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Tivic Health Systems, Inc.
Response Received
1 company response(s)
High - file number match
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Tivic Health Systems, Inc.
Response Received
2 company response(s)
Medium - date proximity
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Tivic Health Systems, Inc.
Awaiting Response
0 company response(s)
High
Tivic Health Systems, Inc.
Response Received
3 company response(s)
High - file number match
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Company responded
2025-06-26
Tivic Health Systems, Inc.
References: June 17, 2025
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Company responded
2025-07-25
Tivic Health Systems, Inc.
References: July 9, 2025
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Tivic Health Systems, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2025-07-09
Tivic Health Systems, Inc.
References: June 26, 2025
Tivic Health Systems, Inc.
Response Received
1 company response(s)
Medium - date proximity
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Company responded
2025-06-06
Tivic Health Systems, Inc.
References: May 21, 2025
Tivic Health Systems, Inc.
Response Received
1 company response(s)
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Tivic Health Systems, Inc.
Response Received
2 company response(s)
High - file number match
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Tivic Health Systems, Inc.
Response Received
12 company response(s)
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Company responded
2023-02-06
Tivic Health Systems, Inc.
Summary
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Company responded
2023-02-06
Tivic Health Systems, Inc.
Summary
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Company responded
2023-02-06
Tivic Health Systems, Inc.
Summary
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Tivic Health Systems, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-02-06
Tivic Health Systems, Inc.
Summary
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Company responded
2023-02-06
Tivic Health Systems, Inc.
Summary
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Tivic Health Systems, Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2021-08-11
Tivic Health Systems, Inc.
Summary
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Company responded
2021-08-12
Tivic Health Systems, Inc.
References: August 11, 2021
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Company responded
2021-09-09
Tivic Health Systems, Inc.
References: August 18, 2021
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Company responded
2021-09-23
Tivic Health Systems, Inc.
References: September 20, 2021
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Company responded
2021-11-05
Tivic Health Systems, Inc.
Summary
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Tivic Health Systems, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-09-20
Tivic Health Systems, Inc.
Summary
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Company responded
2021-11-05
Tivic Health Systems, Inc.
Summary
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Tivic Health Systems, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-08-18
Tivic Health Systems, Inc.
Summary
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Tivic Health Systems, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-07-09
Tivic Health Systems, Inc.
Summary
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Company responded
2021-08-03
Tivic Health Systems, Inc.
References: July 9, 2021
Summary
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Tivic Health Systems, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-06-14
Tivic Health Systems, Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-03 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 333-289953 | Read Filing View |
| 2025-09-03 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-08-08 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-08-08 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-08-05 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-08288 | Read Filing View |
| 2025-07-31 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-08260 | Read Filing View |
| 2025-07-28 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-07-25 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-07-09 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-08017 | Read Filing View |
| 2025-06-26 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-06-17 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-08017 | Read Filing View |
| 2025-06-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-05-21 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-08017 | Read Filing View |
| 2025-05-09 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-05-08 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-07973 | Read Filing View |
| 2024-05-08 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2024-05-08 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2024-04-08 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 333-278383 | Read Filing View |
| 2023-02-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-02-06 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-25 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-24 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-18 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-17 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-12 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-11 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-10 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2022-11-02 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-11-05 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-11-05 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-09-23 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-09-20 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-09-09 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-08-18 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-08-12 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-08-11 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-08-03 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-07-09 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-06-14 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-03 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 333-289953 | Read Filing View |
| 2025-08-05 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-08288 | Read Filing View |
| 2025-07-31 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-08260 | Read Filing View |
| 2025-07-09 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-08017 | Read Filing View |
| 2025-06-17 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-08017 | Read Filing View |
| 2025-05-21 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-08017 | Read Filing View |
| 2025-05-08 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 377-07973 | Read Filing View |
| 2024-04-08 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | 333-278383 | Read Filing View |
| 2023-02-06 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2022-11-02 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-09-20 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-08-18 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-08-11 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-07-09 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-06-14 | SEC Comment Letter | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-03 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-08-08 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-08-08 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-07-28 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-07-25 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-06-26 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-06-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2025-05-09 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2024-05-08 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2024-05-08 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-25 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-24 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-18 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-17 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-12 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-11 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-10 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2023-01-06 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-11-05 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-11-05 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-09-23 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-09-09 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-08-12 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
| 2021-08-03 | Company Response | Tivic Health Systems, Inc. | DE | N/A | Read Filing View |
2025-09-03 - UPLOAD - Tivic Health Systems, Inc. File: 333-289953
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 3, 2025 Jennifer Ernst Chief Executive Officer Tivic Health Systems, Inc. 47685 Lakeview Blvd. Fremont, California 94538 Re: Tivic Health Systems, Inc. Registration Statement on Form S-3 Filed August 29, 2025 File No. 333-289953 Dear Jennifer Ernst: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Conlon Danberg at 202-551-4466 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Caitlin M. Murphey, Esq. </TEXT> </DOCUMENT>
2025-09-03 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm Tivic Health Systems, Inc. 47865 Lakeview Blvd. Fremont, CA 94538 (888) 276-6888 September 3, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-3 File No. 333-289953 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Tivic Health Systems, Inc., a Delaware corporation (the "Registrant"), hereby respectfully requests that the United States Securities and Exchange Commission (the "Commission") take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-289953), to become effective on Friday, September 5, 2025, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter. The Registrant understands that the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Caitlin M. Murphey, Esq. of Snell & Wilmer L.L.P., to orally modify or withdraw this request for acceleration. Please contact Ms. Murphey at (858) 910-4773 with any questions you may have concerning this request, and please notify her when this request for acceleration has been granted. Very truly yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer cc: Caitlin M. Murphey, Snell & Wilmer L.L.P.
2025-08-08 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm Tivic Health Systems, Inc. 47865 Lakeview Blvd. Fremont, CA 94538 (888) 276-6888 August 8, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-3 File No. 333-289441 REQUEST FOR ACCELERERATION OF EFFECTIVENESS Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Tivic Health Systems, Inc., a Delaware corporation (the "Registrant"), hereby respectfully requests that the United States Securities and Exchange Commission (the "Commission") take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-289441), to become effective on Tuesday, August 12, 2025, at 5:15 p.m., Eastern Time, or as soon as reasonably practicable thereafter. The Registrant understands that the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Caitlin M. Murphey, Esq. of Snell & Wilmer L.L.P., to orally modify or withdraw this request for acceleration. Please contact Ms. Murphey at (858) 910-4773 with any questions you may have concerning this request, and please notify her when this request for acceleration has been granted. Very truly yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer cc: Caitlin M. Murphey, Snell & Wilmer L.L.P.
2025-08-08 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm Tivic Health Systems, Inc. 47865 Lakeview Blvd. Fremont, CA 94538 (888) 276-6888 August 8, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-3 File No. 333-289436 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Tivic Health Systems, Inc., a Delaware corporation (the "Registrant"), hereby respectfully requests that the United States Securities and Exchange Commission (the "Commission") take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-289436), to become effective on Tuesday, August 12, 2025, at 5:15 p.m., Eastern Time, or as soon as reasonably practicable thereafter. The Registrant understands that the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Caitlin M. Murphey, Esq. of Snell & Wilmer L.L.P., to orally modify or withdraw this request for acceleration. Please contact Ms. Murphey at (858) 910-4773 with any questions you may have concerning this request, and please notify her when this request for acceleration has been granted. Very truly yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer cc: Caitlin M. Murphey, Snell & Wilmer L.L.P.
2025-08-05 - UPLOAD - Tivic Health Systems, Inc. File: 377-08288
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 5, 2025 Jennifer Ernst Chief Executive Officer Tivic Health Systems, Inc. 47685 Lakeview Blvd. Fremont, CA 94538 Re: Tivic Health Systems, Inc. Draft Registration Statement on Form S-3 Filed August 4, 2025 CIK 0001787740 Dear Jennifer Ernst: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement at least two business days prior to the requested effective date and time. 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 Robert Augustin at 202-551-8483 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Caitlin M. Murphey </TEXT> </DOCUMENT>
2025-07-31 - UPLOAD - Tivic Health Systems, Inc. File: 377-08260
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 31, 2025 Jennifer Ernst Chief Executive Officer Tivic Health Systems, Inc. 47685 Lakeview Blvd. Fremont, CA 94538 Re: Tivic Health Systems, Inc. Draft Registration Statement on Form S-3 Submitted July 25, 2025 CIK No. 0001787740 Dear Jennifer Ernst: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement at least two business days prior to the requested effective date and time. 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: Caitlin Murphey, Esq. </TEXT> </DOCUMENT>
2025-07-28 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm Tivic Health Systems, Inc. 47865 Lakeview Blvd. Fremont, CA 94538 (888) 276-6888 July 28, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-287853 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Tivic Health Systems, Inc., a Delaware corporation (the "Registrant"), hereby respectfully requests that the United States Securities and Exchange Commission (the "Commission") take appropriate action to cause the above-referenced Registration Statement on Form S-1, as amended (File No. 333-287853), to become effective on Wednesday, July 30, 2025, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter. The Registrant understands that the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Christopher L. Tinen, Esq. of Snell & Wilmer L.L.P., to orally modify or withdraw this request for acceleration. Please contact Mr. Tinen at (858) 910-4809 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very truly yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer cc: Christopher L. Tinen, Snell & Wilmer L.L.P.
2025-07-25 - CORRESP - Tivic Health Systems, Inc.
CORRESP
1
filename1.htm
Christopher L. Tinen
Partner
O 858.910.4809 | F 858.434.5006
ctinen@swlaw.com
July 25, 2025
Via
EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention:
Conlon Danberg
Jane Park
Re:
Tivic Health Systems, Inc.
Registration Statement on Form S-1
Response dated June 26, 2025
File No. 333-287853
Ladies and Gentlemen:
On behalf of our client,
Tivic Health Systems, Inc. (the " Company "), we submit this letter in response to comments from the staff (the " Staff ")
of the Securities and Exchange Commission (the " Commission ") contained in its letter dated July 9, 2025, relating
to the Company's Registration Statement on Form S-1 filed with the Commission on June 6, 2025 (the " Registration Statement ")
and its response dated June 26, 2025. We are filing via EDGAR this letter and the Company's Amendment No. 1 to Registration Statement
on Form S-1 (" Amendment No. 1 to Registration Statement ").
In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company's
response. Except for page references appearing in the headings and comments of the Staff below (which are references to the Registration
Statement on Form S-1 filed on June 6, 2025), or as otherwise specifically indicated, all page references herein correspond to the page
of Amendment No. 1 to Registration Statement.
Response Letter filed June 26, 2025
Plan of Distribution,
page 16
1.
