false 0001787740 0001787740 2023-09-26 2023-09-26

 

 

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 26, 2023

 

 

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.)

 

25821 Industrial Blvd.,

Suite 100

  
Hayward, California   94545
(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 September 26, 2023, Tivic Health Systems, Inc. (the “Company”) issued a press release announcing that the Company entered into an agreement with InStep health. A copy of that press release is furnished as Exhibit 99.1 to this Current Report, and is incorporated herein by reference.

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, 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, dated September 26, 2023.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).

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 26, 2023     By:  

/s/ Jennifer Ernst

      Name: Jennifer Ernst
Title: Chief Executive Officer

Exhibit 99.1

 

LOGO

Tivic Health Partners with InStep Health to Access over 2,500 Healthcare

Providers and their Patients

New Healthcare Provider Program Set to Educate and

Drive Patient Awareness of ClearUP

SAN FRANCISCO – September 26, 2023 – Tivic Health® Systems, Inc. (“Tivic”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced today that it has signed an agreement with InStep Health® to introduce the Company’s bioelectronic sinus device, ClearUP®, to over 2,500 healthcare providers (HCP) and their patients.

InStep Health assists pharmaceutical, OTC, and consumer-packaged brands to reach consumers at the center of care, whether in the doctor’s office, pharmacy, or within the store aisles. The company offers a fully integrated messaging platform that combines offline tactile and online digital media activation with access to over 250,000 HCPs, working in more than 177,000 offices, and exclusive programs in 40,000+ chain and community pharmacies nationwide.

Tivic’s program with InStep Health will reach allergists, ENTs, and primary care providers through in-office provider education kits, provider 1:1 email campaigns, and digital advertising. The 4-month program will run from November 2023 until February 2024 with the goals of educating HCPs and driving patient awareness of ClearUP during allergy, cold, and flu seasons.

“The InStep Health program is a cost-effective way to reach key physicians who are highly influential in the buying decision for patients with allergic rhinitis, sinus infections, head pain, and congestion,” says Jennifer Ernst, CEO of Tivic. “We’re looking forward to launching the program as an important step to grow the medical community’s awareness, provide education, and increase HCP recommendations and sales.”

Tivic ClearUP’s non-invasive and targeted approach to the treatment of inflammatory health conditions gives consumers a preferred drug-free, FDA approved, and clinically proven solution compared to their current allergy and sinus treatments.

About Tivic

Tivic is a commercial health tech company advancing the field of bioelectronic medicine. Tivic’s patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic’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’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 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. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the issuance of the new patent by the USPTO; clinical trial results; FDA approval of any product developed based on the filed patent; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges, or expenses that reduce Tivic’s capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic’s actual results to differ from those contained in the forward-looking statements, see Tivic’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31, 2023, 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:

Kayleigh Westerfield

Kayleigh.Westerfield@tivichealth.com

Investor Contact:

Hanover International, Inc.

ir@tivichealth.com

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Entity Registrant Name Tivic Health Systems, Inc.
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Entity File Number 001-41052
Entity Tax Identification Number 81-4016391
Entity Address, Address Line One 25821 Industrial Blvd.
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