology, Inc.
Summary
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Company responded
2022-04-27
Nexalin Technology, Inc.
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Company responded
2022-05-16
Nexalin Technology, Inc.
Summary
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Company responded
2022-05-31
Nexalin Technology, Inc.
Summary
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Company responded
2022-09-12
Nexalin Technology, Inc.
Summary
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Company responded
2022-09-12
Nexalin Technology, Inc.
Summary
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Nexalin Technology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-05-06
Nexalin Technology, Inc.
Summary
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Nexalin Technology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-04-22
Nexalin Technology, Inc.
Summary
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Nexalin Technology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-02-09
Nexalin Technology, Inc.
Summary
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Nexalin Technology, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-12-21
Nexalin Technology, Inc.
Summary
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Nexalin Technology, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-11-19
Nexalin Technology, Inc.
Summary
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Nexalin Technology, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-10-15
Nexalin Technology, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-28 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2025-04-07 | SEC Comment Letter | Nexalin Technology, Inc. | DE | 377-07847 | Read Filing View |
| 2025-01-30 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2025-01-03 | SEC Comment Letter | Nexalin Technology, Inc. | DE | 333-283960 | Read Filing View |
| 2024-06-26 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2024-06-26 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2024-06-24 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2024-06-21 | SEC Comment Letter | Nexalin Technology, Inc. | DE | 333-279684 | Read Filing View |
| 2024-06-12 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2024-06-05 | SEC Comment Letter | Nexalin Technology, Inc. | DE | 333-279684 | Read Filing View |
| 2022-09-12 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-09-12 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-05-31 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-05-16 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-05-06 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-04-27 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-04-22 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-04-08 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-02-09 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-01-19 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2021-12-21 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2021-11-19 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2021-10-15 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-07 | SEC Comment Letter | Nexalin Technology, Inc. | DE | 377-07847 | Read Filing View |
| 2025-01-03 | SEC Comment Letter | Nexalin Technology, Inc. | DE | 333-283960 | Read Filing View |
| 2024-06-21 | SEC Comment Letter | Nexalin Technology, Inc. | DE | 333-279684 | Read Filing View |
| 2024-06-05 | SEC Comment Letter | Nexalin Technology, Inc. | DE | 333-279684 | Read Filing View |
| 2022-05-06 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-04-22 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-02-09 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-01-19 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2021-12-21 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2021-11-19 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2021-10-15 | SEC Comment Letter | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-28 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2025-01-30 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2024-06-26 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2024-06-26 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2024-06-24 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2024-06-12 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-09-12 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-09-12 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-05-31 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-05-16 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-04-27 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
| 2022-04-08 | Company Response | Nexalin Technology, Inc. | DE | N/A | Read Filing View |
2025-04-28 - CORRESP - Nexalin Technology, Inc.
CORRESP 1 filename1.htm 1776 Yorktown, Suite 550 Houston, Texas 77056 April 28, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Juan Ganna Re: Nexalin Technology, Inc. Registration Statement on Form S-3 File No. 333-286711 Ladies and Gentlemen: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 4:00 pm, Eastern Time, on April 29, 2025, or as soon thereafter as is practicable. Very truly yours, NEXALIN TECHNOLOGY, INC. By: /s/ Mark White Name: Mark White Title: Chief Executive Officer
2025-04-07 - UPLOAD - Nexalin Technology, Inc. File: 377-07847
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 7, 2025 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-3 Submitted March 31, 2025 CIK No. 0001527352 Dear Mark White: We have conducted a limited review of your draft registration statement and have the following comment. Please respond to this letter by providing any requested information and by publicly filing your registration statement and non-public draft submission on EDGAR. If you do not believe a comment applies 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 this letter and your filed registration statement, we may have additional comments. Draft Registration Statement on Form S-3 General 1. We note that your Current Report on Form 8-K filed on September 3, 2024 disclosed the results of your annual meeting held on August 26, 2024 and does not appear to have been timely filed. Please provide us with your analysis regarding how you meet the eligibility requirements for Form S-3 as it does not appear that you filed in a timely manner all reports required to be filed in the past 12 months as required by General Instruction I.A.3(b) of Form S-3. 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. April 7, 2025 Page 2 We also remind you that your registration statement must be on file at least two business days prior to the requested effective date and time. 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. Please contact Juan Grana at 202-551-6034 or Conlon Danberg at 202-551-4466 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Martin S. Siegel, Esq. </TEXT> </DOCUMENT>
2025-01-30 - CORRESP - Nexalin Technology, Inc.
CORRESP
1
filename1.htm
1776
Yorktown, Suite 550
Houston,
Texas 77056
January
30, 2025
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F. Street, N.E.
Washington,
D.C. 20549
Attention:
Conlon Danberg
Re: Nexalin
Technology, Inc.
Pre-Effective
Amendment No. 2 to Registration Statement on Form S-1
File
No. 333-283960
Ladies
and Gentlemen:
In
accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned
respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become
effective at 4:00 pm, Eastern Time, on February 3, 2025, or as soon thereafter as is practicable.
Very truly yours,
NEXALIN TECHNOLOGY, INC.
By:
/s/ Mark White
Name:
Mark White
Title:
Chief Executive Officer
2025-01-03 - UPLOAD - Nexalin Technology, Inc. File: 333-283960
January 3, 2025
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 December 20, 2024
File No. 333-283960
Dear Mark White:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Conlon Danberg at 202-551-4466 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Martin S. Siegel, Esq.
2024-06-26 - CORRESP - Nexalin Technology, Inc.
CORRESP
1
filename1.htm
1776
Yorktown, Suite 550
Houston,
Texas 77056
June
26, 2024
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F. Street, N.E.
Washington,
D.C. 20549
Attention:
Robert
Augustin
Jane
Park
Re:
Nexalin
Technology, Inc.
Pre-Effective
Amendment No. 3 to Registration Statement on Form S-1
File
No. 333-279684
Ladies
and Gentlemen:
In
accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, the undersigned
respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become
effective at 4:30 pm, Eastern Time, on Thursday, June 27, 2024, or as soon thereafter as is practicable.
Very truly yours,
NEXALIN TECHNOLOGY, INC.
By:
/s/
Mark White
Name:
Mark
White
Title:
Chief
Executive Officer
2024-06-26 - CORRESP - Nexalin Technology, Inc.
CORRESP
1
filename1.htm
June
26, 2024
VIA
EDGAR
Robert
Augustin
Jane
Park
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Industrial Applications and Services
100
F Street, N.E.
Washington,
D.C. 20549
Re: Nexalin
Technology, Inc.
