Latest news with #TivicHealth
Business Wire
25-06-2025
- Health
- Business Wire
Tivic Health Completes Optimization Study for Its Non-Invasive Vagus Nerve Stimulation Device
FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company developing treatments that stimulate immune pathways to treat disease, today announced it has completed all study visits in the Optimization Study for its patent pending, non-invasive cervical vagus nerve stimulation (ncVNS) device. Initial findings reinforce the importance of personalization for therapeutic efficacy. Tivic expects to release the study results later this year. The study was conducted by The Feinstein Institute of Bioelectronic Medicine with the objective of identifying device parameters that optimally influence autonomic nervous system function. These comprised frequency, amplitude, electrode positioning and personalization, all key parameters previously under-researched, especially for non-invasive VNS treatments. Key findings from the first stages of this study were previously presented in a poster titled, ' Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation, ' at the Sixth Bioelectronic Medicine Summit: Neurotechnologies for Communities & Individuals, on March 4, 2025. 'This study has provided Tivic with key breakthroughs in the scientific understanding of how to most effectively deliver stimulation to the vagus nerve and thereby the modulation of the pathways implicated in many prevalent and debilitating diseases,' stated Tivic Health's Chief Executive Officer, Jennifer Ernst. 'As we prepare to report these new findings, we are more confident than ever that our novel bioelectronic approach to VNS has the potential to form the basis of future compelling and highly differentiated treatments for large patient populations with unmet clinical needs,' added Ernst. Market Opportunity Polaris Market Research estimates the global VNS market will grow from $8.59 billion in 2021 to $21.3 billion in 2030, a 10.6% CAGR over the forecast period. Additionally, IDTechEx has forecast peripheral nerve stimulation, the segment targeted by Tivic Health, will grow at 35% CAGR, one of the fastest growth segments in bioelectronic medicine. About the Vagus Nerve The vagus nerve is the longest autonomic nerve in the body and regulates many organ systems associated with chronic disease. VNS is approved by the US Food & Drug Administration for treatment-resistant epilepsy and depression, cluster and migraine headaches, and stroke rehabilitation. It is being studied for other neurological, cardiac, and immune conditions. However, many of the applications of VNS rely on surgical implants, which are not suitable for many patients. About Tivic Health Systems, Inc. Tivic Health seeks to treat underserved medical conditions through biochemical and bioelectric therapies that modulate patients' immune system. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™ to treat ARS, has been granted Fast Track and Orphan Drug designation by the FDA. Tivic Health's bioelectronic program is developing non-invasive medical devices that personalize key stimulation to modulate the pathways implicated in many prevalent and debilitating diseases. Tivic Health's first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: 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, including as a result of the company's interactions with and guidance from the FDA and other regulatory authorities; changes to the company's relationship with its partners; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company's business strategy; timing and success of clinical trials and study results, including the ncVNS optimization study with The Feinstein Institute of Bioelectronic Medicine; regulatory requirements and pathways for approval; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, 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 the company undertakes no duty to update such information except as required by applicable law.
Business Wire
24-06-2025
- Business
- Business Wire
Tivic Health Announces 2025 Annual Meeting of Stockholders
FREMONT, Calif.--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today its Virtual Annual General Meeting of Shareholders will be held on Monday, June 30, 2025 at 1:00 PM, Pacific Time | 4:00 PM Eastern Time. The Company has adopted a virtual format for its Annual Meeting to provide a consistent and convenient experience for all stockholders regardless of their location. In lieu of a live Q&A session, stockholders can submit questions for management's consideration through the virtual Annual Meeting platform both before and during the Annual Meeting. Only stockholders of record of shares of Tivic Health's common stock at the close of business on May 14, 2025 are entitled to notice of and to vote at, the Annual Meeting. To attend online and participate in the Annual Meeting, stockholders of record will need to use the control number included on the proxy card they received in the mail to log into the Annual Meeting. Beneficial owners who do not have a control number may gain access to the Annual Meeting by logging into their brokerage firm's website and selecting the stockholder communication mailbox to link through to the Annual Meeting. Instructions should also be provided on the voting instruction card provided by their broker, bank, or other nominee. The company's Proxy Statement, proxy card and Annual Report on Form 10-K for the year ended December 31, 2024, are available on the Internet at: SEC Filings - Tivic Health. About Tivic Health Systems, Inc. Tivic Health is a diversified immunotherapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic program is focused on developing personalized non-invasive therapeutic devices for vagus nerve stimulation to improve clinical outcomes in inflammatory, neurologic and cardiac disease. The program also includes Tivic Health's first FDA approved product, ClearUP®, which has been proven to provide temporary relief of sinus pain, pressure and congestion and is available through top-tier online retail and distribution partners. The company's newly formed biopharmaceutical program is focused on commercial advancement of the toll-like receptor 5 drugs Entolimod™ and Entolasta™, including lead product candidate Entolimod for acute radiation syndrome. The company is also driving expansion into additional indications for Entolimod and Entolasta. For more information about Tivic Health, visit: 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. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, 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 the company undertakes no duty to update such information except as required by applicable law.
