Tivic Health Expands Clinical Study of Post-Operative Pain in Nasal and Sinus Surgeries

Rhea-AI Summary

Tivic Health Systems (Nasdaq: TIVC) announced an expansion of its post-operative pain clinical study to include patients from Otolaryngology and Facial Plastic Surgery. This initiative aims to explore a drug-free alternative to opioids in managing post-surgery pain, amidst the national opioid crisis. With over one million nasal and sinus surgeries performed annually in the U.S., the study signifies a shift towards optimizing pain management practices.

Tivic is collaborating with a leading international hospital and has gained approval to include candidates undergoing rhinoplasty and facial surgeries in addition to functional endoscopic sinus surgeries. The company believes this therapeutic approach can provide a significant option for patients and healthcare providers.

Positive

• Expansion of clinical study to include Otolaryngology and Facial Plastic Surgery patients.
• Potential to provide a drug-free alternative to opioid prescriptions, addressing the national opioid crisis.
• Collaboration with a leading international hospital for enhanced credibility and research efficacy.

Negative

• The study's outcomes remain uncertain until clinical trial results are fully evaluated.

Opportunity for Bioelectronic Medicine to Reduce Dependence on Opioids

SAN FRANCISCO--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (“Tivic”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced today that it has expanded its post-operative pain clinical study to include Otolaryngology and Facial Plastic Surgery patients. This study aims to investigate the potential benefits of a drug-free alternative to traditional post-operative pain management methods.

Tivic is partnering with a renowned international hospital that leads in scientific training, biomedical research, and patient care. The company previously announced a joint clinical program trialing Tivic’s non-invasive bioelectronic medicine for the treatment of pain following functional endoscopic sinus surgeries. The company and its medical research partner have been approved to expand the study to include additional surgical candidates, including rhinoplasty and facial plastic surgeries.

Over one million nasal and sinus surgeries are performed in the U.S. every year and opioids are routinely prescribed for post-operative pain management. Given the ongoing national opioid epidemic, an increased interest has developed in optimizing prescribing practices to reduce the use of opioids as the primary treatment following such surgeries. Tivic's bioelectronic platform may offer a promising alternative for patients to manage post-operative pain without the risk of addiction or other adverse effects associated with opioid use.

“We believe the addition of a drug-free therapeutic solution as part of a post-surgery treatment protocol can add a meaningful option to the pain-management toolkit available to patients and healthcare professionals,” said Jennifer Ernst, CEO of Tivic. “We continue to seek both research and commercial partnerships that will expand our impact in the high-growth field of bioelectronic medicine.”

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: clinical trial results; FDA approval of any product developed based on clinical research; 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/20230419005462/en/

Media Contact:

Kayleigh Westerfield

949-632-3439

Kayleigh.Westerfield@tivichealth.com

Investor Contact:

Hanover International, Inc.

ir@tivichealth.com

Source: Tivic Health Systems, Inc.

FAQ

What is the purpose of Tivic Health's expanded clinical study?

The expanded clinical study aims to investigate a drug-free alternative for managing post-operative pain in Otolaryngology and Facial Plastic Surgery patients.

How many surgeries are performed annually in the U.S. related to this study?

Over one million nasal and sinus surgeries are performed every year in the U.S.

What are the potential market implications of Tivic's bioelectronic medicine?

Tivic’s bioelectronic medicine could significantly impact pain management practices and reduce reliance on opioids, catering to a growing demand for drug-free treatments.

What types of surgeries are included in Tivic's clinical study?

The clinical study includes patients undergoing functional endoscopic sinus surgeries, rhinoplasty, and facial plastic surgeries.

What is the significance of partnering with a renowned international hospital?

Partnering with a leading hospital adds credibility to Tivic's research and enhances the potential for successful outcomes in clinical trials.