BrainsWay Receives FDA 510(k) Clearance for Use of its Next-Generation Stimulator for the Treatment of Obsessive Compulsive Disorder

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Advances BrainsWay’s Leadership in Deep Transcranial Magnetic Stimulation (Deep TMS)

HACKENSACK, N.J., February 19 — BrainsWay Ltd. (TASE: BRIN), the parent company of BrainsWay USA, Inc., and a global leader in the advanced non-invasive treatment of brain disorders, today announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the use of its next-generation stimulator as an integrated component of the Deep TMS System for treatment of Obsessive Compulsive Disorder (OCD).

“BrainsWay’s enhanced stimulator is an important advance in TMS, and its integration into our Deep TMS System for the treatment of OCD is expected to provide patients with improved outcomes while streamlining and simplifying the use of our Deep TMS system for physicians,” said Yaacov Michlin, CEO of BrainsWay. “These enhancements demonstrate BrainsWay’s ongoing commitment and ability to develop and commercialize advanced, non-invasive solutions that can address the unmet needs of patients who are living with brain disorders.”

BrainsWay OCD provides patients with a non-invasive personalized treatment option that augments existing therapeutic approaches, including pharmacological or psychological therapy. BrainsWay’s Deep TMS system received De Novo clearance from the U.S. Food and Drug Administration (FDA) for the treatment of obsessive-compulsive disorder (OCD) in adults in August 2018 using a commercially available stimulator. BrainsWay’s next-generation stimulator, which includes enhanced features focused on increasing ease of use for the physician, received FDA 510(k) clearance in May 2018. The current FDA clearance allows the use of this next-generation stimulator with BrainsWay OCD. The new clearance also covers additional modifications to the BrainsWay OCD, including an improved aiming apparatus to assist in proper helmet positioning.

About OCD
More than 2 million adults in the United States suffer from obsessive-compulsive disorder (OCD). It is a severe, chronic psychiatric disease characterized by a pattern of obsessive thoughts and compulsive repetitive behaviors, which has a significantly destructive effect on patients’ day-to-day activities. Current treatment options include SSRI antidepressant medications, which must be given at very high doses for OCD patients, cognitive-behavioral treatment (CBT), or a combination of these treatment options. OCD is very difficult to treat since many patients do not respond to pharmacologic or CBT treatment, and many have difficulty tolerating the side effects of the pharmacological treatment.