Latest news with #TivicHealth®Systems
Associated Press
06-03-2025
- Health
- Associated Press
Tivic Health and Feinstein Institute Present New Data Showing Personalized Vagus Nerve Stimulation Method Optimizes Impact on Autonomic Nervous System
Tivic Health ® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today new data that shows personalizing its non-invasive vagus nerve stimulation (ncVNS) method optimized the stimulation's impact on autonomic nervous system activity. Tivic Health believes these findings strongly support its strategy to develop highly personalized neuromodulation devices that can better address inflammatory, cardiac and neurologic disorders compared to current, more invasive treatment options. The data were presented in a poster presentation, titled, ' Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation, ' at the Sixth Bioelectronic Medicine Summit, March 4 & 5. The findings were based on Tivic's collaboration with The Feinstein Institute of Medicine, one of the global scientific leaders in bioelectronic medicine. 'These promising findings reinforce Tivic's premise that non-invasive bioelectronic devices can effectively treat inflammatory, cardiac and neurologic disorders without invasive surgeries or pharmaceuticals - both of which carry burdensome side effects,' said Jennifer Ernst, CEO of Tivic Health. 'With these new data secured with pending patents, we believe that we have demonstrated the potential for developing personalized, scalable bioelectronic therapies to treat patients in need.' Tivic Health's poster presentation, titled, ' Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation, ' highlighted a novel ncVNS approach and its ability to modulate autonomic nervous system (ANS) function and brain activity. Key results included: Personalized stimulation approach for optimal autonomic modulation: No single stimulation frequency had a universally dominant effect on HRV, highlighting the need for personalized neuromodulation strategies. Choosing the optimal ncVNS stimulation frequency for each study subject resulted in a meaningful increase in effect size of HRV change, paving the way for patient-specific therapy. Significant increase in heart rate variability (HRV), indicating enhanced parasympathetic activity: In 60% of participants (responders), raw HRV nearly doubled on average following ncVNS stimulation. Normalized HRV increased 2.67x post-stimulation, suggesting a strong activation of vagal tone and improved autonomic balance. The data presented resulted from Tivic's ongoing collaboration with the Feinstein Institute of Bioelectronic Medicine to advance high-precision vagus nerve stimulation in a non-invasive form factor. About The Bioelectronic Medicine (BEM) Summit The BEM Summit is a premier gathering of industry leaders, researchers, and clinicians exploring cutting-edge neurotechnologies and neuromodulation therapies. Hosted by the Feinstein Institutes for Medical Research, the event brings together experts in bioelectronic medicine, autonomic neuroscience, and inflammation research to discuss the latest advancements in the field. 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 division is developing non-invasive medical devices that personalize key stimulation parameters for the vagus nerve to deliver meaningfully improved effects on measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. Tivic Health's biopharma division's lead product candidate is the TLR5 agonist, Entolimod™, which is in late-stage studies to treat acute radiation syndrome. The FDA has granted Fast Track and Orphan Drug designation to Entolimod™. Tivic Health already has an FDA-approved over-the-counter device, ClearUP™ that treats 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 changes to the company's relationship with the Feinstein Institute, future development of the company's ncVNS treatment, changes to the company's business strategy, clinical trial and study results, consummation of any strategic transactions, the company's need for, and ability to secure when needed, additional working capital, and the company's ability to maintain its Nasdaq listing. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year 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. Hanover International, Inc. SOURCE: Tivic Health Systems, Inc. Copyright Business Wire 2025. PUB: 03/06/2025 08:15 AM/DISC: 03/06/2025 08:17 AM
Associated Press
05-03-2025
- Business
- Associated Press
Tivic Health Systems, Inc. Announces Reverse Stock Split
Tivic Health® Systems, Inc. (Nasdaq: TIVC) ('Tivic Health' or the 'Company), a diversified therapeutics company, announced today that its Board of Directors has declared a 1-for-17 reverse stock split of the Company's issued and outstanding shares of common stock. The purpose of the reverse stock split is to bring the Company into compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market ('Nasdaq'), and is part of the Company's Compliance Plan, as presented to Nasdaq on February 18, 2025. The reverse stock split was approved by the stockholders of the Company at a special meeting of the Company held on January 31, 2025. The reverse stock split will become effective on March 7, 2025 (the 'Effective Date') at 12:01 AM Eastern Time. The Company's common stock is expected to begin trading on a split-adjusted basis when the markets open on March 7, 2025, under the current Nasdaq trading symbol 'TIVC.' The new CUSIP for the Company's common stock following the reverse split will be 888705308. As a result of the reverse stock split, every 17 shares of the Company's common stock issued and outstanding or held by the Company as treasury stock on the Effective Date will be automatically reclassified into one new share of Company common stock. Proportionate adjustments will be made to the conversion and exercise prices and the number of shares underlying the Company's preferred stock, outstanding warrants, equity awards and options, and the number of shares reserved under the Company's amended and restated 2021 equity incentive plan. The reverse stock split will not affect the number of shares of preferred stock issued and outstanding, the number of shares