BrainsWay, a global leader in advanced non-invasive neurostimulation treatments for mental health disorders, announced on Monday the publication of a post-marketing data analysis that demonstrates high response and remission rates for depression and anxious depression patients undergoing Deep Transcranial Magnetic Stimulation (Deep TMS) treatment. The data, which was published in Psychiatry Research, showed the substantial benefits of Deep TMS treatment, with patients who had received 30 or more treatments achieving an 82% response rate and a 65% remission rate.
BrainsWay collected an aggregate data set from 1,753 patients across 21 clinics, of which 1,351 patients met the inclusion criteria for the analysis. All patients were treated with the Deep TMS H1 Coil, utilizing either a standard protocol (typically 18Hz, 20-minutes long) or a shorter intermittent theta burst (iTBS) protocol. The study found that the average patient achieved sustained response at 16 sessions, or 21 days after beginning treatment.
The evidence also showed that the efficacy rates were similar between the standard and iTBS protocols. Data from questionnaires that are not specific to depression, and thus less relevant for assessing depression changes, were intentionally excluded.
“BrainsWay is pleased to share this real-world evidence on Deep TMS, as it further validates the immense potential of this treatment in addressing the global mental health crisis,” said Hadar Levy, Chief Executive Officer of BrainsWay. “The average patient in this data analysis had already failed more than seven medication trials in their lifetime, and it is exciting to see that patients undergoing a full course of treatment achieved such significant outcomes. These results embolden us in our mission to improve health and transform lives.”
“These findings are truly notable,” said Aron Tendler, M.D., Chief Medical Officer of BrainsWay. “Keeping in mind that these are patients who have not had success with other treatment modalities, it is compelling to see that four out of five patients in real-world settings achieved at least a 50% reduction in their depression symptoms. Furthermore, nearly three out of four were found to have reached remission based on the Hamilton Depression Rating Scale, a gold standard clinician-administered measurement tool.”
In the United States alone, over 21 million adults suffer from Major Depressive Disorder (MDD) episode within a given year. Comorbidity of moderate to severe anxiety affects 60-90% of patients with MDD, a condition commonly referred to as anxious depression. The economic burden in the United States for major depressive disorder totaled $326 billion prior to the recent COVID pandemic.
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction.
The Company is committed to increasing global awareness of and broad access to Deep TMS. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. BrainsWay was founded in 2003, with offices in Burlington, Massachusetts, and Jerusalem, Israel. For the latest news and information about BrainsWay, please visit www.brainsway.com.
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