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Aclarion, Inc.
Response Received
1 company response(s)
High - file number match
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Aclarion, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2024-12-16
Aclarion, Inc.
Summary
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Aclarion, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-11-07
Aclarion, Inc.
Summary
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Aclarion, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-11-01
Aclarion, Inc.
Summary
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Aclarion, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2024-01-26
Aclarion, Inc.
Summary
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Aclarion, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-09-16
Aclarion, Inc.
Summary
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Aclarion, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-09-16
Aclarion, Inc.
Summary
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Aclarion, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-06-17
Aclarion, Inc.
Summary
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Aclarion, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2023-12-20
Aclarion, Inc.
Summary
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Aclarion, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-10-19
Aclarion, Inc.
Summary
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Aclarion, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Aclarion, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-07-11
Aclarion, Inc.
Summary
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Aclarion, Inc.
Response Received
6 company response(s)
High - file number match
SEC wrote to company
2022-01-26
Aclarion, Inc.
Summary
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Company responded
2022-03-04
Aclarion, Inc.
References: January 25, 2022
Summary
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Company responded
2022-03-23
Aclarion, Inc.
References: March 15, 2022
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Aclarion, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-03-15
Aclarion, Inc.
Summary
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Aclarion, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-11-30
Aclarion, Inc.
Summary
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Company responded
2022-01-05
Aclarion, Inc.
References: November 29, 2021
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-30 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2025-04-29 | SEC Comment Letter | Aclarion, Inc. | DE | 333-286761 | Read Filing View |
| 2025-01-10 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2025-01-10 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-12-16 | SEC Comment Letter | Aclarion, Inc. | DE | 333-283724 | Read Filing View |
| 2024-11-07 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-11-07 | SEC Comment Letter | Aclarion, Inc. | DE | 333-282970 | Read Filing View |
| 2024-11-01 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-11-01 | SEC Comment Letter | Aclarion, Inc. | DE | 333-282842 | Read Filing View |
| 2024-10-18 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-09-20 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-09-16 | SEC Comment Letter | Aclarion, Inc. | DE | 333-276648 | Read Filing View |
| 2024-09-16 | SEC Comment Letter | Aclarion, Inc. | DE | 333-281999 | Read Filing View |
| 2024-06-20 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-06-17 | SEC Comment Letter | Aclarion, Inc. | DE | 024-12447 | Read Filing View |
| 2024-02-23 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-02-23 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-02-01 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-01-26 | SEC Comment Letter | Aclarion, Inc. | DE | 333-276648 | Read Filing View |
| 2023-12-20 | SEC Comment Letter | Aclarion, Inc. | DE | 333-275989 | Read Filing View |
| 2023-10-19 | SEC Comment Letter | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2023-10-18 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2023-07-13 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2023-07-11 | SEC Comment Letter | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-04-20 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-04-20 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-04-20 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-04-01 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-03-23 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-03-15 | SEC Comment Letter | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-03-04 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-01-26 | SEC Comment Letter | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-01-05 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2021-11-30 | SEC Comment Letter | Aclarion, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-29 | SEC Comment Letter | Aclarion, Inc. | DE | 333-286761 | Read Filing View |
| 2024-12-16 | SEC Comment Letter | Aclarion, Inc. | DE | 333-283724 | Read Filing View |
| 2024-11-07 | SEC Comment Letter | Aclarion, Inc. | DE | 333-282970 | Read Filing View |
| 2024-11-01 | SEC Comment Letter | Aclarion, Inc. | DE | 333-282842 | Read Filing View |
| 2024-09-16 | SEC Comment Letter | Aclarion, Inc. | DE | 333-276648 | Read Filing View |
| 2024-09-16 | SEC Comment Letter | Aclarion, Inc. | DE | 333-281999 | Read Filing View |
| 2024-06-17 | SEC Comment Letter | Aclarion, Inc. | DE | 024-12447 | Read Filing View |
| 2024-01-26 | SEC Comment Letter | Aclarion, Inc. | DE | 333-276648 | Read Filing View |
| 2023-12-20 | SEC Comment Letter | Aclarion, Inc. | DE | 333-275989 | Read Filing View |
| 2023-10-19 | SEC Comment Letter | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2023-07-11 | SEC Comment Letter | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-03-15 | SEC Comment Letter | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-01-26 | SEC Comment Letter | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2021-11-30 | SEC Comment Letter | Aclarion, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-30 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2025-01-10 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2025-01-10 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-11-07 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-11-01 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-10-18 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-09-20 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-06-20 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-02-23 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-02-23 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2024-02-01 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2023-10-18 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2023-07-13 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-04-20 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-04-20 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-04-20 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-04-01 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-03-23 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-03-04 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
| 2022-01-05 | Company Response | Aclarion, Inc. | DE | N/A | Read Filing View |
2025-04-30 - CORRESP - Aclarion, Inc.
CORRESP 1 filename1.htm ACLARION, INC. 8181 ARISTA PLACE, SUITE 100 BROOMFIELD, CO 80021 VIA EDGAR April 30, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, N.E. Washington, D.C. 20549 Attn: Jane Park Re: Aclarion, Inc. Registration Statement on Form S-3 SEC File No. 333-286761 Request for Acceleration Ms. Park: Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, Aclarion, Inc. (the " Company ") hereby requests that the effective date of the Company's Registration Statement on Form S-3 (File No. 333-286761) (the " Registration Statement "), be accelerated so that the Company's Registration Statement will become effective at 4:05 P.M., Eastern Time, on May 5, 2025, or as soon thereafter as is practicable, or at such other time thereafter as our counsel, Carroll Legal LLC, may request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Carroll Legal LLC, by calling James H. Carroll, Esq. at (303) 888-4859. Please feel free to direct any questions or comments concerning this request to James H. Carroll, Esq. of Carroll Legal LLC at (303) 888-4859. Sincerely, ACLARION, INC. By: /s/ John Lorbiecki Name: John Lorbiecki Title: Chief Financial Officer
2025-04-29 - UPLOAD - Aclarion, Inc. File: 333-286761
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 29, 2025 John Lorbiecki Chief Financial Officer Aclarion, Inc. 8181 Arista Place, Suite 100 Broomfield, Colorado 80021 Re: Aclarion, Inc. Registration Statement on Form S-3 Filed April 25, 2025 File No. 333-286761 Dear John Lorbiecki: 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 Jane Park at 202-551-7439 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: James H. Carroll, Esq. </TEXT> </DOCUMENT>
2025-01-10 - CORRESP - Aclarion, Inc.
CORRESP 1 filename1.htm DAWSON JAMES SECURITIES, INC. 101 North Federal Highway Suite 600 Boca Raton, Fl 33432 January 10, 2025 VIA EDGAR Division of Corporation Finance Office of Industrial Applications and Services U.S. Securities & Exchange Commission 100 F Street, NE Washington, D.C. 20549-3628 Attn: Ms. Jane Park RE: Aclarion, Inc. (the “Company”) Registration Statement on Form S-1 (File No. 333-283724) (the “Registration Statement”) Dear Ms. Park: Dawson James Securities, Inc., the underwriter in the offering contemplated in the Registration Statement, 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 as of 4:00 P.M. Eastern Time on Tuesday, January 14, 2025, or as soon thereafter as practicable. Once the Registration Statement has been declared effective, please orally confirm that event with James H. Carroll, Esq. of Carroll Legal LLC, counsel to the Company, at (303) 888-4859. Very truly yours, DAWSON JAMES SECURITIES, INC. By: /s/ Robert D. Keyser, Jr. Name: Robert D. Keyser, Jr. Title: Chief Executive Officer
2025-01-10 - CORRESP - Aclarion, Inc.
CORRESP
1
filename1.htm
VIA EDGAR
January 10, 2025
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Judiciary Plaza
Washington, D.C. 20549
Attn: Jane Park
Re:
Aclarion, Inc.
Registration Statement on Form S-1 File No. 333-283724
Acceleration Request:
·
Requested Date: January 14, 2025
·
Requested Time: 4 P.M. Eastern Time
Dear Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Aclarion,
Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-l (File No. 333-283724) (the
“Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth
above or as soon thereafter as practicable.
In connection with this acceleration request, the Company hereby acknowledges
that:
(a) should the United States Securities and Exchange Commission
(the “Commission”) or its staff, acting 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;
(b) the action of the Commission or its staff, acting pursuant
to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for
the accuracy and adequacy of the disclosure in the Registration Statement; and
(c) it 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.
The Company understands that the staff will consider this request as confirmation
by the Company of its awareness of its responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they
relate to the proposed public offering of the securities specified in the Registration Statement.
Sincerely,
ACLARION, INC.
/s/ John Lorbiecki
John Lorbiecki
Chief Financial Officer
2024-12-16 - UPLOAD - Aclarion, Inc. File: 333-283724
December 16, 2024
John Lorbiecki
Chief Financial Officer
Aclarion, Inc.
8181 Arista Place, Suite 100
Broomfield, Colorado 80021
Re:Aclarion, Inc.
Registration Statement on Form S-1
Filed December 11, 2024
File No. 333-283724
Dear John Lorbiecki:
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 Jane Park at 202-551-7439 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:James H. Carroll, Esq.
2024-11-07 - CORRESP - Aclarion, Inc.