of common stock or preferred stock authorized for issuance under the Company's charter or the par value of the Company's common stock or preferred stock. Each stockholder's percentage ownership interest in the Company and proportional voting power will remain materially unchanged, except for changes and adjustments that result from rounding fractional shares into whole shares. The rights and privileges of the holders of shares of common stock will be substantially unaffected by the reverse stock split. No fractional shares will be issued as a result of the reverse stock split. Any fractional shares of common stock resulting from the reverse stock split will be rounded up to the nearest whole share and no stockholders will receive cash in lieu of fractional shares. The reverse stock split will affect all stockholders uniformly and will not alter any stockholder's percentage interest in the Company, except to the extent that the reverse stock split would result in a stockholder owning more common shares as a result of the rounding up to the next whole share for each fractional share. The Company's transfer agent, Equiniti Trust Company ('Equiniti'), is acting as the exchange agent for the reverse stock split. Stockholders who hold their shares in book-entry form or through a bank, broker, or other nominee do not need to take any action in connection with the reverse stock split. Stockholders of record will be receiving information from Equiniti regarding their common stock ownership post-reverse stock split. As previously announced, in December 2024, the Company received a notification letter from the Listing Qualifications Department of Nasdaq notifying the Company that the Staff has determined to delist the Company's common stock from Nasdaq because the Company did not regain compliance with the minimum bid price requirement on or before December 26, 2024, the deadline for doing so, and did not comply with the minimum $4,000,000/$5,000,000 stockholders' equity requirement for initial listing on The Nasdaq Capital Market. The Company appealed the determination, and a hearing was held on February 18, 2025. Although no guarantees can be offered, the Company believes that this reverse stock split will allow it to regain compliance with the Nasdaq continued listing requirements and will enable the Company to maintain its Nasdaq listing. Additional information about the reverse stock split and Tivic Health can be accessed and viewed at the SEC's website, and at the Company's website, 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 division is developing non-invasive medical devices that personalize key stimulation parameters for the vagus nerve to deliver meaningfully improved effects on measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. Tivic Health's biopharma division's lead product candidate is the TLR5 agonist, Entolimod™, which is in late-stage studies to treat acute radiation syndrome. The FDA has granted Fast Track and Orphan Drug designation to Entolimod™. Tivic Health already has an FDA-approved over-the-counter device, ClearUP™ that treats 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'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: Nasdaq's grant of additional time to regain compliance with the minimum bid price requirement; the effectiveness of the reverse stock split; the number of shares of the Company's common stock that will be issued as a result of rounding up fractional shares resulting from the reverse stock split to the nearest whole share, including dilution resulting from such issuances; the price at which the Company's common stock will trade after the reverse stock split is effected; the continued listing of the Company's common stock on the Nasdaq Capital Market; and the Company's financial condition. 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 25, 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 undertakes no duty to update such information except as required by applicable law. SOURCE: Tivic Health Systems, Inc. PUB: 03/05/2025 08:15 AM/DISC: 03/05/2025 08:15 AM
Associated Press
03-03-2025
- Health
- Associated Press
Tivic Health Files Patent For Optimized Electrical Stimulation of the Vagus Nerve
Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health, announced today that it has filed a new patent application with the U.S. Patent Office. Patent No. 63,492,402, entitled ' Method and Apparatus for Electrical Stimulation of the Vagus Nerve,' expands the claims and protection around the technology in advance of potential U.S. Food & Drug Administration approval and commercialization of Tivic's non-invasive cervical vagus nerve stimulation (VNS) device. 'This patent for our VNS technology builds upon the findings from our sponsored research at the Feinstein Institute, which has demonstrated that tailoring key stimulation parameters to each study subject results in a meaningfully improved effect on measures of the autonomous nervous system,' said Blake Gurfein, Tivic Health Chief Scientific Officer. 'When compared with other technologies that apply the same stimulation approach to all patients, we believe this improvement will enable Tivic Health to develop more effective device therapies, which will be a key differentiator and create compelling use cases for the indications we plan to target.' 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 takes a multi-pronged approach to treating the root causes of diseases caused by immune dysregulation and dysautonomia. The combination of bioelectronic and biologic medicines allow Tivic to target disorders and disease via both neural pathways and molecular approaches. 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, Tivic Health's ability to commercialize products arising out of the ncVNS treatment, 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; unexpected costs, charges or expenses that reduce Tivic Health's capital resources; and Tivic Health's ability to maintain its Nasdaq listing. 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. Hanover International, Inc. SOURCE: Tivic Health Systems, Inc. Copyright Business Wire 2025. PUB: 03/03/2025 08:15 AM/DISC: 03/03/2025 08:15 AM
