BrainsWay Launches First Clinical Trial of Deep TMS 360 System for Alcohol Use Disorder

Multicenter, randomized, controlled study will evaluate Company’s next-generation multichannel TMS technology in reducing heavy drinking and cravings

BURLINGTON, Mass. and JERUSALEM, Nov. 17, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced the launch of a multicenter clinical trial investigating the use of its novel Deep TMS 360 system in individuals with Alcohol Use Disorder (AUD). AUD represents a major economic and health burden, affecting about 29 million Americans (10% of those aged 12+) and, despite available treatments, up to 60% of patients relapse within 3-6 months. This study will mark the first multicenter clinical trial utilizing BrainsWay’s next-generation multichannel TMS platform, representing a major milestone in advancing the company’s innovation pipeline.

The Company’s new Deep TMS 360 technology has been designed to provide more comprehensive and uniform stimulation of the neurons in the targeted brain regions. BrainsWay believes that the multichannel architecture of this new system may be better suited for complex clinical populations such as those suffering from chronic AUD, where there may be greater difficulty in achieving desired stimulation levels due to cortical atrophy (i.e. brain shrinkage).

“The launch of this trial represents a pivotal step in expanding our quest to advance into new and highly important therapeutic areas,” said Hadar Levy, CEO of BrainsWay. “Alcoholism is one of the most pressing public health challenges worldwide, and we believe our new 360 technology has the potential to make a meaningful difference for patients seeking to reduce or overcome alcohol dependence.”

The study will be a randomized, double-blind, sham-controlled clinical trial, and will enroll over 200 patients aged 18–86 with moderate to severe AUD as determined using the DSM-5 criteria. Participants will receive either active or sham Deep TMS 360 treatments for approximately six months, including an intensive treatment phase during the first 3–5 weeks, followed by weekly maintenance sessions until the 6-month follow-up visit. Each visit comprises two sessions per day. The trial’s primary endpoint is the proportion of participants who experience no heavy drinking days (NHDD) during the initial four-month treatment period – an endpoint recognized by the FDA as clinically meaningful in AUD research. Subjects will also undergo educational and behavioral sessions focused on coping strategies and alcohol use reduction.