Yahoo
13-05-2025
- Business
- Yahoo
Tivic Expands VNS Intellectual Property Portfolio
- New patent protects methods for increasing efficacy via personalization of stimulation parameters and electrode positioning - FREMONT, Calif., May 13, 2025--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it is expanding its non-invasive VNS patent portfolio with the filing of a new patent application with the United States Patent and Trademark Office. Patent No. 63,801,058 entitled "Vagus Nerve Stimulation System" expands the claims and protection around the technology that Tivic is developing and which it expects will redefine state-of-the art in non-invasive vagus nerve stimulation. "We continue to build a defensible position for our next generation VNS technology," said Blake Gurfein, Tivic Chief Scientific Officer. "This patent protects key learnings from our VNS optimization study, which is advancing the science of vagus nerve interventions. In fact, we believe we are moving the needle on what will become the state-of-the art treatment approach by delivering much greater and more consistent therapeutic effects compared to what is currently available." Jennifer Ernst, Tivic CEO, stated, "As we continue to advance our VNS program, protecting our proprietary and intellectual property is critical. Tivic's diversified portfolio of bioelectronic VNS and biologic immunotherapies represent a unique breadth of treatments to address health issues where immune system dysregulation is a significant underlying factor." About Tivic Health Systems, Inc. Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic program is developing non-invasive medical devices that personalize key stimulation for the vagus nerve to deliver meaningful improvements in clinically relevant measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™ to treat ARS, has been granted Fast Track and Orphan Drug designation by the FDA. Tivic Health's first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: 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 of ncVNS treatment, the Tivic Health's ability to commercialize products arising out of the ncVNS treatment and the Tivic Health's plans to seek regulatory approval for such clinical products and 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; 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. View source version on Contacts Investor Contact: Hanover International, Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
13-05-2025
- Business
- Business Wire
Tivic Expands VNS Intellectual Property Portfolio
FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health ® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it is expanding its non-invasive VNS patent portfolio with the filing of a new patent application with the United States Patent and Trademark Office. Patent No. 63,801,058 entitled ' Vagus Nerve Stimulation System ' expands the claims and protection around the technology that Tivic is developing and which it expects will redefine state-of-the art in non-invasive vagus nerve stimulation. 'We continue to build a defensible position for our next generation VNS technology,' said Blake Gurfein, Tivic Chief Scientific Officer. 'This patent protects key learnings from our VNS optimization study, which is advancing the science of vagus nerve interventions. In fact, we believe we are moving the needle on what will become the state-of-the art treatment approach by delivering much greater and more consistent therapeutic effects compared to what is currently available.' Jennifer Ernst, Tivic CEO, stated, 'As we continue to advance our VNS program, protecting our proprietary and intellectual property is critical. Tivic's diversified portfolio of bioelectronic VNS and biologic immunotherapies represent a unique breadth of treatments to address health issues where immune system dysregulation is a significant underlying factor.' About Tivic Health Systems, Inc. Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic program is developing non-invasive medical devices that personalize key stimulation for the vagus nerve to deliver meaningful improvements in clinically relevant measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™ to treat ARS, has been granted Fast Track and Orphan Drug designation by the FDA. Tivic Health's first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: 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 of ncVNS treatment, the Tivic Health's ability to commercialize products arising out of the ncVNS treatment and the Tivic Health's plans to seek regulatory approval for such clinical products and 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; 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.
