Tivic Health’s Non-Invasive Cervical Vagus Nerve Stimulation Approach Wins Study Approval
This clinical research collaboration with Feinstein is designed to advance the development of Tivic Health’s ncVNS technology by refining and optimizing stimulation parameters. Physiological measurements will be used to enhance device performance and refine specifications such as electrode positioning and electrical waveform parameters. Study data will be used to inform the selection of clinical populations of interest and help shape the clinical study design for upcoming trials.
The company has previously announced the successful completion of its Phase 1 study on ncVNS. Key goals of the current study include:
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Optimizing Treatment Strategies: The research will provide critical data to advance both personalizing treatment and optimizing stimulation parameters. -
Accelerating Product Development: The optimized parameters will help accelerate development of Tivic Health’s ncVNS product offerings.
The company recently announced its collaboration with Fletcher Spaght, a healthcare growth strategy firm. Fletcher Spaght has begun substantiating clinical applications with high unmet needs that have potential to be addressed by Tivic Health’s patent-pending ncVNS system.
“We are taking an integrated approach to clinical, product development and go-to-market planning for our medical-grade non-invasive VNS program,” Tivic Health CEO Jennifer Ernst stated. “We believe this approach creates the best opportunities to generate significant new revenue based on this work.”
The optimization study will be conducted by The Feinstein Institute of Bioelectronic Medicine. It will be led by 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 at Northwell Health, in partnership with Tivic Health Chief Scientific Officer Dr. Blake Gurfein.
“Precision optimization is an important but often overlooked step in non-invasive neurostimulation device development,” Dr. Gurfein commented. “I am pleased we are working with Dr. Zanos and other leaders in the field as we move from proof-of-concept to disease-specific validation in clinical trials anticipated next year.”
Polaris Market Research estimates the global vagus nerve stimulation market, valued at $8.59 billion in 2021, will expand 10.6% annually to reach $21.3 billion by 2030.
Tivic Health is a commercial health tech company advancing bioelectronic medicine. Its technology platforms use stimulation of 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. ClearUP is clinically proven and available through online retailers and commercial distributors.
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