SAN FRANCISCO–(BUSINESS WIRE)–Tivic Health® Systems, Inc. (“Tivic”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced today that the research study that the company is funding at The Feinstein Institutes for Medical Research has received study approval from the Institutional Review Board (“IRB”) and has initiated study recruitment and enrollment for its novel non-invasive bioelectronic device approach to vagus nerve stimulation.
An IRB is an FDA-registered group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
In collaboration with Tivic Health, The Feinstein Institutes for Medical Research has initiated the recruitment and completed the first patient enrollment of subjects in the study. The pilot study will utilize a new neurostimulation approach with 20 individuals, along with data analysis and algorithm development performed by researchers at Feinstein Institutes’ Institute of Bioelectronic Medicine. This study may provide greater targeting strategies of stimulation and more control over the types of physiologic effects that result from stimulation.
“We’re excited for the proprietary value this work has the potential to deliver, as we continue to explore expanding Tivic’s non-invasive bioelectronic solutions to vagus nerve pathways and other clinical uses,” said Jennifer Ernst, CEO at Tivic.
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: the recruitment and enrollment efforts of The Feinstein Institutes for Medical Research; results of the study, once commenced; clinical trial results; 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.
Contacts
Media Contact:
Kayleigh Westerfield
Kayleigh.Westerfield@tivichealth.com
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com