Tivic Health Systems said that its ClearUP device for allergy-induced sinus pain has received 510(k) clearance from FDA.
ClearUP is an over-the-counter device that provides consumers with a simple, non-invasive and drug-free option to relieve sinus pain caused by various environmental allergies such as dust, mold, pollens and pet dander, according to the San Francisco-based company.
ClearUP’s technology measures the user’s unique skin properties to target the optimal treatment points along the outside of the nasal passages with low-current electrical waveforms.
As part of its FDA submission, Tivic Health conducted a double-blind, randomized control trial with 71 patients to evaluate the effect of microcurrent waveforms on sinus pain. In this pivotal trial, it was demonstrated that after one treatment with ClearUP, three out of four users achieved sinus pain relief. In addition, 82% of those who used ClearUP preferred it over their current treatment(s). The results of this trial were presented at the American Rhinologic Society Annual Meeting in October 2018.
“In line with our corporate vision to create accessible, cutting-edge solutions for chronic conditions, we are very pleased to bring to market a next-generation microcurrent device that will help transform treatment for the common allergy sufferer,” said Tivic Health CEO Jennifer Ernst in a statement. “ClearUP’s FDA clearance marks a major milestone for Tivic Health.”
“For the many patients suffering from allergy-related sinus pain, we now have an effective treatment option that does not involve pills, a spray or nasal flush, surgery or opioids. ClearUP is an important new option that is drug-free, side-effect free and non-invasive,” added Subinoy Das, M.D., CEO and medical director of the U.S. Institute for Advanced Sinus Care and Research, and a member of Tivic Health’s medical advisory board.
The company’s earlier third-party research with 600 sinus pain sufferers revealed that 95% wanted to decrease the number of medicines they were taking and 91% were concerned about side effects from their current treatments.
ClearUP will be available over-the-counter without a prescription by mid-2019.