Tivic Health Announces Successful Completion of Non-Invasive Vagus Nerve Stimulation Study; Demonstrates Clinically Effective Biological Changes in the Autonomic, Cardiac, and Central Nervous Systems

Tivic Health® Systems, Inc. announced the final results of their pilot research study with The Feinstein Institutes for Medical Research at Northwell Health. Through this collaboration, Tivic Health has confirmed the effectiveness of its patent-pending non-invasive cervical vagus nerve stimulation (ncVNS) approach, which induces responses in the autonomic, cardiac, and central nervous systems and can be expected to have clinical utility in several major disease areas. Study Design: 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 novel and proprietary approach to ncVNS using objective measures of the autonomic nervous system, cardiac function, and brain activity. Results: Compared to baseline measurement, Tivic Health?s ncVNS intervention resulted in a 97% increase in the root mean square of successive differences (RMSSD) measure of heart rate variability, which is a widely accepted proxy for vagus nerve activity.

Measurements of brain activity using EEG demonstrated that Tivic Health?s 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 ncVNS data imply potential for greater clinical effects and enhanced reproducibility. While these results were in healthy subjects, the data suggest ncVNS approach may have clinical utility in several patient populations including those with epilepsy, post-traumatic stress disorder, and ischemic stroke, among others.

VNS is a growing market that is part of the $8.3B neurostimulation market, which has a projected CAGR of 12.2% from 2023 through 2032, according to Global Market Insights. The vagus nerve is the longest autonomic nerve in the body. The vagus nerve regulates many organ systems associated with chronic disease and thus 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, with collaborators such as The Feinstein Institute for Bioelectronic Medicine, hopes to lead the way to meaningful improvement in how VNS devices can more precisely target and modulate vagus nerve activity to achieve intended biological and clinical outcomes, in particular with non-invasive or minimally invasive devices.

Previously the company has announced: January 2024: Tivic Health Announces Enrollment Complete for Study of Novel Non- Invasive Bioelectronic Approach to Vagus Nerve Stimulation August 2023: Tivic Health Funded Study Begins Enrollment for Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation April 2023: Tivic Expands Bioeletronic Portfolio: Files Patent Application for New Approach to Non-Invasive Vagus Nerve Stimulation.

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