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Provides updates on vagus nerve stimulation (VNS) program and expectations for 2025

FREMONT, Calif. – December 23, 2024 – Tivic Health® Systems, Inc. (Nasdaq: TIVC), a health tech company developing and commercializing bioelectronic medicine, today released its annual CEO letter to shareholders.

Dear Fellow Shareholders:
As we conclude 2024 and look forward to 2025, I’d like to take this  opportunity to recap some of the important developments this year and share some of our expectations for 2025.

Improvements in Commercial Business:

  • We launched ClearUP 2.0, resulting in improved customer experience and  correcting technical issues that had surfaced in late 2023.
  • We saw go-to-market partnerships with McKesson and Cardinal Health accelerating dramatically in the second half of the year.
  • Improvements in both customer engagement and the product itself drove customer reviews to 4.4 Stars and significantly reduced defect-related returns.
  • We continued optimizing our marketing mix to improve marketing  effectiveness and reach.
  • We restructured our supply chain establishing a recurring gross margin greater than 65% in our direct-to-consumer (D2C) channels, which makes up the bulk of our business. A marked change from the less than 28% aggregate gross margin we reported in 2023.

Tivic’s Future is in Vagus Nerve Stimulation (VNS)

While we continue to improve the performance of our commercial business, some of the most important news this year pertains to our focused entry into Vagus Nerve Stimulation (VNS).

VNS has been steadily emerging as a transformative technology in medicine, mostly based on surgically implanted simulators. Polaris Research forecasts that the VNS market will be worth $21B in the next five years, growing at a CAGR of 10.6%. Implanted stimulators have been approved for— or are  nearing approval for—treatment of depression, epilepsy, chronic stroke  rehabilitation and rheumatoid arthritis in the US and additional conditions overseas. The companies behind these devices are driving both practitioner awareness and adoption and reimbursement pathways.

Our strategy is to build on this momentum, focusing on achieving the same or better results using non-invasive stimulation approaches. Our non-invasive cervical approach to VNS (ncVNS) offers a less capital-intensive pathway to market while generating similar biological and clinically meaningful effects. In fact, our non-invasive VNS system has shown best-in- industry effects on outcomes like heart rate variability and achieved  comparable-to” or “better-than” results when compared to invasive  implants.

In May 2024, we completed a pilot study with the Feinstein Institute of  Bioelectronic Medicine and demonstrated that our ncVNS approach was able to drive clinically meaningful changes in brain, cardiac, and nervous system activity, consistent with vagus nerve engagement.

We are now underway with our second collaborative study that is designed to further optimize ncVNS parameters and their impact on vagus nerve activation.  This includes electrode positioning, frequency, and amplitude of stimulation. Results thus far have been positive, increasing confidence as we plan to move into clinical trials with the target populations of medical interest in 2025.

These investments to tune the device specifications have both yielded meaningful improvements in efficacy markers and created new intellectual property (IP) that we are protecting on a global scale. The study has been fully enrolled and data from the study will be announced following study
completion next year.

In parallel with our clinical work, we have worked with seasoned advisors to aggressively evaluate the VNS landscape. This in-depth analysis has involved both primary and secondary research and uncovered targeted opportunities for our ncVNS approach exceeding $30B in annual market opportunity.

Today, Tivic has a robust U.S. and international IP portfolio that includes a total of 16 issued patents and 10 pending patents spanning the U.S., Europe, India and China. We expect to continue to grow this base, for broad international protection of our innovations.

We are confident that our investment in research and development, combined with a deep understanding of the regulatory processes,  commercial drivers and medical needs, will serve us well as we transform Tivic to drive greater degrees of success.

Equally as important, we are seeing positive trends in the industry as a whole. Industry awareness of VNS and the accompanying insurance coverage continues to improve. We expect that patient demand for these drug-free therapeutics, supported by appropriate financial access, will accelerate as information about VNS makes its way into mainstream media. VNS and bioelectronic medicine more broadly are expected to play a  growing role in the future of healthcare.

Looking back at 2024:

  • We announced best-of-breed results in a field new to Tivic Health
  • We demonstrated clinically meaningful benefits from innovations in non-invasive VNS that parallel or exceed those of approved implanted devices, based on key biometric markers.
  • We expanded our partnership with The Feinstein Institute of Bioelectronic Medicine, one of the preeminent academic institutes in the field.
  • We filed new intellectual property and received our first international patents.

Company Priorities for 2025

Looking at both the improvements in the base business and the advances we made with vagus nerve stimulation (VNS), we have a lot to be proud of in 2024.

I am even more pleased we accomplished all of this while slashing our net operating loss by more than 30%.

