Pulvinar Neuro, a wholly owned subsidiary of Electromedical Products International, Inc. (EPI), specializing in non-invasive brain stimulation therapeutics, has received FDA Breakthrough Device designation for its Closed-Loop Transcranial Alternating Current Stimulation (tACS) device for the treatment of Major Depressive Disorder (MDD).
This innovative device is designed to provide rapid and effective relief from depressive symptoms. It is intended for the acute reduction and treatment of MDD symptoms within two weeks following treatment completion when used as an adjunct to standard care in adult patients who are not considered refractory to medication.
An initial clinical trial, published in August in the American Journal of Psychiatry, demonstrated a significant reduction in symptom severity among participants with MDD. Notably, 80% of patients were assessed to be free of clinical depression symptoms two weeks post-treatment by a psychiatrist.
The technology employs personalized brain stimulation tailored to real-time measurements of brain activity, targeting specific rhythmic electric activity patterns disrupted in MDD. Researchers identified a strong correlation between successful modulation of the targeted brain activity and symptom reduction. This precision-medicine approach to treating brain disorders was developed with the support of the National Institute of Mental Health.
Dr. Flavio Frohlich, Professor of Psychiatry at the University of North Carolina at Chapel Hill, described the FDA’s Breakthrough Device designation for Closed-Loop tACS technology as a “recognition of its transformative potential and a step forward in advancing innovative treatments for Major Depressive Disorder that bring rapid relief”. Dr. Leah Townsend, Chief Science Officer of EPI, called the designation “a significant milestone in the development of this cutting-edge, neurobiology-driven treatment that will accelerate making closed-loop tACS available for patients.”
Brian Burke, President of EPI, stated, “We are pleased the FDA has granted Breakthrough Device designation for our Closed-Loop tACS technology. This milestone further highlights our commitment to advancing drug-free neuromodulation technologies and redefining mental health treatment through innovation and evidence-based therapeutics.”
*Research reported in this press release was supported in part by National Institute of Mental Health of the National Institutes of Health under award number R44MH119872. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
EPI is a leading neuromodulation therapeutic company specializing in non-invasive brain stimulation for psychiatric disorders and insomnia, along with microcurrent therapy for pain management, with devices for both clinical use and research. The company’s flagship product, Alpha-Stim, is FDA-cleared for the treatment of anxiety and insomnia through cranial electrotherapy stimulation (CES) and pain relief via microcurrent electrical therapy (MET).
Pulvinar Neuro is a neurotechnology company dedicated to supporting the research community with cutting-edge non-invasive brain stimulation research tools as well as the technical development of innovative therapeutics to address some of the most pressing challenges in mental health.