BURLINGTON, Mass. and JERUSALEM, Aug. 18, 2021 - BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) allowing the Company to market its Deep Transcranial Magnetic Stimulation (Deep TMS™) System for the reduction of comorbid anxiety symptoms in adult patients with depression, also known as anxious depression.
“This clearance expands upon BrainsWay’s depression indication, and represents yet another in a series of firsts for the Company,” said Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Many patients suffering from major depression experience anxiety symptoms. This most recent regulatory achievement further establishes BrainsWay’s leadership position at the forefront of bringing transformative solutions to advance patient wellness.”
Data from 573 patients who had undergone Deep TMS treatment in 11 studies, including both randomized controlled trials (RCT) and open-label studies, was submitted by BrainsWay in support of its application to the FDA. The data demonstrated a treatment effect that was consistent, robust, and clinically meaningful for decreasing anxiety symptoms in adult patients suffering from major depressive disorder. An analysis of the BrainsWay data found favorable outcomes with Deep TMS when compared to sham or medication as standard of care. For example, using the Cohen’s d statistical method, data from the 3 RCT studies of Deep TMS demonstrated effect sizes ranging from 0.34 (when compared to sham) to 0.90 (when compared to medication), and an overall weighted, pooled effect size of 0.55.
As a reference, published articles from approximately 16,000 subjects in over 70 studies of drug-based anxiety treatments – including studies of standard-of-care medications frequently prescribed for patients suffering from anxious depression and general anxiety disorder – report effect sizes ranging from 0.2 – 0.37.
“This clearance is confirmation of what many have believed anecdotally for years – that Deep TMS is a unique form of therapy that can address comorbid anxiety symptoms using the same depression treatment protocol,” said Aron Tendler, MD, Chief Medical Officer of BrainsWay. “We look forward to continuing to work with our providers to bring the very best in care to the patients that have come to rely on BrainsWay’s deeper and broader neurostimulation and our groundbreaking approach to mental health disorder treatment.”
The expanded FDA labeling now allows BrainsWay to market its Deep TMS System for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from major depressive disorder and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.