Will Demo FDA-Approved ClearUP that Treats Sinus Pain and Congestion from Colds, Flu, and Allergies
SAN FRANCISCO – November 7, 2022 – Tivic Health® Systems, Inc. (Nasdaq: TIVC) (“Tivic Health”), a commercial-phase health technology company focused on bioelectronic medicine, is bringing bioelectronic medicine to HLTH with ClearUP, an FDA-approved and clinically proven device that uses low-level electrical stimulation to treat sinus pain and congestion from allergies, colds, and flu. Tivic Health is exhibiting in the UCSF Health Hub Pavilion booth #1158-33. HLTH takes place November 13-16, at the Venetian Expo in Las Vegas.
Last month, Tivic Health announced it has entered into a definitive agreement to acquire the Reliefband product line for nausea treatment and substantially all related assets from Reliefband Technologies, LLC. Reliefband offers wearable, FDA-cleared electronic therapeutics for the treatment of nausea and vomiting and has multiple products available both over-the-counter and by prescription.
“Key goals of ours are to grow consumer awareness of bioelectronic therapies and to advance these non-invasive drug-free technologies toward becoming mainstream treatment options for common health conditions,” said Blake Gurfein, chief scientific officer of Tivic Health. “The use of bioelectronic medicine to address various conditions has increased during recent years and is expected to continue to expand in scope and commercial traction in the near term. We intend to continue to pioneer bioelectronic medicine research and to grow a trusted brand that builds and delivers evidence-based, safe, and effective bioelectronic therapies.”
The company has undertaken a clinical study investigating the extensibility of Tivic’s platform as a specialized treatment for pain following functional endoscopic sinus surgery and a potentially new alternative to opioids for post-operative care. This 60-person double-blind, randomized sham-controlled trial is being conducted with the Icahn School of Medicine at Mount Sinai, a leader in medical and scientific training. Clinical measures for this study include postoperative pain and the use of opiate medication during the study period.
The development process for ClearUP ran from 2016-2019 and consisted of clinical trials, safety testing and consumer usability testing. ClearUP achieved its first FDA approval in 2019, making it the first bioelectronic device product to receive FDA approval to treat allergy-related sinus pain. ClearUP received CE Mark approval in 2020 for temporary relief of sinus pain, pressure and congestion, under the brand name ClearUP Sinus Relief.
In 2021, Tivic broke new ground when the FDA granted its De Novo request and expanded the indication of use for ClearUP to include congestion from flu, allergies, and colds.
In support of its FDA De Novo request grant, Tivic Health’s clinical studies showed that ClearUP was effective in treating moderate to severe congestion with no substantive side effects. In one clinical study, subjects with moderate to severe congestion reported, on average, a 35% reduction in congestion symptoms 10 minutes after a ClearUP treatment, which was significantly greater than placebo. In another clinical study, subjects reported, on average, a 44% reduction in congestion symptoms after four weeks of regular use.
ClearUP has received five U.S. patents (18 pending in the U.S. and abroad) for the device, interface, and features that allow it to be comfortable, effective, and easy to use.
ClearUP is a US FDA Class II and EU Class IIa medical device that is currently sold direct to consumers on amazon.com, bestbuy.com, walmart.com, fsastore.com, and tivichealth.com.
About Tivic Health
Tivic Health Systems, Inc. is a commercial-phase health technology company delivering non-invasive bioelectronic treatments that provide consumers a choice in the treatment of inflammation and certain other related conditions. For more information visit https://tivichealth.com @TivicHealth.
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: risks and uncertainties regarding the potential that Tivic and Reliefband are not able to complete the contemplated transaction, and even if they do complete it, that the expected benefits of the transaction are not achieved; market and other conditions; unexpected costs, charges or expenses that reduce Tivic’s capital resources; Tivic’s inability to raise adequate capital to fund the purchase price of the Reliefband assets, as well as its existing business; Tivic’s inability to innovate and attract users for Reliefband’s products; unexpected or unfavorable clinical trial results. 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 S-1 Registration Statement, filed with the SEC on October 26, 2022; Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 31, 2022, 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.
Hanover International, Inc.