Tivic Health Announces Completion of Enrollment for Study of Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation
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Insights
The completion of enrollment in Tivic Health's pilot clinical study represents a significant milestone in the advancement of non-invasive vagus nerve stimulation (VNS) therapies. The medical community is increasingly interested in the potential of bioelectronic medicine as an alternative to drug therapies, particularly given the non-invasive nature of such treatments and their potential to reduce side effects and improve patient compliance.
The proprietary approach being tested by Tivic could have substantial implications for the treatment of neurological and psychiatric disorders, as well as systemic inflammatory diseases. If the pilot study yields positive results, it could lead to a broader acceptance and integration of non-invasive VNS in clinical practice. This would not only expand the market for Tivic's products but could also encourage further investment and research in the field of bioelectronic medicine.
From a market perspective, Tivic's pilot study sits within the burgeoning neurostimulation market, which is expected to grow significantly in the coming years. The neurostimulation market, part of the larger medical device sector, is driven by technological advancements and an increasing prevalence of neurological disorders.
The non-invasive nature of Tivic's approach to VNS could position the company favorably within the market, especially considering the growing patient preference for non-invasive treatments. Furthermore, the company's expansion of its bioelectronic portfolio and recent patent application suggest a strategic move to establish a strong intellectual property position and diversify its offerings, potentially impacting its market share and investor interest.
Investors will be closely monitoring the outcomes of the pilot study, as successful results could lead to a surge in Tivic Health's stock value due to the growth potential in the neurostimulation market. The company's ability to complete enrollment swiftly indicates operational efficiency and could signal to investors that Tivic is capable of executing its clinical development plans effectively.
However, it is essential to consider the risks associated with investing in biotech companies like Tivic, which include the uncertainty of clinical trial outcomes and the regulatory hurdles that new medical devices must overcome. The long-term financial impact will depend on the study's results, the speed at which the product can be brought to market and the adoption rate by healthcare providers.
VNS is a growing market that is part of the
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240221086109/en/
Media Contact:
Morgan Luke
Morgan.Luke@tivichealth.com
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Source: Tivic Health Systems, Inc.
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