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Salvia announces first MySalvia implant in U.S. pivotal migraine trial

Source publication date

Site published

The procedure took place at Vista Clinical Research in Newnan, Georgia. The randomized, double-blind controlled study plans roughly 150 adults at over 20 U.S. sites.

Two thin implants beneath the front and back scalp deliver electrical stimulation to migraine-related nerves, activated by an external wearable. This is nerve modulation, not muscle-stimulating EMS.

Summary

The October 15 announcement marks the first U.S. RECLAIM-II implantation of investigational MySalvia.

Editorial view

Editorial view: a development milestone from early studies to a larger controlled U.S. trial. Recruitment, safety and comparative outcomes remain key evidence to follow.

Evidence and limitations

Investigational and not commercially authorized. First implantation does not establish efficacy or commercial availability. October 15 is the announcement date; the exact procedure date was not disclosed.

Sources

Salvia BioElectronics

Salvia BioElectronics

Salvia BioElectronics