# EDGAR Filing Document

**Accession Number:** 0001787740
**File Stem:** 0001683168-25-008287
**Filing Date:** 2025-11
**Character Count:** 13056
**Document Hash:** a5ba74e3657b9394cad9e11c143c322b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001683168-25-008287.hdr.sgml**: 20251113

**ACCESSION NUMBER**: 0001683168-25-008287

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251113

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251113

**DATE AS OF CHANGE**: 20251113

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Tivic Health Systems, Inc.
- **CENTRAL INDEX KEY:** 0001787740
- **STANDARD INDUSTRIAL CLASSIFICATION:** ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 814016391
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41052
- **FILM NUMBER:** 251475590

**BUSINESS ADDRESS:**
- **STREET 1:** 47685 LAKEVIEW BLVD
- **CITY:** FREMONT
- **STATE:** CA
- **ZIP:** 94538
- **BUSINESS PHONE:** (888)276-6888

**MAIL ADDRESS:**
- **STREET 1:** 47685 LAKEVIEW BLVD
- **CITY:** FREMONT
- **STATE:** CA
- **ZIP:** 94538

?xml version='1.0' encoding='ASCII'?

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION** **WASHINGTON, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported): November 13, 2025**

**Tivic Health Systems, Inc.**

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| **Delaware** | **001-41052** | **81-4016391** |
| **(State or Other Jurisdiction** | **(Commission File Number)** | **(IRS Employer** |
| **of Incorporation)** |  | **Identification No.)** |
| **47685 Lakeview Blvd.** |  |  |
| **Fremont, California** |  | **94538** |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

---

**Registrant's Telephone Number, Including Area Code: 888 276-6888**

**(Former Name or Former Address, if Changed Since Last Report)**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

---

| | | |
|:---|:---|:---|
| **<br> Title of each class** | **Trading<br> Symbol(s)** | **<br> Name of each exchange on which registered** |
| Common Stock, par value $0.0001 per share | TIVC | The Nasdaq Stock Market LLC |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 8.01 Other Events.**

On November 13, 2025, Tivic Health Systems, Inc. (the "Company") issued a press release reporting finding of the Clinical Optimization Study for its non-invasive vagus nerve stimulation device. A copy of this press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K (this "Current Report") and is incorporated by reference herein.

  ****

***Forward-Looking Statements***

This Current Report, including Exhibit 99.1 attached hereto, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms "anticipates," "expects," "estimates," "believes," "will" and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.

Forward-looking statements in this Current Report, including Exhibit 99.1 attached hereto, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission (the "Commission"), reports to the stockholders of the Company and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management's best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits.

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| | |
|:---|:---|
| Exhibit No. | Description |
| 99.1 | [Press Release of Tivic Health Systems, Inc., dated November 13, 2025](tivic_ex9901.htm). |
| 104 | Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101). |

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**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | | |
|:---|:---|:---|:---|
|  |  |  | **TIVIC HEALTH SYSTEMS, INC.** |
| Date: | November 13, 2025 | By: | /s/ Jennifer Ernst |
|  |  |  | Name: Jennifer Ernst<br> Title: Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](image_001.jpg)

**Tivic Health Reports Findings of Clinical Optimization Trial of Non-Invasive Cervical Vagus Nerve Stimulation (ncVNS)**

*The study demonstrated that personalizing the stimulation parameters to each user dramatically enhanced autonomic effects*

**Fremont, Calif.** - November 13, 2025 - Tivic Health Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, announced today it has optimized key device and treatment parameters including frequency, amplitude, electrode positioning, and duration of stimulation as a result of its collaborative study with The **Feinstein Institutes for Medical Research** at Northwell Health.

Physiological measurements taken before, during, and after ncVNS treatment found the following:

● Personalizing the frequency of ncVNS stimulation to each study subject resulted in a 46% increase in heart rate variability, which was 8.9x more effective than applying the same frequency to all subjects

● The optimal ncVNS frequency for each subject was found to be different between visits, indicating the importance of personalizing the stimulation parameters before each treatment

● Certain placement and configurations of electrodes were found to be more effective than others, with some placements increasing heart rate variability and others markedly reduce heart rate variability

● Four minutes of ncVNS stimulation was sufficient to drive a large increase in heart rate variability and was more effective than twenty minutes of stimulation.

While previous studies of non-invasive VNS devices have reported mixed results for autonomic nervous system changes, Tivic's study demonstrated that specific parameters could reproducibly impact outcomes.

"What makes our findings so compelling is that they advance the field of neurostimulation by underscoring the importance of stimulation frequency personalization, laterality and placement of stimulation electrodes, and duration of treatment," stated Jennifer Ernst, CEO of Tivic Health. "While these results were in healthy subjects, this data combined with our past studies suggest our ncVNS approach may have clinical utility in several very large patient populations including ischemic stroke, post-traumatic stress disorder, and inflammatory diseases, among others."

Ernst continued, "Our mission is to harness the immune system to improve clinical outcomes and save lives. We are energized by these results and we believe that this new data will enable us to unlock valuable new opportunities that can be developed either in house or with partners as funding is allocated across a growing pipeline of late-, mid- and early stage product candidates."

**About Tivic Health Systems, Inc.**

Tivic's dual platform utilizes the body's biopharmaceutical and bioelectronic systems to treat unmet medical needs through targeting the immune system.

**Tivic**'**s biologics compounds** activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The company's lead drug candidate, Entolimod™ for acute radiation syndrome, is a novel TLR5 agonist that has been granted Fast Track and Orphan Drug designations and is in late-stage development.

**Tivic**'**s bioelectronic program** is developing a novel, non-invasive medical device designed to target the neural pathways implicated in many prevalent and debilitating diseases. Early trials show promising signals that Tivic's approach may regulate specific biologic responses, and the company believes its early-stage vagus nerve stimulation device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted devices. To learn more about Tivic, visit: https://ir.tivichealth.com.

**Forward-Looking Statements**

This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of interactions with and guidance from the FDA and other regulatory authorities; changes to the company's relationship with the its partners; timing and success of clinical trials and study results; the indications for which the company's ncVNS approach may ultimately be found to have clinical utility based on additional studies and trials; the company's ability to unlock new opportunities for the further development of its ncVNS platform; the failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company's business strategy; regulatory requirements and pathways for approval; the company's ability to successfully commercialize its product candidates in the future; the potential opportunities that may be available to the company and its product candidates in the future; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading "Risk Factors," as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.

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**Investor Contact:**<br> Hanover International, Inc.<br> ir@tivichealth.com

**Media Contact:**<br> Deanne Eagle or Laura Min Jackson<br> media@tivichealth.com