We note your response to previous comment 1 but are unable to agree that the current transaction is consistent with Securities Act Compliance and Disclosure Interpretations Question 139.11. Regardless of whether the closing condition in Section 2.3(b)(xiv) was included to address Nasdaq rules related to future priced securities, it is still a closing condition relating to the market price of the Company's securities, which is not permitted by CDI 139.11. Additionally, while the Selling Stockholder may remain obligated to fund the respective tranche if the trading price subsequently exceeds the Floor Price, there is no guarantee that this will occur. Therefore, the Selling Stockholder is not irrevocably bound to purchase each tranche. In addition, the current transaction does not satisfy the condition discussed in CDI 139.11 that the closing must occur within a "short time" after effectiveness, as subsequent tranche closings could occur as late as December 31, 2025. Accordingly, you must either revise the registration statement to limit the shares registered for resale to those underlying the already-issued preferred shares and warrants, or revise your prospectus to disclose a fixed price at which the selling shareholder will offer the shares for the duration of the offering and identify the selling shareholder as an underwriter.
In response to the Staff's
comments, the Company advises the Staff that it has revised the Registration Statement to limit the shares registered for resale to those
underlying the already-issued preferred shares and warrants.
***
Please direct any questions
regarding the Company's responses or its Amendment No. 1 to Registration Statement to me at (858) 910-4809 or ctinen@swlaw.com.
Sincerely,
SNELL & WILMER L.L.P.
/s/Christopher L. Tinen, Esq.
Christopher L. Tinen, Esq.
cc:
Jennifer Ernst, Tivic Health Systems, Inc.
2
2025-07-09 - UPLOAD - Tivic Health Systems, Inc. File: 377-08017
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 9, 2025 Jennifer Ernst Chief Executive Officer Tivic Health Systems, Inc. 47685 Lakeview Blvd. Fremont, California 94538 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1 Response dated June 26, 2025 File No. 333-287853 Dear Jennifer Ernst: We have reviewed your response letter dated June 26, 2025 and have the following comment. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to this letter, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our June 17, 2025 letter. Response Letter filed June 26, 2025 Plan of Distribution, page 16 1. We note your response to previous comment 1 but are unable to agree that the current transaction is consistent with Securities Act Compliance and Disclosure Interpretations Question 139.11. Regardless of whether the closing condition in Section 2.3(b)(xiv) was included to address Nasdaq rules related to future priced securities, it is still a closing condition relating to the market price of the Company's securities, which is not permitted by CDI 139.11. Additionally, while the Selling Stockholder may remain obligated to fund the respective tranche if the trading price subsequently exceeds the Floor Price, there is no guarantee that this will occur. Therefore, the Selling Stockholder is not irrevocably bound to purchase each tranche. In addition, the current transaction does not satisfy the condition discussed in July 9, 2025 Page 2 CDI 139.11 that the closing must occur within a "short time" after effectiveness, as subsequent tranche closings could occur as late as December 31, 2025. Accordingly, you must either revise the registration statement to limit the shares registered for resale to those underlying the already-issued preferred shares and warrants, or revise your prospectus to disclose a fixed price at which the selling shareholder will offer the shares for the duration of the offering and identify the selling shareholder as an underwriter. Please contact Conlon Danberg at 202-551-4466 or Katherine Bagley at 202-551- 2545 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Christopher L. Tinen, Esq. </TEXT> </DOCUMENT>
2025-06-26 - CORRESP - Tivic Health Systems, Inc.
CORRESP
1
filename1.htm
Christopher L. Tinen
Partner
O 858.910.4809 | F 858.434.5006
ctinen@swlaw.com
June 26, 2025
Via
EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention:
Conlon Danberg
Jane Park
Re:
Tivic Health Systems, Inc.
Registration Statement on Form S-1
Filed June 6, 2025
File No. 333-287853
Ladies and Gentlemen:
On behalf of our client, Tivic
Health Systems, Inc. (the " Company "), we submit this letter in response to comments from the staff (the " Staff ")
of the Securities and Exchange Commission (the " Commission ") contained in its letter dated June 17, 2025, relating
to the Company's Registration Statement on Form S-1 filed with the Commission on June 6, 2025 (the " Registration Statement ").
We are filing via EDGAR this letter in response thereto.
In this letter, we have recited
the comments from the Staff in italicized, bold type and have followed each comment with the Company's response. All page references
herein correspond to the pages of the previously filed Registration Statement.
Registration Statement on Form S-1 filed
June 6, 2025
Plan of Distribution,
page 16
1.
We note your response to previous comment 1. Section 2.3(b)(xiv) of the Securities Purchase Agreement entered into with the Selling Stockholder on April 29, 2025 appears to provide that the Selling Stockholder's obligation to purchase each tranche of Preferred Shares is subject to the closing price of the Company's common stock being equal to or greater than the Floor Price of $1.294 per share for a period proceeding each Tranche Closing Date. Please clarify whether the Selling Stockholder is irrevocably bound to purchase a given tranche of Preferred Stock if the Company's common stock is trading below the Floor Price. As noted in CD&I 139.11, "closing conditions in capital formation transactions relating to the market price of the company's securities . . . are unacceptable conditions" when a company is attempting to register the resale of common stock underlying convertible securities prior to the issuance of the convertible securities. Additionally, CD&I 139.11 provides that in such a scenario, "[t]he closing of the private placement of the unissued securities must occur within a short time after the effectiveness of the resale registration statement." It appears that the six tranche closing dates will be staggered with the final Tranche Closing scheduled to occur within 90 trading days after the effectiveness of the registration statement. Please provide us with your analysis of whether 90 trading days constitutes a "short time" in this context.
In response to the Staff's
comments, the Company advises the Staff that, on June 25, 2025, the Company and the Selling Stockholder held the initial tranche closing
(the " Initial Tranche Closing ") as set forth in Section 2.3(c) of that certain Securities Purchase Agreement, dated
April 29, 2025, by and between the Company and the Selling Stockholder (the "Securities Purchase Agreement"), whereby the
Selling Stockholder paid $700,000 to the Company (the "Initial Tranche Purchase Price") for the purchase of 700 shares of
the Company's Series B Non-Voting Convertible Preferred Stock (the "Preferred Shares") and Warrants to purchase 61,287
shares of Company common stock, thereby completing the Initial Tranche Closing and formally issuing the Initial Tranche Preferred Shares
and Warrants. The Company will revise the Registration Statement to include this update following the Staff's consideration of this
response.
1
The Company reiterates its
belief that the private placement transaction set forth in the Securities Purchase Agreement is consistent with Securities Act Compliance
and Disclosure Interpretations Question 139.11 (" CD&I 139.11 ") as a valid private placement in public equity (" PIPE ")
transaction. Specifically, the Company reiterates that the Securities Purchase Agreement binds the Selling Stockholder to purchase 8,400
Preferred Shares at a fixed purchase price of $1,000 per share for a fixed aggregate purchase price of $8,400,000, along with 30% warrant
coverage. This is further supported by the Initial Tranche Closing and issuance of the Preferred Shares and Warrants. As a result, Helena
is currently at market risk both as to the Initial Tranche and subsequent tranches as a result of its binding obligations set forth in
the Securities Purchase Agreement. CD&I 139.11 further provides that "[w]hen a company attempts to register for resale shares
of common stock underlying unissued, convertible securities, the PIPE analysis applies to the convertible security, not to the underlying
common stock."
Additionally, as it relates
to the Staff's comments related to the Floor Price, such term has been set in response to Nasdaq rules related to future priced
securities, not as the result of Selling Stockholder negotiating a condition to closing that is within its control. As a result, this
condition is not a market term but rather in response to a regulatory requirement. This is further supported by the remainder of the language
set forth in Section 2.3(b)(xiv) of the Securities Purchase Agreement which provides that Selling Stockholder is obligated to fund the
respective tranche "within two (2) Trading Days of the condition set forth in this Section 2.3(b)(xiv) having been met for five
(5) consecutive Trading Days" once the trading price again exceeds the Floor Price. Lastly, there is an additional element of market
risk for tranches that fund near, but above the Floor Price, as subsequent conversions may then be at a premium to the then market price
after funding has occurred as a result of the Floor Price. The Selling Stockholder does not have a corrective provision or closing condition
to address such market risk and such term is outside of the control of the Selling Stockholder.
As it relates to the private
placement closing being a "short time" after the effectiveness of this Registration Statement, the Company advises the Staff
that, as to the Initial Tranche, the Preferred Shares and Warrants have been issued prior to the effectiveness of this Registration Statement.
As for the remaining tranches, the Selling Stockholder is irrevocably bound to invest and no closing conditions are within its control.
Given such facts, and in light of other tranched fundings being extended over periods of as long as 12 or 24 months, the Company views
the time between fundings of the subsequent tranches and effectiveness as short.
Accordingly, based on the
facts and circumstances present, the Company respectfully submits that, based on the foregoing, the proposed resale of the Shares by the
Selling Stockholder as contemplated by the Registration Statement is appropriately characterized as a secondary offering that is eligible
to be made under Rule 415(a)(1)(i) and, as such, the Selling Stockholder should not be deemed to be an underwriter under the Securities
Act.
***
Please direct any questions
regarding the Company's responses or its Registration Statement to me at (858) 910-4809 or ctinen@swlaw.com.
Sincerely,
SNELL & WILMER L.L.P.
/s/ Christopher L. Tinen, Esq.
Christopher L. Tinen, Esq.
cc:
Jennifer Ernst, Tivic Health Systems, Inc.
2
2025-06-17 - UPLOAD - Tivic Health Systems, Inc. File: 377-08017
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 17, 2025 Jennifer Ernst Chief Executive Officer Tivic Health Systems, Inc. 47685 Lakeview Blvd. Fremont, California 94538 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1 Filed June 6, 2025 File No. 333-287853 Dear Jennifer Ernst: We have reviewed your amended registration statement and have the following comment. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to this letter, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our May 21, 2025 letter. Registration Statement on Form S-1 filed June 6, 2025 Plan of Distribution, page 16 1. We note your response to previous comment 1. Section 2.3(b)(xiv) of the Securities Purchase Agreement entered into with the Selling Stockholder on April 29, 2025 appears to provide that the Selling Stockholder's obligation to purchase each tranche of Preferred Shares is subject to the closing price of the Company's common stock being equal to or greater than the Floor Price of $1.294 per share for a period proceeding each Tranche Closing Date. Please clarify whether the Selling Stockholder is irrevocably bound to purchase a given tranche of Preferred Stock if the Company's common stock is trading below the Floor Price. As noted in CD&I 139.11, "closing conditions in capital formation transactions relating to the market price of the company s securities . . . are unacceptable conditions" when a company is attempting June 17, 2025 Page 2 to register the resale of common stock underlying convertible securities prior to the issuance of the convertible securities. Additionally, CD&I 139.11 provides that in such a scenario, "[t]he closing of the private placement of the unissued securities must occur within a short time after the effectiveness of the resale registration statement." It appears that the six tranche closing dates will be staggered with the final Tranche Closing scheduled to occur within 90 trading days after the effectiveness of the registration statement. Please provide us with your analysis of whether 90 trading days constitutes a "short time" in this context. Please contact Conlon Danberg at 202-551-4466 or Jane Park at 202-551-7439 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Christopher L. Tinen, Esq. </TEXT> </DOCUMENT>
2025-06-06 - CORRESP - Tivic Health Systems, Inc.
