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Neuroelectrics Granted FDA Breakthrough Device Designation for New Therapeutic Neuromodulation Platform to Treat Refractory Focal Epilepsy

CAMBRIDGE, Mass. & BARCELONA, Spain–()–Neuroelectrics, a clinical-stage company pioneering brain stimulation therapies, has been granted FDA Breakthrough Device Designation for its Starstim® neuromodulation platform in refractory focal epilepsy.

Neuroelectrics’ therapeutic platform combines safe and proven transcranial electrical stimulation (tES) with personalized treatment protocols and a secure cloud-based mechanism to deliver treatment to patients anywhere. Treatment protocols are derived from personalized brain models developed using cutting edge data science, the latest neuroscience research, and the patient’s own physiological data.

“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 Ana Maiques, co-founder and CEO of Neuroelectrics.

Neuroelectrics recently completed a pilot study (NCT02866240) of its Starstim tES system in twenty adult and pediatric patients with medically-refractory focal epilepsy. These patients experienced a 44% median reduction in seizure frequency in the eight-week post-treatment follow-up period relative to baseline, with four patients experiencing a ≥75% reduction in seizure frequency.

Neuroelectrics expects to commence a pivotal study (NCT04770337) led by co-principal investigator Alexander Rotenberg, MD, PhD, Professor of Neurology at Boston Children’s Hospital and Harvard Medical School, evaluating the safety and efficacy of Starstim tES in patients with medically-refractory focal epilepsy in the third quarter using a trial design similar to the pilot study.

“We are encouraged by the pilot study results, specifically by seizure suppression in patients whose seizures have not been controlled by drugs or surgery. An effective non-invasive and non-pharmacologic anti-seizure treatment option should improve our patients’ well-being and quality of life,” said Principal Investigator Alexander Rotenberg, MD, PhD, Professor of Neurology at Boston Children’s Hospital and Harvard Medical School.

According to the website, the Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way.

About Neuroelectrics

Neuroelectrics is developing a therapeutic platform that uses neuromodulation for the treatment of a range of neurological and psychiatric disorders. The platform combines safe and proven neuromodulation capabilities with remote-controlled delivery and personalized treatment protocols to restore and maintain brain health. Based in Cambridge, Massachusetts and Barcelona, Neuroelectrics has an expanding pipeline of computationally driven solutions for neurologic and psychiatric disorders. Visit


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