Tivic Health® Systems Inc., announced that ClearUP® Sinus Pain Relief, a small handheld device that delivers a proprietary microcurrent waveform, has received CE Mark approval for temporary relief of sinus pain, pressure and congestion, under the brand name ClearUP Sinus Relief. The combination of the Company’s FDA Clearance and CE Mark approval opens the market for ClearUP to sell in over 190 countries.
Tivic Health will evaluate opportunities for international expansion through direct sales, partnerships, and retail distribution to establish a presence in overseas markets in 2021. ClearUP is part of a wave of new non-invasive neuromodulation devices coming to market that provide safe, non-drug options for patients with a variety of medical conditions.
“We have had overwhelming interest both from customers and distributors in international markets,” said Jennifer Ernst, CEO of Tivic Health. “With the worldwide growth in sinus and allergy diseases, we look forward to forming strong partnerships to launch ClearUP internationally. For decades, the medical community has focused on treating conditions almost exclusively with chemical and drug therapies. We now see a growing number of companies exploring bioelectronic medicine – replacing drugs with targeted electrical stimulation. I am excited to be delivering one of the first non-prescription bioelectronic solutions to mainstream markets.”
Clinically proven, and FDA cleared, ClearUP is a small handheld device that is drug-free, has no chemical side effects and is available over-the-counter without a prescription to help 50+ million allergy sufferers in the U.S. manage their sinus pain. To use, glide ClearUP along the outside of your cheek, nasal bone and around the brow bone for a quick five-minute treatment. ClearUP guides the user to the most optimal treatment points with its light and vibration system. As ClearUP vibrates, it delivers a low-level, proprietary electrical stimulation waveform called microcurrent that stimulates sinus nerve fibers under the skin of the face to relieve sinus pain. There is a one-button control and three levels of customization.
About Tivic Health Systems Inc.
Tivic Health is a bioelectronic device company dedicated to developing microcurrent therapy solutions to treat chronic diseases and conditions. ClearUP has received awards from: Last Gadget Standing at CES 2020, Digital Trends Best Health Gadgets CES 2020, TIME’s 2019 Best Inventions and CES 2020 Innovation Honoree Award. Founded in 2016, Tivic Health is part of a $6.2B global bioelectronics industry and is dedicated to harnessing the power of neuromodulation for home use products and empowering people to improve their health and quality of life.