Yahoo
21-03-2025
- Business
- Yahoo
Tivic Reports Year End 2024 Financial Results and Provides Overview of Strategy for Transformation and Growth
Pre-recorded Conference Call and Webcast to Follow Today at 1:30 PM PDT / 4:30 PM EDT FREMONT, Calif., March 21, 2025--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, today announced year end December 31, 2024 financial results, highlighted key developments in its clinical program expansion and discussed progress made across the company's operations. "The important strategic events of the past several months have been nothing short of transformative," stated Tivic Health Chief Executive Officer, Jennifer Ernst. "We have successfully reshaped the company by expanding Tivic's opportunities in the biotech sector by in-licensing a late-stage biologic immunotherapy and advancing our ongoing work on our next-generation non-invasive cervical vagus nerve stimulation (ncVNS) devices. "Our expansion into drug development with our newly licensed TLR5 agonist assets not only gives us a late-stage drug candidate in the target market of treating acute radiation syndrome, or ARS, but also lays the foundation for building a biopharmaceutical program with a robust pipeline focused on immune dysregulation. Simultaneously, work is progressing well on Tivic's ncVNS device program, having recently reported important study results that indicate our patent-pending personalized approach has the potential to treat inflammatory, cardiac and neurologic disorders without the need for invasive surgeries or pharmaceuticals," added Ernst. "As we look further into 2025 and the evolution of the company, our confidence grows as we prepare to move into disease-specific clinical trials for ncVNS later this year. We continue our focus on achieving upcoming key milestones and view this year as one of growth and progress that will continue to reshape Tivic for the benefit of patients in need and shareholders alike," concluded Ernst. In the fourth quarter 2024 and subsequent weeks, the company announced the following developments: Acquired from Statera Biopharma worldwide exclusive license rights to the late-stage TLR5 agonist Entolimod™ for the treatment of acute radiation syndrome (ARS), as well as the exclusive option to license five additional indications for Entolimod™ and its derivative, Entolasta™. Named former CEO, President and Chairman of Statera Biopharma, Michael Handley, to the newly created posts of Chief Operating Officer of Tivic Health and President of Tivic Biopharma. Handley will be responsible for establishing and leading Tivic Health's biopharmaceutical operations. Presented a poster at the Sixth Bioelectronic Medicine Summit showing that personalizing ncVNS resulted in optimized effects on autonomic nervous system activity. Tivic Health believes these findings strongly support its strategy of developing highly personalized neuromodulation devices that will better treat inflammatory, cardiac and neurologic disorders without the need for invasive surgeries or pharmaceuticals, both of which carry side effects and risks. The study is the result of an ongoing research collaboration with The Feinstein Institute for Medical Research. Completed enrollment for the optimization study for Tivic's patent pending, ncVNS device. The results of this study will be combined with the commercial and market research conducted by growth strategy firm, Fletcher Spaght, to inform the selection and prioritization of indications that Tivic expects to advance into disease-specific trials and product development in 2025. Further expanded the scope of the optimization study currently underway for its ncVNS device following positive findings related to achieving enhanced effects on autonomic nervous system function. Expanded its intellectual property portfolio, bringing the total number of patents issued and pending to 27. Separately, Tivic exclusively licensed rights under more than 60 patents from Statera related to Entolimod™ and Entolasta™. Executed a 1-for-17 reverse stock split of the company's issued and outstanding shares of common stock, which commenced trading on a post-split basis on March 7 and resulted in 10 days trading above Nasdaq minimum bid price on March 21. Appointed Lisa Wolf as interim CFO. She brings 30 years of financial leadership experience in both public and private companies across industries including served as chief accounting officer of Nasdaq-listed Resonant, Inc., where she played a pivotal role in the company's growth and successful acquisition in 2022. Invested in and deployed a new e-commerce web infrastructure for ClearUP® to enhance conversation rates, as well as upgraded the Tivic Health investor relations website. Secured access to a $25M equity line of credit to support the company's advance research programs, which, if fully utilized, would fully fund commercialization of Entolimod™. Decreased year-over-year net loss by 30 percent. Financial Results for the Year Ended December 31, 2024: Revenue (net of returns) totaled $0.8 million, compared to $1.2 million, for the year ended December 31, 2023. The decline was primarily due to a decrease in unit sales of 41 percent, in line with reductions