Enrollment Complete in Tivic Health’s VNS Device Trial

Tivic Health Systems Inc. has finished enrolling patients in an optimization study of its patent pending, non-invasive vagus nerve stimulation (VNS) device.

The trial is being conducted by The Feinstein Institute of Bioelectronic Medicine and aims to identify device parameters that optimally influence autonomic nervous system (ANS) function, including treatment frequency and duration. Tivic Health will use the results to prioritize clinical indications the company expects to carry forward into further testing and commercial development. The trial is expected to be completed early this year.

“Already we have established that our non-invasive cervical vagus stimulation device has shown large, rapid effects in clinically important biological measures,” Tivic Health 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 current treatment options.”

Polaris Market Research estimates the global vagus nerve stimulation (VNS) market will expand 10.6% annually from $8.59 billion in 2021 to $21.3 billion. Additionally, IDTechEx has forecast peripheral nerve stimulation—the segment targeted by Tivic Health—to swell 35% annually, one of the fastest growth segments in bioelectronic medicine.

The vagus nerve is the longest autonomic nerve in the body and regulates many organ systems associated with chronic disease. VNS is approved by the U.S. Food and Drug Administration for treatment-resistant epilepsy and depression, cluster and migraine headaches, and stroke rehabilitation. It is being studied for other neurological, cardiac, and immune conditions. However, many of the applications of VNS rely on surgical implants.

“While implanted VNS technologies have proven their clinical efficacy and commercial viability, they are not always appropriate for certain clinical scenarios,” Tivic Health Systems CEO Jennifer Ernst said. “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.”

Tivic previously announced it has engaged healthcare growth strategy firm Fletcher Spaght Inc. (FSI) to accelerate its product development and commercial strategy. FSI has conducted a comprehensive market assessment of Tivic Health’s ncVNS technology drawing from clinical outcomes from Tivic Health’s successful Phase 1 trial, which it announced in May. FSI, in conjunction with Tivic Health’s scientific and clinical leadership, will help drive the company’s clinical strategy and product development this year and beyond.

Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Its patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic Health’s non-invasive and targeted approach to treating inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic Health’s first commercial product ClearUP is a U.S. Food and Drug Administration-approved, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. With collaborators including The Feinstein Institute for Bioelectronic Medicine, Tivic Health is developing new VNS devices that will more precisely target and modulate vagus nerve activity to deliver better clinical outcomes, with non-invasive or minimally invasive devices.