Tivic Health® Systems, Inc. (“Tivic”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced today that enrollment in its pilot clinical study of a proprietary approach to non-invasive vagus nerve stimulation (VNS) has been completed.

VNS is a growing market that is part of the $8.3B global neurostimulation market, which has a projected CAGR of 12.2%, according to Global Market Insights. Implanted VNS is currently used in the treatment of various neurologic and psychiatric disorders and is being tested in systemic inflammatory diseases. Tivic is testing a proprietary approach to more precisely influence vagus nerve signals, while enhancing effectiveness and safety with a non-invasive treatment.

The pilot study utilized a new neurostimulation approach with 20 individuals during which the data collection and analysis were performed by researchers at The Feinstein Institutes for Medical Research. This work aims to provide more precise targeting strategies for VNS and more control over the types of physiologic effects that result from stimulation.

“With study enrollment completed less than six months from initiation, we are looking forward to receiving and analyzing the final study results. This is one of the studies underway to expand Tivic’s non-invasive bioelectronic portfolio to new clinical uses beyond our existing product line,” said Jennifer Ernst, CEO at Tivic.

Previously, the company has announced:

  • April 2023: Tivic, The Feinstein Institutes for Medical Research Announce Pilot Study to Test Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation
  • April 2023: Tivic Expands Bioelectronic Portfolio: Files Patent Application for New Approach to Non-Invasive Vagus Nerve Stimulation
  • April 2023: Tivic Health Expands Clinical Study of Post-Operative Pain in Nasal and Sinus Surgeries
  • August 2023: Tivic Health Funded Study Begins Enrollment for Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation

About Tivic

Tivic is a commercial health tech company advancing the field of bioelectronic medicine. Tivic’s patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic’s non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic’s first commercial product ClearUP is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information visit http://tivichealth.com @TivicHealth

Forward-Looking Statements

This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: final results of the study, once commenced; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic’s capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic’s actual results to differ from those contained in the forward-looking statements, see Tivic’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31, 2023, under the heading “Risk Factors”; as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.

Media Contact: Morgan Luke Morgan.Luke@tivichealth.com

Investor Contact: Hanover International, Inc. ir@tivichealth.com

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