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

Insights

Clinical Neurophysiology Expert

Personalized ncVNS parameters markedly increased autonomic response in healthy subjects; reproducible parameters identified for frequency, placement, and duration.

Tivic Health and The Feinstein Institutes measured autonomic changes before, during, and after ncVNS and found that personalizing stimulation frequency produced a 46% increase in heart rate variability and was 8.9x more effective than a one-size-fits-all frequency.

Results also show that optimal frequency varied between visits for the same subject, electrode placement and configuration materially changed outcomes, and four minutes of stimulation produced larger heart rate variability changes than twenty minutes. These are direct, within-study physiological findings in healthy volunteers and speak to parameter sensitivity rather than clinical efficacy in disease.

Key dependencies and risks include reproducibility in patient populations and whether the same autonomic gains translate to clinical benefit for conditions listed in the release (ischemic stroke, PTSD, inflammatory diseases). Concrete items to watch are subsequent trials that test these optimized parameters in the stated patient groups and any reports confirming that per-visit frequency-titration is feasible in practice; near-term follow-up studies and protocol details should appear within typical clinical development timelines.

Medical Device Development Strategist

Optimization study identifies actionable device and protocol variables that can change physiological effect size; translational steps remain.

The study identifies four levers that altered autonomic response: personalized stimulation frequency, electrode laterality/placement, amplitude, and stimulation duration, with electrode configuration sometimes reducing heart rate variability. The finding that per-visit optimal frequency shifted underscores the need for a workflow to personalize settings before each treatment.

Operational risks include implementing reliable frequency titration protocols, training for electrode placement, and validating that 4-minute treatments outperform longer sessions in target patients. Concrete near-term milestones to monitor are protocolized personalization methods, reproducibility data in patient cohorts, and any partnering or development plans to integrate these parameter controls into commercial devices or trials; these will determine practical impact on development timelines.

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 subjects

• The 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?

Tivic announced a study showing personalized ncVNS parameters increased HRV by 46% and that personalization was 8.9x more effective than a fixed frequency.

How long should ncVNS stimulation be according to the Tivic TIVC study?

The study found 4 minutes of ncVNS produced larger HRV increases than 20 minutes.

Does Tivic’s TIVC study say electrode placement matters for ncVNS?

Yes; certain electrode placements increased HRV while others markedly reduced HRV, showing placement impacts outcomes.

Will Tivic’s TIVC ncVNS results apply directly to patients with stroke or PTSD?

The study was in healthy subjects; Tivic said the data suggests potential utility in conditions like ischemic stroke and PTSD but did not claim direct clinical proof.

Did Tivic report consistent optimal ncVNS frequency across visits for TIVC?

No; the optimal frequency varied between visits, indicating the need to personalize before each treatment.

Who collaborated with Tivic Health on the ncVNS optimization study for TIVC?

The study was a collaboration with The Feinstein Institutes for Medical Research at Northwell Health.