As we look to 2025,

  • We are exploring new opportunities to increase cash flow generated by the ClearUP business.
  • We look forward to completing the current work with Feinstein Institute of Bioelectronic Medicine.
  • We are charting disease-specific clinical trials, moving the company closer to securing regulatory approvals for what we expect will be life-changing  treatments for patients in need.
  • We look forward to talking in more detail about the specific target indications as we advance into the next stage of clinical trial work in 2025.

We anticipate that the advancement of our clinical programs for ncVNS will be key to increasing long-term shareholder value. In addition, the board and I continue to evaluate a range of options to maximize shareholder returns,  including taking the necessary steps to ensure we regain Nasdaq listing  compliance.

I would like to recognize the exceptional efforts of the lean and dedicated Tivic Health team. I thank them for their relentless drive and hard work. Together, with our investors, collaborators, and supporters, we are striving to build a company that can transform the future of medicine and make a lasting, positive impact on the lives of people around the world.

We are excited about the opportunities that lie ahead, and we look forward to continuing this journey with all of you in 2025.

Sincerely,

Jennifer Ernst
Chief Executive Officer

About Tivic Health

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

Forward-Looking Statements

This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the future development of ncVNS treatment; Tivic Health’s ability to commercialize products arising out of the ncVNS treatment and Tivic Health’s plans to seek regulatory approval for such clinical products; Tivic Health’s continued focus on developing 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; Tivic Health's ability to raise additional capital on favorable terms, or at all, when needed; Tivic Health's ability to maintain its Nasdaq listing; 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.

Investor Contact:

Hanover International, Inc.

ir@tivichealth.com ...Read More

 Pre-recorded Conference Call to Follow at 1:30 p.m. PDT/4:30 p.m EDT

FREMONT, Calif.– November 14, 2024 – Tivic Health® Systems, Inc. (Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced third quarter and nine-months ended September, 30, 2024 financial results and discussed growth strategies based on its novel, patent-pending vagus nerve stimulation (VNS) science and device technology.

“This quarter we made significant progress on each of the three prongs of our strategy for delivering shareholder value," stated Jennifer Ernst, CEO of Tivic Health. "The first prong is the aggressive steps we have taken to improve the economics of the ClearUP product line -- our commercially available handheld, trigeminal nerve stimulation device for sinus and allergy conditions. This quarter, we completed the redesign of our supply chain,  and, net of one-time costs, saw upwards of 70% gross margin in the months following the transition.

"The second leg, and most important element of our strategy, is our development of a non-invasive vagus nerve stimulation system that has the potential to catalyze Tivic's  long-term value. In a Phase 1 trial earlier this year, we demonstrated clinically meaningful changes in autonomic, cardiac and neurologic systems using a patent-pending approach to non-invasive VNS. This positions the company to enter significantly higher value markets. This quarter we began the clinical optimization of our system, working with industry experts at the Feinstein Institute of Bioelectronic Medicine.

"In parallel, we have also engaged a leading growth consulting firm to work closely with our clinical team on prioritizing these high value use cases based on the needs of patients, providers and payers. Already we have identified several multi-billion dollar market opportunities for the program. We expect to reach a significant inflection point in the business in the next twelve months as we build out our VNS medical device program," concluded Ernst.

Third Quarter and Subsequent Weeks Business and Operational Updates

In the third quarter 2024 and subsequent weeks, the company announced the following:

  • Started and completed enrollment of patients in a Phase 1a optimization study designed to identify device parameters that optimally influence autonomic nervous system (ANS) function.
  • Partnered with Fletcher Spaght (FSI), a leading healthcare growth strategy firm, to accelerate development of Tivic's commercial strategy for non-invasive cervical VNS (ncVNS).
  • Appointed Lisa Wolf as interim CFO, effective October 1, replacing Kimberly Bambach, who will continue to provide special project work and strategic consulting to the company.
  • Completed supply chain redesign to drive increased profitability of ClearUPTM product line. 

Financial Performance

  • Revenue (net of returns) for the three and nine months ended September 30, 2024 was $126,000 and $600,000, respectively, a decrease of $219,000, or 27%, compared with the first nine months of 2023 primarily due to a 36% decrease in unit sales, offset by a 13% increase in the per unit average sales price.
  • Cost of sales for the three and nine months ended September 30, 2024 was $82,000 and $359,000, respectively, a decrease of $178,000, or 34%, compared with the first nine months of 2023.
  • Gross profit in the three and nine months ended September 30, 2024 was $44,000 and $241,000, respectively, compared with $108,000 and $282,000 in 2023.
  • Total operating expenses year to date 2024 were reduced by $1.9 million compared to the nine months ended September 30, 2023. For three months ended September 30, 2024 operating expenses totaled $1.5 million, down from $1.9 million a year ago. For the nine months ended September 30, 2024 total operating expenses were $4.4 million, down from $6.3 million in 2023.
  • During the three months ended September 30, 2024 company incurred a net loss of $1.4 million, compared with $1.8 million for the same period in 2023. Net loss for the first nine months of 2024 was $4.2 million, a decrease of $1.8 million compared to the same period in 2023.
  • At September 30, 2024 cash and cash equivalents totaled $2.2 million, compared with $3.4 million at December 31, 2023. During October and November 2024, the Company raised net proceeds of $775,000 through sales of common stock pursuant to an Equity Distribution Agreement. 