Amendment
No. 3 to Registration Statement on Form S-1
File
No. 333-279684
Ladies
and Gentlemen:
Pursuant
to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Securities
Act”), Maxim Group LLC, as representative of the several underwriters, hereby joins the request of Nexalin Technology, Inc.
that the effective date of the above-referenced Registration Statement be accelerated so that it may become effective at 4:30 p.m., Eastern
Time, on Thursday June 27, 2024, or as soon as possible thereafter, or at such later time as the Company or its counsel may request via
telephone call to the staff.
Pursuant
to Rule 460 of the General Rules and Regulations of the Securities and Exchange Commission under the Act, please be advised that we will
take reasonable steps to secure adequate distribution of the prospectus to underwriters, dealers, institutions and others prior to the
requested effective time of the Registration Statement.
The
undersigned advises that it has complied and will continue to comply, and that it has been informed by the participating underwriters
and dealers that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under the Securities Exchange
Act of 1934, as amended.
Very truly yours,
Maxim Group LLC
By:
/s/
Ritesh M. Veera
Name:
Ritesh M. Veera
Title:
Co-Head
of Investment Bank
cc:
Andrew M. Tucker, Esq., Nelson
Mullins Riley & Scarborough LLP
[Signature
Page to Underwriters Acceleration Request]
2024-06-24 - CORRESP - Nexalin Technology, Inc.
CORRESP
1
filename1.htm
WARSHAW BURSTEIN, LLP
575 Lexington Avenue
New York, NY 10022
Telephone: 212-984-7700
www.wbny.com
June 24, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
Washington, D.C. 20549
Attention:
Mr. Robert Augustin
Ms. Jane Park
Re:
Nexalin Technology, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed June 14, 2024
File No. 333-279684
Ladies and Gentlemen:
On behalf of our client, Nexalin Technology, Inc., a Delaware corporation (the “Company”), we are writing to submit the Company’s response to the comment of the staff (the “Staff”) of the Division of Corporation Finance of the United States Securities and Exchange Commission (the “SEC”) with respect to the above-referenced Registration Statement on Form S-1 filed on June 14, 2024 (File No. 333-279684, the “Registration Statement”), contained in the Staff’s letter dated June 21, 2024 (the “Comment Letter”).
For ease of reference, the comment contained in the Comment Letter is printed below in bold and is followed by the Company’s response.
Amendment No. 1 to Registration Statement on Form S-1 filed June 14, 2024
General
1.
We note your response to our prior comment 1. Please revise to address the following comments:
●
We note your revised disclosure that you “expect a portion of [y]our revenues will be derived from China through the Joint Venture.” Please revise to expand your disclosure relating to your Joint-Venture related revenue, including the proportion of your revenue that was derived through your Joint Venture during the 2023 fiscal year and the quarterly period ended March 31, 2024.
WARSHAW BURSTEIN, LLP
United States Securities and Exchange Commission
Division of Corporation Finance - Office of Industrial Applications and Services
June 24, 2024
Page 2
Response:
During the 2023 fiscal year, the
Company sold equipment to the Joint Venture, resulting in revenue to the Company in the amount of $3,614 (accounting for 3.3% of the
Company’s revenues in such year). In the first fiscal quarter of 2024, the Company recognized $5,783 in pass-through other
income from the Joint Venture included in “Other Income”, as disclosed in the Company’s Report on Form 10-Q for
the quarter ended March 31. 2024. As stated in such Form 10-Q, the Company recognizes its investment in the Joint Venture as an
asset at cost and measures its investment by recognizing the Company’s share of earnings or losses of the Joint Venture on a
one-quarter reporting lag. As noted in our June 14, 2024 response to the Staff’s comment letter dated June 5, 2024, the Company
received no revenue from operations from China during the first quarter of 2024. As China continues to emerge from restrictions
related to the Covid-19 pandemic, the Company expects the Joint Venture to begin generating revenue in fiscal year 2025.
●
We note your statement in your response that 70.5% of the company’s revenue was derived from sales in Oman and 29.5% of the quarterly revenue came from U.S. sales during the first fiscal quarter of 2024. We also refer to your disclosure on page 8 that The Sultanate of Oman’s Ministry of Health granted the approval for the distribution of your Gen-2 device in March 2024 and that you commenced sales of your device in Oman in the first quarter of 2024. Please revise to specify when you obtained approval for distribution of your Gen-2 device in March 2024 and when you commenced sales of your device in Oman.
Response:
Oman’s Ministry of Health
granted conditional approval for use of the Company’s second generation (Gen-2) device on June 16, 2022, effective upon the
end user of our device opening and operating a mental health care clinic being constructed in Oman. The Company’s first
shipment of a device to Oman was made on January 30, 2024 and received in Oman on February 5, 2024, in connection with the opening
of the end user’s clinic, rendering the approval effective. Two additional devices were shipped to Oman on February 29, 2024 and were received by the end user
on March 6, 2024. Upon receipt of the two additional devices, the end user’s clinic was operational, and the use of the device
to treat patients commenced pursuant to the approval. In total, the Company’s sales in Oman totaled $55,500 in the first
quarter of 2024 (constituting 70.5% of the Company’s revenue in such quarter).
Please do not hesitate to contact Martin Siegel, of Warshaw Burstein, LLP, at (212) 984-7741 with any questions or comments regarding this letter.
Best regards,
/s/ Warshaw Burstein, LLP
cc:
Nexalin Technology, Inc.
Mark White, President and Chief Executive Officer
2024-06-21 - UPLOAD - Nexalin Technology, Inc. File: 333-279684
United States securities and exchange commission logo
June 21, 2024
Mark White
President and Chief Executive Officer
Nexalin Technology, Inc.
1776 Yorktown
Suite 550
Houston, TX 77056
Re:Nexalin Technology, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed June 14, 2024
File No. 333-279684
Dear Mark White:
We have reviewed your amended registration statement and have the following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies 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 this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our June 5, 2024 letter.
Amendment No. 1 to Registration Statement on Form S-1 filed June 14, 2024
General
1.We note your response to our prior comment 1. Please revise to address the following
comments:
•We note your revised disclosure that you “expect a portion of [y]our revenues will be
derived from China through the Joint Venture.” Please revise to expand your
disclosure relating to your Joint-Venture related revenue, including the proportion of
your revenue that was derived through your Joint Venture during the 2023 fiscal year
and the quarterly period ended March 31, 2024; and
•We note your statement in your response that 70.5% of the company’s revenue was
derived from sales in Oman and 29.5% of the quarterly revenue came from U.S. sales
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
June 21, 2024 Page 2
FirstName LastName
Mark White
Nexalin Technology, Inc.
