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 year1; 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.”