Neuronetics files federal lawsuit against Brainsway for misleading psychiatrists and patients

neuronetics

MALVERN, Pa., May 11, 2022 (GLOBE NEWSWIRE) — Neuronetics, Inc. (NASDAQ:STIM), a commercial-stage medical technology company focused on the design, development and commercialization of products that improve the quality of life of patients who suffer from neurological disorders, today announced the filing of a federal lawsuit in the District of Delaware against Brainsway Ltd. and Brainsway USA Inc. for unfair competition under Lanham and state law.

In the lawsuit, the company claims that, for commercial gain, Brainsway grossly misrepresented efficacy data for treating anxious depression with NeuroStar Advanced Therapy for Mental Health. Specifically, the company argues that Brainsway manipulated NeuroStar’s effect size by presenting an endpoint representing incomplete treatment. Brainsway then compared these results to inappropriately aggregated data from three disparate studies using Brainsway devices with effect sizes derived from full cycles of therapy. The company alleges that Brainsway’s manipulated presentation of these results misled clinicians and patients about the effectiveness of NeuroStar. As part of the litigation, Neuronetics seeks an injunction as well as damages.

“Neuronetics considers strong, high-quality data to be the cornerstone for conducting TMS as a mainstream treatment for mental health disorders. We have made a significant investment to develop a strong body of clinical evidence and believe we have the best data in the industry,” said Keith J. Sullivan, President and CEO. He added, “We will vigorously defend ourselves against the misinterpretation of the effectiveness of NeuroStar TMS, the damage it causes to our business, and the confusion it causes to healthcare professionals and their patients. We look forward to pursuing this case in federal court and beginning to correct this serious mischaracterization of our efficacy data beginning this week at the annual meeting of the Clinical TMS Society in Chicago.

About Neuronetics
Neuronetics, Inc. believes that mental health is as important as physical health. As the world leader in neuroscience and the industry’s largest TMS company, Neuronetics is redefining patient and physician expectations by designing and developing products that improve the quality of life for people with psychiatric disorders. An FDA-approved non-drug, non-invasive treatment for people with depression and obsessive-compulsive disorder, NeuroStar from Neuronetics® The Advanced Therapy System is the leading transcranial magnetic stimulation (TMS) treatment for major depressive disorder today with over 4.3 million treatments administered. NeuroStar is extensively researched and backed by the largest clinical data set of any TMS system for depression, including the world’s largest registry of depression outcomes. Neuronetics is committed to transforming lives by delivering exceptional treatment that produces extraordinary results. For safety information and directions for use, visit NeuroStar.com.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995:
Statements contained in the press release regarding Neuronetics, Inc. (the “Company”) that are not historical facts constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by terms such as “outlook”, “potential”, “believe”, “expect”, “plan”, “anticipate”, “predict”, “may”, “will”, “could”, ” would” and “should” and the negative of these similar terms and expressions. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, but are not limited to, risks and uncertainties related to: the impact of COVID-19 on general political and economic conditions, including as a result of efforts by governmental authorities to mitigate COVID -19, such as travel bans, accommodation in placing orders and closing third-party businesses and the related impact on resource allocation, manufacturing and supply chains and patient access to products commercial; the Company’s ability to execute its business continuity, operational and budgetary plans in light of the COVID-19 outbreak; the Company’s ability to achieve or maintain profitable operations due to its history of losses; the company’s reliance on the sale and use of its NeuroStar advanced therapy system to generate revenue; the scale and effectiveness of the Company’s sales force; the availability of coverage and reimbursement by third-party payers for treatments using the Company’s products; demand from physicians and patients for treatments using the Company’s products; developments in competing technologies and therapies for the indications that the Company’s products address; product defects; the Company’s ability to obtain and maintain intellectual property protection for its technology; developments in clinical trials or regulatory review of the NeuroStar Advanced Therapy System for additional indications; and regulatory developments in the United States and other applicable jurisdictions. For a discussion of these and other related risks, please refer to the Company’s recent filings with the SEC which are available on the SEC’s website at www.sec.gov. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Except as required by law, the Company assumes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in the Company’s expectations. .

Investor contacts:
Mike Vallie or Mark Klausner
ICR Westwicke
443-213-0499
[email protected]

Media Contact:
EvolveMKD
646-517-4220
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