Salvia BioElectronics Initiates Pivotal Study with First Patient in the U.S. Receiving Ultra Thin Neuromodulation Implant for Resistant Migraine

RECLAIM-II evaluates Salvia’s purpose-built neuromodulation system for migraine as a potential new preventive treatment for adults with resistant migraine.

Eindhoven, the Netherlands and Newnan, Georgia, 15 October 2026 – Salvia BioElectronics, a clinical-stage medical device company pioneering a novel neuromodulation therapy for people with resistant migraine, today announced that the first patient has been implanted with the MySalvia System at Vista Clinical Research in Newnan, Georgia, marking the start of U.S. enrollment in RECLAIM-II (NCT07719608), the company's pivotal trial evaluating the investigational therapy in adults with resistant migraine. RECLAIM‑II is expected to enroll approximately 150 patients across more than 20 sites throughout the United States.

The MySalvia System is a minimally invasive, implantable neuromodulation therapy purpose-built for migraine. It is designed to target key nerves involved in the disease through two ultra-thin implants placed just beneath the skin of the head. The therapy is part of the emerging category of Implantable Extracranial Neuromodulation (IEN), which could help open new treatment possibilities for people who remain underserved by existing therapies.

"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," said Amaal Starling, MD, Headache Specialist at Mayo Clinic and Steering Committee Chair of RECLAIM-II. "Neuromodulation aims to restore the balance of how the brain processes pain-related signals. RECLAIM-II is designed to evaluate whether this implantable neuromodulation therapy, purpose-built for migraine, can offer a safe and effective new treatment option and bring relief for people whose migraine remains difficult to treat."

The initiation of RECLAIM-II follows FDA IDE approval for the MySalvia System and marks an important milestone in Salvia’s clinical development program. The pivotal U.S. study is designed to assess the safety, durability, and effectiveness of the MySalvia System in a larger patient population. RECLAIM‑II builds on results from Salvia's RELIEF feasibility study (NCT05858801) and the ongoing European RECLAIM pilot study (NCT06450444), which demonstrated favorable procedural outcomes and safety, and provided early signs that combined nerve stimulation may offer sustained clinical benefit for people with resistant migraine.

"Implanting the first patient in RECLAIM‑II is a defining milestone for Salvia and for the resistant migraine community," said Hubert Martens, Co-Founder & Chief Executive Officer at Salvia BioElectronics. "Our goal is to develop a drug-free bioelectronic therapy that fits seamlessly into patients' lives. RECLAIM-II represents an important step toward that vision and is designed to generate the clinical evidence needed to support potential future U.S. market authorization and ultimately bring our therapy to patients across the United States.”

RECLAIM-II is a pivotal, multicenter, randomized, double-blind, controlled trial evaluating the MySalvia System for the preventive treatment of adults with resistant migraine. The study will continue to enroll adults ages 22 to 84 as additional sites across the United States become active. Participants receive two ultra-thin implants placed just beneath the skin, one positioned at the front of the head and one at the back and use a small wearable device to activate the therapy twice daily.

Additional perspectives from the people behind RECLAIM‑II are available on Salvia’s website, along with a dedicated media library featuring different visual assets.

About the MySalvia System        

The MySalvia System is a minimally invasive, implantable neuromodulation therapy designed specifically for the preventive treatment of migraine. The system 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 involved in migraine. Neuromodulation aims to restore the balance of pain-related signal processing in the brain; the MySalvia System applies this approach, purpose-built for migraine, with the goal of reducing the frequency and severity of attacks. The system is tailored to the anatomy of the head, intended to enable a minimally invasive, patient-friendly treatment experience. The MySalvia System is currently being evaluated in clinical studies in the United States and Europe, including the pivotal U.S. RECLAIM-II study (NCT07719608) and the ongoing European RECLAIM pilot study (NCT06450444).

More information on the RECLAIM-II Study is available on the patient website: https://mysalviamigrainestudy.com/

About Salvia BioElectronics         
Salvia BioElectronics is pioneering a novel neuromodulation therapy for resistant migraine. MySalvia Therapy features ultra-thin implants, designed to target key nerves involved in migraine, and is activated by the press of a button on a wearable device. Built for everyday life, it is currently being evaluated in clinical studies. Our commitment is to work toward a future of drug-free relief without compromise, so people with migraine can live life uninterrupted.

Founded in 2017 in Europe's tech capital Eindhoven, Salvia brings together skilled device makers and MedTech entrepreneurs with extensive experience in medical devices and neuromodulation. Active in the United States, Europe, and Australia, the company is advancing clinical development with the support of leading investors. Salvia is also exploring the potential of its technology for the treatment of cluster headache.

Visit our website for more information: www.salviabioelectronics.com

Media contact
Trophic Communications
Anja Heuer or Adinda Wens, PhD
Tel: +49 (0) 151 106 199 05
Email: salvia@trophic.eu

Salvia’s ultra-thin implant for migraine | The MySalvia System | A small wearable device lets people activate therapy with the press of a button.