Tivic Health Systems Inc. is teaming up with The Feinstein Institutes for Medical Research at Northwell Health to optimize its non-invasive cervical vagus nerve stimulation (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 used 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,” Tivic Health Chief Scientific Officer Blake Gurfein, Ph.D., said. “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 improve treatment for epilepsy, post-traumatic stress disorder, and ischemic stroke, among others.
VNS is a growing market that is part of the $8.3 billion neurostimulation market, which is projected to grow 12.2% annually through 2032, according to Global Market Insights. The vagus nerve is the body’s longest autonomic nerve. Since it regulates many organ systems associated with chronic disease, 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 VNS applications rely on surgical implants.
Tivic Health, with collaborators such as The Feinstein Institute for Bioelectronic Medicine, hopes to improve the ways in which VNS devices can more precisely target and modulate vagus nerve activity to achieve intended biological and clinical outcomes, with non-invasive or minimally invasive devices.
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 used 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,” Tivic Health Chief Scientific Officer Blake Gurfein, Ph.D., said. “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 improve treatment for epilepsy, post-traumatic stress disorder, and ischemic stroke, among others.
VNS is a growing market that is part of the $8.3 billion neurostimulation market, which is projected to grow 12.2% annually through 2032, according to Global Market Insights. The vagus nerve is the body’s longest autonomic nerve. Since it regulates many organ systems associated with chronic disease, 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 VNS applications rely on surgical implants.
Tivic Health, with collaborators such as The Feinstein Institute for Bioelectronic Medicine, hopes to improve the ways in which VNS devices can more precisely target and modulate vagus nerve activity to achieve intended biological and clinical outcomes, with non-invasive or minimally invasive devices.
Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health’s patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic Health’s non-invasive and targeted approach to the treatment of 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, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors.
Previous company announcements:
January 2024: Tivic Rolls Out ClearUP 2.0 Bioelectronic Sinus Device
August 2023: Tivic Health Initiates Bioelectronic Vagus Nerve Stimulation Study
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