Tivic Health Systems has commenced patient enrolment for its new non-invasive bioelectronic device approach to vagus nerve stimulation.
The latest development comes after the company received approval from the FDA-registered Institutional Review Board.
Enrolment in the study, funded by Tivic Health, has begun at the Feinstein Institutes for Medical Research.
In partnership with Tivic Health, the Feinstein Institutes has successfully enrolled the first patients for the study.
The pilot study will leverage a new neurostimulation approach involving 20 participants.
Additionally, data analysis and algorithm development will be conducted by researchers at the Feinstein Institutes’ Institute of Bioelectronic Medicine.
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This research could offer improved approaches for targeting stimulation strategies and enhanced regulation of the specific physiological effects arising from stimulation.
Tivic CEO Jennifer Ernst 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.”
In April this year, Tivic Health announced the expansion of its intellectual property portfolio with a new patent in vagus nerve stimulation.
The company filed the patent with the US Patent Office.
Tivic’s technology platform utilises stimulation of the trigeminal, sympathetic and vagus nerve structures.
Its first commercial product, ClearUP, is a handheld bioelectronic sinus device that received approval from the US Food and Drug Administration.