CORRESP 1 filename1.htm VIA EDGAR November 7, 2024 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Judiciary Plaza Washington, D.C. 20549 Attn: Jane Park Re: Aclarion, Inc. Registration Statement on Form S-3 File No. 333-282970 Acceleration Request: · Requested Date: November 8, 2024 · Requested Time: 2 P.M. Eastern Time Dear Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Aclarion, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-282970) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. In connection with this acceleration request, the Company hereby acknowledges that: (a) should the United States Securities and Exchange Commission (the “Commission”) or its staff, acting 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; (b) the action of the Commission or its staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the accuracy and adequacy of the disclosure in the Registration Statement; and (c) it 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. The Company understands that the staff will consider this request as confirmation by the Company of its awareness of its responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the Registration Statement. Sincerely, ACLARION, INC. /s/ John Lorbiecki John Lorbiecki Chief Financial Officer
2024-11-07 - UPLOAD - Aclarion, Inc. File: 333-282970
November 7, 2024
John Lorbiecki
Chief Financial Officer
Aclarion, Inc.
8181 Arista Place, Suite 100
Broomfield, Colorado 80021
Re:Aclarion, Inc.
Registration Statement on Form S-3
Filed November 4, 2024
File No. 333-282970
Dear John Lorbiecki:
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 Jane Park at 202-551-7439 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:James H. Carroll, Esq.
2024-11-01 - CORRESP - Aclarion, Inc.
CORRESP 1 filename1.htm VIA EDGAR November 1, 2024 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Judiciary Plaza Washington, D.C. 20549 Attn: Margaret Sawicki Re: Aclarion, Inc. Registration Statement on Form S-1 File No. 333-282842 Acceleration Request: · Requested Date: November 4, 2024 · Requested Time: 4 P.M. Eastern Time Dear Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Aclarion, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-l (File No. 333-282842) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. In connection with this acceleration request, the Company hereby acknowledges that: (a) should the United States Securities and Exchange Commission (the “Commission”) or its staff, acting 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; (b) the action of the Commission or its staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the accuracy and adequacy of the disclosure in the Registration Statement; and (c) it 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. The Company understands that the staff will consider this request as confirmation by the Company of its awareness of its responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the Registration Statement. Sincerely, ACLARION, INC. /s/ John Lorbiecki John Lorbiecki Chief Financial Officer
2024-11-01 - UPLOAD - Aclarion, Inc. File: 333-282842
November 1, 2024
John Lorbiecki
Chief Financial Officer
Aclarion, Inc.
8181 Arista Place, Suite 100
Broomfield, Colorado 80021
Re:Aclarion, Inc.
Registration Statement on Form S-1
Filed October 25, 2024
File No. 333-282842
Dear John Lorbiecki:
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 Margaret Sawicki at 202-551-7153 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:James H. Carroll, Esq.
2024-10-18 - CORRESP - Aclarion, Inc.
CORRESP
1
filename1.htm
October 18, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
Division of Corporation Finance
Office of Industrial Applications and Services
Attention: Juan Grana
Re:
Aclarion, Inc.
Post-Effective Amendment No. 1 to Registration Statement
on Form S-1
Filed September 9, 2024
File No. 333-276648
Dear Mr. Grana:
We are submitting this letter on behalf of our
client Aclarion, Inc. (the “Company”), in response to the written comments of the staff (the “Staff”)
of the U.S. Securities and Exchange Commission (the “SEC”) contained in your letter, dated September 16, 2024
(the “Comment Letter”) in connection with the Company’s Post-Effective Amendment No. 1 to the Registration
Statement on Form S-1 (the “Post-Effective Amendment No. 1”), filed with the SEC on September 9, 2024. In response
to the comments set forth in the Comment Letter, the Company has filed a Post-Effective Amendment No. 2 to the Registration Statement
on Form S-1 (the “Post-Effective Amendment No. 2”) with the SEC on October 11, 2024.
For your convenience, our responses are set forth
below, with the headings and numbered items of this letter corresponding to the headings and numbered items contained in the Comment Letter.
Each of the comments from the Comment Letter is restated in bold and italics prior to the Company’s response. Page references in
the text of this response letter correspond to the page numbers of the Post-Effective Amendment No. 2.
Post-Effective Amendment No. 1 to Registration
Statement on Form S-1
Cover Page
1. We note that you are offering up to 1,450,000 shares of your common stock for resale by White Lion
Capital, compared to the 2,500,000 shares that you initially registered pursuant to this registration statement, which was declared effective
on February 1, 2024. We also note your disclosure on page 63 that "[you] are filing this registration statement to register for resale
additional shares of [y]our common stock as [you] have already sold all shares covered by the Initial Registration Statement." Please
clarify whether you are registering additional shares of your common stock, and if so, file a new registration statement to register the
additional shares or provide us with your analysis as to why you are eligible to register the additional shares on this post-effective
amendment. If you are not registering additional shares of your common stock, please revise your disclosures, including on page 63, to
disclose that you are not registering additional securities and to note the number of shares of your common stock that have been sold
pursuant to this registration statement, and in connection with the White Lion equity line agreement.
The Company respectfully
acknowledges the Staff’s comment and has revised the disclosure on the cover page and pages 17 and 63 to clarify that the Post-Effective
Amendment No. 1 does not register additional shares of the Company’s common stock. The Company further revised the disclosure to
provide the number of shares of the Company’s common stock that have been sold pursuant to the Registration Statement and
the number of shares of the Company’s common stock that have been sold under the Purchase Agreement, dated as of October 9, 2023,
with White Lion Capital, LLC.
1
Securities and Exchange Commission
October 18, 2024
Page 2
2. We note your disclosure that on April 8, 2024, you received a written notice from Nasdaq indicating
that you are not in compliance with the bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2), and that on August 22, 2024,
you received a subsequent letter from Nasdaq indicating that you are also not in compliance with the stockholders’ equity requirement
set forth in Nasdaq Listing Rule 5550(b)(1). Please revise your cover page to note that Nasdaq had originally intended to suspend trading
of your common stock on September 3, 2024, and clarify when you requested an appeal before the Nasdaq Panel. Please also discuss any updates
regarding the appeal.
The Company respectfully
acknowledges the Staff’s comment and has revised the disclosure on the cover page and pages 10-12 and 19-20 in the Post-Effective
Amendment No. 2 to disclose that Nasdaq determined to delist the Company’s common stock from Nasdaq and provided the Company until
August 29, 2024 to request an appeal of this determination. The Company further revised the disclosure to state that the Company appealed
each of the matters relating to the bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) and stockholders’ equity requirement
set forth in Nasdaq Listing Rule 5550(b)(1) and had an appeal hearing on October 10, 2024 before the Nasdaq Panel to appeal the
delisting notices.
Exhibits
3. Please amend your filing to provide a signed consent from Haynie & Company.
The Company
acknowledges the Staff’s comment and has filed a signed consent from Haynie & Company as Exhibit 23.1 to the Post-Effective
Amendment No. 2.
We thank you for your prompt attention to this
letter responding to the Staff’s Comment Letter and look forward to hearing from you at your earliest convenience. Please direct
any questions concerning this filing to the undersigned at (303) 888-4859.
Sincerely,
/s/ James H. Carroll
James H. Carroll, Esq.
cc:
Via Email
John Lorbiecki, Aclarion, Inc.
2024-09-20 - CORRESP - Aclarion, Inc.
CORRESP
1
filename1.htm
ACLARION, INC.
8181 ARISTA PLACE, SUITE 100
BROOMFIELD, CO 80021
VIA EDGAR
September 20, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, N.E.
Washington, D.C. 20549
Attn: Juan Grana
Re:
Aclarion, Inc.
Registration Statement on Form S-3
SEC File No. 333-281999
Request for Acceleration
Mr. Grana:
Pursuant to Rule 461 of Regulation C of the General
Rules and Regulations under the Securities Act of 1933, as amended, Aclarion, Inc. (the “Company”) hereby requests
that the effective date of the Company’s Registration Statement on Form S-3, as amended (File No. 333-281999) (the “Registration
Statement”), be accelerated so that the Company’s Registration Statement will become effective at 4:00 P.M., Eastern Time,
on September 23, 2024, or as soon thereafter as is practicable, or at such other time thereafter as our counsel, Carroll Legal LLC, may
request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel,
Carroll Legal LLC, by calling James H. Carroll, Esq. at (303) 888-4859.
Please feel free to direct any questions or comments
concerning this request to James H. Carroll, Esq. of Carroll Legal LLC at (303) 888-4859.
Sincerely,
ACLARION, INC.
By:
/s/ John Lorbiecki
Name: John Lorbiecki
Title: Chief Financial Officer
2024-09-16 - UPLOAD - Aclarion, Inc. File: 333-276648
September 16, 2024
John Lorbiecki
Chief Financial Officer
Aclarion, Inc.
8181 Arista Place, Suite 100
Broomfield, CO 80021
Re:Aclarion, Inc.
Post-Effective Amendment No. 1 to Registration Statement on Form S-1
Filed September 9, 2024
File No. 333-276648
Dear John Lorbiecki:
We have conducted a limited review of your registration statement and have the following
comments. 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.
Post-Effective Amendment No. 1 to Registration Statement on Form S-1
Cover Page
1.We note that you are offering up to 1,450,000 shares of your common stock for resale
by White Lion Capital, compared to the 2,500,000 shares that you initially registered
pursuant to this registration statement, which was declared effective on February 1, 2024.
We also note your disclosure on page 63 that "[you] are filing this registration statement
to register for resale additional shares of [y]our common stock as [you] have already sold
all shares covered by the Initial Registration Statement." Please clarify whether you
are registering additional shares of your common stock, and if so, file a new registration
statement to register the additional shares or provide us with your analysis as to why you
are eligible to register the additional shares on this post-effective amendment. If you are
not registering additional shares of your common stock, please revise your disclosures,
including on page 63, to disclose that you are not registering additional securities and to
note the number of shares of your common stock that have been sold pursuant to this
registration statement, and in connection with the White Lion equity line agreement.
