[8-K] Tivic Health Systems, Inc. Reports Material Event

Rhea-AI Filing Summary

Tivic Health Systems (NASDAQ:TIVC), an emerging growth company, filed an 8-K announcing the completion of their Optimization Study for a non-invasive vagus nerve stimulation device. The announcement was made via press release on June 25, 2025. The filing is being furnished under Regulation FD disclosure rules and includes standard forward-looking statements disclaimers. The company's interim CFO, Lisa Wolf, signed the filing.

Positive

• Completion of Optimization Study for vagus nerve stimulation device
• Development progress in non-invasive medical technology

Negative

• None.

Insights

Medical Device Analyst

Tivic's completion of vagus nerve stimulation device optimization study marks crucial development milestone.

The completion of the Optimization Study represents a significant step in Tivic's medical device development pipeline. Vagus nerve stimulation technology has been gaining traction in the medical device industry, particularly for non-invasive applications. This milestone could position Tivic to advance their device towards potential commercialization, though specific study outcomes and regulatory implications will be critical factors to monitor.

false000178774000017877402025-06-252025-06-25

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): June 25, 2025

Tivic Health Systems, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-41052	81-4016391
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer 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:

Title of each class		Trading Symbol(s)		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 7.01 Regulation FD Disclosure.

On June 25, 2025, Tivic Health Systems, Inc. (the “Company”) issued a press release announcing completion of the 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.

The information set forth under Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific reference in such a filing. This Current Report will not be deemed an admission as to the materiality of any information in this Current Report that is required to be disclosed solely by Regulation FD.

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.

Exhibit No.		Description
99.1		Press Release of Tivic Health Systems, Inc., dated June 25, 2025.
104		Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101).

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:	June 25, 2025	By:	/s/ Lisa Wolf
			Name: Lisa Wolf Title: Interim Chief Financial Officer

FAQ

What did Tivic Health Systems announce in their latest 8-K filing?

Tivic Health Systems announced the completion of their Optimization Study for a non-invasive vagus nerve stimulation device.

Who is the current interim CFO of Tivic Health Systems?

Lisa Wolf is currently serving as the interim Chief Financial Officer of Tivic Health Systems.

Is Tivic Health Systems considered an emerging growth company?

Yes, Tivic Health Systems is classified as an emerging growth company according to the filing.

What type of medical device is Tivic Health Systems developing?

Tivic Health Systems is developing a non-invasive vagus nerve stimulation device.