Tivic Health Kicks Off Vagus Nerve Stimulation Device Trial

The first study subject has been enrolled in Tivic Health Systems Inc.’s optimization study of its patent pending, non-invasive vagus nerve stimulation device.

Conducted by The Feinstein Institute of Bioelectronic Medicine, the trial will identify device parameters— including treatment frequency and duration—that optimally influence autonomic nervous system (ANS) function. The results will be used to inform clinical indication priority and commercial development.

“The effectiveness of Tivic’s non-invasive cervical vagus stimulation (ncVNS), which influences autonomic function, has already been established, demonstrating large ANS responses impacting cardiovascular and central nervous system activity,” Tivic Health Chief Scientific Officer Blake Gurfein stated. “The data from this study will advance our technology toward potential FDA approval for non-invasive treatment of large market indications, where current treatments are invasive, inadequate, or both.”

Polaris Market Research estimates the global vagus nerve stimulation (VNS) market will grow 10.6% annually to reach $21.3 billion in 2030. Additionally, IDTechEx expects peripheral nerve stimulation—the segment targeted by Tivic Health—to be one of the fastest-growing segments in bioelectronic medicine, expanding 35% annually.

The vagus nerve is the body’s longest autonomic nerve, and regulates many organ systems associated with chronic disease. VNS is approved by the U.S. Food and Drug Administration (FDA) for treatment-resistant epilepsy and depression, cluster and migraine headaches, and stroke rehabilitation. It is being studied for other neurological, cardiac, and immune conditions, but many VNS applications rely on surgical implants.

Tivic previously announced it has engaged Fletcher Spaght Inc. (FSI), a healthcare growth strategy firm, to accelerate its product development and commercial strategy. FSI has conducted a comprehensive market assessment of Tivic Health’s ncVNS technology drawing from clinical outcomes from Tivic Health’s successful Phase 1 trial, which it announced in this past spring. FSI, in conjunction with Tivic Health’s scientific and clinical leadership, will help drive the company’s clinical strategy and product development in 2025 and beyond.

Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health’s patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic Health’s non-invasive and targeted approach to treat inflammatory chronic health conditions gives consumers and providers of drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic Health’s first commercial product ClearUP is an FDA-approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. Tivic Health, with collaborators including The Feinstein Institute for Bioelectronic Medicine, is developing new VNS devices that will more precisely target and modulate vagus nerve activity to deliver better clinical outcomes, with non-invasive or minimally invasive devices.