September 16, 2024
Page 2
2.We note your disclosure that on April 8, 2024, you received a written notice from Nasdaq
indicating that you are not in compliance with the bid price requirement set forth in
Nasdaq Listing Rule 5550(a)(2), and that on August 22, 2024, you received a subsequent
letter from Nasdaq indicating that you are also not in compliance with the stockholders’
equity requirement set forth in Nasdaq Listing Rule 5550(b)(1). Please revise your cover
page to note that Nasdaq had originally intended to suspend trading of your common
stock on September 3, 2024, and clarify when you requested an appeal before the Nasdaq
Panel. Please also discuss any updates regarding the appeal.
Exhibits
3.Please amend your filing to provide a signed consent from Haynie & Company.
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 Juan Grana at 202-551-6034 or Jane Park at 202-551-7439 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:James H. Carroll
2024-06-20 - CORRESP - Aclarion, Inc.
CORRESP
1
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Aclarion, Inc.
8181 Arista Place, Suite 100
Broomfield, Colorado 80021
June 20, 2024
VIA EDGAR
Office of Trade & Services
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jane Park
Re:
Aclarion, Inc. (the “Company”)
Offering Statement on Form
1-A
Filed June 20, 2024 (the “Offering
Statement”)
Commission File No. 024-12447
Dear Ms. Park:
On behalf of the Company,
I respectfully request that the qualification date of the Offering Statement be accelerated and that the Offering Statement be declared
qualified June 24, 2024, at 10:00 a.m. EST, or as soon thereafter as is reasonably practicable.
Please contact Jim Carroll, Esq.
of Carroll Legal LLC at (303) 888-4859 to provide notice of qualification, or if you have any questions or comments concerning this request.
Very truly yours,
/s/ John Lorbiecki
John Lorbiecki
Chief Financial Officer
Aclarion, Inc.
2024-06-17 - UPLOAD - Aclarion, Inc. File: 024-12447
United States securities and exchange commission logo
June 17, 2024
John Lorbiecki
Chief Financial Officer
Aclarion, Inc.
8181 Arista Place
Suite 100
Broomfield, Colorado 80021
Re:Aclarion, Inc.
Offering Statement on Form 1-A
Filed June 11, 2024
File No. 024-12447
Dear John Lorbiecki:
This is to advise you that we do not intend to review your offering statement.
We will consider qualifying your offering statement at your request. If a participant in
your offering is required to clear its compensation arrangements with FINRA, please have
FINRA advise us that it has no objections to the compensation arrangements prior to
qualification.
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. We also remind you that, following qualification of your Form 1-A, Rule 257
of Regulation A requires you to file periodic and current reports, including a Form 1-K which
will be due within 120 calendar days after the end of the fiscal year covered by the report.
Please contact Jane Park at 202-551-7439 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: James H. Carroll, Esq.
2024-02-23 - CORRESP - Aclarion, Inc.
CORRESP
1
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February 23, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-1004
RE:
Aclarion,
Inc.
Registration Statement on Form S-1, as amended
File No. 333-275989
Ladies and Gentlemen:
As the placement agent of
the proposed offering of Aclarion, Inc. (the “Company”), we hereby join the Company’s
request for acceleration of the above-referenced Registration Statement, requesting effectiveness for 9:00 a.m., Eastern Time, on Monday,
February 26, 2024, or as soon thereafter as is practicable.
Pursuant to Rule 460 of the
General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, we wish to
advise you that, through February 23, 2024, we distributed to each dealer, who is reasonably anticipated to be invited to participate
in the distribution of the security, as many copies, as well as “E-red” copies of the Preliminary Prospectus dated February
23, 2024, as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned advise that
they have complied and will continue to comply with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
Maxim Group LLC
By:
/s/ Clifford A. Teller
Name: Clifford A. Teller
Title: Co-President
2024-02-23 - CORRESP - Aclarion, Inc.
CORRESP 1 filename1.htm VIA EDGAR February 23, 2024 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Judiciary Plaza Washington, D.C. 20549 Attn: Juan Grana Re: Aclarion, Inc. Registration Statement on Form S-1 File No. 333-275989 Acceleration Request: · Requested Date: February 26, 2024 · Requested Time: 9:00 A.M. Eastern Time Dear Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Aclarion, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-l (File No. 333-275989) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. Once the Registration Statement has been declared effective, please orally confirm that event with James Carroll of Carroll Legal LLC, counsel to the Company, at (303) 888-4859. In connection with this acceleration request, the Company hereby acknowledges that: (a) should the United States Securities and Exchange Commission (the “Commission”) or its staff, acting 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; (b) the action of the Commission or its staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the accuracy and adequacy of the disclosure in the Registration Statement; and (c) it 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. The Company understands that the staff will consider this request as confirmation by the Company of its awareness of its responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the Registration Statement. Sincerely, ACLARION, INC. /s/ John Lorbiecki John Lorbiecki Chief Financial Officer
2024-02-01 - CORRESP - Aclarion, Inc.
CORRESP
1
filename1.htm
Aclarion, Inc.
8181 Arista Place, Suite 100
Broomfield, Colorado
80021
February 1, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Jessica Ansart
Re:
Aclarion, Inc.
Registration Statement on Form S-1 (File No. 333-
276648)
Ladies and Gentlemen:
Pursuant to
Rule 461 under the Securities Act of 1933, as amended, Aclarion, Inc. (the “Company”) hereby requests
that the effective date of the Company’s Registration Statement on Form S-1 (File No. 333- 276648) (the
“Registration Statement”) be accelerated so that the Company’s Registration Statement will become
effective at 4:00 PM, eastern time, on February 1, 2024, or as soon as thereafter as is practicable.
Please contact Justin Platt, Esq.
of Goodwin Procter LLP at (212) 459-7340 to provide notice of effectiveness, or if you have any questions or comments concerning this
request.
[Remainder of the page intentionally left blank]
Very truly yours,
ACLARION, INC.
By:
/s/ John Lorbiecki
Name:
John Lorbiecki
Title:
Chief Financial Officer
Aclarion, Inc. — Acceleration Letter
2
2024-01-26 - UPLOAD - Aclarion, Inc. File: 333-276648
United States securities and exchange commission logo
January 26, 2024
John Lorbiecki
Chief Financial Officer
Aclarion, Inc.
8181 Arista Place, Suite 100
Broomfield, Colorado 80021
Re:Aclarion, Inc.
Registration Statement on Form S-1
Filed January 22, 2024
File No. 333-276648
Dear John Lorbiecki:
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 Jessica Ansart at 202-551-4511 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: James Carroll
2023-12-20 - UPLOAD - Aclarion, Inc. File: 333-275989
United States securities and exchange commission logo
December 20, 2023
John Lorbiecki
Chief Financial Officer
Aclarion, Inc.
8181 Arista Place, Suite 100
Broomfield, Colorado 80021
Re:Aclarion, Inc.
Registration Statement on Form S-1
Filed December 11, 2023
File No. 333-275989
Dear John Lorbiecki:
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 Juan Grana at 202-551-6034 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: James H. Carroll
2023-10-19 - UPLOAD - Aclarion, Inc.
United States securities and exchange commission logo
October 19, 2023
John Lorbiecki
Chief Financial Officer
Aclarion, Inc.
8181 Arista Place, Suite 100
Broomfield , Colorado 80021
Re:Aclarion, Inc.
Registration Statement on Form S-1
Filed October 10, 2023
File No. 333-274914
Dear John Lorbiecki:
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 Jessica Ansart at 202-551-4511 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: James H. Carroll
2023-10-18 - CORRESP - Aclarion, Inc.
CORRESP
1
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Aclarion, Inc.
8181 Arista Place, Suite 100
Broomfield, Colorado
80021
October 18, 2023
VIA EDGAR
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Jessica Ansart
Re: Aclarion, Inc.
Registration Statement on Form S-1 (File No. 333-
274914)
Ladies and Gentlemen:
Pursuant to Rule 461
under the Securities Act of 1933, as amended, Aclarion, Inc. (the “Company”) hereby requests that the effective
date of the Company’s Registration Statement on Form S-1 (File No. 333- 274914) (the “Registration Statement”)
be accelerated so that the Company’s Registration Statement will become effective at 10:00 AM, eastern time, on October 20, 2023,
or as soon as thereafter as is practicable.
Please contact Jennifer Porter, Esq.
of Goodwin Procter LLP at (445) 207-7806 to provide notice of effectiveness, or if you have any questions or comments concerning this
request.
[Remainder of the page intentionally left blank]
Very truly yours,
ACLARION, INC.
By:
/s/ John Lorbiecki
Name:
John Lorbiecki
Title:
Chief Financial Officer
2023-07-13 - CORRESP - Aclarion, Inc.
CORRESP 1 filename1.htm VIA EDGAR July 13, 2023 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Judiciary Plaza Washington, D.C. 20549 Attn: Benjamin Richie Re: Aclarion, Inc. Registration Statement on Form S-1 File No. 333-273113 Acceleration Request: · Requested Date: July 14, 2023 · Requested Time: 4 P.M. Eastern Time Dear Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Aclarion, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement on Form S-l (File No. 333-273113) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. In connection with this acceleration request, the Company hereby acknowledges that: (a) should the United States Securities and Exchange Commission (the “Commission”) or its staff, acting 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; (b) the action of the Commission or its staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the accuracy and adequacy of the disclosure in the Registration Statement; and (c) it 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. The Company understands that the staff will consider this request as confirmation by the Company of its awareness of its responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the Registration Statement. Sincerely, ACLARION, INC. /s/ John Lorbiecki John Lorbiecki Chief Financial Officer
2023-07-11 - UPLOAD - Aclarion, Inc.
