Brainsway announces results from multicenter trial evaluating H4 Deep TMS
BrainsWay announced final results from its pivotal multicenter trial assessing the safety and efficacy of the Company's H4 Deep transcranial magnetic stimulation system as an aid in smoking cessation in adults suffering from chronic smoking addiction. This trial represents the first multicenter pivotal study conducted with any non-invasive brain stimulation device in the addiction space. The results reported are from a randomized, double-blind, multicenter study designed 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 control group. The primary endpoint of the study was a comparison between the two groups of the four-week continuous quit rate, representing abstinence during a consecutive four-week period. Weekly abstinence was defined as a subject's self-report 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, the CQR was 28.4% in the treatment group compared to 11.7% in the sham group. The primary endpoint was defined based on the CQR among those subjects who received at least one H4 Deep TMS treatment session and had at least one post-baseline assessment, even if not completing the treatment period. Within this cohort the CQR was 19.4% in the treatment group and 8.7% in the sham group. 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. 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. 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 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, and no seizures were reported. The result of the study, including patient safety information and adverse event data, remain subject to completion of analysis of the underlying data.