Conference Call and Webcast Information

Management will host a webcast/conference call today, November 14, at 1:30 PM PST / 4:30 PM EST to discuss the company’s third quarter 2024 financial results and provide a business update.

Conference Call Details:

Toll Free: 877-545-0523

International: 973-528-0016

Access Code: 507355

Webcast Link

https://www.webcaster4.com/Webcast/Page/2865/51524

An audio replay of the call will be available for the next 90 days from the investor page on the Tivic Health website at https://tivichealth.com/investor/.

About Tivic Health

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

Forward-Looking Statements

This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the future development of ncVNS treatment; Tivic Health’s ability to commercialize products arising out of the ncVNS treatment and Tivic Health’s plans to seek regulatory approval for such clinical products; Tivic Health’s continued focus on developing 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; Tivic Health's ability to raise additional capital on favorable terms, or at all, when needed; Tivic Health's ability to maintain its Nasdaq listing; 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 ...Read More

Articles

Tivic Health: Christina Valauri Appointed to Board of Directors

By Ryan Sabia

June 18, 2024

Wall Street Capital Markets Veteran and Recognized All-Star Bio-Medical Technology Analyst joins Tivic Health's Governance Team

SAN FRANCISCO - Tivic Health® Systems, Inc. ("Tivic Health", Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, is pleased to welcome Christina Valauri to its board of directors, effective July 1, 2024.

Ms. Valauri has served as a strategic advisor to the company since April 2023, and brings over 30-years of experience as a seasoned capital markets professional with extensive analytical and management experience. Ms. Valauri has a proven track record as a senior healthcare analyst, US and Global Head of Equity Research, senior broker-dealer manager, strategic business consultant, and board director and advisor. As a managing director and senior manager within capital markets, she has successfully developed and executed transformational business strategies in the US and internationally to drive growth, and provide enhanced operating performance and comprehensive regulatory and supervisory oversight. She has held leadership roles at US and international firms, including as the Global Director of Research at Cantor Fitzgerald, and senior research management roles at Credit Lyonnais, ING and Natixis.

Ms. Valauri's career in equity securities research expands the Tivic boards' deep expertise in pharmaceutical, biotech, and med-tech industries. She has extensive experience identifying and analyzing the commercial potential of breakthrough innovations, as well as mentoring and advising C-suite teams of private and public early-stage healthcare companies through product development, regulatory, go-to-market strategies, potential mergers and acquisitions, and IPOs.

Ms. Valauri currently serves as an Entrepreneur in Residence at Weill Cornell Medicine BioVenture eLab, where she applies her skills and experience in life sciences and business. She supports and facilitates the organization's mission to foster an entrepreneurial ecosystem related to the innovations of researchers and clinicians. Ms. Valauri is the founder and CEO of Sagestone Advisory, LLC., and also serves as a senior advisor with Hanover International, Inc. and Astia.org. She has been recognized by The Wall Street Journal's "Best on The Street" All-Star Analyst Survey and has received the Award for Excellence in Medical Education Public Affairs - Association of American Medical Colleges. Ms. Valauri earned her BA in Biology from Reed College and an MBA from Cornell University.

"Over the past year, as an advisor to our Board and the company, Christina Valauri has demonstrated deep commitment to excellence and the highest standards of ethical governance. This, paired with her insight into capital markets and deep background in research analysis, is a powerful combination to help ensure we make the best decisions for the company, our customers and our shareholders," stated Sheryle Bolton, Chair of the Board.

"I could not be more excited that Christina has agreed to serve on our board of directors, particularly as we forge new segments in our bioelectronic portfolio, focused on precision modulation of vagus nerve activity," shared Jennifer Ernst, Chief Executive Officer of Tivic Health.

Additionally, independent director, Karen Drexler, tendered her resignation from the board and the committees thereof, effective September 30, after which she will be continuing with the company as a strategic advisor. Ms. Drexler previously served as an advisor to the company from August 2017 through August 2019 when she joined Tivic Health's board as the company's first independent director. Ernst continued, "Karen was an instrumental force in the early formation of Tivic Health. I deeply appreciate her commitment to Tivic Health's development for the past eight years and her continued support as a strategic advisor to the company."