June 21, 2024
Page 2
during the first fiscal quarter of 2024. We also refer to your disclosure on page 8 that
The Sultanate of Oman’s Ministry of Health granted the approval for the distribution
of your Gen-2 device in March 2024 and that you commenced sales of your device in
Oman in the first quarter of 2024. Please revise to specify when you obtained
approval for distribution of your Gen-2 device in March 2024 and when you
commenced sales of your device in Oman.
Please contact Robert Augustin at 202-551-8483 or Jane Park at 202-551-7439 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Martin Siegel
2024-06-12 - CORRESP - Nexalin Technology, Inc.
CORRESP
1
filename1.htm
WARSHAW
BURSTEIN, LLP
575
Lexington Avenue
New
York, NY 10022
Telephone:
212-984-7700
www.wbny.com
June
12, 2024
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Office
of Industrial Applications and Services
Washington,
D.C. 20549
Attention:
Mr. Robert Augustin
Ms.
Jane Park
Re: Nexalin
Technology, Inc.
Registration
Statement on Form S-1
Filed
May 23, 2024
File
No. 333-279684
Ladies
and Gentlemen:
On
behalf of our client, Nexalin Technology, Inc., a Delaware corporation (the “Company”), we are writing to submit
the Company’s response to the comment of the staff (the “Staff”) of the Division of Corporation Finance
of the United States Securities and Exchange Commission (the “SEC”) with respect to the above-referenced Registration
Statement on Form S-1 filed on May 23, 2024 (File No. 333-279684, the “Registration Statement”), contained
in the Staff’s letter dated June 5, 2024 (the “Comment Letter”).
For
ease of reference, the comment contained in the Comment Letter is printed below in bold and is followed by the Company’s response.
Registration
Statement on Form S-1
1. We note your disclosure on page 4 relating to your joint venture established for the clinical development, marketing, sale and
distribution of your second generation transcranial Alternating Current Stimulation devices in China and other countries in the
region. Additionally, we note your disclosure in your Form 10-Q for the quarterly period ended March 31, 2024 that you
“receive revenue from the sale in China of our Devices to [y]our distributor and from the sale of products relating to the use
of those Devices” and “derive revenue as a royalty fee from the China-based manufacturer for electrodes ordered in
connection with [y]our China sales.” To the extent you do not conduct the majority of your operations in China, please provide
us your analysis supporting this. To the extent you conduct the majority of your operations in China, please revise your filing, as
applicable, to provide more specific and prominent disclosures about the legal and operational risks associated with China-based
companies. For additional guidance, please see the Division of Corporation Finance’s Sample Letter to China-Based Companies
issued by the Staff in December 2021 and the Sample Letter to Companies Regarding China-Specific Disclosures issued by the Staff in
July 2023.
WARSHAW BURSTEIN, LLP
United States Securities and Exchange Commission
Division of Corporation Finance - Office of Industrial Applications and
Services
June 12, 2024
Page 2
Response:
The Company respectfully advises the Staff that the Company does not conduct the majority of its operations in China.
The
Company is a Delaware corporation with its business headquarters and a warehouse located in Houston, Texas. All members of the Company’s
management team are located in the United States. The Company’s President and Chief Executive Officer, Mark White, conducts his
business operations through the Company’s headquarters in Texas. Dr. David Owens, the Company’s Chief Medical Officer, operates
from Georgia; Michael Nketiah, the Company’s Senior Vice President of Quality, Regulatory and Clinical Affairs, operates from California;
and Marilyn Elson, the Company’s Controller, operates from New Jersey. The Company’s financial services team is located in
Arizona, and the Company utilizes manufacturing facilities, and research and development consultants, located in California. All members
of the Company’s board of directors reside in the United States. The Company has no employees or office in China and none of the
Company’s operations are conducted in China.
Company
personnel located in the United States oversee all clinical protocol development for Food and Drug Administration submissions and clinical
trial investigations for future treatment indications (which regulatory clearance submissions are discussed beginning on page 7 of the
Registration Statement). Clinical and pilot testing of the Company’s devices is conducted both in the United States and in China.
However, all activity in China is conducted by and through the Company’s Hong Kong-registered joint venture with Wider Come Limited
(as described in more detail beginning on page 7 of the Registration Statement).
The
Company’s revenue is derived from the sale of devices and equipment, as well as related licensing fees. During the 2023 fiscal
year, 96.7% of the Company’s revenue was derived from sales in the United States, with the remaining 3.3% of revenues being attributable
to China-based sources. For the first fiscal quarter of 2024, 70.5% of the Company’s revenue was derived from sales in Oman, and
29.5% of the quarterly revenue came from U.S. sales (with no revenue from China). The Company may derive additional revenue from China
in the future as a result of sales of devices and equipment and the receipt of licensing fees.
Please
do not hesitate to contact Martin Siegel, of Warshaw Burstein, LLP, at (212) 984-7741 with any questions or comments regarding this letter.
Best
regards,
/s/
Warshaw Burstein, LLP
cc:
Nexalin
Technology, Inc.
Mark
White, President and Chief Executive Officer
2024-06-05 - UPLOAD - Nexalin Technology, Inc. File: 333-279684
United States securities and exchange commission logo
June 5, 2024
Mark White
President and Chief Executive Officer
Nexalin Technology, Inc.
1776 Yorktown
Suite 550
Houston, TX 77056
Re:Nexalin Technology, Inc.
Registration Statement on Form S-1
Filed May 23, 2024
File No. 333-279684
Dear Mark White:
We have conducted a limited review of your registration statement and have the
following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies 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 this letter, we may have additional comments.
Registration Statement on Form S-1
General
1.We note your disclosure on page 4 relating to your joint venture established for the
clinical development, marketing, sale and distribution of your second generation
transcranial Alternating Current Stimulation devices in China and other countries in the
region. Additionally, we note your disclosure in your Form 10-Q for the quarterly period
ended March 31, 2024 that you "receive revenue from the sale in China of our Devices to
[y]our distributor and from the sale of products relating to the use of those Devices" and
"derive revenue as a royalty fee from the China-based manufacturer for electrodes ordered
in connection with [y]our China sales." To the extent you do not conduct the majority of
your operations in China, please provide us your analysis supporting this. To the extent
you conduct the majority of your operations in China, please revise your filing, as
applicable, to provide more specific and prominent disclosures about the legal and
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
June 5, 2024 Page 2
FirstName LastName
Mark White
Nexalin Technology, Inc.