CORRESP
1
filename1.htm
Christopher L. Tinen
Partner
O 858.910.4809 | F 858.434.5006
ctinen@swlaw.com
June 6, 2025
Via
EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention:
Conlon Danberg
Jane Park
Re:
Tivic Health Systems, Inc.
Draft Registration Statement on Form S-1
Submitted May 15, 2025
CIK No. 0001787740
Ladies and Gentlemen:
On behalf of our client, Tivic
Health Systems, Inc. (the " Company "), we submit this letter in response to comments from the staff (the " Staff ")
of the Securities and Exchange Commission (the " Commission ") contained in its letter dated May 21, 2025, relating to
the Company's Draft Registration Statement on Form S-1 submitted to the Commission on May 15, 2025 (the " Draft Registration
Statement "). We are filing via EDGAR this letter in response thereto as well as publicly filing the Company's registration
statement on Form S-1 and non-public draft submission.
In this letter, we have recited
the comments from the Staff in italicized, bold type and have followed each comment with the Company's response. All page references
herein correspond to the pages of the previously submitted Draft Registration Statement.
Draft Registration Statement on Form S-1 submitted
May 15, 2025
Plan of Distribution,
page 17
1.
We note your statement that the Selling Stockholder and any underwriters, broker-dealers or agents that participate in the sale of the common stock or interests therein may be "underwriters" within the meaning of Section 2(a)(11) of the Securities Act. Please clarify if you intend to rely on the guidance provided in Securities Act Compliance and Disclosure Interpretation 139.13 and, if so, revise the registration statement to identify the equity line investor as an underwriter as well as a selling shareholder. If you believe your transaction constitutes a genuine secondary offering rather than an indirect primary offering, please provide us with your analysis of the factors described in Securities Act Compliance and Disclosure Interpretations 612.09 and 139.11.
In response
to the Staff's comments, the Company respectfully submits that, based on the facts and circumstances present, the offering contemplated
in the Draft Registration Statement is properly characterized as a bona fide secondary offering and not an indirect primary offering.
As such, the Company is not relying on the guidance contemplated by Securities Act Compliance and Disclosure Interpretations Question
139.13 (" CD&I; 139.13 "). Accordingly, the Company believes it properly reflected in the Draft Registration
Statement that the selling stockholder listed therein (the " Selling Stockholder ") "may" be an "underwriter"
within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended (the " Securities Act "), under the circumstances
described herein.
1
The offering was consummated
in a one-time, arm's-length private placement (the " Offering ") negotiated between the Company and the Selling
Stockholder pursuant to a securities purchase agreement between the Company and the Selling Stockholder (the " Securities Purchase
Agreement "). The Company believes the registration of the resale of the shares of common stock of the Company issuable upon
conversion of shares of our Series B Non-Voting Convertible Preferred Stock (the " Preferred Stock ") and upon exercise
of the warrants (the " Warrants ") is akin to the registration of convertible or exchangeable securities issued through
a private investment in public equity (" PIPE ") transaction. In a PIPE transaction, a company will be permitted to register
the resale of securities prior to their issuance if the company has completed a sale of the convertible security exempt from the registration
requirements of the Securities Act pursuant to Section 4(a)(2) thereof and Rule 506(b) of the Regulation D thereunder to the investor,
and the investor is at market risk at the time of filing of the resale registration statement. Securities Act Compliance and Disclosure
Interpretations Question 139.11 (" CD&I 139.11 ") states that an investor must be irrevocably bound to purchase a
set number of securities for a set purchase price that is not based on market price or a fluctuating ratio, either at the time of effectiveness
of the resale registration or at any subsequent date under the PIPE analysis. Additionally, there can be no conditions to closing that
are within an investor's control, such as a due diligence or finance closing condition.
Similar to a PIPE transaction
contemplated by CD&I 139.11, the offering of the Preferred Stock and the Warrants occurred pursuant to the exemption from the registration
requirements of the Securities Act, provided by Section 4(a)(2) thereof, in which the terms of the conversion of the Preferred Stock and
exercise of the Warrants, respectively, into shares of common stock of the Company have been established with the number of shares of
common stock issuable upon exercise of the Warrants fixed, subject to standard anti-dilution protections and the number of shares of common
stock issuable upon conversion of the Preferred Stock limited by a fixed floor price, which adjustments cannot increase the maximum number
of shares of common stock registered pursuant to the registration statement (the number of shares of common stock issuable upon exercise
of the Warrants and conversion of the Preferred Stock being the " Shares "). While the number of Shares issuable and
exercise price of the Warrants is subject to change based on certain anti-dilution protections and while the number of Shares issuable
and the conversion price of the Preferred Stock is subject to change based on the market price of the Company's common stock following
certain events, the floor price is the fixed price limit regardless of whether the Company's stock price falls below the floor,
the number of Shares issuable at the floor price is known and being registered and the Offering consideration and price of $8,400,000
is fixed and shall be paid according to a set schedule and not pursuant to a Company "put" right. The tranched structure allows
the Company to space out the capital investment over time to align with its business plan and development goals and to allow it time to
comply with the stockholder approval requirements of Nasdaq. Moreover, the Selling Stockholder cannot revoke its investment even if there
are adverse developments in the economy impacting the Company, which, if such events had occurred prior to the closing of the Offering,
would have resulted in the Selling Stockholder declining to participate in the Offering. Lastly, unlike an equity line transaction, the
amount of investment proceeds to be received by the Company in the tranched closings is fixed at $8,400,000 and is not tied to the subsequent
conversion price of the Preferred Stock or the exercise price of the Warrants.
In connection with the Offering,
the Company entered into a registration rights agreement (the " Registration Rights Agreement ") with the Selling Stockholder,
pursuant to which the Company agreed to file a registration statement covering the resale of Shares.
There is no investment decision
left to be made with respect to the investment in the Offering by the Selling Stockholder and thus the Selling Stockholder is "irrevocably
bound" to the terms and conditions set forth in the Purchase Agreement, the Warrants and the Registration Rights Agreement executed
in connection with the Offering. Further, the Selling Stockholder has assumed the risk that the price of the shares of Company's
common stock will remain above the floor price and, given the historical limited trading volume of shares of the Company's common
stock, as a practical matter, the Selling Stockholder will continue to bear the risk of a significant portion of their investment for
a more extended period of time than would be the case for a more actively traded security.
2
Additionally, below is the
Company's detailed analysis of each factor set forth in C&DI 612.09, with additional reference to the principles articulated
in C&DI 139.11 above, as necessary, demonstrating that the proposed resale is a genuine secondary offering.
(A) How long the Selling
Stockholder has held the Shares
On April 29, 2025, the Company
entered into the Securities Purchase Agreement with the Selling Stockholder, pursuant to which the Company agreed to sell and issue to
the Selling Stockholder, and the Selling Stockholder agreed to purchase from the Company, up to 8,400 shares of the Preferred Stock and
Warrants to purchase shares of the Company's common stock for a total purchase price of up to $8,400,000 in several tranche closings
("Tranche Closings"). The Selling Stockholder has already been irrevocably bound by the Securities Purchase Agreement for
over a month and, based on the tranched closing structure, will remain obligated for many months thereafter until December 31, 2025. Since
April 29, 2025 and through the rest of 2025, the Selling Stockholder bears the full economic and market risk of ownership due to its binding
obligation to purchase securities in the Offering. In addition, the Selling Stockholder is acquiring the Shares with no assurance that
the Shares could be sold in a liquid market. This holding period for the Preferred Stock, Warrants and the Shares demonstrates that the
Selling Stockholder is acquiring the securities for investment, does not have intent to distribute the Shares on behalf of the Company
and is not acting as an underwriter.
In the Registration Rights
Agreement, the Company has covenanted to file a registration statement covering the resale of the Shares and to use commercially reasonable
efforts to cause such registration statement to be declared effective under the Securities Act within sixty (60) days after the closing
date of the Offering. The Company filed the registration statement to perform such obligation under the Registration Rights Agreement.
The Company respectfully submits to the Staff that the registration of the Shares for resale as contemplated in the registration statement
is consistent with a typical PIPE transaction, where an issuer is required to file a resale registration statement shortly after closing.
Although the Staff has acknowledged
in C&DI 139.11 that a valid secondary offering could, in theory, be registered immediately after a closing, the Company believes that
the multi-month holding period here further supports secondary-offering treatment.
(B) The circumstances
under which the Selling Stockholder is receiving the Shares
The Offering was consummated
in a one-time, arm's-length private placement negotiated between the Company and the Selling Stockholder pursuant to the Securities
Purchase Agreement which contained, among other things, customary investment and private placement representations of the Selling Stockholder
to the Company. In addition, the Selling Stockholder has not entered into any underwriting relationships or arrangements with the Company,
has not received any commission or other payment from the Company in connection with the resale of any of its securities, and the Company
will receive no proceeds from the resale of the Shares, if any, by the Selling Stockholder. Selling Stockholder is irrevocably bound to
wire the proceeds as provided in the Tranche Closings; there are no conditions to the Tranche Closings within the Selling Stockholder's
control, and the transaction is not contingent on market price, due diligence completion, or company "put" exercise. These
circumstances are quite distinct from those involving a primary offering by or on behalf of the Company.
Furthermore, Rule 100 of Regulation
M defines a "distribution" as "an offering of securities, whether or not subject to registration under the Securities
Act, that is distinguished from ordinary trading transactions by the magnitude of the offering and the presence of special selling efforts
and selling methods" (emphasis added). The Company is not aware of any evidence that would suggest that any such special selling
efforts or selling methods (such as investor presentations or road shows) by or on behalf of the Selling Stockholder that have or are
currently intended to take place if the registration statement is declared effective.
3
Selling
Stockholder is irrevocably bound to wire the proceeds as provided in the Tranche Closings; there are no conditions to the Tranche Closings
within the Selling Stockholder's control, and the transaction is not contingent on market price, due diligence completion, or company
"put" exercise.
