Eindhoven, The Netherlands, July 4th 2023 - Salvia BioElectronics, a pioneering Dutch company focused on neuromodulation for severe migraine, today announced the successful first implantation of their paper-thin neuromodulation solution. For the first time in medical history, bioelectronic foils were implanted to treat severe migraine and cluster headaches. "A remarkable milestone, ushering in a new era of possibilities in our field," says CEO Hubert Martens. And with success: the first patient experienced immediate improvements in the number and intensity of migraine and cluster headache attacks.
Salvia BioElectronics is a medical device company dedicated to developing a patient-centric therapy for chronic migraines. Founded in 2017 by industry veterans in the field of neuromodulation, the company builds on research around known neural targets in migraine to develop an effective, safe, and accessible modulation method aimed at alleviating migraine.
Migraine is the leading cause of disability in people under the age of 501, affecting one in seven individuals, primarily women. More than five percent of people with migraine suffer from chronic migraines, averaging 22 headache days per month. Despite current approved medical methods, patients with chronic migraine find minimal relief. Consequently, a significant number of patients remain desperate for effective medical treatment2.
Bioelectronic foils
Recognizing this unmet need, Salvia was founded with a clear mission: to give migraine patients back their life. The company aims to develop flexible bioelectronic foils that can uniquely conform to the anatomy of the head, offering a promising neuromodulation solution.
"We restore the balance in the brain," says Wim Pollet, Chief Medical Officer of Salvia. "Migraines and cluster headaches are characterized 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.”
First clinical trials
Salvia's first clinical trial marks the beginning of further building clinical evidence to support a solid market launch of their neuromodulation solution. Dr. Wim Pollet: "This first procedure is a huge milestone in our journey to help patients find relief. We are eager to continue our clinical trial program with the ultimate goal of giving patients their lives back.
Dr. Paul Frank, the principal investigator of the clinical trials, is excited about Salvia’s solution: “Working with Salvia to implant our first patient was an excellent experience. I am excited that this new technology can significantly impact the lives of many patients."
A fish called Salvia
The two young sons of Salvia’s first patient in Australia, a 29-year-old woman who has suffered from debilitating headaches since the age of 14, are so appreciative that they named their new fish after the company.
About Salvia BioElectronics B.V.
Salvia BioElectronics is a medical device company that develops a novel therapy for people with severe migraine.
Salvia’s team of scientists, doctors, and engineers develops a game-changing device that is designed to provide more migraine-free days. Salvia’s ultrathin bioelectronic foil is surgically placed just below the skin and delivers gentle electrical pulses to reduce the hypersensitivity of the nervous system.
Salvia’s unique solution and the large unmet medical need it addresses are recognized by the United States Food and Drug Administration (FDA) who awarded Salvia with a breakthrough medical device designation in 2020.
________________________________
1 Steiner, T.J., Stovner, L.J., Vos, T. et al. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain 19, 17 (2018). https://doi.org/10.1186/s10194-018-0846-2
2 Richard B Lipton, Merle L Diamond, Stewart J Tepper, Expert Perspectives—Migraine Prevention for Highly Impacted Patients.
|
|