Form 8-K - Current report

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): May 17, 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.)

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 1.01 Entry into a Material Definitive Agreement.

On May 17, 2024, Tivic Health Systems, Inc. (the “Company”) entered into a Collaboration and Research Support Agreement (the “Agreement”) with The Feinstein Institutes for Medical Research (the “Institute”) in connection with the Company's vagus nerve stimulation clinical research program. Pursuant to the Agreement, the Company and the Institute will collaborate in the development and drafting of a protocol (the “Protocol”) to advance a research program designed to test Autonomic Nervous System (“ANS”) function and/or balance in healthy able-bodied individuals in response to neuromodulation of the ANS by the Company’s neurostimulation device, by leveraging and augmenting the NDS Lab’s multi-modal index to quantify the activation status of the ANS during various of clinically relevant tests, and to submit such Protocol and the research study described therein (the “Study”) for institutional and IRB approval. If the Protocol and Study are approved, the Study shall be implemented pursuant to the Protocol and shall be governed by the terms of the Agreement. Total length of the project is expected to be one year.

Pursuant to the Agreement, the Company shall be responsible for participant reimbursement and the full time equivalents involved in acquiring IRB approval, recruiting and performing the experiments, and analyzing all the data and development of all algorithms, as more particularly set forth in the Agreement. Payments will be made by the Company upon completion of the following milestones:

MILESTONE 1: Execute Collaboration and Research Support Agreement - $24,485.60

MILESTONE 2: Receive IRB study approval - $48,971.20

MILESTONE 3: Complete enrollment of first all participants and run 1/3 sessions - $85,699.60

MILESTONE 4a/b: Complete all sessions; submit final report - $85,699.60

The term of the Agreement shall continue until the earlier of (i) the completion of the Study at the Institute, or (ii) five years from the date effective date of the agreement, unless terminated earlier pursuant to the Agreement.

The foregoing summary of the Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the complete text of the Collaboration and Research Support Agreement, a copy of which is attached to this Current Report on Form 8-K (this “Current Report”) as Exhibit 10.1 and is incorporated herein by reference.

Item 7.01 Regulation FD Disclosure.

On May 22, 2024, the Company issued a press release announcing execution of the Agreement and the advancement of its non-invasive cervical vagus nerve stimulation. A copy of that press release is furnished as Exhibit 99.1 to this Current Report and incorporated herein by reference.

In addition, on May 22, 2024, the Company began using a new corporate presentation. A copy of that corporate presentation is furnished as Exhibit 99.2 to this Current Report and incorporated herein by reference. A copy of the presentation is also available on the Company’s website located at https://tivichealth.com/investor/.

The information set forth under Item 7.01 of this Current Report, including Exhibits 99.1 and 99.2 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 Exhibits 99.1 and 99.2, 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 Exhibits 99.1 and 99.2 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 Exhibits 99.1 and 99.2 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. 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

10.1†		Collaboration and Research Support Agreement, dated May 17, 2024, by and between Tivic Health Systems, Inc. and The Feinstein Institutes for Medical Research.
99.1		Press Release, dated May 22, 2024.
99.2		Corporate Presentation, dated May 2024.
104		Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101).


†		Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10).

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:	May 22, 2024	By:	/s/ Jennifer Ernst
			Name: Jennifer Ernst Title: Chief Executive Officer

Exhibit 10.1

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS NOT MATERIAL AND IS THE TYPE OF INFORMATION THAT THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE AND CONFIDENTIAL. REDACTED INFORMATION IS INDICATED BY [***].

COLLABORATION AND RESEARCH SUPPORT AGREEMENT

This Collaboration and Research Support Agreement (the “Agreement”), effective as of the date of the last signature below (the “Effective Date”), is entered into by and between The Feinstein Institutes for Medical Research, a New York not-for-profit corporation and 501(c)(3) medical research organization with an address at 350 Community Drive, Manhasset, NY 11030 (“Institute”) and Tivic Health Systems, Inc., with an address at 25821 Industrial Blvd., Suite 100, Hayward, CA USA 94545 (“Company”). Institute and Company are each a “Party” and collectively the “Parties.”

WHEREAS, Institute, an affiliate of Northwell Health, Inc. (“Northwell Health”), is responsible for basic and clinical research and development activities of Northwell Health;

WHEREAS, Company is a commercial-stage bioelectronic medicine company focused on treating diseases and conditions by modulating the electrical signals carried along various nerve pathways and is the manufacturer of a neurostimulation device called the TIVIC Health neurostimulation device (the “Device”);

WHEREAS, Institute, through its Neural and Data Science Lab (the “NDS Lab”), and Company desire to collaborate in a program of research designed to test Autonomic Nervous System (ANS) function and/or balance in healthy able-bodied individuals in response to neuromodulation of the ANS by the Device, by leveraging and augmenting the NDS Lab’s multi-modal index to quantify the activation status of the ANS during a battery of clinically relevant tests (the “Research”);

WHEREAS, to that end, Institute and Company desire to collaborate in designing an experimental protocol and, upon IRB approval, in conducting that protocol under and in accordance with the terms of this Agreement; and

WHEREAS, Institute and Company believe that the relationship contemplated by this Agreement will provide Institute with a means of advancing medical research and will provide Company with access to the expertise of Institute’s physicians and researchers to refine and advance its technology.

NOW, THEREFORE, in consideration of the mutual promises set forth in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

Services

1.1.

Protocol Development

1.1.1.

Institute and Company shall collaborate in the development and drafting of a protocol designed to advance the Research which protocol, when final, (the “Protocol”) will include, among other things, those elements described in Exhibit A hereto (the “Protocol Outline”). Each Party will supply those resources and furnish those deliverables enumerated in the Protocol Outline to the extent required in

the final Protocol.

1.1.2.

To that end, Institute and Company will collaborate and regularly communicate in good faith through each Party’s primary point of contact, identified in Exhibit A. Institute and Company shall take reasonable efforts to complete the Protocol for submission to the institutional review board of record for Institute (the “IRB”) within sixty (60) calendar days from the Effective Date hereof or such longer period as and to which the Parties may agree in writing (the “Protocol Development Period”).

1.1.3.

The Protocol shall be considered the Confidential Information of each Party.

1.1.4.

In the event the Parties are unable to agree on a protocol within the Protocol Development Period, the Parties may mutually agree to terminate this Agreement or either Party may terminate this Agreement by providing the other Party with ten (10) calendar days’ notice and, following termination, subject to Article 5 and Section 9.5 hereto (including the provisions referenced therein), neither Party shall be restricted or prevented in any way from pursuing similar activities, work or research on its own or with any third party collaborator(s).

1.2.

Protocol Implementation

1.2.1.

Promptly following completion of the Protocol, Institute shall submit the Protocol and the research study described therein (the “Study”) for institutional and IRB approval. Institute shall correspond with Company with respect to any changes proposed or questions raised during these approval processes. The Parties will work together in the event the IRB rejects or otherwise objects to the Protocol.

1.2.2.

If the Protocol and Study are approved, the Study shall be implemented pursuant to the Protocol and shall be governed by the terms of this Agreement. If the Protocol is rejected, the Parties may continue to pursue other options for the Study or mutually agree to terminate this Agreement, or either Party may terminate this Agreement by providing the other Party with ten (10) calendar days’ notice and, following termination, subject to Article 5 and Section 9.5 hereto (including the provisions referenced therein), neither Party shall be restricted or prevented in any way from pursuing similar activities, work or research on its own or with any third-party collaborator(s).

1.2.3.

Neither Party will not conduct the Study using human subjects under this Agreement until the Protocol for such Study has been reviewed and approved by the IRB.

Study Protocol Implementation

2.1.

Conduct of Study

2.1.1.

Upon institutional and IRB approval of the Protocol and the Study, Institute shall conduct and supervise the Study through an investigator employed by or under contract with Institute or Northwell Health (the “Principal Investigator”). The initial Principal Investigator shall be Theodore P. Zanos, PhD, who is the head of the NDS Lab.

2.1.2.

In general and as shall be more specifically described in the Protocol, Institute shall provide all personnel, equipment and facilities necessary to conduct the Study except for the following which shall be furnished by Company: (i) Device(s); (ii) personnel with specialized knowledge of the Device; (iii) other Company technology, materials, equipment and services (including training on the use of the Device) as described in the Protocol; and (iv) financial support in the amounts set forth in Exhibit A hereto (“Financial Support”).

2.1.3.

Institute shall and shall require the Principal Investigator and any other Institute affiliate, employee, contractor, or agent performing or assisting with the Study (such affiliates, employees, contractors, and agents, including any additional investigators are collectively the “Study Staff”) to conduct the Study in accordance with this Agreement, the Protocol (as may be amended from time to time), the International Conference on Harmonization Good Clinical Practice guidelines to the extent codified in regulation by the United States Food and Drug Administration (“FDA”), and all applicable United States laws and regulations (collectively, “Applicable Law”); provided, however, that Institute and Principal Investigator may deviate from the Protocol to protect the health, safety and well-being of human subjects.

