Tivic Health Systems, Inc. (Nasdaq: TIVC) has successfully completed a pilot research study of its patent-pending non-invasive cervical vagus nerve stimulation (ncVNS) technology, demonstrating significant physiological responses that suggest potential clinical applications for several major disease areas.
The bioelectronic medicine company, in collaboration with The Feinstein Institutes for Medical Research at Northwell Health, conducted a 20-person clinical trial that validated their proprietary approach to ncVNS through objective measurements of autonomic nervous system activity, cardiac function, and brain activity.
Significant Physiological Responses Observed
The study results revealed substantial physiological changes in response to Tivic's ncVNS intervention. Compared to baseline measurements, researchers documented a 97% increase in the root mean square of successive differences (RMSSD) measure of heart rate variability—a widely accepted proxy for vagus nerve activity.
Brain activity measurements using EEG showed that the ncVNS intervention increased frontal theta power by 24% and reduced gamma power in several brain regions, including a 66% reduction in frontal gamma power. These specific changes in brain activity patterns are consistent with reduced arousal and anxiety states.
Additionally, during ncVNS stimulation, subjects experienced sustained pupil constriction with a 9.5% reduction in pupil diameter, an outcome associated with activation of the parasympathetic nervous system.
"We are strongly encouraged by the magnitude of the treatment effects from our ncVNS approach, particularly in the context of current state of the art," said Blake Gurfein, Ph.D., Chief Scientific Officer of Tivic Health. "This study provided important validation of our approach and will help steer our design of new products leveraging ncVNS."
Potential Clinical Applications
While the study was conducted in healthy subjects, the researchers suggest that the ncVNS approach may have clinical utility in several patient populations, including those with epilepsy, post-traumatic stress disorder, and ischemic stroke, among others.
The magnitude of the observed effects is particularly notable, as previous studies of non-invasive VNS devices have reported mixed results regarding autonomic nervous system changes. The Tivic Health team believes their data implies potential for greater clinical effects and enhanced reproducibility compared to existing approaches.
Growing Market for Neurostimulation
Vagus nerve stimulation is part of the broader neurostimulation market, which is currently valued at $8.3 billion and projected to grow at a compound annual growth rate (CAGR) of 12.2% from 2023 through 2032, according to Global Market Insights.
The vagus nerve, the longest autonomic nerve in the body, regulates many organ systems associated with chronic disease, making it a significant target of interest in the medical industry. VNS is currently indicated for treatment-resistant epilepsy and depression, cluster headache, migraine headache, and stroke rehabilitation, with ongoing studies for other neurological, cardiac, and immune conditions.
However, many current VNS applications rely on surgical implants. Tivic Health aims to develop non-invasive or minimally invasive alternatives that can more precisely target and modulate vagus nerve activity.
Company Strategy and Outlook
Jennifer Ernst, CEO of Tivic Health, emphasized the company's mission: "Our mission is to improve vibrancy of life through advancement of bioelectronic medicine. We are energized about these results and look forward to unlocking valuable new market segments with this program that can benefit both patients and investors."
The study represents the culmination of a research program that Tivic Health has been developing since at least April 2023, when the company filed a patent application for its new approach to non-invasive vagus nerve stimulation. The company began enrollment for the study in August 2023 and announced completion of enrollment in January 2024.
Tivic Health is already established in the bioelectronic medicine field with its first commercial product, ClearUP, an FDA-approved handheld bioelectronic sinus device. The company's technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures to provide non-invasive, targeted approaches to treating inflammatory chronic health conditions.
As the company moves forward with its ncVNS technology, it will likely focus on developing specific applications for the conditions identified in the study, with the goal of seeking regulatory approval for clinical products that could provide alternatives to surgical VNS implants.
