BrainsWay, a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s 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 to 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 successful 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, BrainsWay’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 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 BrainsWay’s leadership position in the field and exemplifies its relentless dedication to the improved health and transformed lives of its growing patient base,” said Dr. von Jako.
Source: Company Press Release