2.2.

Study Deliverables. During the course of the Study, Institute will provide to Company those reports and other information as are more specifically described in the Protocol (“Study Deliverables”). Study Deliverables may include interim reports describing the Study’s progress according to a schedule that is mutually agreed upon by the Parties and/or a final report summarizing the conclusions of the Study.

2.3.

Informed Consent. Institute shall obtain from each human subject participating in the Study (a “Study Subject”) a valid informed consent in the form approved by the IRB (the “Informed Consent”), signed by the Study Subject or the Study Subject’s legally authorized representative (unless such consent or documentation of consent is waived by the IRB) and appropriately documented. Each Party shall conduct the Study and its activities under this Agreement in a manner consistent with the Informed Consent.

2.4.

Human Materials. If, with respect to any Study conducted hereunder, human materials will be collected from Study Subjects, stored by Institute and transferred to Company or other third parties, Institute shall comply with Applicable Law in the collection, storage, and transfer of such human materials and Institute shall ensure that the Informed Consent describes such collection, storage and transfer. Any use of such human materials by a Party, whether in the course of conducting the Study hereunder or otherwise, shall be consistent with the terms of the applicable Informed Consents and Applicable Law.

2.5.

Amendment of the Protocol. Any modification to the Protocol which may impact the performance of the Study will require a formal amendment agreed upon by the Parties and shall not take effect until approved by the IRB.

2.6.

Study Data

2.6.1.

“Study Data” means the raw, non-aggregated human recordings collected from each Study Subject during the course of the Study. Institute owns the Study Data and is free to use the Study Data to further the Institute’s research efforts. Institute cannot share the Study Data with other non-academic parties (commercial entities or commercially sponsored entities) without first obtaining the written approval of Company; provided, however, that (a) subject to the requirements set forth in Article 6, Institute may share Study Data with any journal in connection with publication of Study Results, and such journal may publish the Study Data in connection with such publication, and (b) following initial publication of Study Results, Institute shall be free to share the Study Data without restriction (including without having to secure Company’s prior written approval). Institute hereby grants to Company an exclusive, royalty-free, non-transferrable, non-sublicensable license to the Study Data for Company’s research and development purposes, including regulatory submissions, and in support of Company’s development and commercialization of the Device and other Company technologies, subject at all times to Company’s compliance with Study Subjects’ Informed Consent and HIPAA authorization (to the extent applicable), the terms of this Agreement, and Applicable Law. For avoidance of doubt, Company does not possess any right or permission to sell Study Data or otherwise profit from any similar type of distribution or transfer of Study Data to any third party.

2.6.2.

“Study Results” means the aggregated or summarized Study Data and conclusions about the Study, as would be included in a Study report or publication. The Parties shall jointly own the Study Results and are free to publish the Study Results subject to the provisions of Article 6 (Publication).

2.7.

Study Subject Personal Information. During the Study conducted hereunder, Company may receive or otherwise come into contact with Study Subjects’ medical records, personal identifying information or other health information (collectively, “Personal Information”). Company shall comply with Applicable Law regarding the use and disclosure of any and all such Personal Information with which it comes into contact and shall hold any and all such Personal Information in confidence, whether or not so required by law. Without limiting the generality of the foregoing:

2.7.1.

Company shall only use and further disclose Study Subjects’ Personal Information as necessary to support the Study and perform its obligations pursuant to this Agreement, and only in accordance with the relevant Informed Consents and this Section 2.7;

2.7.2.

Company shall not use or disclose Study Subjects’ Personal Information to (i) attempt to contact any Study Subjects except to the extent expressly permitted by the IRB or as required to comply with Applicable Law; (ii) recruit Study Subjects to additional studies; (iii) advertise additional studies or products to Study Subjects; or (iv) perform marketing or marketing research using Study Subjects;

2.7.3.

Company agrees that the protections it applies to Study Subjects’ Personal Information will be at least equal to the protections it applies to Company Confidential Information and other proprietary information; and

2.7.4.

If, in connection with the performance of the Study, Company and/or any of its agents, employees, officers or representatives (collectively, “Representatives”) come into contact with Personal Information relating to patients of Northwell Health who are not Study Subjects, Company agrees to, and agrees to ensure its Representatives agree to, promptly notify Institute, maintain such information in confidence, not use such information it for any purpose, and follow Institute’s direction regarding the disposition or destruction of such information.

2.8.

Medical Records. All Study Subjects’ medical records are and shall remain the property of Northwell Health. Company’s personnel and Representatives who are on site at any premises of Northwell Health shall comply with all applicable policies and procedures of Northwell Health of which they are duly informed, including but not limited to security, safety, infection control and patient privacy.

2.9.

Audits by Regulatory Authorities. Institute shall, to the extent permitted by Applicable Law, including any confidentiality, peer review, or legal privileges that may attach, provide Company reasonable advance notification of any audit by a regulatory authority to the extent the audit is directly related to the Study being conducted hereunder (each a “Regulatory Study Audit”). If advance notification is impracticable, Institute will provide Company notification of any completed Regulatory Study Audit.

Additional Company Obligations

3.1.

Compliance with Law. Company shall comply with Applicable Law in the performance of its activities and responsibilities under this Agreement and the Protocol including, but not limited to, in the manufacture and delivery of the Device(s) and other technologies being furnished by Company in preparation for and in the conduct of the Study. Company shall also obtain all approvals and consents required in connection with any and all such activities if and as needed.

3.2.

Subject Injury. Company shall pay for all costs of diagnosis and treatment, including hospitalization, emergency care, acute care and long-term care, of any physical or mental illness or injury to a Study Subject, including side effects, which may have been caused by Company’s negligence or willful misconduct including, but not limited to, in the manufacture and/or production of the Device(s) or Company-provided technology or equipment.

3.3.

Use of Study Deliverables. With respect to the Study conducted hereunder, Company may use Study Deliverables that it receives under this Agreement only as required to enable Company to evaluate its support of that Study and as permitted to publish the results of the Study in accordance with Article 6 (Publication) of this Agreement or as otherwise permitted by this Agreement. Without limiting the foregoing, Study Deliverables will not be used by Company for any purpose other than the foregoing purposes in this Section 3.3, as applicable, without the prior written consent of Institute and to the extent Company obtains Institute’s prior written consent to transfer, distribute, or provide a third party with access to Study Deliverables, Company will (i) only disclose Study Deliverables to such third party in a complete and accurate manner; and (ii) ensure that such third party is bound to terms and conditions that are at least as stringent as those contained in this Agreement. Company will maintain Study Deliverables under safe and secure conditions designed to prevent any unauthorized use or access to Study Deliverables. For clarity, the above limitations on the use and disclosure of Study Deliverables shall cease to apply to just that portion of the Study Deliverables published in accordance with Article 6 (Publication) of this Agreement.

Intellectual Property

4.1.

Background Intellectual Property. It is expressly agreed that neither Institute nor Company transfers by operation of this Agreement to the other Party any patent right, copyright, trade secret rights, know-how, or other proprietary right owned by the Party as of the Effective Date of this Agreement or otherwise developed by such Party outside the scope of the Study and this Agreement (“Background Intellectual Property”). Institute solely owns Institute’s Background Intellectual Property and Company solely owns Company’s Background Intellectual Property. Neither Party will have any claims to or rights in any such Background Intellectual Property of the other Party, except that each Party hereby grants to the other Party, to the extent it legally can do so, a non-exclusive, worldwide, royalty-free license to its Background Intellectual Property only as is necessary and for such necessary time period for the other Party to perform its obligations under this Agreement and the Protocol.

4.2.

Invention Definition. As used in this Agreement, the term “Invention” means any information, invention, innovation, idea, discovery, or product (whether or not copyrightable or patentable), suggestion, communication, correspondence, evaluation, work product or result that is conceived, derived, reduced to practice, made or developed during and in the course of conducting the Study.

4.2.1.

Inventorship. Inventorship of Inventions shall be determined in accordance with United States intellectual property laws.

4.3.

Foreground Intellectual Property

4.3.1.

Institute Inventions

4.3.1.1.

Inventions made solely by Institute personnel (inclusive of the Principal Investigator and Study Staff) during and in the course of performing the Study (each an “Institute Invention”) shall be the sole property of Institute and, for the avoidance of doubt and without limiting the foregoing and any other provision of this Agreement, Institute Inventions shall include any surgical stimulation or therapeutic techniques, hands-on patient care techniques, instructions regarding any such techniques, surgical stimulation or therapeutic know-how, and diagnostic techniques, and all derivatives of any of the foregoing developed by Institute, any of its employees, contractors or medical staff members,

Study Staff and/or Principal Investigator in connection with this Agreement.

4.3.1.2.

