This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
Program supports physicians in successfully implementing OCD Deep TMS treatment, through in-depth clinical guidance and patient awareness campaigns.
HACKENSACK, N.J., March 5, 2019 – 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 the initiation of “Launchpad to Success,” a program to support physicians as they introduce patients to the company’s deep transcranial magnetic stimulation (dTMS) system for the treatment of Obsessive-Compulsive Disorder (OCD) in adults. Initiatives include:
• Consulting and reference materials to guide physicians as they design personalized treatment protocol
• Patient generation resources to create awareness, attract new patients and build referral networks
• 90-day hands-on practice development, incorporating marketing campaigns, reimbursement support, ongoing training and clinic workflow guidance.
“The goal of the ‘BrainsWay OCD Launchpad to Success’ program is to provide resources and support to physicians as they introduce the BrainsWay OCD treatment. We recognize the challenges to introducing a new a treatment option to patients and we want to provide the necessary support to our providers so they can successfully treat their OCD patients. More importantly, patient access to our transformative treatment should be as easy as possible, and
the first step in this effort is to assist and support physicians any way that we can,” said Joseph Perekupka, senior vice president of North America at BrainsWay U.S. “We are looking forward to working closely with mental health practitioners across the U.S. to bring our Deep TMS treatment to as many patients as possible.”
BrainsWay’s Deep TMS technology received De Novo clearance from the U.S. Food and Drug Administration (FDA) for the treatment of OCD in adults in August 2018. The clearance was the first ever non-invasive medical device clearance for the treatment of OCD and the second indication granted for BrainsWay Deep TMS, which was cleared for the treatment of treatment resistant major depressive disorder (MDD) in 2013. BrainsWay is installing BrainsWay OCD as an upgrade of its current systems and as part of new installations.
More than two million adults in the U.S. suffer from 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 Selective serotonin reuptake inhibitors (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.
BrainsWay is engaged in the research, development and sales and marketing of a medical system for non-invasive treatment of common brain disorders. The medical system developed and manufactured by the company is based on a unique breakthrough technology called Deep TMS, which can reach significant depth and breadth of the brain and produce broad stimulation and functional modulation of targeted brain areas. In the U.S., the Company’s device has been FDA cleared for the treatment of major depressive disorder (MDD) since 2013 and is now FDA cleared (De-Novo) for the treatment of obsessive-compulsive disorder (OCD). The Company’s systems have also received CE clearance and are sold worldwide for the treatment of various brain disorders.