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BrainsWay Resolves Neuronetics Litigation

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BrainsWay Ltd. (NASDAQ: BWAY) announced the settlement of litigation with Neuronetics, Inc. in the District of Delaware. The settlement terms remain confidential, and BrainsWay did not admit liability. CEO Christopher von Jako emphasized the company's focus on advancing its Deep TMS™ therapy for patients. BrainsWay is recognized for its innovative neurostimulation treatments for various mental health disorders, holding three FDA clearances for its technology. The company remains committed to expanding the use of Deep TMS and conducting further clinical trials.

Positive
  • Settlement of litigation reduces uncertainty and legal expenses.
  • Focus on advancing Deep TMS therapy post-litigation.
Negative
  • None.

BURLINGTON, Mass. and JERUSALEM, Jan. 10, 2023 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a world leader in advanced and non-invasive treatment for brain disorders, today reported that it has settled litigation filed by Neuronetics, Inc. (“Neuronetics”) in the District of Delaware.

BrainsWay had filed a motion to dismiss the case, and, while that motion was pending, agreed to settle the case on mutually agreeable terms and without any admission of liability or wrongdoing, including the release of certain potential counterclaims, to avoid the time, expense and uncertainty of litigation. “We are pleased to have resolved this litigation so that we can focus our full attention on our technology and bringing our Deep TMS™ therapy to patients,” said Christopher von Jako, P.h.D., President and CEO of BrainsWay.

Except as set forth in this press release, and a corresponding announcement from Neuronetics, the parties have agreed to keep the terms of the settlement agreement confidential.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. 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: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; 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 the Company’s filings with the U.S. Securities and Exchange Commission.

Contacts:

BrainsWay:
Scott Areglado
SVP and Chief Financial Officer
Scott.Areglado@BrainsWay.com 


FAQ

What was the recent legal development for BrainsWay (BWAY)?

BrainsWay settled litigation with Neuronetics in the District of Delaware.

Did BrainsWay admit any wrongdoing in the settlement?

No, BrainsWay settled without any admission of liability.

How does the settlement affect BrainsWay's focus?

The settlement allows BrainsWay to focus on advancing its Deep TMS therapy.

What is Deep TMS therapy?

Deep TMS is a non-invasive treatment for mental health disorders, including depression and OCD.

What are the FDA indications for BrainsWay's technology?

BrainsWay's Deep TMS has three FDA clearances for major depressive disorder, OCD, and smoking addiction.

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