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Tivic Health Collaborates With Leading Medical Research Hospital on First Controlled Trial to Extend Tivic’s Bioelectronic Platform
Rhea-AI Impact
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Rhea-AI Summary
Tivic Health Systems (Nasdaq: TIVC) has launched a 60-person clinical trial to investigate a new bioelectronic device as an alternative to opioids for post-operative care after sinus surgeries. This double-blind study aims to evaluate pain management following functional endoscopic sinus surgery, a common procedure affecting over one million patients annually in the U.S. The company currently offers an FDA-cleared treatment for sinus pain and nasal congestion, seeking to expand its application in pain reduction while minimizing opioid dependence.
Positive
Initiation of a clinical trial involving 60 participants creates potential for revenue growth.
The trial investigates a bioelectronic device as an alternative to opioids, catering to a significant market with over one million surgeries annually.
Existing FDA-cleared treatment for sinus pain shows credibility in the bioelectronic domain.
Negative
Clinical trials involve risks of underperformance or failure, which could hinder product development and market entry.
Heavy reliance on successful outcomes to shift market perceptions and gain acceptance in a competitive healthcare environment.
60-person clinical trial to investigate therapeutic device as an alternative to opioids following sinus surgeries
SAN FRANCISCO--(BUSINESS WIRE)--
Tivic Health® Systems, Inc., (Nasdaq: TIVC), a commercial-phase healthtech company focused on bioelectronic medicine, today announced initiation of its second clinical study investigating the extension of the company’s bioelectronic platform, offering a potentially new alternative to opioids for post-operative care following sinus surgeries. This 60-person double-blind, randomized controlled trial will be conducted with an international hospital leading in medical and scientific training, biomedical research, and patient care.
Tivic Health currently offers an FDA-cleared bioelectronic treatment for sinus pain and nasal congestion - a condition that impacts over 200-million U.S. adults. The upcoming trial will investigate the extensibility of Tivic Health’s platform as a specialized treatment for pain following functional endoscopic sinus surgery, an intervention involving removal or modification of bone and tissue in the sinus airway passages. Tivic Health previously completed an open-label pilot study with the U.S. Institute for Advanced Sinus Care and Research comparing different programming modes for the device. Clinical measures for the newly initiated study will include postoperative pain and use of opiate medication during the study period.
Over one million sinus and nasal surgeries are conducted in the U.S. every year and most patients are prescribed opioid medications to treat postoperative pain. The clinical research program announced today is part of an initiative to identify new alternatives for treating pain following such surgeries.
“Bioelectronic devices work by modulating the electrical activity in peripheral and central nerves to mitigate both symptoms and underlying causes of health concerns,” said Jennifer Ernst, CEO of Tivic Health. “By supporting this investigator-initiated study, we will be testing a new product extension of Tivic Health’s bioelectronic device for sinus pain and congestion with the goal of minimizing study subject’s pain and their need for pain medication. We are delighted by this opportunity to work with a world-class research team in exploring the first extension of Tivic Health’s bioelectronic platform to a new application area.”
About Tivic Health Systems, Inc.
Tivic Health Systems, Inc. is a commercial-phase healthtech company delivering non-invasive bioelectronic treatments that provide consumers choice in the treatment of inflammation and related conditions. For more information visit https://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. Additional information concerning Tivic Health and its business, including a discussion of factors that could materially affect the company operating results, are contained in the company’s Registration Statement on Form S-1 (and amendments thereto) under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. 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.