June 5, 2024
Page 2
operational risks associated with China-based companies. For additional guidance, please
see the Division of Corporation Finance's Sample Letter to China-Based Companies
issued by the Staff in December 2021 and the Sample Letter to Companies Regarding
China-Specific Disclosures issued by the Staff in July 2023.
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.
Please contact Robert Augustin at 202-551-8483 or Jane Park at 202-551-7439 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
2022-09-12 - CORRESP - Nexalin Technology, Inc.
CORRESP
1
filename1.htm
September
12, 2022
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street NE
Washington,
D.C. 20549
Re: Nexalin
Technology, Inc.
Registration
Statement on Form S-1
File
No. 333-261989
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Maxim Group LLC, as representative of
the several underwriters, hereby joins Nexalin Technology, Inc. in requesting that the Securities and Exchange Commission take appropriate
action to cause the Registration Statement on Form S-1 (File No. 333-261989) (the “Registration Statement”) to become effective
on Thursday, September 15, 2022, at 5:00 p.m., Eastern Time, or as soon as practicable thereafter.
Pursuant
to Rule 460 of the General Rules and Regulations of the Securities and Exchange Commission under the Act, please be advised that we will
take reasonable steps to secure adequate distribution of the prospectus to underwriters, dealers, institutions and others prior to the
requested effective time of the Registration Statement.
We,
the undersigned, as representatives of the several underwriters, have complied and will continue to comply, and we have been informed
by the participating underwriters and dealers that they have complied and will continue to comply, with the requirements of Rule 15c2-8
under the Securities Exchange Act of 1934, as amended.
[Signature
Page Follows]
Very
truly yours,
MAXIM
GROUP LLC
By:
/s/ Clifford A. Teller
Name:
Clifford A. Teller
Title:
Co-President
[Signature
Page to Acceleration Request]
2022-09-12 - CORRESP - Nexalin Technology, Inc.
CORRESP
1
filename1.htm
Nexalin Technology, Inc.
1776 Yorktown, Suite 550
Houston, TX 77056
(281) 830-8900
September 12, 2022
VIA EDGAR
Division of Corporate Finance
Office of Life Sciences
Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549
Attn: Branch Chief
Re: Nexalin Technology, Inc.
Registration Statement on Form S-1
File No. 333-261989
Ladies and Gentlemen:
The Company hereby requests, pursuant to Rule 461
promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration Statement so that such Registration
Statement will become effective at 5:00 p.m., Washington D.C. time, on Thursday, September 15, 2022, or as soon thereafter as practicable.
The Company hereby acknowledges that:
● Should the Securities and Exchange Commission (the “Commission”)
or the Staff, acting as pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission
from taking any action with respect to the Registration Statement;
● The action of the Commission or the Staff, acting pursuant
to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility
for the adequacy and accuracy of the disclosure in the Registration Statement; and
● The Company may not assert Staff comments and the declaration
of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United
States.
Nexalin Technology, Inc.
By: /s/ Mark White
Mark White
Chief Executive Officer
2022-05-31 - CORRESP - Nexalin Technology, Inc.
CORRESP
1
filename1.htm
Warshaw Burstein, LLP
575 Lexington Avenue
New York, NY 10022
(212) 984-7700
www.wbny.com
Brian C. Daughney
EMAIL: bdaughney@wbny.com
DIRECT DIAL: (212) 984-7797
May 31, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention: Joshua Gorsky
Re: Nexalin Technology, Inc.
Amendment No. 6 to Registration Statement on Form
S-1
File No. 333-261989
Ladies and Gentlemen:
We are submitting this letter
on behalf of Nexalin Technology, Inc. (the “Company” or “Nexalin”) in connection with
the filing of Amendment No.6 to the Company’s Form S-1 (Registration No. 333-261989) filed with the Commission on May 31, 2022
(the “Registration Statement”).
Amendment No. 6 to the Registration
Statement is being filed solely to removed references to any underwriter’s warrants which have now been removed as compensation
payable to the underwriters.. No changes to the financial statements, operations or any disclosures have been made from Amendment No.
5 previously filed. We have also removed the form of underwriters warrant as an exhibit.
Should the Staff have additional questions
or comments regarding the foregoing, please do not hesitate to contact the undersigned at (212) 984-7797.
WARSHAW BURSTEIN, LLP
By:
/s/ Brian C. Daughney
Brian C. Daughney, Esq.
cc: Mark White, CEO
2022-05-16 - CORRESP - Nexalin Technology, Inc.
CORRESP
1
filename1.htm
Warshaw Burstein, LLP
575 Lexington Avenue
New York, NY 10022
(212) 984-7700
www.wbny.com
Brian C. Daughney
EMAIL: bdaughney@wbny.com
DIRECT DIAL: (212) 984-7797
May 16, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention:
Gary Newberry
Terence O'Brien
Joshua Gorsky
Jeffrey Gabor
Re: Nexalin Technology, Inc.
Amendment No. 4 to Registration Statement on Form
S-1
Filed on April 28, 2022
File No. 333-261989
Ladies and Gentlemen:
We are submitting this letter
on behalf of Nexalin Technology, Inc. (the “Company” or “Nexalin”) in response to
comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
received by electronic mail dated May 6, 2022, relating to the Company’s Registration Statement on Form S-1 Amendment 3 (Registration
No. 333-261989) filed with the Commission on April 28, 2022 (the “Registration Statement”).
Amendment No. 5 to the
Registration Statement (“Amendment No. 5”) is being filed concurrently herewith. The numbered
paragraphs below correspond to the numbered comments in the Staff’s letter and the Staff’s comments are
presented in bold italics.
We advise Staff
that Amendment No. 5 reflects updated financial information to include March 31, 2022 quarter results. We have also modified the filing
to reflect an offering range of $6.00 to $7.00 and prepared the disclosures based upon the minimum of $6.00 per unit.
Amendment No. 4 to Registration Statement on Form S-1 filed April
28, 2022
Report of Independent Registered Public Accounting Firm, page F-2
1. The scope of the audit report refers to the
statements of operations, stockholders’ deficit, and cash flows for the years ended December 31, 2020 and 2019, rather than 2021
and 2020. Please provide a revised audit report to address this.
Response
We have revised the audit report per Staff’s
request. We have also updated the Exhibit 23.1 consent.
Should the Staff have additional questions
or comments regarding the foregoing, please do not hesitate to contact the undersigned at (212) 984-7797.
WARSHAW BURSTEIN, LLP
By:
/s/ Brian C. Daughney
Brian C. Daughney, Esq.
