BrainswWay Ltd. (NASDAQ & TASE: BWAY), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s Deep Transcranial Magnetic Stimulator (Deep TMS™) H7 Coil for its use in treating adults suffering from major depressive disorder and depression including those with comorbid anxiety symptoms commonly known as anxious depression.
“This clearance is a significant milestone in BrainsWay’s pursuit of refining and optimizing noninvasive options for treatment-resistant mental health conditions,” said Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Clinicians are accustomed to having myriad pharmaceutical options tailor treatment plans for their patients, and expanding depression clearance to the Deep TMS H7 Coil provides them with another powerful non-pharmaceutical tool. Similar to most medical interventions, TMS treatment for depression is not a one-size-fits-all solution with respect to all anatomical targets: The H1 Coil targets one region of the brain, and the H7 Coil targets a different region, and we now see that stimulating either of these regions can mitigate depressive symptoms. We believe that this clearance may advance our goal of enabling clinicians to provide more personalized medicine for their patients depending upon what works best for them.”
The FDA’s grant of clearance was based on its review of succesfsful results from a randomized, double-blind controlled multicenter trial completed by the Company. The trial was designed to better understand the H7 Coil’s efficacy in addressing treatment-resistant depression. The study, which included 144 subjects, found overall efficacy rates for the H7 Coil which were comparable to those achieved with BrainsWay’s H1 Coil.
“This study was originally conducted after receiving feedback from Deep TMS practitioners in the field which indicated that certain depressed patients not responding to treatment with the H1 Coil would sometimes see success when switched over to the H7 Coil,” said Dr. Aron Tendler, BrainswWay’s Chief Medical Officer. “Now we have high-quality randomized study data which validates this observation scientifically.”
With this new clearance, there is no need to upgrade or add software to systems currently installed in the field. BrainsWay’s Deep TMS H7 Coil, which is housed within a cushioned, cooled helmet, has been cleared to treat obsessive-compulsive disorder (OCD) since 2018. It can now be put to use against depression. The H7 Coil is designed to allow for stimulation of deeper and broader brain structures than traditional TMS coils.
BrainsWay will be implementing a training program in the coming months to educate customers on using the Deep TMS H7 Coil to treat depression within the new FDA clearance.
“This latest clearance, our ninth from the FDA, is a testament to BrainsWay’s unparalleled commitment to take on ambitious research projects that continue to advance the field. This research further cements our leadership position in the field and exemplifies our relentless dedication to improving health and transforming the lives of our customer’s growing patient base,” said Dr. von Jako.
“We recorded solid second-quarter results, again reflecting the growing demand for our non-invasive therapy in multiple indications and markets, despite certain macroeconomic challenges impacting existing and potential new customers,” stated Dr. von Jako. “We generated $8.0 million in revenue for the second quarter of 2022, which represented a 14% increase as compared to the second quarter of 2021, our eighth consecutive quarter of year-over-year growth. These results are especially impressive as the team faced the realities of inflation and concerns over an economic recession in the U.S. from our customers and their patients.”
“We also continue to achieve important reimbursement progress, highlighted by the recent Highmark Blue Cross Blue Shield (BCBS) positive coverage policy in Obsessive Compulsion Disorder (OCD) that increased the total number of lives eligible for Deep TMS coverage in this indication to nearly 70 million.”
“Given the increasing demand for mental healthcare, we believe that Deep TMS is well positioned to grow versus other non-invasive medical technology and pharmaceutical therapy options. With approved indications for Depression (including Anxious Depression), OCD, and Smoking Addiction, and data from 34 randomized clinical trials, many of which were placebo controlled, no other TMS therapy can equal the depth of the clinical evidence reinforcing the significant benefits of our Deep TMS system,” concluded Dr.von Jako.
About Major Depressive Disorder and Anxious Depression
Major depressive disorder (MDD) is a common and debilitating form of depression characterized by physiological, emotional, and cognitive symptoms. According to the World Health Organization (WHO), depression affects approximately 264 million people worldwide, and the U.S. National Institute of Mental Health (NIMH) estimates that 21 million adults in the United States suffer from an MDD episode within a given year. Common symptoms of MDD include loss of interest, depressed mood, reduced energy, disturbed sleep, and changes in appetite. Sixty to ninety percent of depression patients also exhibit comorbid moderate to severe anxiety, a condition commonly referred to as an anxious depression. These 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 recent COVID pandemic.
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 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), OCD, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. 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 of and broad access to Deep TMS.
Scott Areglado, SVP and Chief Financial Officer Tel: 1-617-771-2287 or 1-844-386-7001 email: Sareglado AT BrainsWay.com
Bob Yedid, LifeSci Advisors, tel: 1-646-597-6989 email: Bob AT LifeSciAdvisors.com
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