Brain stimulation tech developer Neuroelectrics announced today that it’s secured FDA breakthrough device designation for its Starstim neuromodulation platform to treat refractory focal epilepsy.
Starstim includes transcranial electrical stimulation (tES), personalized treatment protocols and a secure cloud-based mechanism to deliver treatment anywhere.
“We are excited to receive the FDA Breakthrough Device Designation for our lead program in refractory focal epilepsy. We hope that it will speed the evaluation of a new therapeutic modality that could potentially help patients who currently have no effective treatments available,” said Neuroelectrics co-founder and CEO Ana Maiques said in a news release.
The Cambridge, Mass./Barcelona, Spain–based company recently completed a pilot study of its Starstim tES system in 20 adult and pediatric patients with medically refractory focal epilepsy. The study found a 44% median reduction in seizure frequency in the eight-week post-treatment follow-up period relative to baseline. In addition, four patients saw their seizure frequency reduced by three-fourths or more.
Neuroelectrics plans a pivotal study led by co-principal investigator Dr. Alexander Rotenberg, a neurology professor at Boston Children’s Hospital and Harvard Medical School.