2022-05-06 - UPLOAD - Nexalin Technology, Inc.
United States securities and exchange commission logo
May 6, 2022
Mark White
Chief Executive Officer
Nexalin Technology, Inc.
1776 Yorktown, Suite 550
Houston, TX 77056
Re:Nexalin Technology, Inc.
Amendment No. 4 to Registration Statement on Form S-1
Filed on April 28, 2022
File No. 333-261989
Dear Mr. White:
We have reviewed your amended 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.
Amendment No. 4 to Registration Statement on Form S-1 filed April 28, 2022
Report of Independent Registered Public Accounting Firm, page F-2
1.The scope of the audit report refers to the statements of operations, stockholders’ deficit,
and cash flows for the years ended December 31, 2020 and 2019, rather than 2021 and
2020. Please provide a revised audit report to address this.
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
May 6, 2022 Page 2
FirstName LastName
Mark White
Nexalin Technology, Inc.
May 6, 2022
Page 2
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,
Division of Corporation Finance
Office of Life Sciences
cc: Martin Siegel, Esq.
2022-04-27 - CORRESP - Nexalin Technology, Inc.
CORRESP
1
filename1.htm
Warshaw Burstein, LLP
575 Lexington Avenue
New York, NY 10022
(212) 984-7700
www.wbny.com
Brian C. Daughney
EMAIL: bdaughney@wbny.com
DIRECT DIAL: (212) 984-7797
April 27, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention:
Gary Newberry
Terence O'Brien
Joshua Gorsky
Jeffrey Gabor
Re: Nexalin Technology, Inc.
Amendment No. 3 to Registration Statement on Form
S-1
Filed on April 8, 2022
File No. 333-261989
Ladies and Gentlemen:
We are submitting this letter on behalf of Nexalin Technology,
Inc. (the “Company” or “Nexalin”) in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) received by electronic mail dated April 22, 2022,
relating to the Company’s Registration Statement on Form S-1 Amendment 3 (Registration No. 333-261989) and filed with the Commission
on April 8, 2022 (the “Registration Statement”).
Amendment No. 4 to the Registration Statement (“Amendment
No. 4”) is being filed concurrently herewith. The numbered paragraphs below correspond to the numbered comments in the Staff’s
letter and Staff’s comments are presented in bold italics.
Amendment No. 3 to Registration Statement on Form S-1 filed April 8,
2022
Cover Page
1. We note your disclosure that in the first quarter of 2022, you had
sales of your "Gen-2 devices in China which [you] accomplished through Wider which acted as a distributor of these devices."
Please disclose whether you have entered into a written distribution agreement with Wider that is separate from the Joint Venture Agreement.
Response:
In response to Staff’s comment, we have modified the
disclosure (pages 3 and 80) to state that there is a separate written agreement for the distributor services with Wider. We have also
filed the agreement as Exhibit 10.15.
Overview, page 2
2. Please revise your registration statement to provide context for
the preliminary revenue for the three months ended March 31, 2022 disclosed on page 3, including qualitative and quantitative disclosure,
by providing estimates for other financial statement line items during the same period, such as costs and expenses, that would balance
your disclosure. In this regard, a single financial measure may be considered an incomplete picture of your results of operations or financial
condition.
Response:
In response to Staff’s comment, we have enhanced the disclosure
to discuss costs and expenses related to the revenue. Please see pages 3, 61 and 80.
3. We note your revised disclosure on page 4 that the Gen-1 device
was cleared by the FDA at 4 milliamps and the re classification does not prevent you from servicing previously sold devices. Please explain
what "servicing" your previously sold devices entails and explain if there is a difference between selling your previously sold
Gen-1 device and "servicing" them. If there is a difference, please revise your disclosure accordingly.
Response:
In response to Staff’s comment, we have provided additional
disclosure regarding the “servicing” of previously sold devices. Please see pages 2, 4, 58, 77 and 93. As disclosed, providers
who acquired the devices prior to the FDA’s December 2019 ruling may continue to use the devices for treatments. Some providers
who has licensed devices decided to purchase them. Others remain on lease. The Company received monthly licensing or revenue from the
sale of electrodes.
General
4. We note your response to prior comment 2 and reissue in part. We
note that the maximum aggregate offering price in Exhibit 107 is inconsistent with the disclosure in the registration statement. Please
revise the registration statement and legal opinion accordingly.
Response:
We have filed a new Exhibit 107 to correct the gross offering
amounts. We have also filed a new opinion as Exhibit 5.1 in response to Staff’s comment.
2
Should the Staff have additional questions or comments regarding
the foregoing, please do not hesitate to contact the undersigned at (212) 984-7797. Subject to Staff’s consideration of Amendment
4, we hope to go effective in advance of the year-end financial statements becoming stale.
WARSHAW BURSTEIN, LLP
By:
/s/ Brian C. Daughney
Brian C. Daughney, Esq.
3
2022-04-22 - UPLOAD - Nexalin Technology, Inc.
United States securities and exchange commission logo
April 22, 2022
Mark White
Chief Executive Officer
Nexalin Technology, Inc.
1776 Yorktown, Suite 550
Houston, TX 77056
Re:Nexalin Technology, Inc.
Amendment No. 3 to Registration Statement on Form S-1
Filed on April 8, 2022
File No. 333-261989
Dear Mr. White:
We have reviewed your amended 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 February 9, 2022 letter.
Amendment No. 3 to Registration Statement on Form S-1 filed April 8, 2022
Cover Page
1.We note your disclosure that in the first quarter of 2022, you had sales of your "Gen-2
devices in China which [you] accomplished through Wider which acted as a distributor of
these devices." Please disclose whether you have entered into a written distribution
agreement with Wider that is separate from the Joint Venture Agreement.
Overview, page 2
2.Please revise your registration statement to provide context for the preliminary revenue
for the three months ended March 31, 2022 disclosed on page 3, including qualitative and
quantitative disclosure, by providing estimates for other financial statement line items
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
April 22, 2022 Page 2
FirstName LastName
Mark White
Nexalin Technology, Inc.
April 22, 2022
Page 2
during the same period, such as costs and expenses, that would balance your disclosure.
In this regard, a single financial measure may be considered an incomplete picture of your
results of operations or financial condition.
3.We note your revised disclosure on page 4 that the Gen-1 device was cleared by the FDA
at 4 milliamps and the re classification does not prevent you from servicing previously
sold devices. Please explain what "servicing" your previously sold devices entails and
explain if there is a difference between selling your previously sold Gen-1 device and
"servicing" them. If there is a difference, please revise your disclosure accordingly.
