BrainsWay Ltd. achieved final positive results from its pivotal multicenter trial on the safety and efficacy of the Company’s H4 Deep transcranial magnetic stimulation system (Deep TMS) as an aid in smoking cessation in adults. This is the first such multicenter pivotal study conducted with any non-invasive brain stimulation device in the addiction space.
This comes as Christopher von Jako, Ph.D., was appointed as President and Chief Executive Officer (CEO of Brainsway starting January 2020, marking a strategic transition to U.S.-based leadership. Christopher von Jako has more than 20 years of experience in medical devices. He was formerly the CEO and Board Director at NeuroTherm, a privately held medical device company as well as Vice President of Marketing at Integra LifeSciences. He has been director of Sales at Covidien (acquired by Johnson & Johnson). He served as General Manager and Executive VP at Odin Medical Technologies (acquired by Medtronic) and President and Board Director at Activiews (acquired by Stryker).
“I am incredibly honored and grateful to the Board for the opportunity to lead this exceptional organization,” said Dr. von Jako. “BrainsWay has done an excellent job of developing and obtaining regulatory clearances for its innovative Deep Transcranial Magnetic Stimulation system (Deep TMS) in multiple large indications. Market demand for Deep TMS continues to grow, and I look forward to working with the management team and the Board to further accelerate BrainsWay’s commercialization and market adoption efforts in the U.S. and around the globe.”
The Brainsway Deep TMS Smoking Cessation study was carried out as a randomized, double-blind, multicenter trial designed. The purpose was to evaluate the safety and efficacy of H4 Deep TMS treatment as an aid in reducing cigarette smoking in individuals suffering from chronic smoking addiction. The trial was conducted at 14 sites, primarily in the U.S., and enrolled 262 eligible subjects randomized into two groups: an active treatment group treated with BrainsWay’s proprietary H4 coil targeting addiction-related brain circuits, and a sham (placebo) control group. The primary endpoint of the study was a comparison between the two groups of the four-week continuous quit rate (CQR), representing abstinence during a consecutive four-week period. Weekly abstinence was defined as a subject’s self-report (in a diary) of no smoking, confirmed by urine tests indicating abstinence from smoking. The participants in the study were highly addicted to smoking, with a history of smoking on average for over 26 years and multiple failed attempts to quit.
Of the 168 participants in the study who actually completed three weeks of H4 Deep TMS or sham treatment, plus the mandatory additional three weeks of follow-up (reaching the six-week endpoint), the CQR was 28.4% in the treatment group compared to 11.7% in the sham group (p=0.0063). The primary endpoint was defined based on the CQR among those subjects who received at least one H4 Deep TMS (or sham) treatment session and had at least one post-baseline assessment, even if not completing the treatment period. Within this cohort (which consisted of 234 participants and included dropouts) the CQR was 19.4% in the treatment group and 8.7% in the sham group (p= 0.0174).
An important secondary endpoint was the reduction in the number of cigarettes smoked. At baseline, the average number of cigarettes smoked per week was 132 for the active group and 127 for the sham group. After 3 weeks of treatment, the average number of cigarettes smoked per week was reduced to 38 in the active group and 57 in the sham group (p= 0.0018, active vs. sham). By the sixth week of the study, the average number of cigarettes smoked per week declined to 31 for the active group and 48 for the sham group (p=0.0125, active vs. sham).
“These are exciting and important results,” said Professor Mark S. George, M.D., Distinguished Professor of Psychiatry, Radiology, and Neurosciences and Director of the Brain Stimulation Laboratory at the Medical University of South Carolina in Charleston, SC, and Co-Principal Investigator of the study, along with Prof. Abraham Zangen. “Smoking tobacco is an enormous burden for patients and society, and we do not have enough good treatment options. H4 Deep TMS combined with induced smoking cues was found to be effective in helping smokers quit in a large sample of smokers who had smoked, on average, for 26 years with numerous prior failed attempts to quit. Additionally, when compared to sham, receiving Deep TMS therapy for 3 weeks more than doubled subjects’ chances of quitting cigarettes. These results are clinically meaningful. I hope this study serves to provide smokers with another option that can help them quit, improving their own health dramatically and driving down the overall cost of medical care.”
BrainsWay’s Deep TMS system uses best-in-class technology to effectively stimulate areas of the brain at a greater depth and breadth than any other commercially available TMS device. The BrainsWay H4 helmet used in this study is different than the Company’s FDA-cleared H1 and H7 coils (cleared for the treatment of major depressive disorder and obsessive-compulsive disorder, respectively) and is designed to non-invasively stimulate brain networks known to be associated with addictions, including the bilateral insula and prefrontal cortex, using brief electromagnetic pulses.
Overall, the treatment was found to be well-tolerated by participants in the study. No seizures were reported. The results of the study, including patient safety information and adverse event data, remain subject to completion of analysis of the underlying data.
BrainsWay is a commercial-stage medical device company focused on the development and sale of non-invasive neuromodulation products using the Company’s proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) technology for the treatment of major depressive disorder (MDD) and obsessive-compulsive disorder (OCD), for which BrainsWay received marketing authorization from the U.S. Food and Drug Administration (FDA) in 2013 (for MDD) and in August 2018 (for OCD). BrainsWay is currently conducting and planning additional clinical trials of Deep TMS in various psychiatric, neurological and addiction disorders.