ClearUP's FDA De Novo Request Grant Breaks New Ground With Use of Microcurrent to Provide Congestion Relief From Colds, Flu, Allergies
San Francisco, April 19, 2021 - It’s spring allergy season and 50 million allergy sufferers are looking for relief from congestion and allergy-related sinus pain. Tivic Health® Systems Inc., a first-in-class bioelectronic health device company, developed a unique drug-free solution for allergy sufferers, ClearUP® Sinus Pain Relief. ClearUP is a small handheld device that uses low-level electrical stimulation called microcurrent to deliver fast and effective allergy sinus pain relief and sinus congestion relief from colds, flu and allergies.
Tivic Health’s FDA De Novo Request grant was received last month and the expanded indication for use breaks new ground for the 200 million Americans who get colds, allergies and the flu each year. Advanced microcurrent technology can now be used for moderate to severe congestion relief.
FDA cleared and clinically proven, the ClearUP device is non-invasive and provides consumers sinus pain and congestion relief without using any drugs or chemicals. To use ClearUP, simply glide the tip along your cheek, nose and brow bone and the microcurrent waveform calms sympathetic nerve fibers and, according to research, shrinks swollen sinus tissue to help reduce sinus pain and congestion. A treatment takes only five minutes and provides relief for up to six hours. ClearUP is rechargeable and available online at Amazon, Best Buy, FSA/HSA stores, Sharper Image, Walgreens and Walmart.
“Healthcare has taken on a self-care focus and consumers are actively searching for alternatives to treat illnesses that are free of drug addiction or chemical side effects,” said Jennifer Ernst, CEO of Tivic Health. “Bioelectronic technologies are being harnessed into medical devices like ClearUP to help patients treat chronic conditions like Parkinson’s, Crohn’s, tremors, migraines, sinus pain, and more. Bioelectronic devices are becoming as important and effective as drug therapies as the industry continues to expand its offerings.”
Clinical Study Congestion Results
Clinical studies showed that the ClearUP device was effective in reducing moderate to severe congestion. Study subjects reported an average of 35% congestion reduction within 10 minutes of first-time use. After four weeks of regular use, subjects reported an average of 44% reduction in congestion symptoms. The ClearUP device already had FDA clearance for reducing allergy-related sinus pain caused by seasonal and year-round allergies.
About Tivic Health Systems Inc.
Founded in 2016, Tivic Health is part of a $6.2B global bioelectronics industry that is dedicated to harnessing the power of neuromodulation for home use products that treat chronic diseases and conditions that empower people to improve their health and quality of life. ClearUP has received awards from: Last Gadget Standing CES 2020, Digital Trends Best Health Gadgets CES 2020, TIME’s 2019 Best Inventions and CES 2020 Innovation Honoree Award. @TivicHealth