BrainsWay (Nasdaq:BWAY) today announced new real-world, post-market data demonstrating the efficacy of its brain stimulation technology.
The data supports the use of BrainsWay’s accelerated deep transcranial magnetic stimulation (Deep TMS) for treating major depressive disorder (MDD). Results were published in the peer-reviewed journal Psychiatry Research.
Deep TMS uses specially designed H-coils to stimulate deep and broad cortical regions associated with depression. The FDA-cleared protocol involves one treatment session per day, five days a week over four weeks. A maintenance period follows.
However, BrainsWay received interest in “accelerated” dosing schedules with multiple sessions per day, aiming to speed up treatment time. The company collected data using this approach at clinical sites and analyzed it in the latest study.
Key findings include an 80% response rate and a 51% remission rate across all dosing schedules with accelerated Deep TMS. BrainsWay found no statistical difference in outcomes between various accelerated dosing schedules. Those schedules varied between two, three, five or 10 sessions per day.
Subjects undergoing protocols involving more than two sessions per day responded and/or remitted typically within 3-5 days. The durability of the treatment proved substantial, too.
BrainsWay’s Deep TMS remains investigational for accelerated depression treatments. The company believes the preliminary results could help support efforts to expand the current labeling.
“While TMS has been around for nearly 40 years, we continue to look for ways to optimize the delivery of our Deep TMS therapy and restore hope for the many patients who have not responded to first-line treatments,” said Dr. Aron Tendler, BrainsWay chief medical officer. “We intend to further investigate the potential efficacy of accelerated Deep TMS in the treatment of MDD, and look forward to sharing those results.”