Institute hereby grants to Company an option to negotiate a non-exclusive or exclusive license under Institute’s rights in and to any Institute Invention (“Institute Invention Option”) and Company may exercise its Institute Invention Option by sending written notice to Institute within thirty (30) days of receipt of notice from either Party that it has identified an Invention through its use of the Study Data, Study Results, or Study Deliverables, and which it believes to be an Institute Invention (“Institute Invention Notice”). The Parties shall negotiate in good faith on commercially reasonable terms for a period not to exceed three (3) months from the date of the Institute Invention Notice, or within such additional time to which the Parties agree in writing (“Institute Invention Negotiation Period”). With respect to any Institute Invention, in the event that Company does not exercise its corresponding Institute Invention Option or in the event that the Parties fail to enter into a license agreement during the corresponding Institute Invention Negotiation Period, then Institute shall have no further obligations to Company with respect to such Institute Invention.

4.3.2.

Company Inventions

4.3.2.1.

Inventions made by Company (inclusive of Company’s Representatives) during and in the course of performing the Study shall be the sole property of Company (each a “Company Invention”).

4.3.2.2.

Company hereby grants Institute a non-exclusive, royalty-free, non-transferrable, non-sublicensable license under Company’s rights in and to any Company Invention solely for Institute’s internal academic research and development purposes. Further, Company hereby grants to Institute an option to negotiate a non-exclusive or exclusive license under Company’s rights in and to any Company Invention (“Company Invention Option”) for commercial purposes. Institute may exercise its Company Invention Option by sending written notice to Company within thirty (30) days of receipt of notice from either Party that it has identified an Invention through its use of the Study Data, Study Results, or Study Deliverables, and which it believes to be a Company Invention (“Company Invention Notice”). The Parties shall negotiate in good faith on commercially reasonable terms for a period not to exceed three (3) months from the date of the Company Invention Notice, or within such additional time to which the Parties agree in writing (“Company Invention Negotiation Period”). With respect to any Company Invention, in the event that Institute does not exercise its corresponding Company Invention Option or in the event that the Parties fail to enter into a corresponding license agreement during the Company Invention Negotiation Period on commercially reasonable terms, then Company shall have no further obligations to Institute with respect to such Company Invention. For avoidance of doubt, in the event Company contemplates pursuing commercialization of any Company Invention, Company may, at its sole discretion, decline to grant Institute a license for commercial use of any Company Invention.

4.3.3.

Joint Inventions

4.3.3.1.

Inventions made in the course of performing the Study jointly by Institute personnel (inclusive of Principal Investigator and Study Staff), and Company personnel (inclusive of Company’s Representatives), shall be jointly owned by Institute and Company (each a “Joint Invention”).

4.3.3.2.

To the extent that any Joint Inventions are or may be patentable under Applicable Law (“Patentable Joint Inventions”), Company will have the first right, but not an obligation, to file, prosecute and maintain, at Company’s expense, such U.S. and foreign applications claiming Patentable Joint Inventions in the names of both Institute and Company. If Company decides not to seek patent protection for a Patentable Joint Invention, or not to seek such protection in a given jurisdiction, Company will provide Institute with timely notice of such decision and Institute will have the right, but not an obligation, to file, prosecute and maintain, at Institute’s expense, such patent applications in the names

of both Company and Institute. Company and Institute will cooperate in good faith to execute and deliver such instruments and take such other action as may be necessary for Company or Institute, as the case may be, to undertake the filing, prosecution and maintenance described herein. Neither Party has an obligation to continue prosecuting any patent application nor to continue to maintain such patents, but if the Party that originally assumes such prosecution or maintenance decides to abandon its prosecution or maintenance, it will give the other Party timely notice and allow it to assume such prosecution or maintenance.

4.3.3.3.

Each Party hereby grants to the other an option to negotiate a non-exclusive or exclusive license under the other Party’s rights in and to any Joint Invention (“Joint Invention Option”) and each Party may exercise its Joint Invention Option by sending written notice to the other Party within thirty (30) days of receipt of notice from either Party that it has identified an Invention through its use of the Study Data, Study Results, or Study Deliverables, and which it believes to be a Joint Invention (“Joint Invention Notice”). The Parties shall negotiate in good faith on commercially reasonable terms for a period not to exceed three (3) months from the Joint Invention Notice date, or within such additional time to which the Parties agree in writing (“Joint Invention Negotiation Period”). In the event that neither Party exercises its Joint Invention Option or in the event that the Parties fail to enter into a license agreement during the Joint Invention Negotiation Period on commercially reasonable terms, then each Party shall have no further obligations to the other with respect to such Joint Invention.

4.3.3.4.

Consistent with the limitations of Section 4.3.3.3 above, each Party shall have the right to freely exploit and grant licenses under all Joint Inventions without the consent of, or a duty of accounting to, the other Party.

4.3.4.

Effect of Dispute. The rights of Institute with respect to Institute Inventions and the rights of Company with respect to Company Inventions will not be limited by any dispute between Institute and Company regarding this Agreement or otherwise.

4.4.

Cooperation. The Parties shall each reasonably execute all documents and provide the filing Party with reasonable assistance, at the filing Party’s expense, in the filing and prosecution of any patents necessary to effect or evidence the ownership of any Invention.

4.5.

No Implied License. The Parties acknowledge and agree that except as expressly provided herein, neither Institute nor Company, by operation of this Agreement, transfers to the other Party any intellectual property rights owned by a Party as of the Effective Date hereof.

Confidentiality

5.1.

Obligations. For purposes of this Agreement, “Confidential Information” of a Party (the “Disclosing Party”) shall mean any information or material proprietary to such Party and disclosed by such Party to the other Party (the “Receiving Party”) that: (i) is clearly marked to indicate its confidential or proprietary status; or (ii) a reasonable person under like circumstances would understand to be proprietary or non-public, even if not marked and regardless of how it is disclosed. The Receiving Party covenants that it will protect any of Disclosing Party’s Confidential Information with which it comes into contact and will restrict the use and disclosure of such Confidential Information to its agents, employees, and affiliates who need to know for the purposes of performing that Study (including Study compliance and oversight), and only to the extent such agents, employees, and affiliates are subject to obligations of confidentiality that are at least as stringent as those that apply to Disclosing Party’s Confidential Information. Each Party’s obligations of confidentiality in this Section 5.1 shall survive for a period of (5) years after the expiration or early termination of this Agreement.

5.2.

Exceptions. The limitations on use and disclosure of Confidential Information in this Agreement shall not apply, or shall cease to apply, as the case may be, to Confidential Information received from either Party that:

5.2.1.

is or later becomes publicly known other than through a breach of this Agreement by the Receiving Party, its employees, its affiliates or its agents (inclusive, with respect to Institute, of the Principal Investigator and Study Staff);

5.2.2.

is lawfully made available to the Receiving Party, its employees, its affiliates or its agents (inclusive, with respect to Institute, of the Principal Investigator and Study Staff) by a third party that the Receiving Party reasonably believes owes no obligation of confidentiality to the other Party;

5.2.3.

was already known to the Receiving Party prior to disclosure under this Agreement, which the receiving Party can reasonably demonstrate;

5.2.4.

is independently developed by the Receiving Party or its personnel without the use of the Disclosing Party’s Confidential Information, which the receiving Party can reasonably demonstrate; or

5.2.5.

is required to be disclosed by the Receiving Party pursuant to Applicable Law or by order of any governmental authority or court of competent jurisdiction; provided, however, the receiving Party shall notify the Disclosing Party, to the extent permitted by law, to enable the Disclosing Party to seek a protective order and/or assert whatever exclusions or exemptions may be available to it, and the Confidential Information shall otherwise remain subject to all terms and conditions of this Agreement and will not lose its confidential status for other purposes merely through such required disclosure.

5.3.

Permitted Disclosures. Notwithstanding Section 5.1, the Confidential Information of one Party may be disclosed by the other Party to the extent that it:

5.3.1.

is disclosed to Study Subjects or prospective Study Subjects as reasonably necessary or appropriate in the course of discussions regarding the Informed Consent, or the performance of the Study;

5.3.2.

is disclosed by the Receiving Party to its attorneys, auditors, accountants or consultants who require the Confidential Information to provide professional services to the Receiving Party and who are doing so under a professional or contractual obligation of confidentiality;

5.3.3.

is published in accordance with this Agreement; or

5.3.4.

is disclosed to a physician or a Study Subject as reasonably necessary or appropriate in connection with the medical treatment of such Study Subject.

5.4.

Return of Confidential Information. Upon the expiration or earlier termination of the Study under this Agreement, each Party shall, at the direction of the other Party, return or destroy the other Party’s Confidential Information. Each Party acknowledges that it shall not be an obligation of the other Party, as recipient of any Confidential Information hereunder, to destroy those archival electronic back-up copies of such Confidential Information as may be made routinely by a Party’s computer data back-up systems so long as such archival electronic copies are maintained in confidence from third parties and not used for any purpose other than as permitted hereunder. Notwithstanding the foregoing, a Party may retain copies of Confidential Information for legal archival purposes and to comply with its obligations under this Agreement, and Institute may use such retained Confidential Information to provide the appropriate medical care to former and present Study Subjects.

