Tivic Health Completes Vagus Nerve Stimulation Study

Tivic Health Systems Inc. is sharing the final results of its pilot research study that verified the efficacy of the firm’s patent-pending non-invasive cervical vagus nerve stimulation (ncVNS) technology.

Conducted with The Feinstein Institutes for Medical Research at Northwell Health, the trial data proved Tivic Health’s ncVNS solution induces responses in the autonomic, cardiac, and central nervous systems, and is likely to have a positive impact in several major disease areas.
 
Tivic Health conducted a 20-person clinical trial in collaboration with Theodoros Zanos, Ph.D., associate professor in the Institute of Bioelectronic Medicine and Head of the Neural and Data Science Lab at the Feinstein Institutes. Physiological measurements were taken before, during, and after ncVNS treatment to assess the impact on the autonomic nervous system, cardiac function, and brain activity. The trial validated Tivic Health’s proprietary approach to ncVNS using objective measures of the autonomic nervous system, cardiac function, and brain activity.

“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,” Tivic Health Chief Scientific Officer Blake Gurfein, Ph.D., said. “This study provided important validation of our approach and will help steer our design of new products leveraging ncVNS.”
 
Results were as follows:

• Compared to baseline measurement, Tivic Health’s ncVNS intervention triggered 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 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 changes in brain activity are consistent with reduced arousal and anxiety.
• During ncVNS stimulation, subjects had sustained pupil constriction, a 9.5% reduction in pupil diameter, an outcome associated with activation of the parasympathetic nervous system. 

Previous studies of non-invasive VNS devices have reported mixed results regarding autonomic nervous system changes. The magnitude of the ncVNS study data suggest the potential for greater clinical impacts and enhanced reproducibility. While these results were in healthy subjects, the data suggest Tivic Health’s ncVNS approach may be effective in several patient populations, including those with epilepsy, post-traumatic stress disorder, and ischemic stroke, among others.
 
“Our mission is to improve vibrancy of life through advancement of bioelectronic medicine,” Tivic Health CEO Jennifer Ernst stated. “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.”
 
VNS is a growing sector within the $8.3 billion neurostimulation market, which is projected to grwo 12.2% annually through 2032, according to Global Market Insights. The body’s longest autonomic nerve, the vagus nerve regulates many organ systems associated with chronic disease; not surprisingly, modulating activity in this nerve pathway is of significant interest in the medical industry.  VNS is currently indicated for treatment-resistant epilepsy and depression, cluster headache, migraine headache, and stroke rehabilitation, and it is being studied for other neurological, cardiac, and immune conditions. However, many of the applications of VNS rely on surgical implants.
 
Tivic Health is a commercial health technology company advancing bioelectronic medicine. Its patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic Health’s non-invasive and targeted approach to treating inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic Health’s first commercial product ClearUP is a U.S. Food and Drug Administration approved handheld bioelectronic sinus device.