BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced data published in World Psychiatry, the official publication of the World Psychiatric Association, from a pivotal, multicenter, placebo-controlled, double-blind clinical trial, supporting the use of Deep TMS™ as a safe and effective treatment for tobacco use disorder – one of the most common substance use disorders and leading cause of preventable death worldwide.
The study is the first large multicenter randomized controlled trial to examine the safety and efficacy of brain stimulation in addiction medicine and was conducted across 12 U.S. sites and two Israel sites among 262 chronic smokers, who reported at least one previous failed attempt to quit.
“Publishing the findings of Deep TMS and its success as a treatment for smoking addiction in a peer-reviewed medical journal like World Psychiatry not only allows us to enrich the evidence around the treatment, but also further disseminate this critical information to providers who are seeking effective, noninvasive options to help their patients,” said Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “We remain deeply committed to helping patients who suffer from mental health disorders and addictions, like tobacco use disorder, and are proud to offer a clinically-proven and noninvasive solution that can change their lives.”
The Company is currently conducting a controlled market release (CMR) to further define the most relevant messaging, business model for clinics, addressable patient population, and to collect post-marketing data to support reimbursement. With 15 sites enrolled in the CMR, BrainsWay has also transitioned to the limited rollout of systems to existing customers to support growing demand.
“It is exciting to see years of work and focus come to fruition with the publication of these results, the FDA Clearance last summer, and the increasing requests to adopt the technology clinically,” said Prof. Abraham Zangen, Head of the Brain Stimulation and Behavior Lab and the Chair of the PsychoBiology Brain Program at Ben-Gurion University and a scientific consultant for and member of the board of directors of BrainsWay. “Advances in neuroscience continue to show growing promise in the field of addiction medicine, and we are excited to be at the forefront of those efforts. There is still much work to be done to explore the full utility of Deep TMS in the field of addiction.”
