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BrainsWay Selected to Participate in FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder | ||
By: Nasdaq / GlobeNewswire - 10 Dec 2018 | Back to overview list |
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Company’s Deep Transcranial Magnetic Stimulation System is One of Only Eight Products Selected from Over 250 Applications for Potential Treatment of Opioid Use Disorder HACKENSACK, N.J., Dec. 10, 2018 (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 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 About BrainsWay Forward-Looking Statement 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: Investors: Media: |
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Copyright 2018 Nasdaq / GlobeNewswire | Back to overview list |