Tivic Health Partners with the Feinstein Institutes to Advance its Patent-pending, Non-Invasive Cervical Vagus Nerve Stimulation; Begins Optimization of ncVNS for use in Clinical Indications

Tivic Health Systems, Inc. (“Tivic Health”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced today it has initiated the second phase of its clinical work to advance its novel non-invasive cervical vagus nerve stimulation (“ncVNS”). The company has entered into a collaboration agreement with The Feinstein Institutes for Medical Research at Northwell Health to optimize its ncVNS device therapy for use in specific clinical indications.

Tivic Health will conduct a second 20-person clinical trial in collaboration with Theodoros Zanos, Ph.D., Associate Professor in the Institute of Bioelectronic Medicine and Head of the Neural and Data Science Lab at the Feinstein Institutes. Physiological measurements will be used to identify optimal device specifications, including refining electrode positioning and key electrical waveform parameters utilized in its successful Phase 1 study.

“Our recently released ncVNS results demonstrated a large clinically important change in biomarkers for the brain, heart, and autonomic nervous system,” says Blake Gurfein, Ph.D., Chief Scientific Officer of Tivic Health. “This next phase of the research will build upon those results to tailor the therapy to specific clinical indications and accelerate our product development.”

Through its successful Phase 1 study, Tivic Health demonstrated a novel ncVNS approach that management believes could have clinical utility in several patient populations, including those with epilepsy, post-traumatic stress disorder, and ischemic stroke, among others.

Background:

VNS is a growing market that is part of the $8.3B neurostimulation market, which has a projected CAGR of 12.2% from 2023 through 2032, according to Global Market Insights. The vagus nerve is the longest autonomic nerve in the body. The vagus nerve regulates many organ systems associated with chronic disease, and thus modulating activity in this nerve pathway is of significant interest in the medical industry. VNS is currently indicated for treatment-resistant epilepsy and depression, cluster headache, migraine headache, and stroke rehabilitation, and it is being studied for other neurological, cardiac, and immune conditions. However, many of the applications of VNS rely on surgical implants.