Publication

6.1.

Right of Publication. Institute may publish, present or otherwise publicly disclose the Study Results as it determines appropriate, subject to the process set forth in this Article 6 (specifically Section 6.3). I. Institute shall comply with standard academic practices regarding authorship of scientific publications and recognition of the contribution of other parties in any publication governed by this Article 6, including the authorship guidelines promulgated by the International Committee of Medical Journal Editors (“ICMJE”) in effect at the time of a given publication.

6.2.

Company Publication. With respect to the Study conducted hereunder, Company will not make, and will ensure that its affiliates, research collaborators, and employees, agents and representatives are contractually bound and/or legally obligated not to make, any public presentation of the Study Deliverables or any information provided by Institute or the Principal Investigator hereunder until the earlier of either twelve (12) months following completion of the Study or until the Study Results and information have been publicly disclosed by Institute or the Principal Investigator. If, at any time, Company desires to so publish, its personnel shall obtain Institute’s written approval regarding the content and format of the publication prior to the submission of the publication to ensure that the Study Results are presented in a complete and accurate manner. Company shall comply with standard academic practices regarding authorship of scientific publications and recognition of the contribution of other parties in any publication governed by this Article 6, including the authorship guidelines promulgated by the ICMJE in effect at the time of a given publication.

6.3.

Review Period. With respect to the Study conducted hereunder, not less than thirty (30) days’ prior to the earlier of publication or submission for publication of any manuscript, the publishing Party shall provide the other Party with a copy of the manuscript. The reviewing Party will provide its comments within thirty (30) days after receipt of the manuscript (the “Review Period”) and the publishing Party shall consider in good faith any comments submitted by the reviewing Party regarding the content thereof. The publishing Party shall delete any Confidential Information of the reviewing Party identified in writing by the reviewing Party except to the extent the identified Confidential Information is necessary to the integrity of the publication, in which case the Parties will negotiate in good faith an appropriate way to present the information. In addition, if during the Review Period the reviewing Party identifies to the publishing Party an Invention for which the reviewing Party intends to obtain a patent or perfect another intellectual property right, the publishing Party shall then delay publication for an additional period of up to sixty (60) days in order to allow the reviewing Party to file for or perfect patent protection or other intellectual property rights in such Invention in accordance with Article 4 (Intellectual Property). Company recognizes that Institute’s objective is to expeditiously disseminate new scientific and technical knowledge. To this end Company will take prompt action reasonably necessary to allow public disclosure without jeopardizing its intellectual property rights or Confidential Information. The intent of this Section is to facilitate expeditious removal of Confidential Information that is not essential to the basic validity of the publication and/or to allow sufficient time to file patent or similar applications.

6.4.

Use of Name. Neither Party may use the name, logo, or trademark of the other Party or its employees or affiliates in any press release, publicity, or advertising without the prior written approval of the other Party, except as required by Applicable Law or expressly permitted by this Agreement; provided, however, that if required by the journal to which a manuscript is submitted or upon request by Company, Institute shall publicly acknowledge in any manuscript Company’s contribution to the research and Institute may use Company’s name for that purpose. Further, Company will not use the name of Institute or any of its employees or affiliates or make any form of representation or statement in relation to the Study, Study Data or Study Results which would constitute or may be interpreted to constitute an expressed or implied endorsement by Institute of any commercial product or service of Company, and that Company will not authorize others to do so.

Indemnities and Insurance

7.1.

Indemnification. Company shall indemnify, defend, and hold harmless Institute and its officers, directors, employees, agents, affiliates, and trustees, including the Principal Investigator and the IRB (“Indemnitees”), from and against any and all losses, liabilities, injury, illness, death, property damage, damages, judgments, settlements, costs, fees, suits and expenses (including reasonable attorneys’ fees and court costs) (each a “Loss”, collectively “Losses”) in connection with a claim, action, demand, cause of action or lawsuit (“Claim”) arising in whole or in part out of (i) the negligence, recklessness or willful misconduct on the part of Company, its contractors, and its (or their) respective officers, directors, employees and/or agents; (ii) the misuse by Company or its contractors of Personal Information, Institute’s Confidential Information, the Study Data, Study Results and/or Study Deliverables; (iii) Claims arising out of use of the manufacture of the Device; and/or (iv) any violation of Applicable Laws and/or breach of this Agreement by Company, its contractors, and/or its (or their) officers, directors, employees and/or agents.

7.2.

Indemnification Procedure. Institute shall promptly notify Company of any Claim. Failure to provide timely notice shall not negate Company’s obligation to indemnify, except to the extent such delay in notification actually prejudiced Company’s defense of the Claim. Company shall have the right to manage the defense and settlement of any Claim, except that no settlement shall include an admission of liability or a financial obligation on the part of the Indemnitees without their prior written approval. The Indemnitees shall reasonably cooperate with Company in the defense of any such Claim at Company’s expense. Each Indemnitee may participate in any such claim or suit, at his or her own expense.

7.3.

Responsibility. With respect to the Study conducted hereunder, Institute shall be responsible for its acts in conducting the Study limited solely and exclusively to the extent such acts are determined by a court of competent jurisdiction to be caused by the gross negligence or willful malfeasance on the part of Institute. In no event will Institute be liable to Company for any indirect, incidental, special or consequential damages or lost profits arising out of or in connection with the Study or its performing research activities in connection with the Study.

7.4.

Insurance. Company shall maintain the following insurance coverages at its own expense for the term of the Agreement term: (i) Commercial General Liability insurance with limits of not less than $1,000,000 per occurrence and $2,000,000 annual aggregate; (ii) Products Liability insurance for the products provided under this Agreement with limits of not less than $5,000,000 per occurrence and $5,000,000 annual aggregate; (iii) Excess Liability insurance with limits of not less than $5,000,000 per occurrence and $5,000,000 annual aggregate; (iv) if Company receives PHI/PII Network Security/Cyber/Data Breach insurance with limits of not less than $1,000,000 per claim and $3,000,000 annual aggregate; and (v) workers’ compensation and employers’ liability per statutory limits. Policies shall be issued by insurance companies with a minimum A.M. Best rating of A/IX and Company will provide Institute with at least thirty (30) days’ notice of cancellation/non-renewal of any of Company’s insurance policies required herein from Company or its insurers. If any of Company’s insurance policies required herein is written on a claims-made form, as opposed to an occurrence basis, such insurance shall have a retroactive date prior to or coinciding with the effective date of this Agreement and it shall continue for five (5) years following termination of this Agreement. In the event that a claims-made policy is canceled or non-renewed, Company shall obtain extended reporting (tail) coverage for the remainder of the five (5) year period. Company shall furnish certificates of insurance evidencing the insurance required herein to Institute before the first Study begins and thereafter upon request. The minimum amounts of insurance coverage required shall not be construed to limit Company’s liability in any way. The Feinstein Institutes for Medical Research, Northwell Health, Inc. and their respective parents, subsidiaries, owned and/or controlled affiliates, directors, officers, trustees, employees, agents and representatives, and IRB shall be named as Additional Insureds on Company’s liability policies. Company’s policies of insurance shall be primary and non-contributory to any and all commercial insurance, self-insurance, and/or other protections maintained by or on behalf of Institute and Additional Insureds outlined above.

Representations and Covenants

8.1.

Regulatory Approvals. With respect to the Study conducted hereunder, each Party represents that it has and will maintain during the term of this Agreement all regulatory approvals required for the conduct of its respective activities in connection with that Study.

8.2.

Debarment. Each Party agrees that it will not knowingly engage, directly or indirectly, any person (including any Principal Investigator) to perform services under this Agreement if that person is (i) debarred by the FDA under 21 U.S.C. § 335a, (ii) excluded from participation in any federal health care program under 42 C.F.R. Part 1001 et seq., or (iii) otherwise disqualified under federal or state law, from participating in any Study. Each Party certifies that it will promptly notify the other in writing if it receives notice of any such debarment, exclusion, or disqualification.

8.3.

Fair Market Value. Each Party represents that any and all payments or other transfers of value provided with respect to any Study conducted under this Agreement, including the Study Support, are fair market value, have been negotiated in an arm’s-length transaction, and have not been determined in any manner with regard to any implicit or explicit agreement to provide favorable procurement decisions with regard to either Party’s products or services, or to the value or volume of any business or referrals generated between the Parties. Nothing in this Agreement is intended to create an unrestricted gift.

8.4.

No Charge. Institute covenants that it will not charge any Study Subject or any third party for any items or services that are funded by Company under this Agreement or that are provided without charge by Company for Study purposes.

8.5.

Conflicts of Interest. Each Party represents that it has a system in place to manage conflicts of interest. With respect to the Study conducted hereunder, Company shall not, and shall require its agents and contractors to refrain from, making any payments directly to Study Staff for performing the activities set out in the Study Protocol.

