Salvia BioElectronics Launches Pivotal Study for Implantable Migraine Therapy
The first U.S. patient has received an ultra-thin neuromodulation implant as part of a pivotal clinical trial for resistant migraine.
Salvia BioElectronics has commenced the RECLAIM-II pivotal trial in the United States, testing its MySalvia system for patients suffering from resistant migraine. The first participant was implanted with the device at a clinical site in Newnan, Georgia, marking the initiation of a study expected to enroll roughly 150 patients across 20 domestic locations.
The system utilizes two thin implants placed beneath the scalp to provide targeted nerve stimulation. This form of implantable extracranial neuromodulation is intended for individuals who have not found success with conventional preventative treatments. Patients manage the therapy using a small wearable device that activates the implants twice daily.
This trial follows FDA approval of the investigational device exemption (IDE). Previous smaller-scale studies in Europe and pilot programs have provided preliminary data suggesting that this nerve stimulation method may offer sustained clinical benefits. RECLAIM-II aims to produce the robust safety and efficacy data required for potential regulatory submission.
CEO Hubert Martens stated that the company’s objective is to provide a non-pharmacological treatment option for patients currently underserved by existing standards of care. The trial remains ongoing as additional sites begin patient recruitment.