BrainsWay has announced the start of a multicenter, randomized, double‑blind, sham‑controlled trial of its next‑generation Deep TMS 360 system in adults with moderate to severe alcohol use disorder (AUD). The study will enroll more than 200 participants aged 18‑86 across the United States, Israel, and Sweden, and will run for approximately six months.
The trial design includes an intensive 3‑ to 5‑week phase of daily sessions followed by weekly maintenance visits, with each visit delivering two treatments per day. The primary endpoint is the proportion of participants who experience no heavy drinking days (NHDD) during the first four months—a metric that the FDA has recognized as a valid measure of relapse risk.
Deep TMS 360 builds on BrainsWay’s existing platform by incorporating a multichannel H‑coil that delivers more uniform and deeper stimulation. The enhanced depth is intended to overcome the cortical atrophy that can limit efficacy in complex neuropsychiatric conditions such as AUD, potentially improving treatment response compared with earlier Deep TMS models.
This trial represents a strategic expansion of BrainsWay’s pipeline beyond its FDA‑cleared indications for depression, obsessive‑compulsive disorder, and smoking addiction. A successful outcome would position the company to pursue regulatory approval for a new therapeutic area and could open a substantial market for a non‑pharmacologic treatment of AUD, a condition with high relapse rates and limited effective options.
CEO Hadar Levy said the launch “represents a pivotal step in expanding our quest to advance into new and highly important therapeutic areas.” He added that “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.” Vice President of Medical Affairs Dr. Colleen Hanlon noted that the system “is an exciting evolution of our platform, designed to deliver more robust stimulation patterns.”
Prior research, including a feasibility study published in Biological Psychiatry, showed statistically significant reductions in heavy drinking days and cravings compared with placebo. The current multicenter effort builds on those promising early results and will provide the larger, controlled data set needed to support a regulatory submission if the trial demonstrates efficacy and safety.
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