Tivic Health Completes Optimization Study for Non-Invasive Vagus Nerve Stimulation Device.

Tivic Health has completed an Optimization Study for its non-invasive cervical vagus nerve stimulation (ncVNS) device. The study, conducted by The Feinstein Institute of Bioelectronic Medicine, aims to identify optimal device parameters for therapeutic efficacy. Initial findings indicate the importance of personalization for treatment effectiveness. The study results will be released later this year and will inform the upcoming Phase I Clinical Trial.

FREMONT, Calif., June 19, 2025 — Tivic Health Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, has completed the Optimization Study for its patent-pending, non-invasive cervical vagus nerve stimulation (ncVNS) device. The study, conducted by The Feinstein Institute of Bioelectronic Medicine, aims to identify optimal device parameters for therapeutic efficacy.

The study, which concluded all study visits, focused on key parameters such as frequency, amplitude, electrode positioning, and personalization. These parameters are crucial for non-invasive vagus nerve stimulation (VNS) treatments, which have previously relied on under-researched aspects. Initial findings from the study underscore the importance of personalization for treatment effectiveness.

Tivic Health's Chief Executive Officer, Jennifer Ernst, stated, "This study has provided key breakthroughs in our scientific understanding of how to most effectively deliver stimulation to the vagus nerve and thereby modulate the pathways implicated in many prevalent and debilitating diseases." The company expects to release the study results later this year, which will inform the upcoming Phase I Clinical Trial.

The global VNS market is projected to grow from $8.59 billion in 2021 to $21.3 billion in 2030, according to Polaris Market Research [1]. Additionally, IDTechEx forecasts peripheral nerve stimulation, the segment targeted by Tivic Health, will grow at a 35% CAGR, one of the fastest growth segments in bioelectronic medicine [2].

Tivic Health seeks to treat underserved medical conditions through biochemical and bioelectric therapies that modulate patients' immune systems. 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.

References:
[1] https://finance.yahoo.com/news/tivic-health-completes-optimization-study-123000936.html
[2] https://www.marketscreener.com/quote/stock/TIVIC-HEALTH-SYSTEMS-INC-129226105/news/Tivic-Health-Completes-Optimization-Study-for-Its-Non-Invasive-Vagus-Nerve-Stimulation-Device-50332249/