FDA Expands Use of Sinus Treatment to Include Congestion from Allergies, Influenza

March 24, 2021
Kenny Walter

Resident & Staff Physician®, Resident & Staff Physician® March 2021,

ClearUp Sinus Pain Relief treatment was previously approved for allergy-related sinus and nasal congestion and allergy-related sinus pain.

The US Food and Drug Administration (FDA) has expanded the use of ClearUp Sinus Pain Relief treatment to now include indications for treating congestion for common colds, influenza, and allergies.

The Expansion

The expansion, awarded to Tivic Health Systems, builds on the current uses for the treatment, which include allergy-related sinus pain caused by seasonal and year-round allergies.

ClearUp is a small handheld device that provides non-invasive and drug-free treatment utilizing gentle microcurrents to relieve sinus and nasal congestion and allergy-related sinus pain.

Clinical Trials

The expansion is based on various clinical trials showing the treatment was effective in treating moderate to severe congestion as part of a De Novo Request grant. In trials, investigators found patients with moderate to severe congestion reported an average of 35% reduction in congestion symptoms 10 minutes following the use of ClearUp, significantly besting placebo.

Following 4 weeks of regular use, participants reported an average of 44% of symptom reduction.

Reaction

"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. 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," said Subinoy Das, MD, chief medical officer at Tivic Health and CEO and Medical Director, U.S. Institute for Advanced Sinus Care and Research, in a statement.

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