HACKENSACK, N.J., March 05, 2019 (GLOBE NEWSWIRE) -- 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 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.
About OCD
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.
About BrainsWay
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.
Forward-Looking Statement
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our device studies; our products may not be approved by regulatory agencies: we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in BrainsWay Ltd.'s periodic filings with the Tel-Aviv Stock Exchange.
Contacts:
BrainsWay Ltd.
Hadar Levy
Chief Financial Officer
hadarl@Brainsway.com
Investors:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com
Media:
Sara Zelkovic
LifeSci Public Relations
646-876-4933
Sara@lifescipublicrelations.com