This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. BrainsWay D treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
HACKENSACK, N.J., Jan. 03, 2017 (GLOBE NEWSWIRE) — Brainsway® USA Inc., a subsidiary of Brainsway Ltd. (TASE:BRIN), a leader in the advanced non-invasive treatment of brain disorders, announced today the results of an independent geriatric study out of the University of Toronto’s Center for Addiction and Mental Health (CAMH). The study found that 50 percent of the treatment-resistant depressed elderly patients that received deep transcranial magnetic stimulation (Deep TMS) achieved full remission of their depression, compared to only 16 percent of those that received the sham (placebo) treatment. Under the double-blind, placebo-controlled study, Deep TMS was administered to a randomly selected group of patients over the course of several weeks.
The principal investigators overseeing the study are Professor Jeff Daskilakis, a key opinion leader in the field of brain stimulation, and Dr. Daniel Blumberger, a leading psychiatrist. Fifty-two patients over the age of 60 were recruited to participate in the study, which utilized a patented Brainsway coil designed to deeply and broadly stimulate the dorsolateral and ventrolateral prefrontal cortex, which are known to be associated with mood regulation. The widely accepted Hamilton Depression Rating Scale was used to assess the severity of the depression symptoms in the patients throughout the study, and the primary endpoint of the trial was remission of patients.
“Depression rates in the elderly are increasing; current data suggests that over 2 million elderly Americans suffer from some form of depression, and that number is on the rise,” said Aron Tendler, M.D., Brainsway’s chief medical officer. “This study brings hope to even the most challenging of depressed populations.”
The study is particularly important because it reflects the highest published remission rates yet of any double-blind, placebo-controlled TMS study for depression – including those achieved in Brainsway’s own multicenter depression trial, which found impressive, but lower, remission rates of 32.6 percent (versus 14.6 percent for sham), and which led to its 2013 FDA-clearance for the treatment of depression. The new results are even more noteworthy given that they focus exclusively on elderly, hard-to-treat patients.
The protocol used in the Toronto study has not yet been cleared by the FDA and differs in several respects from Brainsway’s cleared depression protocol. While company officials are evaluating the appropriate steps to be taken to sufficiently demonstrate efficacy and safety, no significant side effects were reported by participants in the study.
Brainsway continues to invest heavily in research and development and is engaged with leading institutions around the world to advance the cutting-edge fields of TMS and non-invasive neuromodulation.