General
4.We note your response to prior comment 2 and reissue in part. We note that the
maximum aggregate offering price in Exhibit 107 is inconsistent with the disclosure in the
registration statement. Please revise the registration statement and legal opinion
accordingly.
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,
Division of Corporation Finance
Office of Life Sciences
cc: Martin Siegel, Esq.
2022-04-08 - CORRESP - Nexalin Technology, Inc.
CORRESP
1
filename1.htm
Warshaw Burstein, LLP
575 Lexington Avenue
New York, NY 10022
(212) 984-7700
www.wbny.com
Brian
C. Daughney
EMAIL: bdaughney@wbny.com
DIRECT
DIAL: (212) 984-7797
April
8, 2022
VIA EDGAR
Securities and Exchange
Commission Division of
Corporation
Finance
100 F Street, N.E.
Washington, DC 20549
Attention:
Gary Newberry
Terence O'Brien
Joshua Gorsky
Jeffrey
Gabor
Re: Nexalin Technology, Inc. Registration Statement
on Form S-1 Amendment 2 File No. 333-261989
Ladies and Gentlemen:
We are submitting
this letter on behalf of Nexalin Technology, Inc. (the “Company” or “Nexalin”) in
response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
received by electronic mail dated February 9, 2022, relating to the Company’s Registration Statement on Form S-1 Amendment 2 (Registration
No. 333-261989) filed with the Commission on February 4, 2022 (the “Registration Statement”).
Amendment No.
3 to the Registration Statement (“Amendment No. 3”) is being filed concurrently herewith. The numbered
paragraphs below correspond to the numbered comments in the Staff’s letter and the Staff’s comments are presented
in bold italics. In addition to addressing the comments raised by the Staff in its letter, the Company has revised the Registration
Statement to update other disclosures. For example, we have revised the Registration Statement to include information up to the date of
this filing and updated financial statements and related information to include December 31, 2021 year end.
Securities and Exchange Commission
April 8, 2022
Page 2
Further, please
note that the offering will now be of units, comprised of a share of common stock and a warrant. Units will not be separately issued and
we will not seek to have the units trade. Investors will be required to purchase the securities in a unit The gross proceeds are currently
contemplated for $9,000,000 (1,500,000 units) and Amendment No.3 includes these changes to the offering. Each warrant entitled to holder
to purchase one share. We are registering the shares issuable upon exercise of the warrants. Amendment No.3 includes the form of warrant
agreement as an exhibit and a description of the warrants terms has been included.
Amendment No. 1 to Registration Statement on Form S-1
Prospectus Summary, page 4
1. Given that you are
required to file a new application under Section 510(k) of the Federal Food, Drug and Cosmetic Act for your Gen-1 device, please
revise your disclosure here and throughout the registration statement to note that your Gen-1 device is not "currently . . .
cleared by the FDA at 4 milliamps."
Response
We have made the revisions as requested by Staff
throughout the document, and as noted above, included updated information for the Company’s business plans, included those related
to FDA applications and trials.
General
2. We note that the maximum aggregate offering
price in Exhibit 107 is inconsistent with the disclosure in the registration statement and the legal opinion. Please revise the registration
statement and legal opinion accordingly. Please also revise your cover page to disclose the number of common stock in this offering (i.e.
volume of securities).
Response
As we have modified the offering and the components,
we have revised Exhibit 107.
Securities and Exchange Commission
April 8, 2022
Page
3
Should the Staff have additional questions
or comments regarding the foregoing, please do not hesitate to contact the undersigned at (212) 984-7791.
WARSHAW
BURSTEIN, LLP
By:
/s/ Brian C. Daughney
Brian C. Daughney,
Esq.
cc: Mark White, Nexalin Technology, Inc.
Andrew Tucker, Esq.
2022-02-09 - UPLOAD - Nexalin Technology, Inc.
United States securities and exchange commission logo
February 9, 2022
Mark White
Chief Executive Officer
Nexalin Technology, Inc.
1776 Yorktown, Suite 550
Houston, TX 77056
Re:Nexalin Technology, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed on February 4, 2022
File No. 333-261989
Dear Mr. White:
We have reviewed your amended 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.
Amendment No. 1 to Registration Statement on Form S-1
Prospectus Summary, page 4
1.Given that you are required to file a new application under Section 510(k) of the Federal
Food, Drug and Cosmetic Act for your Gen-1 device, please revise your disclosure here
and throughout the registration statement to note that your Gen-1 device is not "currently
. . . cleared by the FDA at 4 milliamps."
General
2.We note that the maximum aggregate offering price in Exhibit 107 is inconsistent with the
disclosure in the registration statement and the legal opinion. Please revise the
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
February 9, 2022 Page 2
FirstName LastName
Mark White
Nexalin Technology, Inc.
February 9, 2022
Page 2
registration statement and legal opinion accordingly. Please also revise your cover page
to disclose the number of common stock in this offering (i.e. volume of securities).
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,
Division of Corporation Finance
Office of Life Sciences
cc: Martin Siegel, Esq.
2022-01-19 - UPLOAD - Nexalin Technology, Inc.
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
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
January 19, 2022 Page 2
FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc: Martin Siegel, Esq.
2021-12-21 - UPLOAD - Nexalin Technology, Inc.
United States securities and exchange commission logo
December 21, 2021
Mark White
Chief Executive Officer
Nexalin Technology, Inc.
1776 Yorktown, Suite 550
Houston, TX 77056
Re:Nexalin Technology, Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted December 8, 2021
CIK No. 0001527352
Dear Mr. White:
We have reviewed your amended 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.
Amendment No. 2 to Draft Registration Statement on Form S-1 submitted December 8, 2021
Cover Page
1.We note your response to prior comment 2 and your revised disclosure on the cover page
that "there are no regulatory or other restrictions that would restrict either (i) the transfer
from China of any proceeds resulting from such sales by Wider to the Joint Venture in
Hong Kong, other than standard compliance with China’s State Administration of Foreign
Exchange policies and approval process, or (ii) [y]our receipt of [y]our share of such
proceeds from Hong Kong to [you] in the United States." Please explain further
how "standard compliance" with China's State Administration of Foreign Exchange
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
December 21, 2021 Page 2
FirstName LastName
Mark White
Nexalin Technology, Inc.
December 21, 2021
Page 2
policies and approval process would restrict the transfer of any proceeds resulting from
sales by Widner to the Joint Venture or the receipt of your share of such proceeds from
Hong Kong to you in the United States.