8.6.

No Warranty by Institute. The Parties understand, acknowledge and agree that NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE SHALL APPLY to Institute’s research activities, work product, activities or services provided pursuant to the terms and conditions of this Agreement. The Parties further acknowledge and agree that an investigation like the Research contemplated herein is an inherently uncertain undertaking and that, as such, no particular result, outcome or data can be anticipated or assured.

8.7.

Company Compliance with Applicable Law. Company represents that it has not been found by the FDA or any other state or federal government agency or enforcement body to have violated any federal, state or local laws, rules or regulations relating to clinical investigations. If it is so found during the term of this Agreement, whether in connection with the Study or in connection with any other clinical investigations or studies, Company will immediately notify Institute.

Term and Termination

9.1.

Term. This Agreement shall take effect on the Effective Date and continue until the earlier of (i) completion of the Study at Institute as mutually agreed upon among the Parties; or (ii) five (5) years after the Effective Date, unless terminated earlier pursuant to this Article 9.

9.2.

Termination by the Parties. Either Party may terminate this Agreement in the event a material breach by the other Party has not been cured within thirty (30) days after the breaching Party’s receipt of written notice describing such breach in reasonable detail. Either party may terminate this Agreement at any time without cause and without any penalty upon thirty (30) days’ prior written notice.

9.3.

Immediate Termination by Institute. Institute may terminate this Agreement immediately upon written notice to Company if required to do so by the IRB, or if Institute determines that termination of the Study is necessary for the health or safety of the Study Subjects.

9.4.

Return of Property. Upon the earlier of termination or expiration of this Agreement, Institute shall, and shall require the Principal Investigator to, return to Company, at Company’s expense, or destroy, within thirty (30) days, any Devices and other equipment on loan or lease from Company, and any copies of Confidential Information provided by Company that are in the possession or under the control of Institute or the Principal Investigator; provided, however, that Institute may retain copies of such Confidential Information pursuant to the terms set forth in Section 5.4.

9.5.

Survival. The following Sections and Articles shall survive the expiration or earlier termination of this Agreement: Sections 2.6 (Study Data), 2.7 (Study Subject Personal Information), 2.8 (Medical Records), 9.4 (Return of Property), 9.5 (Survival), and all of Articles 3 (Additional Company Obligations), 5 (Confidentiality), 6 (Publication), 7 (Indemnities and Insurance) and 10 (Miscellaneous), provided the terms of Article 5 shall only survive for the time period set forth in Section 5.1.

10.

Miscellaneous

10.1.

Remedies and Waiver. The remedies provided in this Agreement are not exclusive and a Party suffering from a breach of this Agreement may seek any remedy available in a court of competent jurisdiction. No express or implied waiver by a Party of any breach or default will be construed as a waiver of a future or subsequent breach or default. The failure or delay of any Party in exercising any of its rights under this Agreement will not constitute a waiver of any such right, and any single or partial exercise of any particular right by a Party will not exhaust the same or constitute a waiver of any other right provided under this Agreement.

10.2.

Disclaimer of Damages. IN NO EVENT WILL INSTITUTE BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL LOSSES OR DAMAGES ARISING HEREUNDER, EVEN IF INSTITUTE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH POTENTIAL LOSS OR DAMAGE.

10.3.

Assignment. Neither Party may assign this Agreement without the prior written consent of the other Party, except that either Party may assign this Agreement to an Affiliate. For purposes of this Section 11.3, “Affiliate” means, with respect to any corporation or other entity, another corporation or other entity that, directly or indirectly, controls, is controlled by, or is under common control with such corporation or entity, where “control” means the direct or indirect ownership of more than fifty percent (50%) of the voting securities of an entity, or any other relationship that results in actual control over the management of an entity. Any Party making an assignment pursuant to this Section 10.3 (other than an assignment to an Affiliate) shall provide prompt written notification to the other Party. In the case of any assignment, the assignee shall assume all of the obligations of the assignor under this Agreement, including the obligations set out in Article 7. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective heirs, legal representatives, successors and assigns.

10.4.

Independent Contractor. In performing activities under this Agreement, neither Party (including its employees) is or shall act as an agent or employee of the other Party. The relationship between the Parties does not constitute a partnership, joint venture, or agency. Neither Party shall have the authority to bind the other Party without that other Party’s express, written permission.

10.5.

Force Majeure. Noncompliance by a Party with this Agreement due to any cause beyond the reasonable control of the Party, such as war, civil commotion, destruction of production facilities and materials, fire, flood, earthquake or storm, labor disturbances, shortage of materials, failure of public

utilities or common carriers (each, an event of “Force Majeure”), shall not constitute a breach of this Agreement. That Party shall be excused from performance under this Agreement to the extent and for the duration of such event of Force Majeure; provided, however, if such Force Majeure continues for sixty (60) days, either Party shall have the right to terminate this Agreement.

10.6.

Further Assurances. Each Party shall execute such other instruments, give such further assurances, and perform acts reasonably necessary or appropriate to effectuate the provisions of this Agreement.

10.7.

Choice of Law. This Agreement is governed by the laws of the State of New York, without regard to its choice of law provisions.

10.8.

Notices. Any notices given hereunder shall be in writing and shall reference this Agreement. Notice shall be deemed given: (i) on the date delivered when delivered personally; (ii) one (1) day after the date sent when sent by facsimile, followed by a copy sent promptly by registered or certified mail, return receipt requested, postage prepaid; (iii) five (5) days after the date postmarked if sent by registered or certified mail, return receipt requested, postage prepaid; or (iv) two (2) days after deposit with a nationally recognized overnight carrier, with written verification of receipt. Notice shall be given to a Party at the address for that Party set forth below (or to such other address as a Party subsequently designates pursuant to this Section 10.8):


To Institute:	The Feinstein Institutes for Medical Research Grants Management 350 Community Drive Manhasset, NY 11030 Attn: Diane Marbury, Senior Director, Grants Management Email: GMO@northwell.edu
With a copy to:	Northwell Health, Inc. Office of Legal Affairs 2000 Marcus Avenue New Hyde Park, NY 11042 Attn.: General Counsel
To Company:	Tivic Health Systems, Inc. 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 Attn.: CEO Email: Jennifer.Ernst@TivicHealth.com

10.9.

No Third-Party Beneficiary. This Agreement is for the sole benefit of the Parties, and does not confer any rights on any third party.

10.10.

Entire Agreement; Amendments. This Agreement, together with any and all Study-specific appendices hereto, constitutes the entire agreement of the Parties with respect to the subject matter hereof, and supersedes all previous written or oral representations, agreements, and understandings between the Parties with respect to all matters covered by this Agreement. This Agreement may only be amended by a written document signed by both Parties. In the event of any conflict between the terms of the Protocol and the terms of this Agreement, this Agreement shall control with respect to contractual matters and the Protocol shall control with respect to scientific matters.

10.11.

Performance of Other Research or Competing Studies. Nothing in this Agreement, other than provisions of Article 6, or any Study Appendix (including Protocol) will preclude Institute from providing research or similar services in the same subject area with other persons or entities not party to this Agreement. Company acknowledges that, to the extent Institute is able while remaining in compliance with Article 5, Institute may have performed, be performing, or in the future may perform contracts with Company that are separate and apart from the research conducted under this Agreement.

10.12.

Tax-Exempt Status. Company will not undertake any activity or take any action that would, or refrain from taking reasonable action when such inaction would, adversely affect the tax exemption of Institute or any affiliate under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended.

10.13.

Severability. If any provision of this Agreement is held to be unenforceable for any reason, that unenforceability shall not affect the enforceability of any other provision of this Agreement, and the Parties shall negotiate in good faith to substitute an enforceable provision with similar terms.

10.14.

Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which when taken together shall constitute one and the same agreement.

10.15.

Export Controls. Each Party agrees to comply with export control law to the extent applicable.

10.16.

Headings. The Section and Article headings in this Agreement are for reference only and shall not affect the interpretation or meaning of any provision of this Agreement.

10.17.

Authority to Execute. The signatories to this Agreement represent and warrant that they are duly authorized to execute this Agreement on behalf of the Party that they purport to represent.

[Remainder of page intentionally blank; signature page follows]

IN WITNESS WHEREOF, through their duly authorized representatives, the Parties have executed this Collaboration and Research Support Agreement to become effective as of the Effective Date.

    The Feinstein Institutes for Medical Research
 
    Tivic Health Systems, Inc.

     
By: _/s/ Diane M. Marbury, CRA______
Name: Diane M. Marbury, CRA
Title: Sr. Director, Grants Management
Date: _4/30/2024___________________

     
By: _/s/ Jennifer Ernst______________
Name: Jennifer Ernst
Title: CEO
Date: _5/17/2024__________________

   

Exhibit A

Protocol Outline

[***]

Payment will be made upon completion of the following Milestones with written agreement by both parties on satisfactory completion:

MILESTONE 1: Execute Collaboration and Research Support Agreement $ 24,485.60

MILESTONE 2: Receive IRB study approval $ 48,971.20

MILESTONE 3: Complete enrollment of first all participants and run 1/3 sessions $ 85,699.60

MILESTONE 4a/b: Complete all sessions; submit final report $ 85,699.60

Payments from Company to Institute will be issued within Net 30 payment terms.

