BrainsWay Selected to Participate in FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder
HACKENSACK, N.J., Dec. 10, 2018 (GLOBE NEWSWIRE) — BrainsWay Ltd. (BRIN.TA), the parent company of BrainsWay USA, Inc., and a global leader in the advanced non-invasive treatment of brain disorders, today announces that the Company’s deep transcranial magnetic stimulation (Deep TMS) system was one of only eight medical devices selected by the U.S. Food and Drug Administration (FDA) from over 250 applications to participate in the “FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder,” a new program launched by the FDA to help combat the opioid crisis.
BrainsWay will work directly with the FDA to accelerate the conduct of a clinical study and expedite potential marketing application review of its Deep TMS system for the treatment of Opioid Use Disorder (OUD).
“We are extremely gratified to have been chosen by the FDA as one of a select group of companies to participate in this unique program and the only TMS product to be included in the finalist group,” said Yaacov Michlin, president and chief executive officer of BrainsWay. “We believe our inclusion in this Innovation Challenge is further validation of the significant potential for our Deep TMS system. We look forward to expedite the process by which Deep TMS can be investigated and then potentially receive approval as a treatment option for OUD patients.”
BrainsWay’s Deep TMS system has been FDA cleared for the treatment of Major Depressive Disorder (MDD) since 2013 and was FDA cleared (De Novo) for the treatment of Obsessive Compulsive Disorder (OCD) in August 2018.
About Opioid Use Disorder
OUD is a serious health condition that can cause significant physical, emotional, and cognitive impairment. The disorder can arise as an unintended consequence of routine medical care, abuse of prescription opioid pain medications and the use of illicit opioid drugs. OUD affects more than 2 million Americans, disproportionately impacts minority populations, and is increasing among people ages 45 to 64.
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.
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.
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