Tivic Health Systems completed enrollment in a study for its vagus nerve stimulation (VNS) device.
The study, conducted by The Feinstein Institute of Bioelectronic Medicine, evaluates Tivic’s patent-pending, non-invasive VNS system. It aims to identify device parameters that optimally influence autonomic nervous system (ANS) function. These include the frequency and the duration of potential treatments.
Fremont, California-based Tivic plans to use the results to prioritize clinical indications into further testing and commercial development. It expects to complete the trial by early in the first quarter of 2025.
“While implanted VNS technologies have proven their clinical efficacy and commercial viability, they are not always appropriate for certain clinical scenarios,” said Jennifer Ernst, CEO of Tivic Health Systems. “Early non-invasive VNS approaches have resulted in 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.”
The bioelectronic medicine maker’s first commercial product, ClearUP, holds FDA approval for over-the-counter treatment of symptoms of inflammation. That includes sinus pain and congestion. In 2021, the FDA expanded the indication for use of ClearUp to include congestion from allergies, the flu and the common cold.
Tivic Health Chief Scientific Officer Blake Gurfein said the study moves the company closer to potential FDA approval of a non-invasive treatment for clinical indications inadequately addressed by the current treatment options.
