Tivic Health Gets IRB Approval for ncVNS Study, Prepares for Enrollment

Tivic Health® Systems, Inc. (Nasdaq: TIVC), a health tech company specializing in bioelectronic medicine, announced it has received Institutional Review Board (IRB) approval from The Feinstein Institutes for the next phase of clinical work on its non-invasive cervical vagus nerve stimulation (ncVNS) technology.

The collaboration with Feinstein aims to advance the development of Tivic Health’s ncVNS by optimizing stimulation parameters. Physiological data will help improve device performance, refining factors like electrode placement and electrical waveforms. The findings will also guide the selection of clinical populations and help design future trials.

Following the successful completion of its Phase 1 study, key goals of this next study include:

  • Optimizing Treatment: Refining treatment personalization and stimulation parameters.
  • Accelerating Product Development: Using optimized data to speed up product development for ncVNS-based therapies.

Tivic Health has also partnered with Fletcher Spaght, a healthcare growth strategy firm, to identify clinical applications with unmet needs that could benefit from ncVNS technology.

“We are taking an integrated approach to clinical and product development to create significant revenue opportunities,” said Jennifer Ernst, CEO of Tivic Health.

The study will be led by Dr. Theodoros Zanos from The Feinstein Institutes, in collaboration with Dr. Blake Gurfein, Tivic Health’s Chief Scientific Officer. Dr. Gurfein emphasized the importance of precision optimization in non-invasive neurostimulation development as they prepare for disease-specific validation in upcoming clinical trials.

The global vagus nerve stimulation market, valued at $8.59 billion in 2021, is expected to reach $21.3 billion by 2030, according to Polaris Market Research. Tivic Health aims to deliver personalized, non-invasive VNS treatments and become a leader in bioelectronic medicine.

About Tivic Health:
Tivic Health is a health tech company advancing bioelectronic medicine through non-invasive nerve stimulation technologies. Its products target chronic inflammatory conditions, offering drug-free, low-risk solutions. Tivic’s first product, ClearUP, an FDA-approved bioelectronic sinus device, is available through various online and retail distributors.

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