Tivic Health Systems today said the FDA expanded the indication for use of its ClearUp Sinus Pain Relief to include congestion from allergies, the flu and the common cold.
The expanded indication is an addition to the device’s FDA clearance for treating allergy-related sinus pain caused by seasonal and year-round allergies.
ClearUp is a small handheld device that offers a non-invasive and drug-free treatment using gentle microcurrents to relieve sinus and nasal congestion and allergy-related sinus pain. It is available at major online retailers in the U.S.
“Bioelectronic devices stimulate the body to produce factors that it very tightly regulates. In the case of ClearUp, it stimulates the trigeminal nerve, which is responsible for sensing pain and pressure of the face, and also sympathetic fibers of the autonomic nervous system, which can induce vasoconstriction and reduced swelling,” chief medical officer Subinoy Das said. “Together, modulation of these pathways provides rapid relief of sinus pain and congestion without the side effects that often come with drugs used for these symptoms. For the large number of patients affected by sinus pain and congestion, whether from allergies or infections, this is a game-changing new product.”
Tivic Health’s clinical studies of the device showed that it was effective in treating moderate to severe congestion with an average of 35% reduction in congestion symptoms 10 minutes after treatment. After four weeks of regular use, study participants reported an average of 44% reduction in congestion symptoms.
“We are at the tip of the iceberg in developing novel bioelectronic device applications to treat chronic conditions without medication. Of particular note, this FDA De Novo Request grant breaks new ground as it creates an area of technology never before granted by the FDA — microcurrent for congestion relief. We are proud to be the first and look forward to reaching millions without drugs or chemicals,” CEO Jennifer Ernst said in a news release. “As the bioelectronics industry continues to invest in both basic science and clinical research, these devices will become more effective and will tackle all types of inflammatory clinical conditions.”