10
Participants
Start Date
December 1, 2025
Primary Completion Date
October 1, 2026
Study Completion Date
October 1, 2028
The Salvia PRIMUS implantable neurostimulator System
The Salvia PRIMUS implantable neurostimulator System is designed to provide subcutaneous neurostimulation to the V1 branches of the Trigeminal nerves (supra-orbital and supra-trochlear nerves) and the branches of the Greater Occipital Nerves. It is intended to modulate headaches' neural networks by utilizing mild electrical pulses. There are 2 stimulation waveforms options: the Salvia burst waveform providing paresthesia-free stimulation and Tonic waveform, providing paresthesia-provoking stimulation. The PRIMUS System comprises a 25 cm (forehead) and a 17cm (back of the head) subcutaneous implant, a MySalvia device, a programmer, and surgical tooling.
Lead Sponsor
Salvia BioElectronics
INDUSTRY