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 expansion of Tivic Health's product portfolio; changes in board composition; Ms. Drexler's service as an advisor to the company; market and other conditions; 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

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Tivic Health Announces Launch of New and Improved ClearUP 2.0

By Ryan Sabia

January 8, 2024

SAN FRANCISCO - Tivic Health® Systems, Inc. ("Tivic") (Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, announced today the launch of the second generation of Tivic ClearUP. The new and improved Tivic ClearUP 2.0, now with a new chip for power management for faster charge and longer battery life, is available starting today on TivicHealth.com.

ClearUP 2.0 is a clinically proven way to clear congestion and relieve sinus pain. It is an FDA-approved, 100% drug-free and non-addictive way to reduce sinus pain, pressure, sinus headaches, and congestion due to colds, flu, and allergies.

Based on clinical trials of ClearUP:

  • 88% of subjects see meaningful improvement in congestion symptoms

  • 74% experience pain relief on the first use

  • 82% prefer ClearUP to other sinus treatments

  • 10 minutes after treatment, patients reported relief of sinus pain

ClearUP provides an effective, non-invasive and drug-free alternative to over-the-counter medications, using gentle microcurrents to treat symptoms of sinus and nasal inflammation. The bioelectronic device locates treatment points along the cheek, nose and brow and emits gentle microcurrent stimulation for precise, targeted relief that you control. There is no mess, pills or sprays, and its ergonomic design fits in the palm of your hand so you can bring it everywhere you go and experience relief from sinus pain anytime, anywhere. The use of neuromodulation devices is growing throughout the medical industry, offering a new method of helping patients who do not respond to existing remedies.

About Tivic

Tivic Health Systems, Inc. is a commercial-phase health technology company delivering non-invasive bioelectronic treatments that provide consumers with a choice in the treatment of inflammation and certain other related conditions. For more information visit https://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: unknown or unexpected defects with the new ClearUP 2.0 design; market and other conditions; supply chain constraints; macroeconomic factors; and unexpected costs, charges or expenses that reduce Tivic's capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic's actual results to differ from those contained in the forward-looking statements, see Tivic's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31, 2023, under the heading "Risk Factors," as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.

Max Borges Agency

Tivic@maxborgesagency.com

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Tivic Health to Report Third Quarter 2023 Financial Results on November 14th Via Conference Call and Webcast

By Ryan Sabia

November 7, 2023

SAN FRANCISCO -
Tivic Health® Systems, Inc. ("Tivic Health", Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced that it will report financial results for the third quarter 2023 via pre-recorded conference call and webcast on Tuesday, November 14th, 2023 at 1:30 PM PT / 4:30 PM ET.

Teleconference Details:

Toll Free: 888-506-0062

International: 973-528-0011

Participant Access Code: 302318

Webcast Link

https://www.webcaster4.com/Webcast/Page/2865/49228

About Tivic

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

Forward-Looking Statements

This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, many of which are out of Tivic's control. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of relevant risks and uncertainties, and other important factors, any of which could cause Tivic's actual results to differ from those contained in the forward-looking statements, see Tivic's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31, 2023, under the heading "Risk Factors"; as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.

Investor Contact:

Hanover International, Inc.

ir@tivichealth.com

...Read More

Tivic Health Announces Proposed Public Offering of Common Stock

By Ryan Sabia

July 14, 2023

SAN FRANCISCO -
Tivic Health® Systems, Inc. ("Tivic", "Company", Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced that it intends to offer and sell shares of its common stock in a public offering. All of the shares of common stock are being offered by Tivic. Tivic intends to use the net proceeds of the offering, if any, for working capital and general corporate purposes. Consummation of the offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Maxim Group LLC is acting as the sole placement agent, on a reasonable best efforts basis, for the offering.

A shelf registration statement on Form S-3 (File No. 333-269494) relating to the securities being offered was filed with the U.S. Securities and Exchange Commission (the "SEC") on February 1, 2023, and became effective on February 8, 2023. The shares may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the public offering have been filed with the SEC and are available on the SEC's website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the public offering may also be obtained by contacting Maxim Group LLC, at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at syndicate@maximgrp.com. Before you invest, you should read the preliminary prospectus supplement and accompanying prospectus, together with the information incorporated by reference therein, for more complete information about Tivic and the proposed offering. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Tivic

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

Forward-Looking Statements

This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering; the company's financial condition; the company's ability to raise additional capital, if and when necessary; clinical trial results for the company's product candidates; market, economic and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic's capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic's actual results to differ from those contained in the forward-looking statements, see Tivic's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31, 2023, under the heading "Risk Factors"; as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.

Media Contact

Kayleigh Westerfield

Kayleigh.Westerfield@tivichealth.com

Investor Contact

Hanover International, Inc.

ir@tivichealth.com

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