Dutch startup Salvia BioElectronics this week said it received FDA breakthrough device designation for its implantable neurostimulation system to treat chronic migraine.
Salvia’s system is based on a novel device concept using thin and conforming bioelectronic foils that it says uniquely adapt to the anatomy of the head.
“The FDA breakthrough device designation of our neurostimulation system reflects the recognition of the large unmet medical need of patients suffering from refractory chronic migraine, and the potential of Salvia’s bioelectronic foil technology to address this. We look forward to working closely with the FDA to expedite the review process to accelerate the development of our therapy,” chief medical officer Wim Pollet said in a news release.
Neurostimulation has been demonstrated to be effective for treating migraine patients, but there are no approved devices commercially available, according to Salvia.