EINDHOVEN, Netherlands, and NEWNAN, Ga., October 15, 2026
Salvia BioElectronics, a clinical-stage medical device company developing neuromodulation therapies for resistant migraine, announced that the first U.S. patient has been implanted with its investigational MySalvia System in the pivotal RECLAIM-II clinical trial. The multicenter study will evaluate the safety and effectiveness of the implantable therapy for the preventive treatment of adults with resistant migraine, a condition in which substantial disability persists despite multiple preventive treatments. RECLAIM-II is expected to enroll approximately 150 patients across more than 20 U.S. clinical sites. The MySalvia System uses two ultra-thin implants positioned just beneath the skin at the front and back of the head to target nerve pathways involved in migraine. Patients activate the investigational therapy twice daily using a small wearable device. The study builds on Salvia’s earlier RELIEF feasibility study and the ongoing European RECLAIM pilot study, which together have involved more than 60 implanted patients, according to the company. The pivotal U.S. trial is intended to generate further evidence on the system’s safety and effectiveness in a controlled clinical setting. The device remains investigational and is not approved for commercial use in the United States.
RECLAIM-II Advances Clinical Evaluation in the United States
The first implantation in RECLAIM-II marks a milestone in Salvia BioElectronics’ effort to develop a treatment specifically designed for resistant migraine. The trial is a randomized, double-blind, controlled, multicenter pivotal study expected to enroll approximately 150 adults aged 22 to 84 across more than 20 U.S. sites. The first procedure was performed at Vista Clinical Research in Newnan, Georgia, under the leadership of Sandeep Vaid, M.D., an interventional pain physician. Vaid reported that the initial implantation proceeded smoothly, with the two implants positioned beneath the skin at the front and back of the head. Roni Diaz, Vice President of Clinical and Regulatory Affairs at Salvia BioElectronics, said the milestone builds on work completed in earlier feasibility and pilot studies and enables the company to expand evaluation of the therapy among U.S. patients. Amaal Starling, M.D., a headache neurologist at Mayo Clinic and steering committee chair of RECLAIM-II, highlighted the need for additional options for people whose migraine remains disabling despite existing preventive treatments. The study will investigate whether the MySalvia System can provide safe and effective preventive treatment for this population. Its controlled design is intended to generate more rigorous evidence than early feasibility studies alone can provide.
Ultra-Thin Implants Deliver Targeted Neuromodulation
The MySalvia System is an implantable neuromodulation device developed specifically for migraine. It consists of two ultra-thin implants placed just beneath the skin, one at the front of the head and one at the back, to target key nerves associated with migraine. Patients activate the therapy twice daily using a small wearable controller. Neuromodulation is intended to influence pain-related nerve signaling, with the goal of reducing the frequency and severity of migraine attacks. Salvia says its system has been designed around the anatomy of the head, rather than adapted from devices originally developed for chronic pain in the trunk and limbs. The approach belongs to the emerging category of implantable extracranial neuromodulation, which targets nerves outside the skull. According to Chief Medical Officer Wim Pollet, M.D., migraine can involve heightened sensitivity to ordinary sensory inputs, including touch, sound and light. The investigational system is designed to target nerve pathways involved in the condition and potentially help regulate pain-related signaling. The study will assess whether this approach translates into meaningful clinical benefits for adults with resistant migraine. Although implantable neuromodulation has been used in severe migraine previously, Salvia’s purpose-built system requires further controlled clinical evaluation before its safety and effectiveness can be established..
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Earlier Research Supports Continued Investigation
RECLAIM-II builds on the company’s RELIEF feasibility study and the ongoing European RECLAIM pilot study in Belgium, the Netherlands and the United Kingdom. Salvia reports that more than 60 patients have been implanted across these earlier studies, with favorable procedural success and safety observations. Long-term findings extending to 24 months from the small RELIEF study, which involved seven patients, suggest that combined nerve stimulation may provide sustained clinical benefit for some individuals with resistant migraine. However, the small number of participants limits the conclusions that can be drawn, and larger controlled trials are needed to assess effectiveness and durability more reliably. Hubert Martens, Co-Founder and Chief Executive Officer of Salvia BioElectronics, said the company aims to generate robust clinical evidence through RECLAIM-II and investigate the potential role of bioelectronic therapy for people who have exhausted available treatment options. Enrollment is expected to continue as additional U.S. sites become active. The study is registered as NCT07719608, while the European RECLAIM pilot is registered as NCT06450444. Salvia is also exploring the potential of its technology for cluster headache. The RECLAIM-II results will help determine whether the MySalvia System can become a viable preventive treatment option for resistant migraine. Until the pivotal study is completed and the relevant regulatory requirements are met, the system remains limited to investigational use.
Source::Salvia BioElectronics press release
