Salvia BioElectronics starts US pivotal trial for migraine implant

The Dutch medtech has enrolled its first US patient in RECLAIM-II, a 150-patient pivotal study of its MySalvia neuromodulation implant for resistant migraine.

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A brightly lit modern medical imaging room contains a large white MRI machine with an integrated patient table, a separate wheeled medical gurney, and a desk with three computer monitors displaying medical waveforms, all illuminated by natu

Salvia BioElectronics has implanted the first US patient with its MySalvia System at Vista Clinical Research in Newnan, Georgia, marking the formal start of American enrolment in RECLAIM-II, the company's pivotal trial for adults with resistant migraine. The Eindhoven-based company expects to enrol approximately 150 participants across more than 20 sites in the United States.

The MySalvia System comprises two ultra-thin implants placed subcutaneously, one at the front of the head, one at the back, designed to stimulate key nerves involved in migraine pathophysiology. Patients activate the therapy twice daily via a small wearable device. Salvia describes the approach as Implantable Extracranial Neuromodulation (IEN), a category it is positioning as distinct from both pharmaceutical prevention and existing, less targeted neurostimulation devices.

Trial design and clinical rationale

RECLAIM-II is a multicenter, randomised, double-blind, controlled study assessing the safety, durability, and effectiveness of the system in adults aged 22 to 84. It follows the earlier RELIEF feasibility study and an ongoing European RECLAIM pilot study, both of which the company says demonstrated favourable procedural safety and early signals of sustained clinical benefit. FDA Investigational Device Exemption approval was granted prior to the pivotal study initiation.

Amaal Starling, headache specialist at Mayo Clinic and RECLAIM-II steering committee chair, put the unmet need in context: "Migraine is the leading cause of disability among adults under 50 and affects more than 40 million people in the United States. Resistant migraine is a subset of this population for whom significant disability continues despite trying multiple preventive treatments."

Hubert Martens, co-founder and chief executive, said the first implant represented "a defining milestone for Salvia and for the resistant migraine community," with the trial intended to generate the clinical evidence necessary to support a future US market authorisation submission.

Market context and competitive landscape

The resistant migraine device space has grown considerably since the FDA cleared non-invasive neurostimulation headbands such as Cefaly and gammaCore, and more recently authorised the Relivion system for acute use. None of those approved devices require surgical implantation, which means Salvia's IEN approach carries a different risk-benefit profile and will face a higher regulatory bar: pivotal data on durability and safety in a controlled trial will be scrutinised closely.

On the pharmaceutical side, the CGRP antagonist class, encompassing both monoclonal antibodies such as erenumab and fremanezumab, and oral gepants, has reshaped preventive treatment since 2018. For the subset of patients who remain refractory to CGRP-pathway drugs, an implantable option could be compelling, but the company will need to demonstrate meaningful responder rates against a sham-controlled comparator to satisfy the FDA. Salvia has not yet disclosed the primary endpoint definition or responder threshold for RECLAIM-II, details that investors and clinicians will want to see before the trial matures.

The company is also exploring its technology for cluster headache, a related but distinct indication that has historically had very limited device-based options and could represent a secondary regulatory pathway if the migraine programme succeeds.

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