BrainsWay, a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Deep Transcranial Magnetic Stimulation (Deep TMS™) System for the reduction of comorbid anxiety symptoms in adult patients with depression, also known as anxious depression.

Thus, another mental disorder can now be treated by the BrainsWay Deep TMS Systems in the USA, in addition to major depressive disorder, OCD, and smoking cessation. In Europe, the BrainsWay Deep TMS Systems have already been CE-marked in addition to these four disorders for Alzheimer’s disease (AD), Autism, Bipolar disorder, chronic pain, Multiple Sclerosis (MS), Parkinson’s disease, post-stroke rehabilitation, Post-traumatic Stress Disorder (PTSD), and the negative symptoms of Schizophrenia. Studies are being pursued to gain FDA clearance to treat some of these conditions in the USA. . It is important to mention that the same underlying BrainsWay Deep TMS technology can provide this ever-widening range of treatments

“This clearance expands upon BrainsWay’s depression indication, and represents yet another in a series of firsts for the Company,” said Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Many patients suffering from major depression experience anxiety symptoms. This most recent regulatory achievement further establishes BrainsWay’s leadership position at the forefront of bringing transformative solutions to advance patient wellness.”

Data from 573 patients who had undergone Deep TMS treatment in 11 studies, including both randomized controlled trials (RCT) and open-label studies, was submitted by BrainsWay to the FDA. The data demonstrated a treatment effect that was consistent, robust, and clinically meaningful for decreasing anxiety symptoms in adult patients suffering from a major depressive disorder. An analysis of the BrainsWay data found favorable outcomes with Deep TMS when compared to sham or medication as the standard of care. For example, using the Cohen’s d statistical method, data from the 3 RCT studies of Deep TMS demonstrated effect sizes ranging from 0.34 (when compared to sham) to 0.90 (when compared to medication), and an overall weighted, pooled effect size of 0.55.

As a reference, published articles from approximately 16,000 subjects in over 70 studies of drug-based anxiety treatments – including studies of standard-of-care medications frequently prescribed for patients suffering from anxious depression and general anxiety disorder – report effect sizes ranging from 0.2 – 0.37.

“This clearance is confirmation of what many have believed anecdotally for years – that Deep TMS is a unique form of therapy that can address comorbid anxiety symptoms using the same depression treatment protocol,” said Aron Tendler, MD, Chief Medical Officer of BrainsWay. “We look forward to continuing to work with our providers to bring the very best in care to the patients that have come to rely on BrainsWay’s deeper and broader neurostimulation and our groundbreaking approach to mental health disorder treatment.”

The expanded FDA labeling now allows BrainsWay to market its Deep TMS System for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from major depressive disorder and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

Since Christopher van Jako took over as president and CEO at BrainsWay, the company has seen remarkable growth and closed the second quarter of 2021 with very positive financial and operational results, with the following highlights:

• For the three months ended June 30, 2021, revenues were $7.0 million, a 45% increase as compared to the same period in 2020.
• As of June 30, 2021, BrainsWay’s Deep TMS™ installed base was 682 total systems, a 20% increase from the installed base at the same point in the prior year.
• As of June 30, 2021, the total number of OCD add-on helmets shipped was 247, representing OCD treatment capability on 36% of the Company’s installed base.
• Achieved significant progress in reimbursement for Deep TMS in the treatment of OCD and depression
• Received key positive coverage policies in OCD from Centene and Health Care Service Corporation (HCSC), a leading Blue Cross Blue Shield licensee, which collectively represent approximately 42 million covered lives
• First draft Local Coverage Determination (LCD) published applicable to OCD by the Medicare Administrative Contractor (MAC), Palmetto GBA, which represents over 9 million covered lives
•  Multiple smaller private payors covering the Company’s depression treatment have continued the trend of decreasing the number of required prior medication failures from three or four to two

About Anxious Depression

Comorbid anxiety symptoms are common in patients with major depressive disorder. Between 60-90% of patients with depression have moderate anxiety, and 20-25% have more severe anxiety. In the United States, 17.3 million adults experience at least one major depressive episode per year. Considering the rate of comorbidity, 10 to 16 million adults experience moderate to severe anxiety in addition to their primary diagnosis of depression. Common anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty focusing or thinking clearly. The economic burden in the United States for major depressive disorder totaled $326 billion prior to the pandemic.

About BrainsWay

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain four FDA-cleared indications backed by pivotal studies demonstrating clinically proven efficacy. Current indications include major depressive disorder, obsessive-compulsive disorder, anxious depression, and smoking addiction. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway.

Founded in 2003, with offices in Burlington, MA, and Jerusalem, Israel, BrainsWay is committed to increasing global awareness and broad access to Deep TMS.

For the latest news and information about BrainsWay, visit www.brainsway.com.

Source: BrainsWay Aug. 18, 2021

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