Salvia BioElectronics has announced the successful first implantation of its paper-thin neuromodulation solution for severe migraine and cluster headaches treatment.
According to the medical device company, the procedure marked the first time in medical history that bioelectronic foils were implanted for the treatment of the conditions.
The first patient to receive it is a 29-year-old woman in Australia, who has been facing debilitating headaches ever since she was 14.
Salvia BioElectronics said that the flexible bioelectronic foils are designed to adapt to the anatomy of the head to provide a complete neuromodulation solution.
According to the Netherlands-based bioelectronics start-up, the first clinical trial will help build clinical evidence for a market launch of its neuromodulation solution.
Salvia BioElectronics CEO Hubert Martens said: “A remarkable milestone, ushering in a new era of possibilities in our field.
“And with success: the first patient experienced immediate improvements in the number and intensity of migraine and cluster headache attacks.”
The neuromodulation solution secured the US Food and Drug Administration (FDA)’s breakthrough medical device designation in 2020 based on its impact on an unmet medical need.
The Dutch firm claimed that existing solutions offer limited relief.
Salvia BioElectronics chief medical officer Wim Pollet said: “We restore the balance in the brain. Migraines and cluster headaches are characterised by hypersensitivity of the nervous system.
“Our solution aims to restore the balance of the nervous system by delivering gentle electrical pulses via paper-thin bioelectronic foil to reduce migraine and cluster headache attacks.”
Established in 2017, the Dutch medical device company is said to have been built on research focused on known neural targets in migraine to develop an effective, safe, and accessible modulation approach that can reduce symptoms.
