Salvia BioElectronics, an Eindhoven-based medtech company, has implanted the first patient with its investigational MySalvia system in the United States as the RECLAIM‑II study gets under way. The large, multi-centre trial will test the safety and effectiveness of Salvia’s neuromodulation therapy as a preventive treatment for adults with difficult-to-treat migraine.
What is being tested
The MySalvia system is an implantable neuromodulation therapy designed specifically for migraine. It uses two ultra‑thin implants placed just beneath the scalp to target nerves implicated in migraine, while an external wearable device lets users activate the treatment. The device is investigational and not approved for commercial use.
About the RECLAIM‑II study
- RECLAIM‑II has started in the United States following permission from the US Food and Drug Administration to run the trial in the country.
- The study is expected to recruit around 150 participants across more than 20 hospitals and clinics in the US.
- The trial builds on Salvia’s earlier feasibility study (RELIEF) and an ongoing European pilot (RECLAIM), with the aim of producing robust, controlled clinical evidence in a larger population.
Comments from clinicians and company
"Migraine is the leading cause of disability in adults under 50 and affects tens of millions of people worldwide. In my practice I see many patients who have already tried multiple therapies but still suffer major impacts on work and family life," said Dr Amaal Starling, headache specialist and neurologist at the Mayo Clinic in Arizona, quoted by Salvia. "With RECLAIM‑II we are studying whether this neuromodulation therapy can offer a safe and effective new option for that group of patients."
Hubert Martens, co‑founder and CEO of Salvia BioElectronics, said the study is an important milestone toward developing a bio‑electronic therapy that fits into patients' daily lives and toward generating the clinical evidence needed to define the role of neuromodulation in migraine care.
Clinical development and next steps
Salvia says the RELIEF feasibility trial provided encouraging insights on safety and procedural feasibility, and RECLAIM‑II aims to expand on those findings with a larger, controlled trial in the US. The company also continues clinical work in Europe and is exploring applications of its technology in other headache disorders such as cluster headache.
Salvia was founded in 2017 and has its headquarters in Eindhoven. The company is active across the United States, Europe and Australia and is supported by institutional investors as it advances clinical development.
Note: The MySalvia system is an investigational medical device. Its safety and effectiveness are under evaluation in clinical trials and it is not yet approved for commercial use.
Source: Original press release