Accordingly,
the Selling Stockholder has been, and continues to be, fully at risk with respect to its investment. These facts satisfy the indicia identified
in C&DI 139.11 for an irrevocably bound investor described above.
(C)
The Selling Stockholder's relationship with the Company
Based upon
information supplied to the Company by the Selling Stockholder, the Selling Stockholder is a private investment fund that purchased the
securities for its own account and not with a view to resale or distribution. The Company does not have an underwriting relationship with
the Selling Stockholder or any contractual, legal or other relationship that would control the timing, nature or amount of resales of
the Shares following the effectiveness of the registration statement or even whether any Shares are resold at all under the registration
statement. To the Company's knowledge, at no time has the Selling Stockholder been affiliated with or acted as securities broker-dealers
or representatives thereof. Further, as noted above, the Selling Stockholder represented to the Company that they were acquiring the securities
for their own accounts and not with a view to resale or distribution. The Selling Stockholder is not an affiliate of the Company, does
not control the Company and has not provided any strategic advisory, underwriting, or placement services to the Company. The Selling Stockholder
is an institutional accredited investor with no officer, director, employee, or consultant relationships with the Company and no board
representation or management or governance rights.
The registration
rights granted to the Selling Stockholder under the Registration Rights Agreement entered into in connection with the Offering are customary
and are not indicative of any desire of the Selling Stockholder to sell or distribute the Shares on behalf of the Company, or at all.
The Selling Stockholder negotiated for such customary registration rights for a variety of business reasons and the registration rights
were not granted by the Company for the purpose of conducting an indirect primary offering. Absent the contractual obligation contained
in the Registration Rights Agreement, the Company would not be filing the registration statement. In addition, the Selling Stockholder
would be responsible for paying any broker-dealer fees or underwriting discounts or commissions directly to any broker-dealers they engage
to assist in selling any of the Shares.
To the extent
the Selling Stockholder sells the Shares, the Selling Stockholder will retain all proceeds from such sales and the Company will not receive
any of the proceeds from any resale of the Shares.
(D)
The amount of shares involved
The Company
is seeking to register of up to 8,438,949 shares of common stock for resale. While the number of shares of common stock being registered
are a factor considered by the Staff in determining whether an offering should be deemed to be a primary or secondary offering, we submit
that undue weight should not be placed on this single factor. The Staff's own interpretations support this position. Pursuant to
C&DI 612.09, the amount of shares of common stock being offered is onl
2025-05-21 - UPLOAD - Tivic Health Systems, Inc. File: 377-08017
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 21, 2025 Jennifer Ernst Chief Executive Officer Tivic Health Systems, Inc. 47685 Lakeview Blvd. Fremont, California 94538 Re: Tivic Health Systems, Inc. Draft Registration Statement on Form S-1 Submitted May 15, 2025 CIK No. 0001787740 Dear Jennifer Ernst: We have conducted a limited review of your draft registration statement and have the following comment. Please respond to this letter by providing any requested information and by publicly filing your registration statement and non-public draft submission on EDGAR. If you do not believe a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to this letter and your filed registration statement, we may have additional comments. Draft Registration Statement on Form S-1 submitted May 15, 2025 Plan of Distribution, page 17 1. We note your statement that the Selling Stockholder and any underwriters, broker- dealers or agents that participate in the sale of the common stock or interests therein may be underwriters within the meaning of Section 2(a)(11) of the Securities Act. Please clarify if you intend to rely on the guidance provided in Securities Act Compliance and Disclosure Interpretation 139.13 and, if so, revise the registration statement to identify the equity line investor as an underwriter as well as a selling shareholder. If you believe your transaction constitutes a genuine secondary offering rather than an indirect primary offering, please provide us with your analysis of the factors described in Securities Act Compliance and Disclosure Interpretations 612.09 and 139.11. May 21, 2025 Page 2 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 your registration statement must be on file at least two business days prior to the requested effective date and time. Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Conlon Danberg at 202-551-4466 or Jane Park at 202-551-7439 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Christopher L. Tinen, Esq. </TEXT> </DOCUMENT>
2025-05-09 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm Tivic Health Systems, Inc. 47685 Lakeview Blvd. Fremont, CA 94538 (888) 276-6888 May 9, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1 File No. 333- 287157 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentleman: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the "Securities Act"), Tivic Health Systems, Inc., a Delaware corporation (the "Registrant"), hereby respectfully requests that the United States Securities and Exchange Commission (the "Commission") take appropriate action to cause the above-referenced Registration Statement on Form S-1, as amended (File No. 333-287157), to become effective on Tuesday, May 13, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant understands that the Commission will consider this request as a confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Christopher L. Tinen, Esq. of Snell & Wilmer L.L.P., to orally modify or withdraw this request for acceleration. Please contact Mr. Tinen at (858) 910-4809 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2025-05-08 - UPLOAD - Tivic Health Systems, Inc. File: 377-07973
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 8, 2025 Jennifer Ernst Chief Executive Officer Tivic Health Systems, Inc. 47685 Lakeview Blvd. Fremont, California 94538 Re: Tivic Health Systems, Inc. Draft Registration Statement on Form S-1 Submitted May 2, 2025 CIK No. 0001787740 Dear Jennifer Ernst: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement at least two business days prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Conlon Danberg at 202-551-4466 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Christopher L. Tinen, Esq. </TEXT> </DOCUMENT>
2024-05-08 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 May 8, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-278383 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentleman: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), Tivic Health Systems, Inc., a Delaware corporation (the “Registrant”), hereby respectfully requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-1, as amended (File No. 333-278383), to become effective on Thursday, May 9, 2024, at 9:00 a.m., Eastern Time, or as soon thereafter as is practicable. The Registrant understands that the Commission will consider this request as a confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Christopher L. Tinen, Esq. of Procopio, Cory, Hargreaves & Savitch LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Tinen at (858) 720-6320 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2024-05-08 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP May 8, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-1004 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-278383 Ladies and Gentlemen: As the placement agent of the proposed offering of Tivic Health Systems, 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 Thursday, May 9, 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 May 8, 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 May 8, 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/ Ritesh Veera Name: Ritesh Veera Title: Co-Head of Investment Banking
2024-04-08 - UPLOAD - Tivic Health Systems, Inc. File: 333-278383
United States securities and exchange commission logo
April 8, 2024
Jennifer Ernst
Chief Executive Officer
Tivic Health Systems, Inc.
25821 Industrial Blvd., Suite 100
Hayward, CA 94545
Re:Tivic Health Systems, Inc.
Registration Statement on Form S-1
Filed March 29, 2024
File No. 333-278383
Dear Jennifer Ernst:
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: Christopher L. Tinen, Esq.
2023-02-06 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 February 6, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-3 Filed February 1, 2023 File No. 333-269494 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentleman: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), Tivic Health Systems, Inc., a Delaware corporation (the “Registrant”), hereby respectfully requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-269494) to become effective on Wednesday, February 8, 2023, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant understands that the Commission will consider this request as a confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Christopher L. Tinen, Esq. of Procopio, Cory, Hargreaves & Savitch LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Tinen at (858) 720-6320 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2023-02-06 - CORRESP - Tivic Health Systems, Inc.
CORRESP
1
filename1.htm
CORRESP
ThinkEquity LLC
17 State Street, 41st Floor
New York, New York 10004
February 6, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Tivic Health Systems, Inc. (the “Company”)
Registration Statement on Form S-1, as amended (File No. 333-268010)
Withdrawal of Request for
Acceleration
Ladies and Gentlemen:
ThinkEquity LLC, as representative of the underwriters of the offering contemplated by the Company, hereby requests withdrawal of its
acceleration request letter filed as correspondence via EDGAR on January 5, 2023, which requested that the above-referenced Registration Statement on Form S-1, as amended (File No. 333-268010) become effective on Tuesday, January 10, 2023 at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Company terminated its request that such Registration Statement
be declared effective at this specific date and time and ThinkEquity LLC hereby formally withdraws its request for acceleration of the effective date as stated above.
Please contact counsel to ThinkEquity LLC, Leslie Marlow at (212) 885-5358 or Patrick Egan at (212) 885-5346 with any questions you may have concerning this withdrawal of request for acceleration.
Very truly yours,
ThinkEquity LLC
By:
/s/ Priyanka Mahajan
Name:
Priyanka Mahajan
Title:
Managing Director, Investment Banking
cc:
Leslie Marlow, Esq.
Blank Rome LLP
Patrick J. Egan,
Esq.
Blank Rome LLP
2023-02-06 - UPLOAD - Tivic Health Systems, Inc.
United States securities and exchange commission logo
February 6, 2023
Jennifer Ernst
Chief Executive Officer
Tivic Health Systems, Inc.
25821 Industrial Blvd., Suite 100
Hayward, CA 94545
Re:Tivic Health Systems, Inc.
Registration Statement on Form S-3
Filed February 1, 2023
File No. 333-269494
Dear Jennifer Ernst:
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 Jordan Nimitz at 202-551-5831 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
2023-02-06 - CORRESP - Tivic Health Systems, Inc.
CORRESP
1
filename1.htm
CORRESP
ThinkEquity LLC
17 State Street, 41st Floor
New York, New York 10004
February 6, 2023
VIA EDGAR
United States Securities and Exchange
Commission
Division of Corporation Finance
100 F Street,
N.E.
Washington, D.C. 20549
Re:
Tivic Health Systems, Inc. (the “Company”)
Registration Statement on Form S-1, as amended (File
No. 333-268010)
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations of the United States Securities and Exchange Commission under the Securities Act of
1933, as amended (the “Securities Act”), ThinkEquity LLC, as representative of the underwriters of the offering, hereby joins the request of the Company that the effective date of the Company’s Registration Statement on Form S-1, as amended (File No. 333-268010), be accelerated so as to permit it to become effective on Wednesday, February 8, 2023, at 5:00
p.m. (Eastern Time), or as soon thereafter as practicable.
Pursuant to Rule 460 of the General Rules and Regulations of the
Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably anticipated to be invited to participate in the distribution of the securities, as many copies, as well as “E-red” copies of the preliminary prospectus, as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by
participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.
Very truly yours,
ThinkEquity LLC
By:
/s/ Priyanka Mahajan
Name:
Priyanka Mahajan
Title:
Managing Director, Investment Banking
cc:
Leslie Marlow, Esq.
Blank Rome LLP
Patrick J. Egan, Esq.