United States securities and exchange commission logo
July 11, 2023
John Lorbiecki
Chief Financial Officer
Aclarion, Inc.
8181 Arista Place, Suite 100
Broomfield, Colorado 80021
Re:Aclarion, Inc.
Registration Statement on Form S-1
Filed July 3, 2023
File No. 333-273113
Dear John Lorbiecki:
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 Benjamin Richie at 202-551-7857 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: James H. Carroll
2022-04-20 - CORRESP - Aclarion, Inc.
CORRESP
1
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April 20, 2022
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549
Attn:
Gary Guttenberg
Re:
Aclarion, Inc.
Registration Statement on Form S-1 (File No. 333-262026)
Ladies and Gentlemen:
As
the underwriter of the proposed offering of Aclarion, Inc. (the “Company”), we hereby join the Company’s
request for acceleration of the above-referenced Registration Statement, requesting effectiveness for 5:00 p.m., Eastern Time, on April
21, 2022, or as soon thereafter as is practicable.
Pursuant to Rule 460 of the
General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, we, acting
on behalf of the several underwriters, wish to advise you that, through April 19, 2022, we distributed to each underwriter or dealer,
who is reasonably anticipated to be invited to participate in the distribution of the security, as many copies, as well as “E-red”
copies of the Preliminary Prospectus dated April 1, 2022, as appears to be reasonable to secure adequate distribution of the preliminary
prospectus.
The undersigned advises that
it has complied 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/ Clifford A. Teller
Name: Clifford A. Teller
Title: Head of Investment Banking, Executive Managing Director
2022-04-20 - CORRESP - Aclarion, Inc.
CORRESP
1
filename1.htm
VIA EDGAR
April 20, 2022
Securities and Exchange Commission
100 F Street, N.E.
Judiciary Plaza
Washington, D.C. 20549
Attn: Division of Corporation Finance,
Re:
Aclarion, Inc.
Registration Statement on Form S-1 File No. 333-262026
Acceleration Request:
Requested Date: April 21, 2022
Requested Time: 5 P.M.
Dear Ladies and Gentlemen:
Pursuant to Rule 461
under the Securities Act of 1933, as amended, Aclarion, Inc.. (the “Company”) hereby requests that the above-referenced
Registration Statement on Form S-l (File No. 333-262026) (the “Registration Statement”) be declared effective at the
“Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable.
In connection with this
acceleration request, the Company hereby acknowledges that:
(a) should the United
States Securities and Exchange Commission (the “Commission”) or its staff, acting 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;
(b) the action of the
Commission or its staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the
Company from its full responsibility for the accuracy and adequacy of the disclosure in the Registration Statement; and
(c) it 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.
The Company understands
that the staff will consider this request as confirmation by the Company of its awareness of its responsibilities under the Securities
Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the
Registration Statement.
[Signature page follows]
Securities and Exchange Commission
April 20, 2022
Page 2
Sincerely,
Aclarion, Inc.
/s/ Brent Ness
Brent Ness
Chief Executive Officer
2022-04-20 - CORRESP - Aclarion, Inc.
CORRESP 1 filename1.htm April 20, 2022 Securities and Exchange Commission 100 F Street, N.E. Judiciary Plaza Washington, D.C. 20549 Re: Aclarion, Inc. (f/k/a “Nocimed, Inc.”) Draft Registration Statement on Form S-1 Submitted on October 25, 2021 File No. 333-262026 Dear Ladies and Gentlemen: At the request of Aclarion, Inc. (f/k/a “Nocimed, Inc.”) (the “Company”), we have publicly filed, simultaneously herewith, Amendment No. 5 to the registration statement on Form S-1 (the “Registration Statement”), and have attached a marked copy of the Registration Statement indicating the changes that the Company has made to the draft Registration Statement. This Amendment No. 5 is filed to provide a new Exhibit 5.1 and to indicate and disclose that certain of our directors and officers have expressed to us an interest to purchase units in this offering at the offering price, and because these expressions of interest are not binding agreements or commitments to purchase, our directors and officers may determine to purchase no units in this offering or the underwriters may determine to sell no units to our directors and officers. However, in no event will the directors and officers purchase more than 10% of units sold in this offering. There are no changes to any financials statements or any other number or calculation previously disclosed. We hope that the Staff will be able to accommodate the Company by responding to this letter as soon as practicable, as the Company and the underwriter. In the meantime, should members of the Commission Staff have any questions or comments, or require any additional information regarding any of the responses or the attached filing, please contact the undersigned at 760-692-1162 or Stanley M. Moskowitz, who is Of Counsel to this firm at 858 523-0100. Very truly yours, Bingham & Associates Law Group, APC By: s/ Brad Bingham
2022-04-01 - CORRESP - Aclarion, Inc.
CORRESP 1 filename1.htm April 1, 2022 Securities and Exchange Commission 100 F Street, N.E. Judiciary Plaza Washington, D.C. 20549 Re: Aclarion, Inc. (f/k/a “Nocimed, Inc.”) Draft Registration Statement on Form S-1 Submitted on October 25, 2021 File No. 333-262026 Dear Ladies and Gentlemen: At the request of Aclarion, Inc. (f/k/a “Nocimed, Inc.”) (the “Company”), we have publicly filed, simultaneously herewith, Amendment No. 3 to the registration statement on Form S-1 (the “Registration Statement”), and have attached a marked copy of the Registration Statement indicating the changes that the Company has made to the draft Registration Statement. This Amendment No. 3 is filed to reflect a reduction in the amount of Units to be offered by the Company from 2,272,727 to 2,000,000, thus reducing the offering from $12,500,000 to $11,000,000 (assuming the same mid-point price ($5.50) of the range between $4.50 and $6.50. We hope that the Staff will be able to accommodate the Company by responding to this letter as soon as practicable. In the meantime, should members of the Commission Staff have any questions or comments, or require any additional information regarding any of the responses or the attached filing, please contact the undersigned at 760-692-1162 or Stanley M. Moskowitz, who is Of Counsel to this firm at 858 523-0100. Very truly yours, Bingham & Associates Law Group, APC By: s/ Brad Bingham
2022-03-23 - CORRESP - Aclarion, Inc.
CORRESP
1
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March 23, 2022
Securities and Exchange Commission
100 F Street, N.E.
Judiciary Plaza
Washington, D.C. 20549
Re: Aclarion, Inc. (f/k/a “Nocimed, Inc.”)
Draft Registration Statement on Form S-1
Submitted on October 25, 2021
File No. 333-262026
Dear Ladies and Gentlemen:
At the request of Aclarion, Inc. (f/k/a “Nocimed,
Inc.”) (the “Company”), we are responding to the comments raised by the Staff of the Securities and Exchange Commission
(the “Commission”) in the comment letter dated March 15, 2022 from Gary Guttenberg to Brent Ness, President and Chief Executive
Officer of the Company, relating to the registration statement on Form S-1 of the Company filed with the Commission on March 4, 2022.
We have publicly filed, simultaneously herewith, Amendment No. 2 to the registration statement on Form S-1 (the “Registration Statement”),
and have attached a marked copy of the Registration Statement indicating the changes that the Company has made to the draft Registration
Statement.
The numbered paragraph below corresponds to the paragraph in which
the comment was made. For your convenience, we have included above our response a copy of the comment to which we are responding.
Please be advised that the number of Units to be offered pursuant to
the Registration statement has been reduced from 2,727,273 to 2,272,727, thereby reducing the gross proceeds of the offering to $12,500,000,
assuming no exercise of the underwriter’s over-allotment option. Accordingly, the Registration Statement has been edited to reflect
this change.
Amendment No. 1 to Form S-1 filed March 4, 2022
Significant Net Losses, page 16
1. Please expand this risk factor to quantify the financing
expense you will recognize at effectiveness in connection with the issuance of units at a 70% discount to pay interest on the $2 million
promissory notes payable disclosed on page F-17. Given the 33% interest rate on the notes, it appears that the FV of these units may exceed
$1.8 million. Disclose also whether the holders of the promissory notes are existing shareholders, directors or employees of the Registrant.
Response
The following comments have been
added:
In June 2021, the Company issued $2.0 million
promissory notes that mature at the earlier of the consummation of a qualified financing (as defined in the promissory note filed as Exhibit
10.5) or May 31, 2022 (See Note 8 to the financial statements for additional information). The promissory notes accrue interest at 33%,
which will automatically (assuming it occurs before May 31,2022) into the Company securities at 30% (70% discount) of the price per Unit
in this offering. As of February 28, 2022, accrued interest on the Notes totaled $462,904. Assuming a public offering price of $5.50 per
Unit, the financing expense related to the 70% discount, as of February 28, 2022, would be $1,080,110. Accrued interest will increase
by about $55,000 per month until this offering is consummated or May 31, 2022. None of the holders of the promissory notes are existing
shareholders, directors, or employees of the Company.
1
Capitalization, page 61
2. We note your response to our prior
comment #2 and your revisions made to the capitalization disclosures. Given that the reverse stock split will occur immediately prior
to the closing of the offering, please ensure that your historical financial statements for each period presented are retroactively adjusted
in accordance with ASC 505-10-S99-4. Please also clarify Note 12 on page F-21 to indicate how the stock split has been reflected in the
historical financial statements.