in marketing spend. Cost of sales for the year ended December 31, 2024 decreased 12 percent to $0.8 million from $0.9 million for the year ended December 31, 2023, primarily due to the 41 percent decrease in unit sales. Cost of sales for 2024 included inventory reserves of $354,000 compared with inventory reserves of $32,000 in 2023. Additionally, in 2024, the company incurred $21,000 of disposal costs related to returns received prior to the launch of ClearUP 2.0 in early 2024. Gross profit for the year ended December 31, 2024 was $2,000 compared with $287,000 for the year ended December 31, 2023. The lower 2024 gross profit was primarily due to $354,000 in inventory reserves recorded for the year ended December 31, 2024, compared to $32,000 a year ago. Reserves related to excess inventory purchased during supply chain shortages. Total operating expenses for the year ended December 31, 2024 was $5.7 million compared with $8.5 million for the year ended December 31, 2023. Going forward, Tivic plans to increase its research and development investments in its vagus nerve platform and clinical applications and to advance the development of Tivic's licensed TLR5 agonist programs, specifically, Entolimod™ and Entolasta™. Net loss for the year ended December 31, 2024 was $5.7 million, down from $8.2 million for the year ended December 31, 2023. Cash and equivalents at December 31, 2024 totaled $2.0 million, compared with $3.4 million at December 31, 2023. The company had working capital of $2.4 million at year end 2024. Conference Call and Webcast Information Tivic Health will make available a pre-recorded conference call and webcast today at 1:30 PM PDT / 4:30 PM EDT. Teleconference Details:Toll Free: 1-877-407-0779International: 1-201-389-0914Conference ID Code: 13752399 Webcast Link: An audio replay of the call will be available for the next 90 days from the investor page on the Tivic Health website at: About Tivic Health Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic program is developing non-invasive medical devices to meaningfully improve treatment options in neurologic, cardiac and autonomic-related diseases. Tivic Health currently offers a bioelectronic, FDA-approved over-the-counter device, ClearUP®, that treats sinus pain, pressure and congestion. ClearUP® is available through online retailers, commercial distributors and at The bioelectronic portfolio today is primarily focused on non-invasive vagus nerve stimulation. Tivic Health's biologic program focuses on immunotherapeutics and the lead product candidate is the late-stage TLR5 agonist, Entolimod™, to treat acute radiation syndrome. The FDA has granted Fast Track and Orphan Drug designation to Entolimod™. For more information about Tivic Health, visit: 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 Tivic Health's products and product candidates; Tivic Health's plans to seek, and ability to obtain, regulatory approval for its product candidates; timing and progress of clinical development of its product candidates; Tivic Health's ability to commercialize products arising out of its ncVNS program and TLR5 program; Tivic Health's continued focus on developing its ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility of its product candidates, including which patient populations may be pursued; market and other conditions; macroeconomic factors, including tariffs and economic uncertainty arising from geopolitical tensions; 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; uncertainties of intellectual property protection and litigation; 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, 2024, which will be filed with the SEC on or about March 21, 2025, under the heading "Risk Factors"; as well as the company's other 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. Tivic Health Systems, Inc. Condensed Balance Sheets (in thousands, except share and per share data) December 31, 2024 December 31, 2023 ASSETS Cash and cash equivalents $ 2,002 $ 3,395 Other current assets 637 1,257 TOTAL CURRENT ASSETS 2,639 4,652 PROPERTY AND EQUIPMENT, NET 119 122 NONCURRENT ASSETS 49 383 TOTAL ASSETS $ 2,807 $ 5,157 LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable and accrued expenses $ 272 $ 1,208 Other current liabilities — 193 TOTAL CURRENT LIABILITIES 272 1,401 TOTAL LONG-TERM LIABILITIES — 176 STOCKHOLDERS' EQUITY Common stock 1 — Additional paid in capital 46,075 41,466 Accumulated deficit (43,541 ) (37,886 ) TOTAL STOCKHOLDERS' EQUITY 2,535 3,580 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 2,807 $ 5,157 Tivic Health Systems, Inc. Condensed Statements of Operations (in thousands, except share and per share data) Year Ended December 31, 2024 2023 REVENUES $ 780 $ 1,176 COST OF SALES 778 889 GROSS PROFIT 2 287 OPERATING EXPENSES Research and development 1,313 1,655 Sales and marketing 1,187 2,125 General and administrative 3,163 4,752 TOTAL OPERATING EXPENSES 5,663 8,532 NET OPERATING LOSS (5,661 ) (8,245 ) NET LOSS $ (5,655 ) $ (8,244 ) NET LOSS PER SHARE - BASIC AND DILUTED $ (19.68 ) $ (176.80 ) WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED 287,370 46,650 View source version on Contacts Investor Contact:Hanover International,