Blank Rome LLP
2023-02-06 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 February 6, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-268010 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentleman: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), Tivic Health Systems, Inc., a Delaware corporation (the “Registrant”), hereby respectfully requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-1, as amended (File No. 333-268010), to become effective on Wednesday, February 8, 2023, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant understands that the Commission will consider this request as a confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Christopher L. Tinen, Esq. of Procopio, Cory, Hargreaves & Savitch LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Tinen at (858) 720-6320 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2023-01-25 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 January 25, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-268010 WITHDRAWAL OF REQUEST FOR ACCELERATION—REGISTRATION STATEMENT ON FORM S-1, AS AMENDED (FILE NO. 333-268010) Ladies and Gentleman: Reference is made to our letter, filed as correspondence via EDGAR on January 24, 2023, in which we requested the acceleration of the effective date of the above-referenced Registration Statement for Wednesday, January 25, 2023 at 5:00 p.m., Eastern Time, in accordance with Rule 461 under the Securities Act of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective at this time, and we hereby formally withdraw our request for acceleration of the effective date. Should you have any questions regarding this request for withdrawal, please contact Christopher Tinen of Procopio, Cory, Hargreaves & Savitch LLP by telephone at (858) 720-6320. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2023-01-24 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 January 24, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-268010 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentleman: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), Tivic Health Systems, Inc., a Delaware corporation (the “Registrant”), hereby respectfully requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-1, as amended (File No. 333-268010), to become effective on Wednesday, January 25, 2023, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant understands that the Commission will consider this request as a confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Christopher L. Tinen, Esq. of Procopio, Cory, Hargreaves & Savitch LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Tinen at (858) 720-6320 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2023-01-18 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 January 18, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-268010 WITHDRAWAL OF REQUEST FOR ACCELERATION—REGISTRATION STATEMENT ON FORM S-1, AS AMENDED (FILE NO. 333-268010) Ladies and Gentleman: Reference is made to our letter, filed as correspondence via EDGAR on January 17, 2023, in which we requested the acceleration of the effective date of the above-referenced Registration Statement for Wednesday, January 18, 2023 at 5:00 p.m., Eastern Time, in accordance with Rule 461 under the Securities Act of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective at this time, and we hereby formally withdraw our request for acceleration of the effective date. Should you have any questions regarding this request for withdrawal, please contact Christopher Tinen of Procopio, Cory, Hargreaves & Savitch LLP by telephone at (858) 720-6320. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2023-01-17 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 January 17, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-268010 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentleman: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), Tivic Health Systems, Inc., a Delaware corporation (the “Registrant”), hereby respectfully requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-1, as amended (File No. 333-268010), to become effective on Wednesday, January 18, 2023, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant understands that the Commission will consider this request as a confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Christopher L. Tinen, Esq. of Procopio, Cory, Hargreaves & Savitch LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Tinen at (858) 720-6320 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2023-01-12 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 January 12, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-268010 WITHDRAWAL OF REQUEST FOR ACCELERATION—REGISTRATION STATEMENT ON FORM S-1, AS AMENDED (FILE NO. 333-268010) Ladies and Gentleman: Reference is made to our letter, filed as correspondence via EDGAR on January 11, 2023, in which we requested the acceleration of the effective date of the above-referenced Registration Statement for Thursday, January 12, 2023 at 5:00 p.m., Eastern Time, in accordance with Rule 461 under the Securities Act of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective at this time, and we hereby formally withdraw our request for acceleration of the effective date. Should you have any questions regarding this request for withdrawal, please contact Christopher Tinen of Procopio, Cory, Hargreaves & Savitch LLP by telephone at (858) 720-6320. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2023-01-11 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 January 11, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-268010 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentleman: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), Tivic Health Systems, Inc., a Delaware corporation (the “Registrant”), hereby respectfully requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-1, as amended (File No. 333-268010), to become effective on Thursday, January 12, 2023, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant understands that the Commission will consider this request as a confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Christopher L. Tinen, Esq. of Procopio, Cory, Hargreaves & Savitch LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Tinen at (858) 720-6320 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2023-01-10 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 January 10, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-268010 WITHDRAWAL OF REQUEST FOR ACCELERATION - REGISTRATION STATEMENT ON FORM S-1, AS AMENDED (FILE NO. 333-268010) Ladies and Gentleman: Reference is made to our letter, filed as correspondence via EDGAR on January 6, 2023, in which we requested the acceleration of the effective date of the above-referenced Registration Statement for Tuesday, January 10, 2023 at 5:00 p.m., Eastern Time, in accordance with Rule 461 under the Securities Act of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective at this time, and we hereby formally withdraw our request for acceleration of the effective date. Should you have any questions regarding this request for withdrawal, please contact Christopher Tinen of Procopio, Cory, Hargreaves & Savitch LLP by telephone at (858) 720-6320. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2023-01-06 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP ThinkEquity LLC 17 State Street, 41st Floor New York, New York 10004 January 6, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. (the “Company”) Registration Statement on Form S-1 (File No. 333-268010) Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the United States Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), ThinkEquity LLC, as representative of the underwriters of the offering, hereby joins the request of the Company that the effective date of the Company’s Registration Statement on Form S-1, as amended (File No. 333-268010), be accelerated so as to permit it to become effective on Tuesday, January 10, 2023, at 5:00 p.m. (Eastern Time), or as soon thereafter as practicable. Pursuant to Rule 460 of the General Rules and Regulations of the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably anticipated to be invited to participate in the distribution of the securities, as many copies, as well as “E-red” copies of the preliminary prospectus, as appears to be reasonable to secure adequate distribution of the preliminary prospectus. The undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue. Very truly yours, ThinkEquity LLC By: /s/ Kevin Mangan Name: Kevin Mangan Title: Managing Director, Head of Equity Syndicate cc: Leslie Marlow, Esq. Patrick J. Egan, Esq.
2023-01-06 - CORRESP - Tivic Health Systems, Inc.
CORRESP 1 filename1.htm CORRESP Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 January 6, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Re: Tivic Health Systems, Inc. Registration Statement on Form S-1, as amended File No. 333-268010 REQUEST FOR ACCELERATION OF EFFECTIVENESS Ladies and Gentleman: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), Tivic Health Systems, Inc., a Delaware corporation (the “Registrant”), hereby respectfully requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-1, as amended (File No. 333-268010), to become effective on Tuesday, January 10, 2023, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant understands that the Commission will consider this request as a confirmation by the Registrant that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. The Registrant hereby authorizes its counsel, Christopher L. Tinen, Esq. of Procopio, Cory, Hargreaves & Savitch LLP, to orally modify or withdraw this request for acceleration. Please contact Mr. Tinen at (858) 720-6320 with any questions you may have concerning this request, and please notify him when this request for acceleration has been granted. Very Truly Yours, Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer
2022-11-02 - UPLOAD - Tivic Health Systems, Inc.
United States securities and exchange commission logo
November 2, 2022
Jennifer Ernst
Chief Executive Officer
Tivic Health Systems, Inc.
25821 Industrial Blvd., Suite 100
Hayward, CA 94545
Re:Tivic Health Systems, Inc.
Registration Statement on Form S-1
Filed October 26, 2022
File No. 333-268010
Dear Jennifer Ernst:
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 Jordan Nimitz at 202-551-5831 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Roger Rappoport, Esq.
2021-11-05 - CORRESP - Tivic Health Systems, Inc.
CORRESP
1
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ThinkEquity LLC
17 State Street, 22nd Floor
New York, New York 10004
November 5, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Tivic Health Systems, Inc. (the “Company”)
Registration Statement on Form S-1, as amended (File No. 333-258411)
Request for Acceleration of Effectiveness
Ladies and Gentlemen:
Pursuant to Rule 461 of the
General Rules and Regulations of the United States Securities and Exchange Commission under the Securities Act of 1933, as amended (the
“Securities Act”), ThinkEquity LLC, as representative of the underwriters of the offering, hereby joins the request
of the Company that the effective date of the Company’s Registration Statement on Form S-1, as amended (File No. 333-258411), be
accelerated so as to permit it to become effective on Wednesday, November 10, 2021, at 5:00 p.m. (Eastern Time), or as
soon thereafter as practicable.
Pursuant to Rule 460 of the
General Rules and Regulations of the Securities Act, please be advised that there will be distributed to each underwriter or dealer, who
is reasonably anticipated to be invited to participate in the distribution of the securities, as many copies, as well as “E-red”
copies of the preliminary prospectus, as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned confirms that
it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they
have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with
the above-referenced issue.
Very truly yours,
ThinkEquity LLC
By:
/s/ Eric Lord
Name:
Eric Lord
Title:
Head of Investment Banking
cc:
Leslie Marlow, Esq.
Patrick J. Egan, Esq.
2021-11-05 - CORRESP - Tivic Health Systems, Inc.
CORRESP
1
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Tivic Health Systems, Inc.
November 5, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Tivic Health Systems, Inc.
Registration Statement on Form S-1, as amended
File No: 333- 258411
Request for Acceleration
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Tivic Health Systems, Inc. (the “Registrant”)
hereby requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action
to cause the above-referenced Registration Statement on Form S-1, as amended (File No. 333- 258411), to become effective on Wednesday,
November 10, 2021, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The
Registrant understands that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware
of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration
Statement.
The
Registrant hereby authorizes its counsel, Christopher L. Tinen, Esq. of Procopio, Cory, Hargreaves & Savitch LLP, to orally modify
or withdraw this request for acceleration. Please contact Mr. Tinen at (858) 720-6320 with any questions you may have concerning this
request, and please notify him when this request for acceleration has been granted.
Very truly yours,
TIVIC HEALTH SYSTEMS, INC.
By:
/s/ Jennifer Ernst
Name:
Jennifer Ernst
Title:
Chief Executive Officer
cc:
Christopher L. Tinen, Esq., Procopio, Cory, Hargreaves & Savitch LLP
- 1 -
2021-09-23 - CORRESP - Tivic Health Systems, Inc.
CORRESP
1
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PROCOPIO
12544 High Bluff Drive
Suite 400
San Diego, CA 92130
T. 858.720.6300
F. 619.235.0398
DEL MAR HEIGHTS
Las Vegas
Orange County
PHOENIX
SAN DIEGO
SILICON VALLEY
September 23, 2021
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention:
Alan Campbell
Celeste Murphy
Franklin Wyman
Al Pavot
Re: Tivic Health Systems, Inc.
Amendment No. 2 to Registration Statement
on Form S-1
Filed September 9, 2021
File No. 333-258411
Ladies and Gentlemen:
On behalf of our client, Tivic
Health Systems, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in its letter dated September 20, 2021, relating
to the Company’s Amendment No. 2 to Registration Statement on Form S-1 filed with the Commission on September 9, 2021 (“Amendment
No. 2 to Registration Statement”). We are concurrently filing via EDGAR this letter and the Company’s Amendment No. 3
to Registration Statement on Form S-1 (“Amendment No. 3 to Registration Statement”).