Response
Based upon the discussions had with
the Staff on March 16, 2022, the historical financial statements have not been retroactively adjusted. Also in accordance with such discussions,
we have added language in the Prospectus Summary, the Offering, Risk Factors, Capitalization, Dilution, Principal Stockholders, and Note
12 to the financial statements.
3. Please revise to present the Series
B-2 and B-3 preferred stock as mezzanine equity in the Actual column. Please also ensure your Actual total shareholders' equity(deficit)
balance here and on page F-3 do not include mezzanine equity balances.
Response
Staff’s requested adjustments
to mezzanine equity in the Capitalization pro forma table and page F-3 have been completed.
Note 3. Restatement of Previously
Issued Financial Statements, page F-12
4. The $2,000,000 SAFE appears to be
a non-cash item that should be adjusted as a reconciling item in the cash flows from operating activities, rather than presented as a
cash inflow from financing activities. Please revise to include this as part of the restatement too, or tell us why you would consider
otherwise.
Response
Staff’s requested adjustments
to the Statement of Cash Flows and Note 3 restatement have been provided.
Note 7, page F-15
5. Please disclose the amortization
period you are using for your patents and licenses.
Response
Note 7 has been revised to disclose
the amortization period of fifteen years for patents and licenses
Note 11, page F-20
6. Please disclose the weighted average exercise price of options
granted in 2021. Also, disclose details on any issuances of options and warrants in Item 15 of the form. See Item 701 of Regulation S-K.
2
Response
Note 11 has been revised to indicate the weighted average
exercise price of options granted in 2021 to be $0.26.
Item 15 has been revised in response to the Staff’s
comment.
We hope that the Staff will be able to accommodate the Company by responding
to this response letter as soon as practicable. In the meantime, should members of the Commission Staff have any questions or comments,
or require any additional information regarding any of the responses or the attached filing, please contact the undersigned at 760-692-1162
or Stanley M. Moskowitz, who is Of Counsel to this firm at 858 523-0100.
Very truly yours,
Bingham & Associates Law Group, APC
By: s/ Brad Bingham
3
2022-03-15 - UPLOAD - Aclarion, Inc.
United States securities and exchange commission logo
March 15, 2022
Brent Ness
President and CEO
Aclarion, Inc.
951 Mariners Island Blvd, Suite 300
San Mateo, CA 94404
Re:Aclarion, Inc.
Amendment No. 1 to Registration Statement on Form S-1
March 4, 2022
File No. 333-262026
Dear Mr. Ness:
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 January 25, 2022, letter.
Amendment No. 1 to Form S-1 filed March 4, 2022
Significant Net Losses, page 16
1.Please expand this risk factor to quantify the financing expense you will recognize at
effectiveness in connection with the issuance of units at a 70% discount to pay interest on
the $2 million promissory notes payable disclosed on page F-17. Given the 33% interest
rate on the notes, it appears that the FV of these units may exceed $1.8 million. Disclose
also whether the holders of the promissory notes are existing shareholders, directors or
employees of the Registrant.
Capitalization, page 61
2.We note your response to our prior comment #2 and your revisions made to the
FirstName LastNameBrent Ness
Comapany NameAclarion, Inc.
March 15, 2022 Page 2
FirstName LastName
Brent Ness
Aclarion, Inc.
March 15, 2022
Page 2
capitalization disclosures. Given that the reverse stock split will occur immediately prior
to the closing of the offering, please ensure that your historical financial statements for
each period presented are retroactively adjusted in accordance with ASC 505-10-S99-4.
Please also clarify Note 12 on page F-21 to indicate how the stock split has been reflected
in the historical financial statements.
3.Please revise to present the Series B-2 and B-3 preferred stock as mezzanine equity in the
Actual column. Please also ensure your Actual total shareholders' equity(deficit) balance
here and on page F-3 do not include mezzanine equity balances.
Note 3. Restatement of Previously Issued Financial Statements, page F-12
4.The $2,000,000 SAFE appears to be a non-cash item that should be adjusted as a
reconciling item in the cash flows from operating activities, rather than presented as a cash
inflow from financing activities. Please revise to include this as part of the
restatement too, or tell us why you would consider otherwise.
Note 7, page F-15
5.Please disclose the amortization period you are using for your patents and licenses.
Note 11, page F-20
6.Please disclose the weighted average exercise price of options granted in 2021. Also,
disclose details on any issuances of options and warrants in Item 15 of the form. See Item
701 of Regulation S-K.
You may contact Li Xiao at (202) 551-4391 or Al Pavot at (202) 551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Gary Guttenberg at (202) 551-6477 or Laura Crotty at (202) 551-7614 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stanley Moskowitz, Esq.
2022-03-04 - CORRESP - Aclarion, Inc.
CORRESP
1
filename1.htm
March 4, 2022
Securities and Exchange Commission
100 F Street, N.E.
Judiciary Plaza
Washington, D.C. 20549
Re: Aclarion, Inc. (f/k/a “Nocimed, Inc.”)
Draft Registration Statement on Form S-1
Submitted on October 25, 2021
File No. 333-262026
Dear Ladies and Gentlemen:
At the request of Aclarion, Inc. (f/k/a “Nocimed,
Inc.”) (the “Company”), we are responding to the comments raised by the Staff of the Securities and Exchange Commission
(the “Commission”) in the comment letter dated January 25, 2022 from Gary Guttenberg to Brent Ness, President and Chief Executive
Officer of the Company, relating to the draft registration statement on Form S-1 of the Company filed with the Commission on January 6,
2022. We have publicly filed, simultaneously herewith, a registration statement on Form S-1(the “Registration Statement”),
and have attached a marked copy of the Registration Statement indicating the changes that the Company has made to the draft Registration
Statement.
Note: Please be advised that (a) as at December 3, 2021,
the Company changed its name from “Nocimed, Inc.” to “Aclarion, Inc.”. Accordingly, the appropriate edits have
been made to indicate the change; and (b) the financial statements have been updated to include the audit for the year ended 2021
The numbered paragraph below corresponds to the paragraph in which
the comment was made. For your convenience, we have included above our response a copy of the comment to which we are responding.
Registration Statement on Form S-1 filed January 6,
2022
Regulatory Filings, page 7
1. We note your revised disclosure on page 7 in response to prior comment 9. Please revise to identify
the legal firm that you reference in this section and file their consent to summarize portions of their letter. Refer to Securities Act
Rule 436. Also, revise to provide context to counsel's "reasonable to conclude" statement by indicating whether the letter indicates
a degree of uncertainty regarding the regulatory classification and the applicability of the exemption. In this regard, we note that it
does not appear that counsel has provided a firm opinion that the product is not a device.
Response
We have revised the disclosure by deleting any reference
to the legal firm in this Section and in the “Business”, “Government Regulation” section of the prospectus.
1
Capitalization, page 60
2. You disclose that all share and per share amounts set forth have been presented on a retroactive basis
to reflect a 1-for-5.29 reverse stock split. Please clarify whether this reverse stock split has actually occurred and if not, your basis
for providing retroactive adjustment throughout the prospectus. To the extent that the reverse stock split has occurred, please ensure
that your historical financial statements for each period presented are retroactively adjusted in accordance with ASC 505-10-S99-4.
Response
Please be advised that the reverse stock split (“RSS”)
has not occurred. The RSS will occur immediately prior to the closing of the offering.
After considering the guidance of ASC 505-10-S99-4, the Company
did not retroactively reflect the anticipated stock split in its historical consolidated financial statements, as a change to the Company’s
capital structure has not yet occurred. The Company has revised the introduction to the Capitalization section and other pro-forma common
stock presentations throughout the document to clarify the intended timing of the RSS.
Compensation of Our Executive Officers, page 105
3. Please revise to provide executive compensation information for the fiscal year ended December 31,
2021.
Response
The executive compensation table has
been revised to include information for fiscal year ended December 31, 2021
Financial Statements
Note 1. The Company and its Significant Accounting Policies
Net Loss Per Common Share, page F-12
4. Please explain why you removed previously provided disclosures regarding the treatment of potentially
dilutive securities in your calculation of EPS or restore such disclosures in accordance with ASC 260-10-50-1(c).
Response
The staff’s comments are duly
noted and the referenced disclosures have been restored.
Note 3. Restatement of Previously Issued Financial Statements,
page F-13
5. With the restatement of previously issued financial statements, please tell us whether you identified
a material weakness in your internal control over financial reporting. Please also include a risk factor describing any material weaknesses
identified, the restatement that resulted, and any associated remediation procedures and related time frame.
Response
The material weakness related to internal control over financial
reporting is now included as an additional risk factor under the header: “Risks related to financial, operational, commercial and
manufacturing matters.”
2
Note 8. Short Term Notes and Convertible Debt
NuVasive, Inc. Convertible Note and SAFE Agreement,
page F-17
6. It appears that your Future Preferred Equity Commitment balance of $5,201,977 as of September 30, 2011
includes $2 million related to the SAFE Agreement entered into with Nuvasive. Please tell us how you determined that this liability should
not be measured at fair value each period with gains and losses recognized in earnings. Refer to the authoritative literature upon which
you relied, including your consideration of whether this agreement met the requirements for derivative accounting under ASC 815. Please
also address your disclosure on page 73 which states that as you did not raise $10 million in new capital before June 30, 2021, you agreed
to issue 1,584,660 Series B-2 preferred shares to Nuvasive under the SAFE agreement. Explain how the $2 million carrying value of the
SAFE liability represents the fair value of the preferred shares to be issued.
