North Raleigh Today

The FDA has granted Breakthrough Device designation to a non-invasive brain stimulation device designed to treat major depressive disorder. This device, developed by Flavio Frohlich, PhD, professor of psychiatry at the UNC School of Medicine and member of the UNC Neuroscience Center, is a step closer to becoming available for patients.

Frohlich's lab has been working on this innovative device, known as the XCSITE platform. It emits weak electrical currents to the brain to alter brain waves associated with depression. The technology was developed by Pulvinar Neuro, a neurotechnology company founded by Frohlich and is utilized at the Carolina Center for Neurostimulation.

The FDA's Breakthrough Devices Program aims to expedite market access for devices that can significantly improve treatment or diagnosis of life-threatening 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.

According to the National Institute of Mental Health, an estimated 14.8 million U.S. adults experienced severe major depressive episodes in 2020. Depression often involves prolonged low mood and lack of interest in activities and is typically treated with psychotherapy and medication. However, these treatments are not always effective or easy for patients to adhere to.

The new device provides rapid treatment by targeting specific disrupted brain activity using an electroencephalogram (EEG) to detect individual brain waves before emitting corrective electrical currents. Samantha Meltzer-Brody, MD, MPH, Chair of Psychiatry at UNC stated, “There remains a great unmet need for fast acting and effective treatments for depression... Dr. Frohlich’s innovative platform will have a major impact on the way we treat depression and save lives.”

A clinical trial led by Frohlich in August 2024 demonstrated significant efficacy in reducing symptoms among participants with major depressive disorder. The trial showed that 80% of patients were free from clinical depression symptoms two weeks post-treatment.

Pulvinar Neuro was established in 2016 by Frohlich through Innovate Carolina’s Kickstart Venture Services program to bring this technology into clinical practice. In 2022, Pulvinar Neuro was acquired by Electromedical Products International, Inc., enhancing efforts towards FDA approval.

Research supporting this development received funding from the National Institute of Mental Health under award number R44MH119872.