Will Demo FDA-Approved ClearUP that Treats
Sinus Pain and Congestion from Colds, Flu, and Allergies
Tivic Health® Systems, Inc. (Nasdaq: TIVC) (“Tivic Health”), a
commercial-phase health technology company focused on bioelectronic
medicine, is bringing bioelectronic medicine to HTLH 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.”
Clinical Studies
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.
About ClearUP
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 with a choice in the treatment of
inflammation and immune-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.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221107005162/en/
Investor Contact: Hanover International, Inc.
ir@tivichealth.com
Media Contact: Cheryl Delgreco
Cheryl.Delgreco@tivichealth.com 617-723-4004
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