Attachment: Preliminary Budget

Exhibit 99.1

PRESS RELEASE

Tivic Health Partners with the Feinstein Institutes to Advance its Patent-pending, Non-Invasive Cervical Vagus Nerve Stimulation; Begins Optimization of ncVNS for use in Clinical Indications

SAN FRANCISCO – May 22, 2024– Tivic Health® Systems, Inc. (“Tivic Health”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced today it has initiated the second phase of its clinical work to advance its novel non-invasive cervical vagus nerve stimulation (“ncVNS”). The company has entered into a collaboration agreement with The Feinstein Institutes for Medical Research at Northwell Health to optimize its ncVNS device therapy for use in specific clinical indications.

Tivic Health will conduct a second 20-person clinical trial in collaboration with 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. Physiological measurements will be used to identify optimal device specifications, including refining electrode positioning and key electrical waveform parameters utilized in its successful Phase 1 study.

“Our recently released ncVNS results demonstrated a large clinically important change in biomarkers for the brain, heart, and autonomic nervous system,” says Blake Gurfein, Ph.D., Chief Scientific Officer of Tivic Health. “This next phase of the research will build upon those results to tailor the therapy to specific clinical indications and accelerate our product development.”

Through its successful Phase 1 study, Tivic Health demonstrated a novel ncVNS approach that management believes could have clinical utility in several patient populations, including those with epilepsy, post-traumatic stress disorder, and ischemic stroke, among others.

Background:

VNS is a growing market that is part of the $8.3B neurostimulation market, which has a projected CAGR of 12.2% from 2023 through 2032, according to Global Market Insights. The vagus nerve is the longest autonomic nerve in the body. The vagus nerve regulates many organ systems associated with chronic disease, and thus modulating activity in this nerve pathway is of significant interest in the medical industry. VNS is currently indicated for treatment-resistant epilepsy and depression, cluster headache, migraine headache, and stroke rehabilitation, and it

is being studied for other neurological, cardiac, and immune conditions. However, many of the applications of VNS rely on surgical implants.

Tivic Health, with collaborators such as The Feinstein Institute for Bioelectronic Medicine, hopes to lead the way to meaningful improvement in how VNS devices can more precisely target and modulate vagus nerve activity to achieve intended biological and clinical outcomes, with non-invasive or minimally invasive devices.

Previously, the company has announced:

•

May 2024: Tivic Health Announces Successful Completion of Non-Invasive Vagus Nerve Stimulation Study (VNS); Demonstrates Clinically Effective Biological Changes in the Autonomic, Cardiac, and Central Nervous Systems

•

January 2024: Tivic Health Announces Enrollment Complete for Study of Novel Non- Invasive Bioelectronic Approach to Vagus Nerve Stimulation

•

August 2023: Tivic Health Funded Study Begins Enrollment for Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation

•

April 2023: Tivic Expands Bioeletronic Portfolio: Files Patent Application for New Approach to Non-Invasive Vagus Nerve Stimulation

About Tivic Health

Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health’s patented technology platform leverages stimulation on 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 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: statements regarding the future development and/or effectiveness of ncVNS treatment; Tivic Health’s

ability to develop and commercialize products arising out of the ncVNS treatment; Tivic Health’s plans to seek regulatory approval for such clinical products; Tivic Health’s plans for developing an ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility, including which patient populations may be pursued; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic Health’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 Health’s actual results to differ from those contained in the forward-looking statements, see Tivic Health’s filings with the SEC, including, its Annual Report on Form 10-K for the year 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

Morgan.Luke@tivichealth.com

Investor Contact:

Hanover International, Inc.

ir@tivichealth.com

NASDAQ TIVC INVESTOR PRESENTATION 2022 SEPT The future of medicineis electronic. NASDAQ : TIVC INVESTOR PRESENTATION May 2024

Forward-Looking Statements This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation may be forward-looking statements. Statements regarding our future results of operations and financial position, economic performance, business strategy and plans and objectives of management for future operations, including, among others, statements regarding the consummation of the offering, our expected growth, investments, and future capital expenditures are all forward looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “should,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “target,” “project,” “might,” “plan,” “predict” or “continue” or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. We caution you that any such forward-looking statements are not guarantees of future performance, and are subject to risks, assumptions and uncertainties that are difficult to predict and beyond our ability and control. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements. Any differences could be caused by a number of factors, including but not limited to: our anticipated needs for working capital; our ability to secure additional financing; our ability to continue to satisfy the listing standards of Nasdaq; regulatory or legal developments in the United States and other countries; economic and market conditions; our expectation regarding timing, costs, conduct and development of our products and product candidates; and our efforts to expand our products and business. Many of the important factors that will determine these results are beyond our ability to control or predict. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise. New factors emerge from time to time, and it is not possible for us to predict which will arise. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date made, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to place undue reliance upon these statements. Industry Information Unless otherwise indicated, information contained in this presentation concerning our industry, competitive position and the markets in which we operate is based on information from independent industry and research organizations, other third-party sources, as well as data from our internal research, and are based on assumptions made by us upon reviewing such data, and our experience in, and knowledge of, such industry and markets, which we believe to be reasonable. In addition, projections, assumptions and estimates of the future performance of the industry in which we operate, our addressable market, and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, which could cause results to differ materially from those expressed in the estimates made by the independent parties and by us. Additional Information This presentation shall not constitute an offer to sell or the solicitation of an offer to buy our securities, nor shall there be any sale of our securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Potential investors should review our filings with the Securities and Exchange Commission (“SEC”), including our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 25, 2024, and the Risk Factors included therein, as well as our subsequent filings with the SEC. These filings and other information about us are available on the SEC’s website at www.sec.gov. You may access these materials at our corporate website, www.tivichealth.com, free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. Disclaimers / Safe Harbor Statement This presentation has been prepared to assist us in determining the potential level of investor interest in our company. This presentation and information contained in this presentation is confidential and proprietary to us and is being distributed to you on a confidential basis. No part of this presentation or the information contained herein may be reproduced, photocopied, redistributed or passed on, directly or indirectly, to any other person or published, in whole or in part, for any purpose.

References provided in Appendix . Investment Highlights TIVIC HEALTH Commercial-stage in Bioelectronic Medicine, field projected to grow at 35% CAGR 2019-20291 One of the most promising new fields of medicine. FDA-approved product in market targeting $9.1B addressable market2First product (ClearUP) targets inflammation of sinus passages, proof source from which to build neuromodulation lines. New results on vagus nerve stimulation, which form basis for future growthVagus nerve is a high-value target for medical applications. Tivic’s low-current, non-invasive approach has recently shown potential applications in cardiology, neurology, and psychiatry.3 Significant R&D inflection points within next 6 monthsClinical read-outs on two research programs expected within next 6 months, including first published data from new area of Vagus Nerve Stimulation. Strong fundamental IP: 9 issued patents, 10 patents pending US, Europe, China, and others, issuance dates beginning in 2020. IP covers all factors that make trigeminal nerve stimulation effective, comfortable and easy to use. Recently filed VNS IP covers fundamental differentiation in stimulation circuitry and method. Experienced management teamBackgrounds include growth through organic R&D, strategic partnerships, licensing, M&A and joint ventures.

THE BIG IDEA: BIOELECTRONIC MEDICINE The body is an electrochemical system. Restore healthy function by engaging the body’s electrical signals. Bioelectronic medicine represents a multi-billion-dollar opportunity and has the “potential to become a pillar of medical treatment.” Bioelectronics ‘jump-start’the next wave of device therapeutics. – October 2019 4 4

FDA Approved to clear congestion, stop sinus pain $249 MSRP 5 minutes, 2x per day Bioelectronic Platforms Regulatory Approvals Peer-reviewed Publications AND TIER 1 COLLABORATORS FOR CLEARUP PRODUCT 2 Product in Market 1 Trigeminal and Sympathetic Nerves Signed NewDistribution Agreements 2023 Preferred ClearUP to existing treatments2 Experienced clinically significant benefit within 10 minutes 2 Experienced clinically significant benefit after 4 weeks of use3 3 Patents Pending Patents Issued 10 $9.1B United States Addressable Market1 704687 DEN200006 K182025 Vagus Nerve Clinical Trials In Progress 2 2 Clinical Trials Published TIVICHEALTH.COM 92% $1.1M 9 CLEARUP SINUS RELIEF 2023 Revenue from Direct Channels NEW DATA Q2 2024 (NEAR TERM CATALYSTS) References provided in Appendix TIVIC BUSINESS SNAPSHOT 5

