Bioelectronic health-tech firm Tivic Health Systems has completed a pivotal clinical trial of its ClearUP sinus pain relief solution.
ClearUP is a simple and handheld medical device, which delivers targeted low-level microcurrent to the underlying nerves of the outer facial sinus passages.
The sinus pain relief device is said to target sinus pain and pressure associated with chronic sinusitis, allergic rhinitis and other common sources of sinus pain.
ClearUP sinus pain relief is an investigational technology and claims have been not evaluated by the USA. It is not currently commercialized in the US.
Tivic Health said the data will serve as a crucial factor for the company to get FDA clearance for the new bioelectronic treatment for the temporary relief of sinus pain.
Tivic Health CEO Jennifer Ernst said: “Tivic Health is dedicated to transforming medicine to aid people living with chronic disease through the use of microcurren.
“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 company will use data from the trial to submit marketing application for ClearUP solution with the US Food and Drug Administration (FDA).
The double-blind and randomized controlled study was carried out at the Stanford University’s Sinus Center. It evaluated the effect of microcurrent (low-current electrical stimulation) on sinus pain.
The new bioelectronic medical device will be filed with the FDA in the category of transcutaneous electrical nerve stimulation (TENS).
Tivic Health Systems also announced the podium presentation acceptance at the 2018 American Rhinologic Society (ARS) Annual Meeting.
Ernst further added: “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.”
Established in 2016, Tivic Health Systems is engaged in the development of Microcurrent therapy solutions for chronic diseases and conditions.