In this letter, we have
recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response.
Except for page references appearing in the headings and comments of the Staff below (which are references to the Amendment No. 2 to
Registration Statement on Form S-1 filed on September 9, 2021), or as otherwise specifically indicated, all page references herein
correspond to the page of Amendment No. 3 to Registration Statement.
Securities and Exchange Commission
September 23, 2021
Page 2 of 3
Amendment No. 2 to Registration
Statement on Form S-1
Cover Page
1.
We note your statement that the underwriters of the offering
have informed you that the gross proceeds of the offering will not be less than $15,000,000. However, given your disclosed public offering
price range of $5.00 to $6.00 per share, it appears that if you price the offering in the bottom half of your disclosed range and the
underwriters do not exercise their over-allotment option, the gross proceeds of your offering will be less than $15,000,000. To the extent
that this statement is referencing the listing requirements of the Nasdaq Capital Market, please revise to state, if true, that (i) the
gross proceeds from the offering must be at least $15,000,000 in order for your initial listing application to be approved and (ii) there
is no guarantee that the gross proceeds from the offering will be at least $15,000,000 and that you may need the underwriters to exercise
their over-allotment option in order to meet this threshold.
In response to the Staff’s comment, the Company
has removed reference to the minimum gross proceeds of $15,000,000. The Company further advises the Staff that the Company has the ability
to meet the initial listing requirements of the Nasdaq Capital Market without such minimum gross proceeds and/or the exercise of the over-allotment
option.
Cost of Sales, page 39
2.
Please expand your disclosure to explain how you reasonably
concluded that your June 30, 2021 inventory balance is stated at the lower of cost or net realizable value (page F-8) given the significant
gross loss recognized in the quarter then-ended, and the pattern of historical gross losses, and the 20% decline in second quarter sales
relative to the March 31, 2021 quarter. The disclosure should specifically address your basis for eliminating your inventory reserve
in the June 30, 2021 quarter as reported on page F-38.
In response to the Staff’s comment, the Company
has expanded its disclosures regarding the cost of sales and inventory reserve as requested. The Company further advises the Staff that
the Company sells ClearUP both direct to consumer and through its online retail channel partners. The Company’s retail channel partners
buy large lots of units at discounted pricing. During the second quarter ended June 30, 2021, 70% of units were sold through retail channel
partners as compared to 50% in the first quarter ended March 31, 2021 resulting in lower revenue. All unit product sales exceed the standard
cost per unit used in cost of goods sold and inventory. However, cost of goods sold includes fixed non-cash allocations of Company personnel
related to the manufacturing process and other fixed and semi-fixed charges from the Company’s third party logistics provider, including
monthly minimum management and storage and processing fees, resulting in negative gross margins. The Company expects its gross margin
to increase with the launch of ClearUP Gen 2 and increasing sales volume over which fixed and semi-fixed costs are allocated. Further,
as it relates to the elimination of the inventory reserve, the Company had recorded a 3% inventory reserve for obsolescence for
expected obsolescence related to specifically identified sub-assembly parts to be replaced with upgraded versions of the parts. The sub-assembly
parts were subsequently scrapped in March 2021.
Securities and Exchange Commission
September 23, 2021
Page 3 of 3
***
Please direct any questions regarding the Company’s
responses or Amendment No. 3 to Registration Statement to me at (858) 720-6320 or christopher.tinen@procopio.com.
Sincerely,
PROCOPIO, CORY, HARGREAVES & SAVITCH LLP
/s/Christopher L. Tinen, Esq.
Christopher L. Tinen, Esq.
cc: Jennifer Ernst, Tivic Health Systems, Inc.
2021-09-20 - UPLOAD - Tivic Health Systems, Inc.
United States securities and exchange commission logo
September 20, 2021
Jennifer Ernst
Chief Executive Officer
Tivic Health Systems, Inc.
39899 Balentine Drive, Suite 200
Newark, CA 94560
Re:Tivic Health Systems, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed September 9, 2021
File No. 333-258411
Dear Ms. Ernst:
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.
Amendment No. 2 to Registration Statement on Form S-1
Cover Page
1.We note your statement that the underwriters of the offering have informed you that the
gross proceeds of the offering will not be less than $15,000,000. However, given your
disclosed public offering price range of $5.00 to $6.00 per share, it appears that if you
price the offering in the bottom half of your disclosed range and the underwriters do not
exercise their over-allotment option, the gross proceeds of your offering will be less than
$15,000,000. To the extent that this statement is referencing the listing requirements of the
Nasdaq Capital Market, please revise to state, if true, that (i) the gross proceeds from the
offering must be at least $15,000,000 in order for your initial listing application to be
approved and (ii) there is no guarantee that the gross proceeds from the offering will be at
least $15,000,000 and that you may need the underwriters to exercise their over-allotment
FirstName LastNameJennifer Ernst
Comapany NameTivic Health Systems, Inc.
September 20, 2021 Page 2
FirstName LastName
Jennifer Ernst
Tivic Health Systems, Inc.
September 20, 2021
Page 2
option in order to meet this threshold.
Cost of Sales, page 39
2.Please expand your disclosure to explain how you reasonably concluded that your June
30, 2021 inventory balance is stated at the lower of cost or net realizable value (page F-8)
given the significant gross loss recognized in the quarter then-ended, and the pattern of
historical gross losses, and the 20% decline in second quarter sales relative to the March
31, 2021 quarter. The disclosure should specifically address your basis for
eliminating your inventory reserve in the June 30, 2021 quarter as reported on page F-38.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Frank Wyman at 202-551-3660 or Al Pavot at 202-551-3738 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Christopher L. Tinen, Esq.
2021-09-09 - CORRESP - Tivic Health Systems, Inc.
CORRESP
1
filename1.htm
PROCOPIO
12544 High Bluff Drive
Suite 400
San Diego, CA 92130
T. 858.720.6300
F. 619.235.0398
DEL MAR HEIGHTS
Las Vegas
Orange County
PHOENIX
SAN DIEGO
SILICON VALLEY
September 9, 2021
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention: Alan Campbell
Celeste Murphy
Franklin Wyman
Al Pavot
Re: Tivic Health Systems, Inc.
Amendment No. 1 to Registration Statement
on Form S-1
Filed August 12, 2021
File No.
333-258411
Ladies and Gentlemen:
On behalf of our client, Tivic
Health Systems, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in its letter dated August 18, 2021, relating
to the Company’s Amendment No. 1 to Registration Statement on Form S-1 filed with the Commission on August 12, 2021 (“Amendment
No. 1 to Registration Statement”). We are concurrently filing via EDGAR this letter and the Company’s Amendment No. 2
to Registration Statement on Form S-1 (“Amendment No. 2 to Registration Statement”).
In this letter, we have recited
the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response. Except for page
references appearing in the headings and comments of the Staff below (which are references to the Amendment No. 1 to Registration Statement
on Form S-1 filed on August 12, 2021), or as otherwise specifically indicated, all page references herein correspond to the page of Amendment
No. 2 to Registration Statement.
Securities and Exchange Commission
September 9, 2021
Page 2 of 2
Amendment No. 1 to Registration
Statement on Form S-1
Cover Page
1.
We note your response to prior comment 1. However, we note
that the top of the first graphic continues to reference 200M+ US Adults. Please revise your graphic to remove this statement or to
include an equally prominent discussion of either (i) the competition you face from OTC pharmaceuticals and saline irrigation in
ClearUP's indications, as referenced elsewhere in your registration statement or (ii) your revenues for recently completed fiscal
periods.
In response to the Staff’s comment, the Company
has revised its graphic at the forefront of the prospectus to remove reference to 200M+ US Adults.
***
Please direct any questions regarding the Company’s
responses or Amendment No. 2 to Registration Statement to me at (858) 720-6320 or christopher.tinen@procopio.com.
Sincerely,
PROCOPIO, CORY, HARGREAVES & SAVITCH LLP
/s/Christopher L. Tinen, Esq.
Christopher L. Tinen, Esq.
cc: Jennifer Ernst, Tivic Health Systems, Inc.
2021-08-18 - UPLOAD - Tivic Health Systems, Inc.
United States securities and exchange commission logo
August 18, 2021
Jennifer Ernst
Chief Executive Officer
Tivic Health Systems, Inc.
39899 Balentine Drive, Suite 200
Newark, CA 94560
Re:Tivic Health Systems, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed August 11, 2021
File No. 333-258411
Dear Ms. Ernst:
We have reviewed your amended registration statement and have the following
comment. In our comment, 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 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 comment, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our August 11, 2021 letter.
Amendment No. 1 to Registration Statement on Form S-1
Cover Page
1.We note your response to prior comment 1. However, we note that the top of the first
graphic continues to reference 200M+ US Adults. Please revise your graphic to remove
this statement or to include an equally prominent discussion of either (i) the competition
you face from OTC pharmaceuticals and saline irrigation in ClearUP's indications, as
referenced elsewhere in your registration statement or (ii) your revenues for recently
completed fiscal periods.
You may contact Frank Wyman at 202-551-3660 or Al Pavot at 202-551-3738 if you
have questions regarding comments on the financial statements and related matters. Please
FirstName LastNameJennifer Ernst
Comapany NameTivic Health Systems, Inc.
August 18, 2021 Page 2
FirstName LastName
Jennifer Ernst
Tivic Health Systems, Inc.
August 18, 2021
Page 2
contact Alan Campbell at 202-551-4224 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Christopher L. Tinen, Esq.
2021-08-12 - CORRESP - Tivic Health Systems, Inc.
CORRESP
1
filename1.htm
PROCOPIO
12544 High Bluff Drive
Suite 400
San Diego, CA 92130
T. 858.720.6300
F. 619.235.0398
____
DEL MAR HEIGHTS
Las Vegas
Orange County
PHOENIX
SAN DIEGO
SILICON VALLEY
August 12, 2021
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Real Estate & Construction
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention:
Deanna Virginio
Celeste Murphy
Franklin Wyman
Al Pavot
Re: Tivic Health Systems, Inc.
Registration Statement on Form S-1
Filed August 3, 2021
File No. 333-258411
Ladies and Gentlemen:
On behalf of our client, Tivic
Health Systems, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in its letter dated August 11, 2021, relating
to the Company’s Registration Statement on Form S-1 filed with the Commission on August 3, 2021 (“Registration Statement”).
We are concurrently filing via EDGAR this letter and the Company’s Amendment No. 1 to Registration Statement on Form S-1 (“Amendment
No. 1 to Registration Statement”).
In this letter, we have recited
the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response. Except for page
references appearing in the headings and comments of the Staff below (which are references to the Registration Statement on Form S-1 filed
on August 3, 2021), or as otherwise specifically indicated, all page references herein correspond to the page of Amendment No. 1 to Registration
Statement.