TIVIC SPECIALIZES IN Non-invasive Nerve Stimulation GUIDED HANDHELD NEUROMODULATION (COMMERCIAL) Trigeminal nerve mediates pain signals1,2; Sympathetic nerves regulate vasoconstriction3-7 Detects subcutaneous structures;guides user to optimal treatment points Sold under ClearUP brand, white-labeling opportunities FDA approved for treatment of various sinus and allergy conditions In clinical trial for relief of post-operative pain following sinus and nasal surgeries* Additional applications may include* 8-13 temporomandibular joint disorder migraines trigeminal neuralgia tinnitus pain related to ear infections other inflammation and nerve related conditions involving face WEARABLE VAGUS NERVE SIMULATION (IN DEVELOPMENT) concept References provided in Appendix. Vagus nerve regulates autonomic nervous system, neurologic, cardiac and immune functions14 Recently completed study showed Tivic’s non-invasive approach delivered biological impact relevant to multiple medical indications Applications may include*15-17 Cardiovascular: Arrhythmias, Hypertension Neurological: Epilepsy, Stroke Rehabilitation Psychiatric: Depression, Anxiety, PTSD Immune System: Crohn’s Disease, IBD, Arthritis, MS * May require additional clinical trials and regulatory approvals. For investigatory use only for such conditions. 6

CORE TECHNOLOGYBIOELECTRONIC “PLATFORM” Programmable Signal Parameters Patented Electrical and Industrial Designs Proprietary Algorithms Tivic has unique expertise to optimize the delivery ofeffective, low-current, non-invasive neuromodulation 7

Leveraging core competencies in new high-value target TIVIC’S STRATEGY TO INCREASE VALUE Vagus nerve is a high-value target for medical applications.Connects all major organs. Regulates autonomic nervous system. Effects on cardiac, neurological and immune systems.1 Implanted vagus nerve stimulators have validated clinical efficacy and commercial viability of vagus nerve stimulation (VNS). Implanted VNS is an established treatment method used in epilepsy, depression, and stroke rehabilitation. However, the surgical requirements of these therapeutic devices means they are not appropriate for many clinical scenarios. 2 Tivic Health, has completed clinical testing of a medical-grade, non-invasive cervical VNS system (ncVNS). Results showed large, rapid changes in clinically important biological measures of the autonomic nervous system, heart and enable Tivic to address an entirely new set of high-value diseases. Clinical testing of Tivic Health technology conducted by The Institute for Bioelectronic Medicine at References provided in Appendix 8

Significant whitespace in medical-grade, non-invasive VNS therapeutic devices VNS LANDSCAPE Non-invasive “Wellness” VNS Not rigorously tested, not optimized Not subject to FDA oversight No clinical validation required (not “evidence based”) Low valuations Marketed for Stress1 Marketed for Stress1 Marketed for Stress1 Marketed for Stress1 Marketed for Stress1 Product of electroCore Marketed for Stress1 Marketed for Pain1 Implanted VNS devices Surgically implanted Rigorous clinical testing FDA regulated and approved for specific medical indications High valuations Medical Grade, Non-Invasive VNS Non-invasive, low risk Rigorous clinical testing FDA regulated and approved for specific medical indications DIFFERENTIATION OPPORTUNITIES Disease target, novel circuitry and form factor, signal optimization, stimulation parameters, all factors determining clinical efficacy. Approved for Migraine, Cluster Headache1 Approved for Opioid Withdrawal1 Potential targets based on recent VNS data include: Cardiovascular Disease, Arrythmia, Epilepsy, Depression, PTSD, Stroke Rehabilitation References provided in Appendix Approved for Epilepsy, Depression1 Clinical stage for Rheumatoid Arthritis, Crohn’s Disease1 GSK/Verily JV Clinical Stage for Rheumatoid Arthritis1 Approved for Stroke Rehabilitation1

Sophisticated testing and measurement of VNS response TIVIC’S ncVNS STUDY Non-invasive Cervical Vagus Nerve Stimulation (ncVNS) N = 20 Healthy Subjects One-time stimulation, 20 minutes Novel current delivery methods and proprietary simulation parameters Physiologic Outcome Measures Pupillometry (Pupil Diameter) Electrocardiogram (RMSSD HRV*) Electroencephalography (Brain Activity) Distinct indicators of vagus nerve activation and autonomic nervous system balance Clinical Testing conducted by The Institute for Bioelectronic Medicine at *RMSSD = Root Mean Square of Successive Differences. HRV = Heart Rate Variability concept

Sustained pupil constriction during stimulation TIVIC TOPLINE ncVNS STUDY OUTCOMES Pupil constriction indicates increased parasympathetic tone1 9.5% reduction in pupil diameter Indicates vagus nerve has been engaged Before During Clinical Testing conducted by The Institute for Bioelectronic Medicine at References provided in Appendix

Large, clinically meaningful increase in RMSSD – a measure of heart rate variability, vagal tone and parasympathetic activity TIVIC TOPLINE ncVNS STUDY OUTCOMES Importance of RMSSD RMSSD is an accepted proxy for vagal tone and parasympathetic activity1 Increasing parasympathetic activity may treat or prevent cardiac arrythmia2 Higher RMSSD is associated with lower morbidity and mortality in cardiovascular disease3 Tivic Topline Study Results 97% increase in RMSSD (2x) 170% increase in RMSSD in responders (2.7x) 60% Responder Rate (comparable to implants)4 Implantable devices have shown similar results4Non-invasive devices have varianble results5 Responses in clinical populations with medical issues expected to be larger All Subjects 2x Mean Increase 2.7x Mean Increase Responders (60% responder rate) Heart rate variability (RMSSD; higher is better) Before ncVNS After ncVNS Before ncVNS After ncVNS References provided in Appendix *RMSSD = Root Mean Square of Successive Differences. HRV = Heart Rate Variability

Large, clinically meaningful changes in brain activity TIVIC TOPLINE ncVNS STUDY OUTCOMES Theta Activity: Increased frontal theta activity expected to be useful in treating anxiety, PTSD and other psychiatric disorders1 24% increase in frontal theta activity – associated with calm awake states, learning and memory. Gamma Activity: Reducing gamma activity is an accepted therapeutic strategy for reducing the frequency of epileptic seizures2 66% reduction in frontal gamma activity – associated with reduced arousal, anxiety. 62% reduction in temporal gamma activity – associated with reduction in epileptic activity. Clinical Testing conducted by The Institute for Bioelectronic Medicine at References provided in Appendix

Why this matters Our topline ncVNS data indicate large rapid effects in clinically important biological measures (cardiac, brain, autonomic). Implanted technologies have validated clinical efficacy and commercial viability of VNS but are not always appropriate for the clinical scenario.1 Non-invasive VNS approaches to date have had not been adequately optimized resulting in variable responses and modest efficacy.2 References provided in Appendix There is a sizeable technical and commercial gap in medical-grade, non-invasive VNS. Tivic Health is poised to capitalize on that gap.

cv Catalyst-rich period for Tivic ACCELERATING VALUE CREATION NEAR TERM 12 MONTHS + COMPLETED Clinical Engineering Commercial Proof of Concept Concept demonstrated Phase I Safety validated in healthy subjects Effect size baseline established Enrollment complete Data analysis in progress Successful Phase I Data: ncVNS Phase Ia: ncVNS Optimization Study Enhance and refine stimulation parameters Comparison to sham Catalysts during study include Site secured / collaboration agreement IRB approval Initiation of study enrollment Interim progress updates Study completion Final data readout Functional Prototype Systems Advanced Prototype Matched to form, fit and function of projected commercial design Enrollment of Key Opinion Leaders Beachhead Market Selection COMMERCIAL Market evaluation Phase II: Double-blind randomized controlled studies in Target Populations Phase III: Pivotal Trial for regulatory submission(s) Commercial Design Manufacturing Scale-up Market Development Regulatory Submissions and Approvals de novo pathway anticipated Phase II Data Readout: Post-op Pain Commercial Launch Breakthrough Device Application IP landscape evaluation & patent filing

Experienced, Execution-oriented Team LEADERSHIP TEAM Jennifer Ernst Chief Executive Officer, MBA Founded company in 2016, built Tivic Health from founding to IPO in 5 years; first medical product in market in 3 years. Took prior company (Thin Film Electronics ASA) from 8-person R&D company to $480MM market cap as CEO of US subsidiary. International business development acumen. Blake Gurfein, Ph.D. Chief Scientific Officer Joined 2017. UCSF Neurosurgery Faculty. Neurotechnology thought leader with 5 previous products. Named 40 under 40 by Silicon Valley Business Journal. Journal publications cited more than 1500 times. Expertise in clinical, regulatory, commercialization, and intellectual property strategy. Kimberly Bambach Chief Financial Officer (Interim) Joined 2023. 30 years of financial leadership experience in public and private companies. Recently served as Chief Financial Officer of Jushi Holdings Inc., driving over a dozen acquisitions in 18 months. Experience in consumer, medical, ecommerce, retail and media.

