Enrollment Complete in Tivic Health Optimization Study for its Non-Invasive Vagus Nerve Stimulation Device

Business Wire 14-Nov-2024 8:45 AM

Tivic Health® Systems, Inc. (NASDAQ:TIVC), a health tech company developing and commercializing bioelectronic medicine, announced today that full enrollment has been completed in the optimization study for Tivic Health's patent pending, non-invasive vagus nerve stimulation (VNS) device.

The study is being conducted by The Feinstein Institute of Bioelectronic Medicine. The objective of the study is to identify device parameters that optimally influence autonomic nervous system (ANS) function. These include the frequency and the duration of potential treatments. Tivic Health plans to use these results to prioritize clinical indications that the company expects to carry forward into further testing and commercial development. The trial is expected to be completed in early first quarter 2025.

"Already we have established that our non-invasive cervical vagus stimulation device has shown large, rapid effects in clinically important biological measures," stated Tivic Health Chief Scientific Officer Blake Gurfein. "This study is the next step in moving us closer to potential FDA approval of a non-invasive treatment for clinical indications that are inadequately addressed by the current treatment options."

"While implanted VNS technologies have proven their clinical efficacy and commercial viability, they are not always appropriate for certain clinical scenarios," stated Jennifer Ernst, CEO of Tivic Health Systems. "Early non-invasive VNS approaches have resulted in variable responses and modest efficacy. In contrast, we anticipate this study will allow us to optimize our novel approach to treating diseases with unmet needs and capitalize on the gap between invasive and non-invasive VNS treatments," concluded Ernst.

Market Opportunity

Polaris Market Research estimates the global vagus nerve stimulation (VNS) market will grow from $8.59 billion in 2021 to $21.3 billion in 2030, a 10.6% CAGR over the forecast period. Additionally, IDTechEx has forecast peripheral nerve stimulation, the segment targeted by Tivic Health, will grow at 35% CAGR, one of the fastest growth segments in bioelectronic medicine.

The vagus nerve is the longest autonomic nerve in the body and regulates many organ systems associated with chronic disease. VNS is approved by the US Food & Drug Administration for treatment-resistant epilepsy and depression, cluster and migraine headaches, and stroke rehabilitation. It is being studied for other neurological, cardiac, and immune conditions. However, many of the applications of VNS rely on surgical implants.

Tivic previously announced it has engaged Fletcher Spaght, Inc. (FSI), a leading healthcare growth strategy firm, to accelerate its product development and commercial strategy. FSI has conducted a comprehensive market assessment of Tivic Health's ncVNS technology drawing from clinical outcomes from Tivic Health's successful Phase 1 trial, which it announced in May. FSI, in conjunction with Tivic Health's scientific and clinical leadership, will help drive the company's clinical strategy and product development in 2025 and beyond.

About Tivic Health

Tivic Health (http://tivichealth.com) is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health's patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic Health'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 Health'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. Tivic Health, with collaborators including The Feinstein Institute for Bioelectronic Medicine is developing new VNS devices that will more precisely target and modulate vagus nerve activity to deliver better clinical outcomes, with non-invasive or minimally invasive devices.

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 assumption 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. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241114253534/en/