Securities and Exchange Commission
August 12, 2021
Page 2 of 3
Registration Statement on Form
S-1
Cover Page
1. We
note your response to prior comment 1 and revised graphic. However, your updated graphic does not appear to contain a discussion of the
competition you face from OTC pharmaceuticals and saline irrigation in ClearUP's indications, as previously requested. Please revise
to either include a discussion of this competition on your graphic or to disclose your revenues for recently completed fiscal periods.
Please note that this information should be presented with equal prominence to your market-size statement on the graphic. For guidance,
please refer to Question 101.02 of our Compliance and Disclosure Interpretations, Securities Act Forms.
In response to the Staff’s comment, the Company
has revised its graphic at the forefront of the prospectus to remove reference to the market-size information at issue.
Cost of Sales, page 39
2. Please
expand your disclosure to explain how you determined that your inventory is not impaired given your recurring negative gross margins.
In addition, please quantify your gross margin for each period presented and identify the specific reasons for variances.
In response to the Staff’s comment, the Company
has revised its disclosures as requested by the Staff. In order to provide the Staff with more context, the Company would like to note that the addition of a unit sales reference for revenue
and cost of sales makes clear the Company was not liquidating obsolete inventory at very low prices. For example, by adding the following
unit reference in (costs of sales increased 93% and unit sales increased by 98%) it tells the reader that the unit cost of sales and thus
inventory remained relatively constant and thus was not impaired.
Revenue, page 39
3. Please
expand your disclosure to quantify the extent to which revenue variances were impacted by changes in prices or to changes in the volume
of goods being sold or to the introduction of new products. Such disclosure is necessary for readers to understand the extent to which
these factors impacted your reported operating results. See the guidance in Item 303(b)(2)(iii) of Regulation S-K.
In response to the Staff’s comment, the Company
has expanded its disclosures as requested by the Staff.
Financial Statements for the Years
Ended December 31, 2020 and 2019
Independent Auditors' Report,
page F-2
4. Please
provide a signed audit report from Rosenberg Rich Baker Berman PA.
In response to the Staff’s comment, the Company
has included a signed audit report from Rosenberg Rich Baker Berman PA.
***
Please direct any questions regarding the Company’s
responses or Amendment No. 1 to Registration Statement to me at (858) 720-6320 or christopher.tinen@procopio.com.
Securities and Exchange Commission
August 12, 2021
Page 3 of 3
Sincerely,
PROCOPIO, CORY, HARGREAVES & SAVITCH LLP
/s/Christopher L. Tinen, Esq.
Christopher L. Tinen, Esq.
cc: Jennifer Ernst, Tivic Health Systems, Inc.
2021-08-11 - UPLOAD - Tivic Health Systems, Inc.
United States securities and exchange commission logo
August 11, 2021
Jennifer Ernst
Chief Executive Officer
Tivic Health Systems, Inc.
39899 Balentine Drive, Suite 200
Newark, CA 94560
Re:Tivic Health Systems, Inc.
Registration Statement on Form S-1
Filed August 3, 2021
File No. 333-258411
Dear Ms. Ernst:
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
Cover Page
1.We note your response to prior comment 1 and revised graphic. However, your updated
graphic does not appear to contain a discussion of the competition you face from OTC
pharmaceuticals and saline irrigation in ClearUP's indications, as previously requested.
Please revise to either include a discussion of this competition on your graphic or to
disclose your revenues for recently completed fiscal periods. Please note that this
information should be presented with equal prominence to your market-size statement on
the graphic. For guidance, please refer to Question 101.02 of our Compliance and
Disclosure Interpretations, Securities Act Forms.
FirstName LastNameJennifer Ernst
Comapany NameTivic Health Systems, Inc.
August 11, 2021 Page 2
FirstName LastName
Jennifer Ernst
Tivic Health Systems, Inc.
August 11, 2021
Page 2
Cost of Sales, page 39
2.Please expand your disclosure to explain how you determined that your inventory is not
impaired given your recurring negative gross margins. In addition, please quantify your
gross margin for each period presented and identify the specific reasons for variances.
Revenue, page 39
3.Please expand your disclosure to quantify the extent to which revenue variances were
impacted by changes in prices or to changes in the volume of goods being sold or to the
introduction of new products. Such disclosure is necessary for readers to understand the
extent to which these factors impacted your reported operating results. See the guidance in
Item 303(b)(2)(iii) of Regulation S-K.
Financial Statements for the Years Ended December 31, 2020 and 2019
Independent Auditors' Report, page F-2
4.Please provide a signed audit report from Rosenberg Rich Baker Berman PA.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Frank Wyman at 202-551-3660 or Al Pavot at 202-551-3738 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Christopher L. Tinen, Esq.
2021-08-03 - CORRESP - Tivic Health Systems, Inc.
CORRESP
1
filename1.htm
PROCOPIO
12544 High Bluff Drive
Suite 400
San Diego, CA 92130
T. 858.720.6300
F. 619.235.0398
DEL MAR HEIGHTS
Las Vegas
Orange County
PHOENIX
SAN DIEGO
SILICON VALLEY
August 3, 2021
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Real Estate & Construction
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention:
Deanna Virginio
Celeste Murphy
Franklin Wyman
Al Pavot
Re: Tivic Health Systems, Inc.
Amendment No. 1 to Draft Registration
Statement on Form S-1
Submitted July 2, 2021
CIK No. 0001787740
Ladies and Gentlemen:
On behalf of our client, Tivic
Health Systems, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in its letter dated July 9, 2021, relating to
the Company’s Amendment No. 1 to Draft Registration Statement on Form S-1 confidentially submitted to the Commission on July 2,
2021 (“Amendment No. 1 to Draft Registration Statement”). We are concurrently publicly filing via EDGAR this letter
and the Company’s Registration Statement on Form S-1 (“Registration Statement”).
In this letter, we have recited
the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response. Except for page
references appearing in the headings and comments of the Staff below (which are references to Amendment No. 1 to Draft Registration Statement
on Form S-1 confidentially submitted on July 2, 2021), or as otherwise specifically indicated, all page references herein correspond to
the page of the Registration Statement.
Securities and Exchange Commission
August 3, 2021
Page 2 of 3
Amendment No. 1 to Draft Registration
Statement on Form S-1
Cover Page
1.
Please revise your artwork at the forefront of the
prospectus to remove the $10B US Market Segment claim. You may provide the market opportunity for indications where you have
received marketing authorization for ClearUP. In your revisions, please also clarify that any market opportunity or market segment
claims are for the indications where you have approved products, rather than the bioelectronic industry, and that you face
competition from OTC pharmaceuticals and saline irrigation in these indications.
In response to the Staff’s comment, the Company
has revised its artwork at the forefront of the prospectus as well as further clarified this disclosure as requested by the Staff.
Prospectus Summary, page 1
2.
We note your statement that you have determined that the
ClearUP Gen 2 product is covered by the same regulatory clearances as ClearUP and will not require separate FDA approvals prior to commercialization.
Please revise your statements here and on page 44 to reflect your disclosure on page 16 that the FDA could determine that the ClearUP
Gen 2 device is not covered by the same clearance as your existing ClearUP device.
In response to the Staff’s comment, the Company
has revised its disclosures on pages 1 and 44 to reflect that the FDA could determine that the ClearUP Gen 2 device is not covered by
the same clearance as the Company’s existing ClearUP device.
Our Innovation, page 2
3.
We note your response to prior comment 3 and revised disclosure.
Please further revise your disclosure here and on pages 44 and 49 discussing the potential for new product development to clarify that
the medical device development process is inherently uncertain and that there can be no guarantee that your stimulation approach will
lead to the development of approved products for other clinical indications.
In response to the Staff’s comment related
to “proprietary” market research, the Company has revised its disclosures on pages 2, 44, and 49 to clarify that the medical
device development process is inherently uncertain and that there can be no guarantee that the Company’s stimulation approach will
lead to the development of approved products for other clinical indications.
4.
We note your response to prior comment 6 and revised disclosure.
Please revise further here and on page 49 to briefly clarify (i) how the outcomes of "pain relief, a decrease in opioid medication
use, and inflammation following common sinus surgeries. feasibility for at-home use of the device" were measured and assessed and
(ii) whether the findings from the study were statistically significant.
In response to the Staff’s comment, the Company
has revised its disclosures on pages 2 and 49 to clarify how the outcomes referenced were measured and assessed and to address the statistical
significance of the findings from the study.
Securities and Exchange Commission
August 3, 2021
Page 3 of 3
Competition, page 3
5.
We note your response to prior comment 5 and revised disclosure.
Please revise further here and on page 46 to clarify the basis for your statement that there is increasing interest among consumers to
reduce reliance on drugs and to find non-drug solutions for sinus pain and congestion. If this statement is based on management's belief
or based on the survey described on page 45, please so state.
In response to the Staff’s comment, the Company
has revised its disclosures on pages 3 and 46 to clarify the basis for its statement that there is increasing interest among consumers
to reduce reliance on drugs and to find non-drug solutions for sinus pain and congestion.
Market Opportunity, page 45
6.
We note your response to prior comment 14 and revised
disclosure. Please revise further to disclose how individuals were verified as "recurring sufferers" and selected for
participation in the survey.
In response to the Staff’s comment, the Company
has further revised its disclosures on page 45 to further disclose how individuals were verified as "recurring sufferers" and
selected for participation in the survey.
Principal Stockholders, page 69
7.
Please explain to us why your principal stockholders table
does not reference your shares of preferred stock that will convert into common stock prior to the completion of the offering. For
guidance, please refer to Item 403 of Regulation S-K.
In response to the Staff’s comment, the Company
has revised its Principal Stockholder disclosures to include reference to its shares of preferred stock in accordance with Item 403 of
Regulation S-K.
***
Please direct any questions regarding the Company’s
responses or the Registration Statement to me at (858) 720-6320 or christopher.tinen@procopio.com.
Sincerely,
PROCOPIO, CORY, HARGREAVES & SAVITCH LLP
/s/Christopher L. Tinen, Esq.
Christopher L. Tinen, Esq.
cc: Jennifer Ernst, Tivic Health Systems, Inc.
2021-07-09 - UPLOAD - Tivic Health Systems, Inc.
United States securities and exchange commission logo
July 9, 2021
Jennifer Ernst
Chief Executive Officer
Tivic Health Systems, Inc.
