Correspondence 0001829126-24-004116 from Nexalin Technology, Inc. (NXL)
Nexalin Technology, Inc.
Date: June 12, 2024 · CIK: 0001527352 · Accession: 0001829126-24-004116
AI Filing Summary & Sentiment
File numbers found in text: 333-279684
Referenced dates: June 5, 2024
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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