Tivic Health has completed enrolment in a study being conducted to finetune its non-invasive vagus nerve stimulation (VNS) device that the company hopes to deploy in clinical indications not properly addressed with currently available options.
The optimisation study, being conducted at Northwell Health’s research arm the Feinstein Institute of Bioelectronic Medicine, aims to identify device parameters that optimally influence autonomic nervous system (ANS) function.
The vagus nerve is a key part of the autonomic nervous system and is the longest nerve in the body. It contains both motor and sensory functions and is responsible for various processes such as heart rate, digestion, and mood, amongst others. VNS is an already-established treatment for conditions such as epilepsy, depression, and stroke rehabilitation. In the case of epilepsy, the neuromodulation treatment works by sending electrical pulses to the brain to stabilise irregular neural activity.
Tivic is looking to find out information relating to frequency and duration of potential treatments with its technology. Importantly, results from the study will help the company target and prioritise clinical indications that it “expects to carry forward into further testing and commercial development.” The Nasdaq-listed company said it expects the trial to be finished in early 2025.
Tivic Health’s chief scientific officer Blake Gurfein said: “This study is the next step in moving us closer to 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 forecast to grow to nearly $11bn by 2033, up from $5.7bn in 2023, as per analysis by GlobalData. Medtronic is currently the leader in terms of market share, with Boston Scientific and Abbott also key players. The vagus nerve stimulator segment is predicted to contribute $1bn to the market in 2033, as per GlobalData.
California-based Tivic already has a product on the market called ClearUp. The US Food and Drug Administration (FDA)-cleared transcutaneous electrical nerve stimulator is indicated to relieve congestion and sinus pain. In 2021, the FDA expanded clearance to include congestion from allergies, the flu, and the common cold, in addition to established clearance in treating allergy-related sinus pain caused by seasonal and year-round allergies.
