Tivic Health has announced the completion of enrollment in its optimization study focused on refining its non-invasive vagus nerve stimulation (VNS) device. The study, conducted at the Feinstein Institute of Bioelectronic Medicine, a research arm of Northwell Health, seeks to identify the optimal device parameters for influencing autonomic nervous system (ANS) function. This milestone marks a significant step toward potential FDA approval of a non-invasive treatment for clinical indications inadequately addressed by current options.
The vagus nerve, the longest nerve in the body, plays a crucial role in regulating various bodily functions, including heart rate, digestion, and mood. Vagus nerve stimulation is an established treatment for conditions like epilepsy, depression, and stroke rehabilitation, where it modulates neural activity through electrical pulses.
Tivic Health aims to determine the ideal frequency and duration of treatments using its technology. The results of this study are expected to guide the company in targeting and prioritizing clinical indications for further testing and commercial development. The company anticipates the trial to be completed in early 2025.
According to Tivic Health's chief scientific officer, Blake Gurfein, this study represents a crucial step toward potential FDA approval of a non-invasive treatment for clinical indications that are inadequately addressed by the current treatment options. Tivic’s CEO Jennifer Ernst highlighted the limitations in implanted VNS technologies, which are “not always appropriate for certain clinical scenarios.”
The global neuromodulation device market is projected to reach nearly $11 billion by 2033, a substantial increase from $5.7 billion in 2023, according to GlobalData analysis. The vagus nerve stimulator segment is expected to contribute $1 billion to this market by 2033. Key players in the neuromodulation device market include Medtronic, Boston Scientific, and Abbott.
Tivic Health already markets ClearUp, an FDA-cleared transcutaneous electrical nerve stimulator indicated for relieving congestion and sinus pain. The FDA expanded its clearance in 2021 to include congestion from allergies, the flu, and the common cold, in addition to allergy-related sinus pain caused by seasonal and year-round allergies.
