With a designation from the FDA, a device created and patented by Flavio Frohlich, PhD, professor of psychiatry at the UNC School of Medicine and member of the UNC Neuroscience Center, is one step closer to being available for patients.
Within the walls of the Frohlich lab, researchers have been engineering a new device that is revolutionizing the way that doctors treat depression, anxiety, and other psychiatric illnesses. The non-invasive brain stimulation device, termed the XCSITE platform, emits very weak electrical currents to the brain, altering brain waves that are implicated in depression.
The innovative platform was developed by Pulvinar Neuro, a neurotechnology company founded by Flavio Frohlich, PhD, professor of psychiatry at the UNC School of Medicine, and has become a staple of the Carolina Center for Neurostimulation. The Center, which Frohlich directs, regularly offers access to the technology for the treatment of depression and anxiety through clinical trials that are open to the public.
Now, after years of innovation and clinical trials, the FDA has issued Breakthrough Device designation for a non-invasive brain stimulation device. The Breakthrough Devices Program supports manufacturers in their efforts to get their devices to market more quickly, giving patients timely access to cutting-edge technologies that can lead to more effective treatment and/or diagnosis of life-threatening or incapacitating conditions.
“Receiving this FDA Breakthrough Device designation is a recognition of its transformative potential and a step forward in advancing innovative treatments for Major Depressive Disorder that bring rapid relief,” said Frohlich.
In 2020, an estimated 14.8 million U.S. adults aged 18 or older had at least one major depressive episode with severe impairment in the past year, according to the National Institute of Mental Health.
Depression, which is characterized by at least two weeks of low mood, low self-esteem, and a lack of interest in normally enjoyable activities, is typically treated with psychotherapy and antidepressant medication. However, medication is not always effective. And for those who do respond, adhering to their medication plan can be difficult.
The device is designed to provide rapid, personalized treatment for depressive symptoms by targeting specific brain activity that is disrupted in people with the condition. The device detects the individual’s distinct brain waves through an electroencephalogram (EEG). Once recorded, the device emits very weak electrical currents to alter the disrupted electric activity in the brain, causing little to no sensation to the wearer.
“There remains a great unmet need for fast acting and effective treatments for depression, said Samantha Meltzer-Brody, MD, MPH, the Assad Meymandi Distinguished Professor and Chair of Psychiatry at the Department of Psychiatry. “Dr. Frohlich’s innovative platform will have a major impact on the way we treat depression and save lives.”
In August of 2024, a clinical trial led by Frohlich and David Rubinow, MD, a Distinguished Professor and Chair Emeritus in the Department of Psychiatry, demonstrated the efficacy of the non-invasive brain stimulation device. They found that use of the device significantly reduced symptom severity among participants with major depressive disorder, with 80% of patients declared free of clinical depression symptoms two weeks post-treatment.
The device is designed for the acute reduction and treatment of depression symptoms in adult patients who do not respond to standard pharmacological treatment. It is intended to be used acutely within two weeks of finishing treatment.
It was a long, but overall successful, process to get to this point. Pulvinar Neuro was founded in 2016 by Frohlich to bring XCSITE 100 to the clinical market and augment their research goals. Frohlich built the startup through Innovate Carolina’s Kickstart Venture Services, a department that supports the launch of growth of research startups through education, early-stage funding, and an on-campus accelerator space.
In 2022, Pulvinar Neuro was acquired by Electromedical Products International, Inc. (EPI), a private medical device manufacturer and leader in non-invasive brain stimulation for psychiatric disorders, to accelerate the clinical trials program towards FDA approval.
Research was supported in part by National Institute of Mental Health of the National Institutes of Health under award number R44MH119872.
About Pulvinar Neuro, LLC
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. Learn more at www.pulvinarneuro.com.
About EPI
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).
Media contact: Kendall Daniels Rovinsky, Communications Specialist, UNC Health | UNC School of Medicine