Tivic Health’s Vagus Nerve Stimulation Device Study is Complete

Tivic Health Systems Inc. has completed all visits in the Optimization Study for its patent-pending, non-invasive cervical vagus nerve stimulation (ncVNS) device. Results are expected to be released later this year.

The study was conducted by The Feinstein Institute of Bioelectronic Medicine with the objective of identifying device parameters that optimally influence autonomic nervous system function. These comprised frequency, amplitude, electrode positioning, and personalization, all key parameters previously under-researched, especially for non-invasive VNS treatments. Key findings from the first stages of this study were previously presented in a poster titled, “Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation,” at the Sixth Bioelectronic Medicine Summit: Neurotechnologies for Communities & Individuals, in early March.

“This study has provided Tivic with key breakthroughs in the scientific understanding of how to most effectively deliver stimulation to the vagus nerve and thereby the modulation of the pathways implicated in many prevalent and debilitating diseases,” Tivic Health CEO Jennifer Ernst stated. “As we prepare to report these new findings, we are more confident than ever that our novel bioelectronic approach to VNS has the potential to form the basis of future compelling and highly differentiated treatments for large patient populations with unmet clinical needs.”

Polaris Market Research estimates the global VNS market will grow 10.6% annually over the next five years, rising from $8.59 billion in 2021 to $21.3 billion in 2030. Additionally, IDTechEx has forecast peripheral nerve stimulation—the segment targeted by Tivic Health—will swell 35% annually, one of the fastest growth segments in bioelectronic medicine.

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. However, many of the applications of VNS rely on surgical implants, which are not suitable for many patients.

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