Prospectus Summary, page 5
2.We note your response to prior comment 3 and your revised disclosure on pages 5 and 6
summarizing the risk factors associated with doing business in China. We reissue in part
our comment. Please specifically discuss risks arising from the legal system in China,
including risks and uncertainties regarding the enforcement of laws and that rules and
regulations in China can change quickly with little advance notice; and the risk that the
Chinese government may intervene or influence your operations at any time, or may exert
more control over offerings conducted overseas and/or foreign investment in China-based
issuers, which could result in a material change in your operations and/or the value of
your common stock. Acknowledge any risks that any actions by the Chinese government
to exert more oversight and control over offerings that are conducted overseas and/or
foreign investment in China-based issuers could significantly limit or completely hinder
your ability to offer or continue to offer securities to investors and cause the value of such
securities to significantly decline or be worthless.
3.We note your response to prior comment 4 and your revised disclosure on pages 6 and 56
that, when formed, the Joint Venture "will have received, all requisite permissions from
the PRC to conduct its business and no permissions will have been denied." We reissue in
part our comment. Please revise your disclosure further to disclose each permission that
you are required to obtain from Chinese authorities to operate the Joint Venture.
The approval of the CSRC, and other compliance procedures may be required in connection with
any offering..., page 25
4.We note your response to prior comment 10 and your revised disclosure on page 25
stating that “[you] do not intend to obtain the approval from either the CSRC or the CAC
in connection with any such offering, since [you] do not believe that such approval is
required under these circumstances.” Please revise to provide the basis for your belief.
Our amended and restated certificate of incorporation will provide that the Court of Chancery of
the State of Delaware..., page 40
5.We note your response to prior comment 15. Please revise to state that investors cannot
waive compliance with the federal securities laws and the rules and regulations
thereunder. In that regard, we note that 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.
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
December 21, 2021 Page 3
FirstName LastName
Mark White
Nexalin Technology, Inc.
December 21, 2021
Page 3
Regulatory Strategy, page 78
6.We note your response to prior comment 18 and your revised disclosure on page 78
stating that "[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" and
that "[t]his decision was made voluntarily because of the "pre-sub" meetings with the
FDA and the lack of clarity provided by the FDA during such meetings concerning
deadlines and extensions due to the COVID-19 pandemic." Please include this, and
related disclosure, prominently within the Summary. Please also revise
for consistency throughout the submission/filing (e.g., "[t]hrough our existing “Gen-1”
device, we provide an FDA-cleared, easy-to-administer treatment that utilizes
bioelectronic medical technology treat anxiety and insomnia"; "we currently sell a medical
device to medical professionals which is administered by them to patients in a clinical
setting and which emits our original waveform at 4 milliamps during treatment—referred
to as Generation 1 or Gen-1"; and "[w]e will continue to market the Gen-1 device for the
treatment of anxiety and insomnia until the amended 510(k) application is provided to the
FDA and approved").
Intellectual Property Matrix, page 79
7.We note your response to comment 19 and your revised disclosure on pages 79-81.
Please revise further to clarify the expected expiration dates for pending patent
applications.
Board of Advisors, page 96
8.We note your response to prior comment 20 and reissue. Please file the board of advisors
agreements with Tucker Anderson, Leonard Osser, and Gian Domenic Trombetta as
exhibits pursuant to Item 601(b)(10) of Regulation S-K or tell us why such filings are not
required. See Item 601(b)(10)(ii)(A) and 601(b)(10)(iii)(B) of Regulation S-K.
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,
Division of Corporation Finance
Office of Life Sciences
cc: Martin Siegel, Esq.
2021-11-19 - UPLOAD - Nexalin Technology, Inc.
United States securities and exchange commission logo
November 19, 2021
Mark White
Chief Executive Officer
Nexalin Technology, Inc.
1776 Yorktown, Suite 550
Houston, TX 77056
Re:Nexalin Technology, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted November 2, 2021
CIK No. 0001527352
Dear Mr. White:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted November 2, 2021
Cover Page
1.We note that you expect to conduct a material portion of your research and a portion of
your operations in China through a joint venture. Please disclose this prominently on the
prospectus cover page. Your disclosure should make clear whether these risks could
result in a material change in your operations and/or the value of your common stock or
could significantly limit or completely hinder your ability to offer or continue to offer
securities to investors and cause the value of such securities to significantly decline or be
worthless. Your disclosure should address how recent statements and regulatory actions
by China’s government, such as those related to the use of variable interest entities and
data security or anti-monopoly concerns, has or may impact the company’s ability to
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
November 19, 2021 Page 2
FirstName LastNameMark White
Nexalin Technology, Inc.
November 19, 2021
Page 2
conduct its business, accept foreign investments, or list on an U.S. or other foreign
exchange. Your prospectus summary should address, but not necessarily be limited to, the
risks highlighted on the prospectus cover page.
2.Provide a clear description of how cash is transferred through your organization. Describe
any restrictions on foreign exchange and your ability to transfer cash between entities,
across borders, and to U.S. investors. Describe any restrictions and limitations on your
ability to distribute earnings from your businesses, including joint ventures, subsidiaries
and/or consolidated VIEs, to the parent company and U.S. investors.
Prospectus Summary, page 2
3.In your summary of risk factors, disclose the risks related to doing business in China
poses to investors. In particular, describe the significant regulatory, liquidity, and
enforcement risks with cross-references to the more detailed discussion of these risks in
the prospectus. For example, specifically discuss risks arising from the legal system in
China, including risks and uncertainties regarding the enforcement of laws and that rules
and regulations in China can change quickly with little advance notice; and the risk that
the Chinese government may intervene or influence your operations at any time, or may
exert more control over offerings conducted overseas and/or foreign investment in China-
based issuers, which could result in a material change in your operations and/or the value
of your common stock. Acknowledge any risks that any actions by the Chinese
government to exert more oversight and control over offerings that are conducted overseas
and/or foreign investment in China-based issuers could significantly limit or completely
hinder your ability to offer or continue to offer securities to investors and cause the value
of such securities to significantly decline or be worthless.
4.Disclose each permission that you are required to obtain from Chinese authorities to
operate and issue these securities to foreign investors. State affirmatively whether you
have received all requisite permissions and whether any permissions have been
denied. Please disclose the consequences to you and your investors if you inadvertently
conclude that approvals are not required, or applicable laws, regulations, or interpretations
change.
Overview, page 3
5.We note your response to prior comment 2 and reissue in part. Please provide the basis
for your statement that "[t]he stigma of expensive psychotherapy or pharmaceutical
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."
