Tivic Health Systems has completed enrollment in a clinical trial evaluating its patent-pending, non-invasive vagus nerve stimulation (VNS) device. The study, conducted by The Feinstein Institute of Bioelectronic Medicine, seeks to identify optimal device parameters for influencing autonomic nervous system (ANS) function, including treatment frequency and duration.
The company plans to use the trial data to prioritize clinical indications for further testing and commercial development. Tivic Health anticipates completing the trial in early Q1 2025.
According to Jennifer Ernst, CEO of Tivic Health Systems, implanted VNS technologies have demonstrated clinical efficacy but are not always suitable for every clinical scenario. She added that early non-invasive VNS approaches have shown variable responses and modest efficacy. "In contrast, we anticipate this study will allow us to optimize our novel approach to treating diseases with unmet needs and capitalize on the gap between invasive and non-invasive VNS treatments."
Tivic Health's first commercial product, ClearUP, is FDA-approved for over-the-counter treatment of inflammation symptoms, including sinus pain and congestion. In 2021, the FDA expanded ClearUP's indication to include congestion from allergies, the flu, and the common cold.
Blake Gurfein, Chief Scientific Officer at Tivic Health, stated that the study brings the company closer to potential FDA approval of a non-invasive treatment for clinical indications inadequately addressed by current treatment options.
