Therapy Areas: AIDS & HIV
Tivic Health wins US FDA's 510(k) clearance for ClearUP for the treatment of sinus pain associated with allergic rhinitis/hay fever
4 January 2019 -

Bioelectronic device company Tivic Health Systems Inc reported on Thursday the receipt of the 510(k) clearance from the US Food and Drug Administration (FDA) for the first-in-class bioelectronic ClearUP Sinus Pain Relief treatment for sinus pain in adults due to allergic rhinitis (hay fever).

The company said ClearUP is an over-the-counter (OTC) device that provides consumers with a simple, non-invasive and drug-free option to relieve sinus pain caused by various environmental allergies including dust, mold, pollens and pet dander. The one-button control is easy-to-use and offers three intensity levels to personalize treatment to best suit the needs of the individual. It can be used up to four times a day. Each treatment session takes five minutes and is reusable and rechargeable.

A small, handheld device, ClearUP easily glides along the outside of the nasal passages -- the cheek, nose and brow bone -- to deliver low current electrical waveforms that stimulate the nerves under the skin to help relieve sinus pain. The device will be available over-the-counter without a prescription by mid-2019, added the company.

Under the US FDA's submission, the company launched a double-blind, randomized control trial at a top-tier US research science centre in 71 patients with sinus pain. In this pivotal trial, it was demonstrated that after one treatment with ClearUP, three out of four users achieved sinus pain relief (74%).

In conjunction, the results of this trial were presented at the American Rhinologic Society Annual Meeting in October 2018.



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