BrainsWay Receives FDA Clearance for Smoking Addiction in Adults

Company Intends to Execute a Controlled U.S. Market Release in Early 2021

This is the Company’s third FDA-cleared indication for its Deep TMS System, and is the first FDA clearance in the addiction space for any TMS device

CRESSKILL, N.J. and JERUSALEM, Aug. 24, 2020 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in the advanced non-invasive treatment of brain disorders, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s deep transcranial magnetic stimulation (Deep TMS) system for its use as an aid in short-term smoking cessation in adults.

“This FDA clearance represents a significant milestone for BrainsWay and our Deep TMS platform technology,” stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Smoking is one of the leading causes of death in the U.S. and also leads to other serious conditions, such as lung cancer and heart disease. While other therapies are currently available, a substantial medical need continues to exist for treatments that can increase the continuous quit rate among smokers. Based on the compelling data from our large, randomized pivotal study of 262 subjects, we are confident that our Deep TMS technology can play an important role in treating cigarette smokers who seek to quit. We look forward to executing a controlled U.S. market release of our newly cleared and proprietary H4 Deep TMS coil for this indication early next year.”

Dr. von Jako added, “Importantly, this is the first FDA clearance in the addiction space for any TMS device, and it represents BrainsWay’s third FDA-cleared coil and indication, following the clearance of our H1-coil for patients suffering from major depressive disorder and the H7-coil as an adjunct therapy for the treatment of OCD. This latest clearance cements BrainsWay’s status as an industry leader, and further demonstrates our commitment to leveraging our platform technology to advance innovative therapeutic solutions across multiple patient populations.”

About the Pivotal Study
The efficacy of the BrainsWay Deep TMS System with H4-coil as an aid to short-term smoking cessation was demonstrated in a prospective, double blind, randomized, sham controlled, multi-center trial which enrolled 262 eligible subjects randomized into two groups: an active treatment group treated with BrainsWay’s H4 Deep TMS coil which was designed to target addiction-related brain circuits, and a sham (placebo) control group. Subjects were randomly assigned to either the active Deep TMS group or the sham group. The treatments were performed daily, five days a week for 3 weeks, followed by an additional 3 sessions once a week for 3 weeks (for a total of 18 sessions over the course of 6 weeks).