ClearUP™ poised to be first bioelectronic solution for sinus pain
MENLO PARK, Calif., July 13, 2018 /PrNewswire/ -- Tivic Health Systems Inc. (Tivic Health™), a bioelectronic health-tech company, has reached a key milestone in their pursuit of FDA approval for ClearUP™ Sinus Pain Relief (ClearUP™). This milestone includes the successful completion of a pivotal clinical trial and podium presentation acceptance at the 2018 American Rhinologic Society (ARS) Annual Meeting.
“Tivic Health is dedicated to transforming medicine to aid people living with chronic disease through the use of microcurrent,” said Jennifer Ernst, CEO of Tivic Health. “Chronic sinusitis is the most frequently cited respiratory condition in the United States with almost 34 million cases reported each year 1; we’re poised to disrupt the status-quo treatment space for people suffering from chronic sinus pain.”
The double-blind, randomized controlled trial conducted at Stanford University’s Sinus Center investigated the effect of microcurrent (low-current electrical stimulation) on sinus pain. Data from the clinical trial supports an upcoming FDA submission for ClearUP™ and will be a key factor as Tivic Health seeks FDA clearance of the new bioelectronic treatment for the temporary relief of sinus pain.
ClearUP™ is a simple, handheld medical device that delivers targeted low-level microcurrent to the underlying nerves of the outer facial sinus passages. The device will be registered with the FDA in the category of Transcutaneous Electrical Nerve Stimulation (TENS).
“Our goal is to provide convenient, effective at-home sinus care,” continued Ernst. “We’re previewing ClearUP™ with physicians at the ARS Spring Summer Sinus Symposium this week and look forward to following the preview with our data presentation during the ARS Annual Meeting this fall.”
Tivic Health is actively engaging with investor communities in preparation for a product launch following FDA clearance.
ClearUP™ Sinus Pain Relief is an investigational technology. Claims have not been evaluated by the FDA. This device is not currently for sale in the U.S.
About Tivic Health Systems Inc.
Tivic Health Systems Inc. (Tivic Health™) is a bioelectronic device company dedicated to developing MICROCURRENT therapy solutions for chronic diseases and conditions. Tivic Health’s first product, ClearUp™ Sinus Pain Relief, targets sinus pain and pressure associated with chronic sinusitis, allergic rhinitis and other common sources of sinus pain.
Tivic Health, founded in 2016, is part of a $7.5B global neuromodulation industry. The team is dedicated to harnessing the power of neuromodulation for home use products, empowering people to improve their health and quality of life.
Forward Looking Statement
This news release contains forward-looking statements that are based on the current expectations and beliefs of Tivic Health Systems Inc. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including FDA submission, product launch and timing.
Tivic Health, Menlo Park, CA
Media - Maureen Perou, 773-230-7026
Media - Caroline Baumgartner, 630-962-6006
Investors - Jennifer Ernst, 510-512-6477
1 Centers for Disease Control and Prevention. Vital and Health Statistics: Prevalence of Selected Chronic Conditions: United States, 1990-92. Series 10, No. 194. Pg. 12, Table 8.