Response
As noted above, the registration statement on Form S-1 now
reflects the Company’s financial statements as of December 31, 2021.
On December 3, 2021 the Company issued the Series B-2 and
B-3 preferred shares, resulting in the extinguishment of the SAFE liability. As further described below, this liability was marked to
fair value until the Series B-2 and B-3 preferred shares were issued on December 3, 2021.
In February 2020, the Company issued to NuVasive the right
to the Company’s preferred shares subject to the terms of a $2 million “SAFE” (Simple Agreement for Future Equity).
The SAFE provided that NuVasive would receive $2 million of capital stock if the Company would raise a minimum of $10.0 million of new
capital on or before December 31, 2020, which was later extended to June 30, 2021. If the $10.0 million was not raised, the Company would
issue shares of preferred stock to NuVasive.
The Company historically has measured the SAFE at fair value.
The Company initially recorded the SAFE as a liability, measured at $2 million when issued. The fair value of the SAFE remained unchanged
at $2 million, until June 30, 2021, as the terms of the SAFE entitled NuVasive to receive a variable number of shares with an aggregate
value of $2 million upon the occurrence of a Qualifying Offering, as defined.
As the Qualifying Offering did not occur, the Company subsequently
became obligated to issue a fixed number of shares of Series B-2 Preferred Stock at June 30, 2021. The number of shares of Series B-2
Preferred Stock to be issued to NuVasive was based upon arms-length negotiation of the derived per-share value based on the fully diluted
enterprise valuation of the Stock to be issued, valued at $2 million (a per-share value of $1.2621) at June 30, 2021. This was consistent
with earlier transactions in the Company’s preferred stock, and further supported by pre-IPO valuations of the Company’s equity
as a private enterprise.
The Company did not have shares of Series B-2 Preferred Stock
authorized for issuance to NuVasive until December 3, 2021. Under U.S. GAAP (ASC 815-40-25-10), net-cash settlement may be assumed if
an entity has insufficient authorized and unissued shares to settle the contract. In such situations, we understand that these contracts
typically would be accounted for as a liability and marked to fair value through earnings each period.
In response to the staff’s comment, the Company completed
a valuation of the Series B-2 and B-3 Preferred Stock at September 30, 2021 and December 3, 2021. At September 30, 2021, the $5.2 million
Future Preferred Equity Commitment was adjusted to $7.3 million, resulting in a $2.1 million charge to earnings. On the issuance date
of the Series B-2 and B-3 preferred shares at December 3, 2021, the Future Preferred Equity Commitment was adjusted to $7.1 million before
settlement. The Company a recorded a gain in earnings of $0.2 million during the fourth quarter of 2021. The Company has further included
expanded disclosure for the fair value accounting treatment of the SAFE and the associated liability to issue shares.
We hope that the Staff will be able to accommodate the
Company by responding to this response letter as soon as practicable. In the meantime, should members of the Commission Staff have any
questions or comments, or require any additional information regarding any of the responses or the attached filing, please contact the
undersigned at 760-692-1162 or Stanley M. Moskowitz, who is Of Counsel to this firm at 858 523-0100.
Very truly yours,
Bingham & Associates Law Group, APC
By: s/ Brad Bingham
3
2022-01-26 - UPLOAD - Aclarion, Inc.
United States securities and exchange commission logo
January 25, 2022
Brent Ness
President and CEO
Nocimed, Inc.
951 Mariners Island Blvd, Suite 300
San Mateo, CA 94404
Re:Nocimed, Inc.
Registration Statement on Form S-1
Filed October 25, 2021
File No. 333-262026
Dear Mr. Ness:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1 filed January 6, 2022
Regulatory Filings, page 7
1.We note your revised disclosure on page 7 in response to prior comment 9. Please revise
to identify the legal firm that you reference in this section and file their consent to
summarize portions of their letter. Refer to Securities Act Rule 436. Also, revise to
provide context to counsel's "reasonable to conclude" statement by indicating whether the
letter indicates a degree of uncertainty regarding the regulatory classification and the
applicability of the exemption. In this regard, we note that it does not appear that counsel
has provided a firm opinion that the product is not a device.
FirstName LastNameBrent Ness
Comapany NameNocimed, Inc.
January 25, 2022 Page 2
FirstName LastName
Brent Ness
Nocimed, Inc.
January 25, 2022
Page 2
Capitalization, page 60
2.You disclose that all share and per share amounts set forth have been presented on a
retroactive basis to reflect a 1-for-5.29 reverse stock split. Please clarify whether this
reverse stock split has actually occurred and if not, your basis for providing retroactive
adjustment throughout the prospectus. To the extent that the reverse stock split has
occurred, please ensure that your historical financial statements for each period presented
are retroactively adjusted in accordance with ASC 505-10-S99-4.
Compensation of Our Executive Officers, page 105
3.Please revise to provide executive compensation information for the fiscal year ended
December 31, 2021.
Financial Statements
Note 1. The Company and its Significant Accounting Policies
Net Loss Per Common Share, page F-12
4.Please explain why you removed previously provided disclosures regarding the treatment
of potentially dilutive securities in your calculation of EPS or restore such disclosures in
accordance with ASC 260-10-50-1(c).
Note 3. Restatement of Previously Issued Financial Statements, page F-13
5.With the restatement of previously issued financial statements, please tell us whether you
identified a material weakness in your internal control over financial reporting. Please also
include a risk factor describing any material weaknesses identified, the restatement that
resulted, and any associated remediation procedures and related time frame.
Note 8. Short Term Notes and Convertible Debt
NuVasive, Inc. Convertible Note and SAFE Agreement, page F-17
6.It appears that your Future Preferred Equity Commitment balance of $5,201,977 as of
September 30, 2011 includes $2 million related to the SAFE Agreement entered into with
Nuvasive. Please tell us how you determined that this liability should not be measured at
fair value each period with gains and losses recognized in earnings. Refer to the
authoritative literature upon which you relied, including your consideration of whether
this agreement met the requirements for derivative accounting under ASC 815. Please
also address your disclosure on page 73 which states that as you did not raise $10 million
in new capital before June 30, 2021, you agreed to issue 1,584,660 Series B-2 preferred
shares to Nuvasive under the SAFE agreement. Explain how the $2 million carrying
value of the SAFE liability represents the fair value of the preferred shares to be issued.
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.
FirstName LastNameBrent Ness
Comapany NameNocimed, Inc.
January 25, 2022 Page 3
FirstName LastName
Brent Ness
Nocimed, Inc.
January 25, 2022
Page 3
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 Li Xiao at (202) 551-4391 or Al Pavot (202) 551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Gary Guttenberg at (202) 551-6477 or Joe McCann at (202) 551-6262 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stanley Moskowitz, Esq.
2022-01-05 - CORRESP - Aclarion, Inc.
CORRESP
1
filename1.htm
January 4, 2022
Securities and Exchange Commission
100 F Street, N.E.
Judiciary Plaza
Washington, D.C. 20549
Re: Aclarion, Inc. (f/k/a “Nocimed, Inc.”)
Draft Registration Statement on Form S-1
Submitted on October 27, 2021
CIK No. 37705621
Dear Ladies and Gentlemen:
At the request of Aclarion, Inc. (f/k/a “Nocimed,
Inc.”) (the “Company”), we are responding to the comments raised by the Staff of the Securities and Exchange Commission
(the “Commission”) in the comment letter dated November 29, 2021 from Gary Guttenberg, , to Brent Ness, President and Chief
Executive Officer of the Company, relating to the draft registration statement on Form S-1 of the Company filed with the Commission on
October 27, 2021. We have publicly filed, simultaneously herewith, a registration statement on Form S-1(the “Registration Statement”), and have attached a marked copy of the Registration Statement indicating the changes that the Company has made to the draft Registration
Statement.
Note: Please be advised that as at December 3, 2021, the
Company changed its name from “Nocimed, Inc.” to “Aclarion, Inc.”. Accordingly, the appropriate edits have been
made to indicate the change.
The numbered paragraph below corresponds to the paragraph in which
the comment was made. For your convenience, we have included above our response a copy of the comment to which we are responding.
Draft Registration Statement on Form S-1
Market and Industry Data, page ii
1. We refer to your disclosure concerning the reliability of third-party
sources and the lack of verification. Please either delete these statements or specifically state that you are responsible for such disclosure.
Response
The Registration Statement has been amended in response to
the Staff’s Comment.
Overview, page 1
2. You state: “Aclarion has taken the first steps to demonstrate
the effectiveness of our technology...” Please advise or revise this sentence, as effectiveness is solely within the determination
of FDA and it does not appear that you have plans to seek FDA clearance or approval.
Response
The Registration Statement has been amended in response to
the Staff’s Comment. The referred to sentence has been revised.
1
3. Initially you state “The Company is addressing this market
by initially focusing on improving the outcomes of surgical interventions to treat low back pain.” Afterwards you state: “We
will then move upstream into the low back and neck pain care pathway.” Please clarify if your initial focus is on the low back
pain and how the "low back and neck pain pathway" differs from low back pain.
Response
The Registration Statement has been amended in response to
the Staff’s Comment.
4. We note that the first sentence indicates that you leverage artificial
intelligence. With reference to your disclosures on pages 7 and 79, please tell us whether your current applications were developed using
artificial intelligence. If they were, then please discuss this aspect of product development in the Business section. If they were not,
then please revise the Summary discussion to remove the reference or explain that it is aspirational in nature.
