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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.

For more information, visit www.tivichealth.com and follow us on www.twitter.com/TivicHealth.

 

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.

 

Contact

Tivic Health, Menlo Park, CA

Media - Maureen Perou, 773-230-7026
Maureen.Perou@TivicHealth.com

Media - Caroline Baumgartner, 630-962-6006
CBaumgartner@agencyinmotion.com

Investors - Jennifer Ernst, 510-512-6477
Jennifer.Ernst@TivicHealth.com

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.

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Tivic Health introduces SYNUS Pain Relief TM, the first bioelectronic device developed to relieve sinus pain, at The Future of Healthcare Event, May 6-9, in Las Vegas

(note: Since this press release, product name has changed to ClearUPTM Sinus Pain Relief)

Menlo Park, CA. (May 3, 2018) Tivic Health Systems Inc TM (“Tivic Health”), a bioelectronic health-tech start-up, introduces SYNUS Pain Relief™, the first bioelectronic healthcare home device developed to offer temporary relief of sinus pain by harnessing the body’s natural electrical system. As a start-up exhibitor at The Future of Healthcare Event May 6-9, Tivic Health is actively reaching out to the medical and investor communities in preparation for the launch of SYNUS Pain Relief later this year.

Approximately 30 million U.S. adults are diagnosed with sinusitis. (Center for Disease Control, National Health Interview Survey 2015). Tivic Health’s simple-to-use device uses microcurrent waveforms at very low current levels to target sinus pain, pressure and congestion. This new treatment approach targets the sinus passages directly by stimulating the sinus nerve pathways.

Tivic Health Systems CEO Jennifer Ernst, a hi-tech business builder, joined forces with inventor, John Claude, an experienced biomedical engineer, in 2016 to commercialize SYNUS. “I saw an untapped opportunity to help millions suffering from frequent sinus issues. Our research told us that over 70{2f70a2dd97cb4fa49fdf9c573fec96c0e5f5754bdeec0e0dd28fa6f6e8f69928} of sinus sufferers receive little to no relief from existing products, and only 8{2f70a2dd97cb4fa49fdf9c573fec96c0e5f5754bdeec0e0dd28fa6f6e8f69928} are fully satisfied with their current treatment regimen,” said Ernst.

Ernst and Dr. Blake Gurfein, VP of Research and Scientific Affairs at Tivic and member of UC San Francisco’s medical faculty, will participate in the Future Healthcare Event. “My work has focused on non-invasive neuromodulation. It’s exciting to join a team that’s leveraging the potential healing properties of microcurrent neuromodulation,” explains Gurfein. “Presently, we are conducting a clinical trial for submission to the FDA”, says Gurfein.

About Tivic Health Systems: Founded in 2016, Tivic Health Systems is a bioelectronic company that designs modern medical devices that harness the science of neuromodulation. The Tivic Health team is dedicated to exploring the use of microcurrents for therapeutic benefit and pioneering advances in the field of bioelectronic medicine. (This investigational product is not yet available for commercial sale).

 

For more information:PRESS KIT AVAILABLE               

Contact: Maureen F. Perou
Tivic Health Systems
773-230-7026
Maureen.perou@tivichealth.co ...Read More

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