Therapy Areas: Devices
Salvia BioElectronics awarded FDA breakthrough device designation for neurostimulation solution to treat migraine patients
4 November 2020 -

Neurostimulation platform company Salvia BioElectronics BV reported on Tuesday the receipt of US Food and Drug Administration (FDA) breakthrough device designation for its implantable neurostimulation system to address chronic migraine based on a novel device concept with unique benefits to both patients and physicians.

Migraine is the first cause of disability in under 50s, affecting one out of seven people, predominantly women. People with migraine experience episodes of throbbing, pulsating pain, sometimes accompanied by nausea, vomiting and sensitivity to light.

The company revealed that only one in three of drug-refractory chronic patients are helped with the newest generation of anti-migraine drugs, leaving many patients in medical need. While neurostimulation has been demonstrated to be effective for these patients, there are no approved devices commercially available.

Salvia BioElectronics added that it plans to develop thin and conforming bioelectronic foils that uniquely adapt to the anatomy of the head. Based on research around known neural targets in migraine, it is developing the right form factor for stimulation that is effective, safe and affordable.