Response
The First sentence under “Overview” has been
amended in response to the Staff’s Comment.
5. With reference to page F-2, please revise the Summary to highlight
that recurring losses from operations and a deficiency in shareholders’ equity raise substantial doubt about your ability to continue
as a going concern. Also revise to explain that you have limited commercial sales to date.
Response
A new Paragraph entitled “Going
Concern Opinion” has been added to the disclosure under “Overview”.
6. With reference to paragraph (c) on page 70, please revise the
Overview to describe briefly each of the products and explain how they interact and operate as a suite.
Response
A new Paragraph entitled “ NOCISCAN-LS Post-Processor
Suite”” has been added to the disclosure under “Overview”.
Market Opportunity, page 3
7. Please substantially revise to identify and explain the “early
clinical evidence” that points to a marked improvement in surgical outcomes from using your product. Please also make sure that
this Summary discussion here and at the top of page 2 is balanced and addresses any material limitations to that early evidence. For
instance, it should be clear whether the evidence is or is not statistically significant. In addition, we refer to your disclosure on
page 7 indicating that your current product is supported by a single clinical study at a single clinical center involving one spine surgeon
as well as your disclosure that authors of the study cited on page 66 had a financial relationship with you.
Response
A new Section under the title “Clinical
Evidence” has been added to the disclosure under “Overview”.
2
Reimbursement by Third Party Payers, page 4
8. We note your disclosure concerning the strength of the improvement
in surgical outcomes from the Gornet study. Please describe this study here and in the Business section. Tell us whether this is the
same study as those ones referenced on pages 2 and 3 as well as the "pivotal clinical trial involving 100 patients" referenced
on page 68.
Response
The new Section under the title “Clinical
Evidence” under “Overview” responds to the Staff’s comment.
Regulatory Filings, page 5
9. Please revise here and/or on pages
80-81 to explain the basis for your conclusion that NOCICALC-LS qualifies as an exempt Class I device. Similarly, please discuss the
exclusion criteria of the 21st Century Cures Act for Clinical Support Software and explain how NOCIGRAM-LS meets such criteria.
In this regard, it should be clear what is considered a "clinical decision tool" and how it differs from a medical device and
why you believe that NOCIGRAM-LS meets the "clinical decision tool" classification.
Response
The “Regulatory Filings” Section under “Overview”
as well as the “Government Regulations” Section under “Business of the Company” Section have been revised to include
disclosure in response to the Staff’s comment.
Risk Factors, page 12
10. Please add a risk factor that discusses the challenges you face
with the commercialization process in support of moving temporary Category III codes to permanent Category I codes, and that if you don't,
you likely would not be able to generate enough revenue from patients paying directly out of pocket.
Response
In response to the Staff’s comment A new Risk Factor
has been added entitled:
“If adequate reimbursement
for our temporary Category III CMS Code designation for our products cannot be obtained or we are not successful in obtaining conversion
to permanent Category I codes at an adequate reimbursement level, it would diminish our sales and would affect our ability to market our
technology.”
Use of Proceeds, page 54
11. Please revise to provide separate estimates for "market development"
and “clinical evidence" and explain what each of those uses entails.
Response
The Use of Proceeds Section has been amended in response
to the Staff’s comment.
3
Capitalization, page 56
12. Please address the following comments related to your capitalization:
• Remove accounts payable and accrued liabilities, and PPP loans to only include long-term debt
and equity as part of your capitalization
• If you choose to present a cash balance, double underline it to clarify that it is not part of your total
capitalization;
• If the offering would trigger your cash Milestone Payment obligation under the license agreement with
UCSF as disclosed at F-17, please include the impact either in the cap table or note it as excluded, whichever is more appropriate.
Response
The Capitalization Section has been amended in response to
the Staff’s comments.
Management's Discussion and Analysis of Financial Condition
and Results of Operations, page 60
13. To the extent possible, revise your results of operations to separately
disclose the estimated impact of the factors for the changes in your revenues and expenses, as well as any known trends or uncertainties
as required under Item 303 of Regulation S-K. For example:
• Expand to discuss whether price, in addition to volume, is also a key factor in your revenue increase.
• Expand to discuss the key components of your cost of services and their
impact to your gross profit. In that regard, we note that you disclosed at F-17 that you recorded UCSF royalty costs as part of
cost of revenue.
Response
The Management’s discussion and Analysis Section has been substantially
amended in response to the Staff’s comment and to the inclusion of the explanation of a recorded charge to operations of $2 million
related to the amended Marketing Agreement with NuVasive.
Company History, page 68
14. Please revise to disclose the endpoints of the "pivotal clinical
trial" and explain the trial results relative to those endpoints. In light of your disclosure that your technology does not require
FDA clearance or approval, please explain why a pivotal clinical trial was initiated. With reference to disclosures on pages 2 and 66,
explain the criteria for "clinical improvement" that was met.
Response
A new Section entitled “Clinical Evidence” has
been added in response to the Staff’s comment.
License Agreement with the Regents of the University of
California San Francisco, page 68
15. Please revise to discuss the term and termination provisions of
the agreement.
Response
The Registration Statement has been amended in response to
the Staff’s Comment.
4
16. With reference to Paragraph 20 of the UCFS agreement, please revise
your disclosure to explain that the patent prosecution and maintenance process is controlled by UCSF and that Regents' counsel will take
instructions only from the Regents. Please also include this information in the "Summary of Risk Factors" section.
Response
The Registration Statement has been amended in response to
the Staff’s Comment.
Financial Statements Balance Sheets, page F-3
17. Here for common stock, you disclosed that only 35,000 shares were
authorized but 6,755,740 shares were outstanding. Please revise or clarify the gap for us. As a related matter, the outstanding number
of common stock was 6,765,470 on the statement of equity at F-6. Please revise to be consistent.
Response
Please be advised that both the 35,000 and the 6,755,470
numbers were typographical errors. The 35,000 should have been 35,000,000 and the 6,755,740 should have been 6,765,470, as was presented
on Page F-6. Both of these typos have been corrected in the September 30, 2021 financial statements contained in the amended S-1.
Note 6 -- Deferred Marketing, page F-15
18. Given that deferred marketing exceeds 25% of your total assets,
please clarify for us how you determined that this item is properly characterized as an asset under GAAP. Fully describe the rights and
obligations of both parties to the agreement and reference the specific provisions in the contract that justify your accounting conclusion.
Please also site the authoritative accounting guidance that you are relying on and tell us how you determined that the amount is realizable
given your liquidity problems and the substantial doubt over your ability to continue as a going concern. We may have further comment.
Response
The Company issued the $2.0 million Simple Agreement for
Future Equity (“SAFE”) to NuVasive as consideration for NuVasive entering into an amendment to the sales commission agreement
which, among other provisions, lowered the rate of the cash commission payable to NuVasive from 20% to 6%. At that time, the Company relied
on Paragraph 31 to FASB Concepts Statement No. 6, as the intention of the SAFE was to replace 14% of the sales commission cash payment
amount associated with marketing services from NuVasive.
In light of the staff’s comment, management has amended
its financial statements to reflect the $2.0 million as a current charge in earnings when issued.
Note 6. Intangible Assets and Deferred Marketing Convertible
Notes, page F-15
19. Here you report capitalized USCF royalty for all periods presented.
You also stated at F- 17 that you recorded UCSF royalty costs in cost of revenue. Please reconcile those statements for us.
Response
The following was added to Note 6: “Patents and licenses
costs are accounted for as intangible assets and amortized over the life of the patent or license agreement and charged to Research and
Development. UCSF royalties are paid annually and amortized over twelve months to Cost of Revenue.”
5
Note 7. Short Term Notes and Convertible Debt Convertible
Notes, page F-15
20. Here you disclosed that as of June 30, 2021, the convertible notes
payable balance and accrued interest to be converted totaled $4,162,125, which, together with the $2,000,000 SAFE under the NuVasive
agreement, appear to contribute to the balance of $5,151,978 Future Preferred Equity Commitment on the balance sheet. Please reconcile
for the difference in balances for us. Revise if necessary.
Response
The $4,162,125 number was a typographical error, and the
correct number should have been $3,151,978 for June 30, 2021. In the accompanying filing, containing the September 30, 2021 results, Note
7 now reads “the convertible notes payable balance and accrued interest to be converted totaled $3,201,977.” That amount,
plus the NuVasive SAFE of $2,000,000, totals to $5,201,977, which is presented on the September 30, 2021 Balance Sheet as “Future
Preferred Equity Commitment”.
NuVasive, Inc. Convertible Note and SAFE Agreement, page F-16
21. Here you disclose that the balance
sheet reflects a liability to issue Series B-2 preferred shares to the SAFE holder. However at page 69, you state that the company
issued the 1,584,660 Series B-1 preferred shares to NuVasive. Please revise to be consistent.
Response
The disclosure under “Transactions with NuVasive, Inc.”
has been amended in response to the Staff’s comment.
Note 9. Shareholder's Equity, page F-18
22. Please revise to disclose other significant terms for your preferred
stocks, if any, for example, distribution rights, redemption rights, or significant terms to issue additional shares, or terms that may
change conversion prices. Refer to ASC 505-10-50-3.
Response
In response to the staff’s comment, additional
terms related to our Preferred shares are included in Note 10), Shareholder’s Equity (previously Note 9). In addition, significant
terms related to the December 2, 2021 issuances of a new series of B2 and B3 Preferred shares are included in Note 12, Subsequent Events.
