The US Food and Drug Administration (FDA) has expanded the indication for use of Tivic Health Systems’ handheld device, ClearUP Sinus Pain Relief, to include congestion from allergies, flu and the common cold.
The latest indication is in addition to FDA clearance for treating allergy-related sinus pain caused by seasonal and year-round allergies.
Using gentle microcurrent waveforms, ClearUP offer sinus pain and congestion relief to users. It is used outside the nasal passages, along the cheek, nose and brow bone, and provides low current electrical waveforms which stimulate the nerves under the skin to aid in relieving sinus pain and congestion.
ClearUP is a non-invasive and drug-free treatment that can offer users congestion relief without the need for medication.
Tivic Health CEO Jennifer Ernst said: “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.
“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.”
Clinical studies, as part of the FDA De Novo Request grant, demonstrated that ClearUP could effectively treat moderate to severe congestion.
Study participants with moderate to severe congestion reported an average 35% reduction in congestion symptoms ten minutes after using ClearUP. This was significantly superior to the placebo.
Participants also reported an average 44% reduction in congestion symptoms after four weeks of regular use.
Tivic Health chief medical officer Subinoy Das said: “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 fibres of the autonomic nervous system, which can induce vasoconstriction and reduced swelling.”