An IRB is an FDA-registered group that has been formally designated to review and monitor biomedical research involving human subjects
The pilot study will utilize a new neurostimulation approach with 20 individuals. (Credit: Nappy on Unsplash)
Tivic Health Systems, a health tech company that develops and commercializes bioelectronic medicine, announced today that the research study that the company is funding at The Feinstein Institutes for Medical Research has received study approval from the Institutional Review Board (“IRB”) and has initiated study recruitment and enrollment for its novel non-invasive bioelectronic device approach to vagus nerve stimulation.
An IRB is an FDA-registered group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
In collaboration with Tivic Health, The Feinstein Institutes for Medical Research has initiated the recruitment and completed the first patient enrollment of subjects in the study. The pilot study will utilize a new neurostimulation approach with 20 individuals, along with data analysis and algorithm development performed by researchers at Feinstein Institutes’ Institute of Bioelectronic Medicine. This study may provide greater targeting strategies of stimulation and more control over the types of physiologic effects that result from stimulation.
“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.
Source: Company Press Release