6.We note your response to prior comment 3 and reissue. Please revise the Overview
section of the Summary 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
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
November 19, 2021 Page 3
FirstName LastNameMark White
Nexalin Technology, Inc.
November 19, 2021
Page 3
anxiety indications, please also revise the Overview section of the Summary to clarify
whether you have completed the required special control trials and the new 510(k) filing
that you reference on page 14.
7.We note your response to prior comment 4 and your revised disclosure on pages 3, 34, 43,
and 46 regarding your statements that "based on responses from [y]our clinical providers,"
the alternating current waveform "has proven to be highly effective in stimulating a
positive response from the mid-brain structures;" that your alternating current waveform
"is safely administered to the human brain;" and that your Gen-2 device "will generate
enhanced patient response[.]" We reissue in part our prior comment. 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 your characterizations of results to
discuss the data, rather than drawing conclusions from the results.
Risk Factors, page 9
8.To the extent that your joint venture uses or may use a variable interest entity structure to
conduct China-based operations, please revise your risk factors to acknowledge that if the
PRC government determines that the contractual arrangements constituting part of your
VIE structure do not comply with PRC regulations, or if these regulations change or are
interpreted differently in the future, your shares may decline in value or be worthless if
you are unable to assert your contractual control rights over the assets of your PRC
subsidiaries that may conduct all or substantially all of your operations.
9.Given the Chinese government’s significant oversight and discretion over the conduct of
your business, please revise to separately highlight the risk that the Chinese government
may intervene or influence your operations at any time, which could result in a material
change in your operations and/or the value of your common stock. Also, given recent
statements by the Chinese government indicating an intent to exert more oversight and
control over offerings that are conducted overseas and/or foreign investment in China-
based issuers, acknowledge the risk that any such action could significantly limit or
completely hinder your ability to offer or continue to offer securities to investors and
cause the value of such securities to significantly decline or be worthless.
10.In light of recent events indicating greater oversight by the Cyberspace Administration of
China over data security, particularly for companies seeking to list on a foreign exchange,
please revise your disclosure to explain how this oversight impacts your business and your
offering and to what extent you believe that you are compliant with the regulations or
policies that have been issued by the CAC to date.
11.We note from the audit opinion that you have a U.S. based auditor that is registered with
the PCAOB and currently subject to PCAOB inspection. Please disclose any material
risks to the company and investors if it is later determined that the PCAOB is unable to
inspect or investigate completely your auditor because of a position taken by an authority
in a foreign jurisdiction. For example, disclose the risk that lack of inspection could cause
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
November 19, 2021 Page 4
FirstName LastName
Mark White
Nexalin Technology, Inc.
November 19, 2021
Page 4
trading in your securities to be prohibited under the Holding Foreign Companies
Accountable Act and as a result an exchange may determine to delist your securities.
12.Please expand your risk factor disclosure to discuss that the United States Senate passed
the Accelerating Holding Foreign Companies Accountable Act, which, if enacted, would
decrease the number of non-inspection years from three years to two, thus reducing the
time period before your securities may be prohibited from trading or delisted.
13.Please tell us your consideration of whether the PRC Scientific Data Measures presents a
risk to your business that should be disclosed here. We note that you may be restricted
from transferring your scientific data abroad, such as your preclinical and/or clinical
studies conducted within China, or to your foreign partners in China. Please tell us which
parts of your business are relevant to this consideration. Please also clarify the risk factor
on page 17 to disclose whether the PRC could prevent you from seeking foreign approval
and commercialization of your product candidates.
We may require substantial additional funding to meet our financial needs and to pursue our
business objectives, page 10
14.We note your response to prior comment 7 and your revised disclosure on page 10 stating
that the use of the net proceeds will enable you to fund your operating expenses and
capital expenditure requirements through calendar year 2023. However, we were unable
to locate specific disclosure that provides a basis for the statement that you expect to be
cash flow positive in 2023. Please revise your disclosure to more clearly explain the basis
for this statement.
Our amended and restated certificate of incorporation will provide that the Court of Chancery of
the State of Delaware..., page 27
15.We note your response to prior comment 11 and your revised disclosure stating that there
is uncertainty as to whether a court would enforce your exclusive forum provision and that
provision may result in increased costs for investors to bring a claim. We reissue in part
our prior comment. Please revise to disclose whether this provision applies to actions
arising under the Exchange Act.
Next Generations, page 48
16.We note your response to prior comment 16 and your revised disclosures regarding your
hypotheses about your new advanced waveform and the current pilot study. We also note
your statement that "deeper penetration also enhances patient response . . . ." We reissue
in part our prior comment. Please revise this 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. In your revised disclosure,
please discuss the data, rather than drawing conclusions from the results.
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
November 19, 2021 Page 5
FirstName LastName
Mark White
Nexalin Technology, Inc.
November 19, 2021
Page 5
Summary of Current Clinical Trial Strategy for the Joint Venture, page 51
17.We note your response to prior comment 21 and your revised disclosure that "[c]linical
providers have indicated to [you] a strong and positive response from treatment-resistence
patients." We reissue in part our prior comment. Please revise statements 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 53
18.We note your response to prior comment 22 and your revised disclosure on page 53
related to the deadline to submit clinical testing data to the FDA. We reissue in part our
prior comment. Please 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 54
19.We note your response to prior comment 23 and your revised disclosure on the intellectual
property matrix. Please revise further to clarify the patent expiration dates for all issued
patents as well as the expected expiration dates for pending patent applications.
Board of Advisors, page 66
20.Please file the board of advisors agreements with Tucker Anderson, Leonard Osser, and
Gian Domenic Trombetta as exhibits pursuant to Item 601(b)(10) of Regulation S-K or
tell us why such filings are not required.
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,
Division of Corporation Finance
Office of Life Sciences
cc: Martin Siegel, Esq.
2021-10-15 - UPLOAD - Nexalin Technology, Inc.
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
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
October 15, 2021 Page 2
FirstName LastName
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 with Our Business, page 7
6.Please revise to highlight your auditor's explanatory paragraph regarding your ability to
continue as a going concern.
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
October 15, 2021 Page 3
FirstName LastName
Mark White
Nexalin Technology, Inc.
October 15, 2021
Page 3
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
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
October 15, 2021 Page 4
FirstName LastNameMark White
Nexalin Technology, Inc.
October 15, 2021
Page 4
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.
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
October 15, 2021 Page 5
FirstName LastNameMark White
Nexalin Technology, Inc.
October 15, 2021
Page 5
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.
FirstName LastNameMark White
Comapany NameNexalin Technology, Inc.
October 15, 2021 Page 6
FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc: Martin Siegel, Esq.