. Investment Highlights TIVIC HEALTH Commercial-stage in Bioelectronic Medicine, field projected to grow at 35% CAGR 2019-20291 One of the most promising new fields of medicine. FDA-approved product in market targeting $9.1B addressable market2First product (ClearUP) targets inflammation of sinus passages, proof source from which to build neuromodulation lines. New results on vagus nerve stimulation, which form basis for future growthVagus nerve is a high-value target for medical applications. Tivic’s low-current, non-invasive approach has recently shown potential applications in cardiology, neurology, and psychiatry.3 Significant R&D inflection points within next 6 monthsClinical read-outs on two research programs expected within next 6 months, including first published data from new area of Vagus Nerve Stimulation. Strong fundamental IP: 9 issued patents, 10 patents pending US, Europe, China, and others, issuance dates beginning in 2020. IP covers all factors that make trigeminal nerve stimulation effective, comfortable and easy to use. Recently filed VNS IP covers fundamental differentiation in stimulation circuitry and method. Experienced management teamBackgrounds include growth through organic R&D, strategic partnerships, licensing, M&A and joint ventures. References provided in Appendix

Jennifer Ernst CEO, Tivic Health jennifer.ernst@tivichealth.com

APPENDIX: FOOTNOTES NON-INVASIVE NERVE STIMULATION Wilson-Pauwels, L., Akesson, E. J., Stewart, P. A. Cranial Nerves: Anatomy and Clinical Comments. B. C. Decker, 1998. Maul, Ximena A., et al. "Microcurrent technology for rapid relief of sinus pain: a randomized, placebo‐controlled, double‐blinded clinical trial." International forum of allergy & rhinology. Vol. 9. No. 4. 2019. Fischer, Laurent, et al. "Adrenergic and non-adrenergic vasoconstrictor mechanisms in the human nasal mucosa." Rhinology 31.1 (1993): 11-15. Mandel, Yossi, et al. "Vasoconstriction by electrical stimulation: new approach to control of non-compressible hemorrhage." Scientific reports 3.1 (2013): 1-7. Franco, O.S., et al. “Effects of different frequencies of transcutaneous electrical nerve stimulation on venous vascular reactivity.” Brazilian Journal of Medical and Biological Research 47.5 (2014): 411-418. Malm, L. “Stimulation of sympathetic nerve fibres to the nose in cats.” Acta otolaryngologica 75.2-6 (1973); 519-526. Fischer, Laurent, et al. “Adrenergic and non-adrenergic vasoconstrictor mechanisms in the human nasal mucosa.” Rhinology 31.1 (1993): 11-15. https://americanmigrainefoundation.org/resource-library/what-is-migraine/; Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23 Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar https://tmj.org/living-with-tmj/basics/ https://my.clevelandclinic.org/health/diseases/14164-tinnitus https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Trigeminal-Neuralgia https://jamanetwork.com/journals/jamapediatrics/fullarticle/2759422 Johnson, Rhaya L., and Christopher G. Wilson. "A review of vagus nerve stimulation as a therapeutic intervention." Journal of inflammation research (2018): 203-213. IBID Toffa, Dènahin Hinnoutondji, et al. "Learnings from 30 years of reported efficacy and safety of vagus nerve stimulation (VNS) for epilepsy treatment: a critical review." Seizure 83 (2020): 104-123. Badran, Bashar W., and Christopher W. Austelle. "The future is noninvasive: a brief review of the evolution and clinical utility of vagus nerve stimulation." Focus 20.1 (2022): 3-7. SIGNIFICANT WHITESPACE IN MEDICAL GRADE, NON-INVASIVE VNS THERAPEUTIC DEVICES Information on clinical stage, approvals, and target indications from individual company websites. LARGE, CLINICALLY MEANINGFUL CHANGES IN BRAIN ACTIVITY McLoughlin, Gráinne, et al. "Midfrontal theta activity in psychiatric illness: an index of cognitive vulnerabilities across disorders." Biological psychiatry 91.2 (2022): 173-182. 4. Hughes, John R. "Gamma, fast, and ultrafast waves of the brain: their relationships with epilepsy and behavior." Epilepsy & Behavior 13.1 (2008): 25-31. TIVIC BUSINESS SNAPSHOT See Investment Highlights: Footnote 2 Maul, Ximena A., et al. "Microcurrent technology for rapid relief of sinus pain: a randomized, placebo‐controlled, double‐blinded clinical trial." International forum of allergy & rhinology. Vol. 9. No. 4. 2019. Mandel, Yossi, et al. "Vasoconstriction by electrical stimulation: new approach to control of non-compressible hemorrhage." Scientific reports 3.1 (2013): 1-7. INVESTMENT HIGHLIGHTS IDTechEx Bioelectronic Medicine, 2019-2029. https://markets.businessinsider.com/news/stocks/growth-of-non-invasive-peripheral-nerve-stimulation-technologies-supported-by-positive-results-idtechex-finds-1029798202 Multiple billion-dollar segments: Data from publicly available census information (that has not been independently verified by the company) combined with company sponsored market research study of 2000+ people with recurring sinus conditions (conducted by consumer research firm, Intellego Insights). Intellego Intelligence conducted a 2000-person market segmentation study that identified the following addressable markets in the United States, based on the Company’s current pricing structure for ClearUP Individuals with severe sinus conditions representing a $0.9 billion addressable market, of which the Company has achieved less than 0.002% penetration Allergy sufferers seeking to avoid pharmaceutical side effects, representing $1.2 billion addressable market, of which the Company has achieved less than 0.002 penetration. High-performance athletes seeking improved breathing to enhance performance, representing a $2.4 billion addressable market that the Company has not yet targeted. CPAP and Sleep Apnea sufferers for whom congestion is a significant contributing factor to lack of quality sleep and/or CPAP compliance, representing a $0.6 billion addressable market. Individuals for whom sinus conditions cascade into severe headaches and migraine, representing a $4.0 billion addressable market. Claims for migraine would require separate FDA submissions beyond the Company’s currently approved indications. Unpublished data from clinical research program at The Feinstein Institutes for Medical Research at Northwell Health LEVERAGING CORE COMPETENCIES IN NEW HIGH-VALUE TARGET Johnson, Rhaya L., and Christopher G. Wilson. "A review of vagus nerve stimulation as a therapeutic intervention." Journal of inflammation research (2018): 203-213. Toffa, Dènahin Hinnoutondji, et al. "Learnings from 30 years of reported efficacy and safety of vagus nerve stimulation (VNS) for epilepsy treatment: a critical review." Seizure 83 (2020): 104-123. Badran, Bashar W., and Christopher W. Austelle. "The future is noninvasive: a brief review of the evolution and clinical utility of vagus nerve stimulation." Focus 20.1 (2022): 3-7. LARGE, CLINICALLY MEANINGFUL INCREASE IN RMSSD Laborde, Sylvain, Emma Mosley, and Julian F. Thayer. "Heart rate variability and cardiac vagal tone in psychophysiological research–recommendations for experiment planning, data analysis, and data reporting." Frontiers in psychology 8 (2017): 238557. Kharbanda, Rohit K., et al. "Vagus nerve stimulation and atrial fibrillation: revealing the paradox." Neuromodulation: Technology at the Neural Interface 25.3 (2022): 356-365. Jarczok, Marc N., et al. "Heart rate variability in the prediction of mortality: A systematic review and meta-analysis of healthy and patient populations." Neuroscience & Biobehavioral Reviews 143 (2022): 104907. Toffa, Dènahin Hinnoutondji, et al. "Learnings from 30 years of reported efficacy and safety of vagus nerve stimulation (VNS) for epilepsy treatment: a critical review." Seizure 83 (2020): 104-123. Badran, Bashar W., and Christopher W. Austelle. "The future is noninvasive: a brief review of the evolution and clinical utility of vagus nerve stimulation." Focus 20.1 (2022): 3-7. WHY THIS MATTERS Toffa, Dènahin Hinnoutondji, et al. "Learnings from 30 years of reported efficacy and safety of vagus nerve stimulation (VNS) for epilepsy treatment: a critical review." Seizure 83 (2020): 104-123. Badran, Bashar W., and Christopher W. Austelle. "The future is noninvasive: a brief review of the evolution and clinical utility of vagus nerve stimulation." Focus 20.1 (2022): 3-7. SUSTAINED PUPIL CONSTRICTION DURING STIMULATION McDougal, David H., and Paul D. Gamlin. "Autonomic control of the eye." Comprehensive physiology 5.1 (2015): 439. THE BIG IDEA: BIOELECTRONIC MEDICINE https://www.mckinsey.com/industries/life-sciences/our-insights/bioelectronics-jump-start-the-next-wave-of-device-therapeutics

Document And Entity Information	May 17, 2024
Cover [Abstract]
Document Type	8-K
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Document Period End Date	May 17, 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	25821 Industrial Blvd.,
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Hayward
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94545
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