Tivic Health Reports Findings of Clinical Optimization Trial of Non-Invasive Cervical Vagus Nerve Stimulation (ncVNS)
Rhea-AI Summary
Tivic Health (NASDAQ:TIVC) reported results from a collaborative clinical optimization study with The Feinstein Institutes showing personalization of non-invasive cervical vagus nerve stimulation (ncVNS) parameters strongly affected autonomic outcomes on November 13, 2025.
Key findings: personalizing stimulation frequency produced a 46% increase in heart rate variability (HRV) and was 8.9x more effective than a fixed frequency; optimal frequency varied between visits; electrode placement and configuration materially changed HRV; and 4 minutes of stimulation outperformed 20 minutes.
The study used healthy subjects and the company said the data may inform development for multiple patient populations.
Positive
- Personalized frequency produced 46% HRV increase
- Personalization was 8.9x more effective than fixed frequency
- 4-minute stimulation yielded larger HRV gains than 20 minutes
- Electrode placement reliably altered autonomic response
Negative
- Optimal stimulation frequency varied between visits, adding operational complexity
- Study conducted in healthy subjects, limiting immediate clinical inference
News Market Reaction – TIVC
On the day this news was published, TIVC declined 7.14%, reflecting a notable negative market reaction. Argus tracked a trough of -33.4% from its starting point during tracking. Our momentum scanner triggered 14 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $292K from the company's valuation, bringing the market cap to $4M at that time. Trading volume was elevated at 2.8x the daily average, suggesting increased selling activity.
Data tracked by StockTitan Argus on the day of publication.
The study demonstrated that personalizing the stimulation parameters to each user dramatically enhanced autonomic effects
FREMONT, CA / ACCESS Newswire / November 13, 2025 / Tivic Health Systems, Inc. (Nasdaq:TIVC), a diversified immunotherapeutics company, announced today it has optimized key device and treatment parameters including frequency, amplitude, electrode positioning, and duration of stimulation as a result of its collaborative study with The Feinstein Institutes for Medical Research at Northwell Health.
Physiological measurements taken before, during, and after ncVNS treatment found the following:
Personalizing the frequency of ncVNS stimulation to each study subject resulted in a
46% increase in heart rate variability, which was 8.9x more effective than applying the same frequency to all subjectsThe optimal ncVNS frequency for each subject was found to be different between visits, indicating the importance of personalizing the stimulation parameters before each treatment
Certain placement and configurations of electrodes were found to be more effective than others, with some placements increasing heart rate variability and others markedly reduce heart rate variability
Four minutes of ncVNS stimulation was sufficient to drive a large increase in heart rate variability and was more effective than twenty minutes of stimulation.
While previous studies of non-invasive VNS devices have reported mixed results for autonomic nervous system changes, Tivic's study demonstrated that specific parameters could reproducibly impact outcomes.
"What makes our findings so compelling is that they advance the field of neurostimulation by underscoring the importance of stimulation frequency personalization, laterality and placement of stimulation electrodes, and duration of treatment," stated Jennifer Ernst, CEO of Tivic Health. "While these results were in healthy subjects, this data combined with our past studies suggest our ncVNS approach may have clinical utility in several very large patient populations including ischemic stroke, post-traumatic stress disorder, and inflammatory diseases, among others."
Ernst continued, "Our mission is to harness the immune system to improve clinical outcomes and save lives. We are energized by these results and we believe that this new data will enable us to unlock valuable new opportunities that can be developed either in house or with partners as funding is allocated across a growing pipeline of late-, mid- and early stage product candidates."
About Tivic Health Systems, Inc.
Tivic's dual platform utilizes the body's biopharmaceutical and bioelectronic systems to treat unmet medical needs through targeting the immune system.
Tivic's biologics compounds activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The company's lead drug candidate, Entolimod™ for acute radiation syndrome, is a novel TLR5 agonist that has been granted Fast Track and Orphan Drug designations and is in late-stage development.
Tivic's bioelectronic program is developing a novel, non-invasive medical device designed to target the neural pathways implicated in many prevalent and debilitating diseases. Early trials show promising signals that Tivic's approach may regulate specific biologic responses, and the company believes its early-stage vagus nerve stimulation device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted devices. To learn more about Tivic, visit: https://ir.tivichealth.com.
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 interactions with and guidance from the FDA and other regulatory authorities; changes to the company's relationship with the its partners; timing and success of clinical trials and study results; the indications for which the company's ncVNS approach may ultimately be found to have clinical utility based on additional studies and trials; the company's ability to unlock new opportunities for the further development of its ncVNS platform; the 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; regulatory requirements and pathways for approval; the company's ability to successfully commercialize its product candidates in the future; the potential opportunities that may be available to the company and its product candidates in the future; 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. 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, 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 Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.
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Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Media Contact:
Deanne Eagle or Laura Min Jackson
media@tivichealth.com
SOURCE: Tivic Health Systems
View the original press release on ACCESS Newswire
FAQ
What did Tivic Health announce about ncVNS optimization on November 13, 2025 for TIVC?
How long should ncVNS stimulation be according to the Tivic TIVC study?
Does Tivic’s TIVC study say electrode placement matters for ncVNS?
Will Tivic’s TIVC ncVNS results apply directly to patients with stroke or PTSD?
Did Tivic report consistent optimal ncVNS frequency across visits for TIVC?
Who collaborated with Tivic Health on the ncVNS optimization study for TIVC?
