Form 8-K - Current report

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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): September 18, 2024

 

 

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. ☐

 

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Item 8.01 Other Events.

On September 18, 2024, Tivic Health Systems, Inc. (the “Company”) issued a press release announcing it has received approval from The Feinstein Institutes’ Institutional Review Board for the next phase of clinical work on its non-invasive cervical vagus nerve stimulation approach. The full text of that press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”), and is incorporated herein by reference.

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, 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 Securities and Exchange Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein.

Item 9.01 Financial Statements and Exhibits.

	(d)	Exhibits.

Exhibit		Description
99.1		Press Release, September 18, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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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:	September 18, 2024	By:	/s/ Jennifer Ernst
			Name: Jennifer Ernst Title: Chief Executive Officer

 

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Exhibit 99.1

PRESS RELEASE

 

 

 

 

Tivic Health Receives Approval from Institutional Review Board for ncVNS Optimization Study, Readies for Enrollment

 

SAN FRANCISCO – (Business Wire) – September XX, 2024 – Tivic Health® Systems, Inc. (“Tivic Health”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced that it has received approval from The Feinstein Institutes’ Institutional Review Board for the next phase of clinical work on its non-invasive cervical vagus nerve stimulation (“ncVNS”) approach.

 

This clinical research collaboration with Feinstein is designed to advance the development of Tivic Health’s ncVNS technology by refining and optimizing stimulation parameters. Physiological measurements will be used to enhance device performance and refine specifications such as electrode positioning and electrical waveform parameters. The data derived from the study will be used to inform the selection of clinical populations of interest and help shape the clinical study design for upcoming trials.

 

The company has previously announced the successful completion of its Phase 1 study on ncVNS. Key goals of the current study include:

 

•

Optimizing Treatment Strategies: The research will provide critical data to advance both personalization of treatment and optimization of stimulation parameters.

•

Accelerating Product Development: The optimized parameters will help accelerate development of Tivic Health’s product offerings based on ncVNS.

 

The company has also recently announced its collaboration with Fletcher Spaght, a leading healthcare growth strategy firm. Fletcher Spaght has begun substantiating clinical applications with high unmet needs that have potential to be addressed by Tivic Health’s patent-pending ncVNS system.

 

“We are taking an integrated approach to clinical, product development and go-to-market planning for our medical-grade non-invasive VNS program, explained Jennifer Ernst, CEO of Tivic Health. “We believe this approach creates the best opportunities to generate significant new revenue based on this work,”

 

 

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The optimization study will be conducted by The Feinstein Institute of Bioelectronic Medicine. It will be led by Dr. Theodoros Zanos, Ph.D., Associate Professor in the Institute of Bioelectronic Medicine and Head of the Neural and Data Science Lab at The Feinstein Institutes at Northwell Health, in partnership with Dr. Blake Gurfein, Tivic Health’s Chief Scientific Officer.

 

“Precision optimization is an important but often overlooked step in non-invasive neurostimulation device development,” Dr. Gurfein commented. “I am pleased we are working with Dr. Zanos and other leaders in the field as we move from proof-of-concept to disease-specific validation in clinical trials anticipated next year.”

 

Polaris Market Research estimates the global vagus nerve stimulation market, valued at $8.59 billion in 2021, will reach $21.3 billion by 2030, with a CAGR of 10.6% over the forecast period. Tivic Health aims to deliver more personalized and effective treatment options for patients using non-invasive VNS and, in so doing, establish itself as a market leader in the field of bioelectronic medicine.

 

About Tivic Health

Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health’s technology platforms use stimulation of the trigeminal, sympathetic, and vagus nerve structures. Tivic Health’s non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic Health’s first commercial product ClearUP is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information visit http://tivichealth.com @TivicHealth

 

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 assumption 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 changes to the company’s relationship with Fletcher Spaght or The Feinstein Institutes, changes to the company’s business strategy, timing of clinical trials and studies, clinical trial and study results, consummation of any strategic transactions, and the company’s need for, and ability to secure when needed, additional working capital. 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

 

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ended December 31, 2023, filed with the SEC on March 29, 2024, 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.

Media Contact:

Morgan Luke

[e-mail]

 

Investor Contact:

Hanover International, Inc.

[e-mail]

 

 

 

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Document And Entity Information	Sep. 18, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 18, 2024
Entity Registrant Name	Tivic Health Systems, Inc.
Entity Central Index Key	0001787740
Entity Emerging Growth Company	true
Entity File Number	001-41052
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	81-4016391
Entity Address, Address Line One	47685 Lakeview Blvd.
Entity Address, City or Town	Fremont
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94538
City Area Code	888
Local Phone Number	276-6888
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	TIVC
Security Exchange Name	NASDAQ

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