Salvia BioElectronics announced the first successful implementation of their neuromodulation device intended to treat migraines and cluster headaches.
"This first procedure is a huge milestone in our journey to help patients find relief," said Chief Medical Officer of Salvia, Dr. Wim Pollet. "We are eager to continue our clinical trial program with the ultimate goal of giving patients their lives back."
According to Salvia, the first patient to receive the neuromodulation treatment reported immediate improvements in both the frequency and intensity of their migraines and cluster headaches.
According to the American Migraine Foundation (AMF), migraines are more than just bad headaches. Migraine is a neurological disease, AMF states, and an estimated 39 million Americans live with migraine. However, many people remain undiagnosed.
A migraine, which affects one in seven individuals, primarily women, is a significant cause of disability among those under the age of 50, according to Salvia.
Chronic migraines, experienced by over five percent of migraine sufferers, result in an average of 22 headache days per month.
According to Salvia, the neuromodulation device is a paper-thin implant with bioelectronic foils.
The bioelectronic foils are flexible and conform to the unique anatomy of the head. "We restore balance in the brain," Dr. Pollet said. "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."
The company received FDA Breakthrough Device Designation in 2020 for its neurostimulation device, which was just a concept at the time.
Salvia stated benefits of neurostimulation had been demonstrated in patients suffering from chronic migraines, but there are no commercially approved devices available.
The company was founded with the intention of developing a neurostimulation treatment option for patients suffering from migraine.
