Salvia BioElectronics said on October 15 that the first US patient has been implanted in RECLAIM-II, its trial of the MySalvia System. The procedure took place at Vista Clinical Research in Newnan, Georgia. The study started after FDA granted an investigational device exemption, and Salvia says the data are meant to support a future US market authorization.
RECLAIM-II (NCT07719608) is a multicenter, randomized, double blind, controlled trial of preventive treatment in adults with resistant migraine. Salvia plans about 150 patients across more than 20 US sites, enrolling adults aged 22 to 84. The system places two ultra thin implants under the skin, one at the front of the head and one at the back, and a small wearable turns therapy on twice a day.
Salvia ran the RELIEF feasibility study (NCT05858801) and its European RECLAIM pilot (NCT06450444) is still running. The company was founded in Eindhoven in 2017 and raised a $60M Series B in May 2025. A double blind implant study means patients spend time on inactive settings, and blinded stimulation is where device neuromodulation has historically handed back its effect size.