BrainsWay Receives FDA Clearance for Three-Minute Theta Burst Treatment Protocol for Major Depressive Disorder
CRESSKILL, N.J. and JERUSALEM, April 26, 2021 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that the U.S. Food and Drug Administration (FDA) granted 501(k) clearance for the Company’s Theta Burst three-minute protocol utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) system for the treatment of major depressive disorder (MDD).
“Adding our three-minute treatment protocol to the list of growing solutions available to our provider partners expands the platform nature of this lifechanging technology,” said Hadar Levy, Senior Vice President and General Manager of BrainsWay. “Many patients and providers can benefit from significantly shorter treatment sessions, and our Theta Burst protocol can provide these patients with another option to manage their treatment resistant depression.”
In support of its successful application to the FDA – the Company’s seventh to date – BrainsWay submitted safety and efficacy data from 146 subjects who had received either the standard Deep TMS protocol or the three-minute Deep TMS protocol. Subjects in both groups demonstrated a statistically and clinically meaningful reduction in depression scores, and the results met the equivalence criteria needed for clearance of the shorter treatment.
“The addition of Theta Burst to the available protocols further demonstrates BrainsWay’s commitment to expanding the utility of the BrainsWay Deep TMS system,” said Moria Ankri, Vice President of Research & Development. “This protocol shows that innovation need not be revolutionary or radical to have a positive effect on peoples’ lives. Having a three-minute option for patients has the potential to expand access to care by providing patients with added flexibility in selecting courses of treatment that may fit better with their lifestyle.”
The BrainsWay Theta Burst protocol will be immediately available on all BrainsWay systems already installed. About Major Depressive Disorder
Major depressive disorder (MDD) is a common and debilitating form of depression characterized by physiological, emotional, and cognitive symptoms. According to the World Health Organization (WHO), depression affects approximately 264 million people worldwide, and the U.S. National Institute of Mental Health (NIMH) estimates that 17.3 million adults in the United States suffer from an MDD episode within a given year. Common symptoms of MDD include loss of interest, depressed mood, reduced energy, disturbed sleep and appetite, and comorbid anxiety. The ongoing pandemic continues to exacerbate the incidence of depression globally with more than a three-fold increase in depression symptoms since the onset of COVID-19, and more recent research suggests that more than 50% of patients recovering from COVID-19 suffer from symptoms of MDD.