As of September 30, 2021, both the B and B1 series of Preferred
shares had time-based redemption rights, which were controlled by the holders. Those redemption rights subsequently were revoked concurrent
with the Company’s issuance of the series of B2 and B3 Preferred shares on December 3, 2021. The series B and B1 Preferred shares
were not classified within mezzanine, due to the subsequent revocation of the future redemption rights.
6
Note 11. Subsequent Events, page F-20
23. Please revise to provide the details, including the exercise price,
of the new option grants authorized subsequent to June 30, 2021.
Response
The significant terms of options granted subsequent to
June 30, 2021 through September 30, 2021, are included in Notes 8 and 10 to our financial statements. No options have been granted subsequent
to September 30, 2021.
24. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities
Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities
Act, whether or not they retain copies of the communications.
Response
Duly noted and the Company will provide the “written
communications” when such communications are utilized.
We hope that t
2021-11-30 - UPLOAD - Aclarion, Inc.
United States securities and exchange commission logo
November 29, 2021
Brent Ness
President and CEO
Nocimed, Inc.
951 Mariners Island Blvd, Suite 300
San Mateo, CA 94404
Re:Nocimed, Inc.
Draft Registration Statement on Form S-1
Submitted October 25, 2021
CIK No. 37705621
Dear Mr. Ness:
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
Market and Industry Data, page ii
1.We refer to your disclosure concerning the reliability of third-party sources and the lack of
verification. Please either delete these statements or specifically state that you are
responsible for such disclosure.
Overview, page 1
2.You state: "Aclarion has taken the first steps to demonstrate the effectiveness of our
technology..." Please advise or revise this sentence, as effectiveness is solely within the
determination of FDA and it does not appear that you have plans to seek FDA clearance
or approval.
FirstName LastNameBrent Ness
Comapany NameNocimed, Inc.
November 29, 2021 Page 2
FirstName LastNameBrent Ness
Nocimed, Inc.
November 29, 2021
Page 2
3.Initially you state "The Company is addressing this market by initially focusing on
improving the outcomes of surgical interventions to treat low back pain." Afterwards you
state: "We will then move upstream into the low back and neck pain care pathway."
Please clarify if your initial focus is on the low back pain and how the "low back and neck
pain pathway" differs from low back pain.
4.We note that the first sentence indicates that you leverage artificial intelligence. With
reference to your disclosures on pages 7 and 79, please tell us whether your current
applications were developed using artificial intelligence. If they were, then please discuss
this aspect of product development in the Business section. If they were not, then please
revise the Summary discussion to remove the reference or explain that it is aspirational in
nature.
5.With reference to page F-2, please revise the Summary to highlight that recurring losses
from operations and a deficiency in shareholders’ equity raise substantial doubt about
your ability to continue as a going concern. Also revise to explain that you have limited
commercial sales to date.
6.With reference to paragraph (c) on page 70, please revise the Overview to describe briefly
each of the products and explain how they interact and operate as a suite.
Market Opportunity, page 3
7.Please substantially revise to identify and explain the "early clinical evidence" that points
to a marked improvement in surgical outcomes from using your product. Please also make
sure that this Summary discussion here and at the top of page 2 is balanced and addresses
any material limitations to that early evidence. For instance, it should be clear whether the
evidence is or is not statistically significant. In addition, we refer to your disclosure on
page 7 indicating that your current product is supported by a single clinical study at a
single clinical center involving one spine surgeon as well as your disclosure that authors
of the study cited on page 66 had a financial relationship with you.
Reimbursement by Third Party Payers, page 4
8.We note your disclosure concerning the strength of the improvement in surgical outcomes
from the Gornet study. Please describe this study here and in the Business section. Tell us
whether this is the same study as those ones referenced on pages 2 and 3 as well as the
"pivotal clinical trial involving 100 patients" referenced on page 68.
Regulatory Filings, page 5
9.Please revise here and/or on pages 80-81 to explain the basis for your conclusion
that NOCICALC-LS qualifies as an exempt Class I device. Similarly, please discuss
the exclusion criteria of the 21st Century Cures Act for Clinical Support Software and
explain how NOCIGRAM-LS meets such criteria. In this regard, it should be clear what
is considered a "clinical decision tool" and how it differs from a medical device and why
FirstName LastNameBrent Ness
Comapany NameNocimed, Inc.
November 29, 2021 Page 3
FirstName LastNameBrent Ness
Nocimed, Inc.
November 29, 2021
Page 3
you believe that NOCIGRAM-LS meets the "clinical decision tool" classification.
Risk Factors, page 12
10.Please add a risk factor that discusses the challenges you face with the commercialization
process in support of moving temporary Category III codes to permanent Category I
codes, and that if you don't, you likely would not be able to generate enough revenue from
patients paying directly out of pocket.
Use of Proceeds, page 54
11.Please revise to provide separate estimates for "market development" and "clinical
evidence" and explain what each of those uses entails.
Capitalization, page 56
12.Please address the following comments related to your capitalization:
•Remove accounts payable and accrued liabilities, and PPP loans to only include long-
term debt and equity as part of your capitalization
•If you choose to present a cash balance, double underline it to clarify that it is not part
of your total capitalization;
•If the offering would trigger your cash Milestone Payment obligation under the
license agreement with UCSF as disclosed at F-17, please include the impact either in
the cap table or note it as excluded, whichever is more appropriate.
Management's Discussion and Analysis of Financial Condition and Results of Operations, page
60
13.To the extent possible, revise your results of operations to separately disclose the
estimated impact of the factors for the changes in your revenues and expenses, as well as
any known trends or uncertainties as required under Item 303 of Regulation S-K. For
example:
•Expand to discuss whether price, in addition to volume, is also a key factor in your
revenue increase.
•Expand to discuss the key components of your cost of services and their impact to
your gross profit. In that regard, we note that you disclosed at F-17 that
you recorded UCSF royalty costs as part of cost of revenue.
Company History, page 68
14.Please revise to disclose the endpoints of the "pivotal clinical trial" and explain the trial
results relative to those endpoints. In light of your disclosure that your technology does
not require FDA clearance or approval, please explain why a pivotal clinical trial was
initiated. With reference to disclosures on pages 2 and 66, explain the criteria for "clinical
improvement" that was met.
FirstName LastNameBrent Ness
Comapany NameNocimed, Inc.
November 29, 2021 Page 4
FirstName LastNameBrent Ness
Nocimed, Inc.
November 29, 2021
Page 4
License Agreement with the Regents of the University of California San Francisco, page 68
15.Please revise to discuss the term and termination provisions of the agreement.
16.With reference to Paragraph 20 of the UCFS agreement, please revise your disclosure to
explain that the patent prosecution and maintenance process is controlled by UCSF and
that Regents' counsel will take instructions only from the Regents. Please also include this
information in the "Summary of Risk Factors" section.
Financial Statements
Balance Sheets, page F-3
17.Here for common stock, you disclosed that only 35,000 shares were authorized but
6,755,740 shares were outstanding. Please revise or clarify the gap for us. As a related
matter, the outstanding number of common stock was 6,765,470 on the statement of
equity at F-6. Please revise to be consistent.
Note 6 -- Deferred Marketing, page F-15
18.Given that deferred marketing exceeds 25% of your total assets, please clarify for us how
you determined that this item is properly characterized as an asset under GAAP. Fully
describe the rights and obligations of both parties to the agreement and reference the
specific provisions in the contract that justify your accounting conclusion. Please also site
the authoritative accounting guidance that you are relying on and tell us how you
determined that the amount is realizable given your liquidity problems and the substantial
doubt over your ability to continue as a going concern. We may have further comment.
Note 6. Intangible Assets and Deferred Marketing
Convertible Notes, page F-15
19.Here you report capitalized USCF royalty for all periods presented. You also stated at F-
17 that you recorded UCSF royalty costs in cost of revenue. Please reconcile those
statements for us.
Note 7. Short Term Notes and Convertible Debt
Convertible Notes, page F-15
20.Here you disclosed that as of June 30, 2021, the convertible notes payable balance and
accrued interest to be converted totaled $4,162,125, which, together with the $2,000,000
SAFE under the NuVasive agreement, appear to contribute to the balance of $5,151,978
Future Preferred Equity Commitment on the balance sheet. Please reconcile for the
difference in balances for us. Revise if necessary.
NuVasive, Inc. Convertible Note and SAFE Agreement, page F-16
21.Here you disclose that the balance sheet reflects a liability to issue Series B-2 preferred
FirstName LastNameBrent Ness
Comapany NameNocimed, Inc.
November 29, 2021 Page 5
FirstName LastName
Brent Ness
Nocimed, Inc.
November 29, 2021
Page 5
shares to the SAFE holder. However at page 69, you state that the company issued the
1,584,660 Series B-1 preferred shares to NuVasive. Please revise to be consistent.
Note 9. Shareholder's Equity, page F-18
22.Please revise to disclose other significant terms for your preferred stocks, if any, for
example, distribution rights, redemption rights, or significant terms to issue additional
shares, or terms that may change conversion prices. Refer to ASC 505-10-50-3.
Note 11. Subsequent Events, page F-20
23.Please revise to provide the details, including the exercise price, of the new option grants
authorized subsequent to June 30, 2021, .
General
24.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
You may contact Li Xiao at (202) 551-4391 or Al Pavot (202) 551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Gary Guttenberg at (202) 551-6477 or Joe McCann at (202) 551-6262 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stanley Moskowitz, Esq.