39899 Balentine Drive, Suite 200
Newark, CA 94560
Re:Tivic Health Systems, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted July 2, 2021
CIK No. 0001787740
Dear Ms. Ernst:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1
Cover Page
1.Please revise your artwork at the forefront of the prospectus to remove the $10B US
Market Segment claim. You may provide the market opportunity for indications where
you have received marketing authorization for ClearUP. In your revisions, please also
clarify that any market opportunity or market segment claims are for the indications where
you have approved products, rather than the bioelectronic industry, and that you face
competition from OTC pharmaceuticals and saline irrigation in these indications.
FirstName LastNameJennifer Ernst
Comapany NameTivic Health Systems, Inc.
July 9, 2021 Page 2
FirstName LastNameJennifer Ernst
Tivic Health Systems, Inc.
July 9, 2021
Page 2
Prospectus Summary, page 1
2.We note your statement that you have determined that the ClearUP Gen 2 product is
covered by the same regulatory clearances as ClearUP and will not require separate FDA
approvals prior to commercialization. Please revise your statements here and on page 44
to reflect your disclosure on page 16 that the FDA could determine that the ClearUP Gen
2 device is not covered by the same clearance as your existing ClearUP device.
Our Innovation, page 2
3.We note your response to prior comment 3 and revised disclosure. Please further revise
your disclosure here and on pages 44 and 49 discussing the potential for new product
development to clarify that the medical device development process is inherently
uncertain and that there can be no guarantee that your stimulation approach will lead to
the development of approved products for other clinical indications.
4.We note your response to prior comment 6 and revised disclosure. Please revise further
here and on page 49 to briefly clarify (i) how the outcomes of "pain relief, a decrease in
opioid medication use, and inflammation following common sinus surgeries. feasibility
for at-home use of the device" were measured and assessed and (ii) whether the findings
from the study were statistically significant.
Competition, page 3
5.We note your response to prior comment 5 and revised disclosure. Please revise further
here and on page 46 to clarify the basis for your statement that there is increasing interest
among consumers to reduce reliance on drugs and to find non-drug solutions for sinus
pain and congestion. If this statement is based on management's belief or based on the
survey described on page 45, please so state.
Market Opportunity, page 45
6.We note your response to prior comment 14 and revised disclosure. Please revise further
to disclose how individuals were verified as "recurring sufferers" and selected for
participation in the survey.
Principal Stockholders, page 69
7.Please explain to us why your principal stockholders table does not reference your shares
of preferred stock that will convert into common stock prior to the completion of the
offering. For guidance, please refer to Item 403 of Regulation S-K.
FirstName LastNameJennifer Ernst
Comapany NameTivic Health Systems, Inc.
July 9, 2021 Page 3
FirstName LastName
Jennifer Ernst
Tivic Health Systems, Inc.
July 9, 2021
Page 3
You may contact Franklin Wyman at 202-551-3660 or Al Pavot at 202-551-3738 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Christopher L. Tinen, Esq.
2021-06-14 - UPLOAD - Tivic Health Systems, Inc.
United States securities and exchange commission logo
June 14, 2021
Jennifer Ernst
Chief Executive Officer
Tivic Health Systems, Inc.
750 Menlo Avenue, Suite 200
Menlo Park, CA 94025
Re:Tivic Health Systems, Inc.
Draft Registration Statement on Form S-1
Submitted May 14, 2021
CIK No. 0001787740
Dear Ms. Ernst:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1 submitted May 14, 2021
Prospectus Summary , page 2
1.We note your disclosure that ClearUP has received three regulatory clearances. Please
revise to disclose that your product is a Class II medical device and specify the regulatory
clearances that ClearUP has received.
2.Please revise your statements that you have shown that non-invasive bioelectronic
treatments can safely and comfortably deliver therapeutic benefits, with favorable safety
profiles, as determinations of safety and efficacy are solely within the authority of the
FDA. In this regard we note that only your ClearUP product has received FDA clearance.
FirstName LastNameJennifer Ernst
Comapany NameTivic Health Systems, Inc.
June 14, 2021 Page 2
FirstName LastName
Jennifer Ernst
Tivic Health Systems, Inc.
June 14, 2021
Page 2
3.Please revise to provide the basis for your statement that your market research is
"proprietary" and that the design of your product is your platform for "accelerated
development" of additional product candidates.
4.We note your disclosure that studies demonstrated that ClearUP is highly effective at
treating common symptoms with no substantive side effects. Please revise to specify the
common symptoms referred to. In this regard, we note that you have received FDA
clearance for the treatment of sinus pain from allergic rhinitis and moderate to severe
congestion.
Market Opportunity and Regulatory Clearance, page 3
5.We note your disclosure that with the de novo clearance, the addressable estimated market
for ClearUP expands to over 200 million U.S. adults. Please balance your disclosure with
a discussion of the competition you face in this market, including your overall position in
the market relative to your competitors.
Our Innovation, page 3
6.Please revise statements that your pilot study showed that your "approach is promising as
an alternative to opioids for managing pain," to eliminate conclusions or predictions that
your product candidates are effective as determinations of efficacy are solely within the
authority of the FDA. You may provide a summary of the data that you used to draw these
conclusions, and such discussion is more appropriate in the Business section where full
and proper context can be provided.
Tivic Health Pipeline, page 3
7.Please identify the product candidates for the treatment of Post-Operative Pain Relief and
Migraine, TMJ. Alternatively, please explain to us why such product candidates are
sufficiently material to be included in your pipeline chart.
8.Please revise your pipeline chart to include separate columns for Phase 1, Phase 2 and
Phase 3 clinical trials or tell us why it is appropriate to include "clinical proof of concept"
and "pivotal" as stages for all products.
9.We note your disclosure that on page 4 that ClearUP Gen 2version is in development.
However, the status in your pipeline chart appears to indicate that it has received
regulatory clearance. Please revise or explain.
FirstName LastNameJennifer Ernst
Comapany NameTivic Health Systems, Inc.
June 14, 2021 Page 3
FirstName LastName
Jennifer Ernst
Tivic Health Systems, Inc.
June 14, 2021
Page 3
Growth Strategy , page 4
10.We note your disclosure on pages 2 and 4 that your ClearUp Gen 2 is covered under the
same regulatory clearances as ClearUP. However we note on page 16 you disclose that it
is your belief that ClearUP Gen 2 devices will be covered by the same clearance as your
existing ClearUP device. Please revise to clarify whether you have received regulatory
clearance for your ClearUp Gen 2 device. To the extent you have not yet received
clearance, please revise the summary to clarify that these statements are management's
belief and revise to provide the basis for your belief that ClearUp Gen 2 will be covered
by the same regulatory clearance for ClearUP.
Our business, financial condition, results of operations and growth may be impacted by the
effects of the COVID-19 pandemic, page 17
11.We note your disclosure that although you have experienced growth in your sales volume
during the COVID-19 pandemic, this and any other favorable impacts you have
experienced in connection with the pandemic may subside, and the ultimate effect of
COVID-19 on your sales volume and other results of operations could differ substantially
from your expectations and your experience to date. Please revise to quantify the effect of
the COVID-19 pandemic on your sales volume. Additionally, please specify the "other
favorable impacts" you have experienced in connection with the pandemic as well as the
"other results of operations" that have been impacted by the COVID-19 pandemic.
Our amended and restated certificate of incorporation and amended and restated bylaws will
provide that the Court of Chancery, page 24
12.Please revise your risk factor to disclose that there is also a risk that your exclusive forum
provision may result in increased costs for investors to bring a claim.
Use of Proceeds, page 28
13.We note your disclosure that you intend to use the net proceeds from the offering to
support your organic growth, to expand your products in the bioelectronic markets, and
for other general corporate purposes. Please revise to provide more meaningful and
specific disclosure of the intended use of proceeds, as well as the approximate amounts
intended to be used for each such purpose. Refer to Item 504 of Regulation S-K.
Market Opportunity , page 45
14.We note your disclosure that according to your research, among recurring sufferers, 90%
are interested in treatments that reduce use of medications, 66% are concerned about the
side effects of pharmaceutical choices, and over 40% are concerned about addiction.
Please expand your disclosure to explain how you conducted your research, including the
total number of recurring suffers.
FirstName LastNameJennifer Ernst
Comapany NameTivic Health Systems, Inc.
June 14, 2021 Page 4
FirstName LastName
Jennifer Ernst
Tivic Health Systems, Inc.
June 14, 2021
Page 4
15.Please expand your disclosure to provide additional context regarding how the market and
clinical research studies were conducted, including but not limited to, whether the studies
were conducted by you or a third party and the number of subjects surveyed or observed.
Competitive Landscape, page 46
16.We note your disclosure regarding the types of pharmaceutical treatments that compete
with ClearUp. Please expand your disclosure to identify your likely
principal competitors and their products and/or product candidates that you believe may
compete with your own products or product candidates.
Key Technical Features, page 47
17.We note your disclosure that studies showed an efficacy level for ClearUP comparable to
that of intranasal glucocorticoids, without any significant side effects and that results
observed in your pivotal study and open-label prospective trial were equivalent to efficacy
seen in studies of fluticasone propionate after one-week of use. Please refrain from
making such comparisons unless you have conducted head-to-head trials.
Research Initiatives: New Product Candidates, page 48
18.Please revise statements that data from your pilot study "has been promising for reduction
of pain following functional endoscopic sinus surgeries (“FESS”)," to eliminate
conclusions or predictions that your product candidates are effective as determinations of
efficacy are solely within the authority of the FDA. You may provide a summary of the
data that you used to draw these conclusions.
19.Please revise to discuss the status of development of each of the research initiatives/new
product candidates identified, including a discussion of your product candidates for post-
operative pain relief and migraines.
Future Product Candidates/Pipeline, page 49
20.We note that the list of future product candidates include certain indications that appear to
be repetitive of those associated with your ClearUP product as well as those listed in your
current research initiatives. Please revise or advise.
Intellectual Property / Barriers to Entry, page 51
21.We note your chart of issued patents on page 51. Please revise your intellectual property
disclosure to clearly identify each material patent or group of related patents, the type of
patent protection granted for each technology, the product or product candidate(s)
dependent on each patent, related expiration and jurisdiction, including any foreign
jurisdiction, of each pending or issued patent.
FirstName LastNameJennifer Ernst
Comapany NameTivic Health Systems, Inc.
June 14, 2021 Page 5
FirstName LastName
Jennifer Ernst
Tivic Health Systems, Inc.
June 14, 2021
Page 5
General
22.Please provide us with copies of all written communications, as defined in Rule 405 under
the Securities Act, that you, or anyone authorized to do so on your behalf, present to
potential investors in reliance on Section 5(d) of the Securities Act, whether or not they
retain copies of the communications.
You may contact Franklin Wyman at 202-551-3660 or Al Pavot at 202-551-3738 if you
have questions regarding comments on the financial statements and related matters. Please
contact Deanna Virginio at 202-551-4530 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Christopher L. Tinen, Esq.