Tivic Health (Nasdaq:TIVC) announced today that its funded study for vagus nerve stimulation received Institutional Review Board (IRB) approval.
San Francisco-based Tivic Health’s study takes place at the Feinstein Institutes for Medical Research. With IRB approval, the company can begin recruitment and enrollment for the study of its non-invasive bioelectronic nerve stimulation device. In collaboration with Tivic Health, the Feinstein Institutes initiated recruitment and completed the first patient enrollment.
An IRB, an FDA-registered group, reviews and monitors biomedical research involving human subjects. It can approve, require modifications to or disapprove research. An IRB serves an important role in protecting the rights and welfare of human research subjects, Tivic said in a news release.
The study utilizes a new neurostimulation approach with 20 individuals, plus data analysis and algorithm development. It may provide greater targeting strategies for stimulation and more control over its physiologic effects, Tivic said.
“We’re excited for the proprietary value this work has the potential to deliver, as we continue to explore expanding Tivic’s non-invasive bioelectronic solutions to vagus nerve pathways and other clinical uses,” said Jennifer Ernst, CEO at Tivic.
The bioelectronic medicine maker’s first commercial product, ClearUP, holds FDA approval for over-the-counter treatment of symptoms of inflammation. That includes sinus pain and congestion. In 2021, the FDA expanded the indication for use of ClearUp to include congestion from allergies, the flu and the common cold.
Positive trial news follows last month’s letter from Ernst to investors updating them on the current situation at Tivic. Ernst’s letter stated that the company took several measures to fortify its position, including a workforce reduction and internal restructuring. The company did not disclose further details about the reduction or restructuring.
