MALVERN, PA — Neuronetics, Inc. (NASDAQ: STIM) this week announced the filing of a federal lawsuit in the District of Delaware against Brainsway Ltd. and Brainsway USA Inc. for unfair competition under the Lanham Act and state law.
In the litigation, the Company asserts that, for commercial gain, Brainsway egregiously misrepresented efficacy data for the treatment of 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 an incomplete course of therapy. Brainsway then compared these results to inappropriately aggregated data from three disparate studies using Brainsway devices with effect sizes derived from full courses of therapy. The Company alleges Brainsway’s manipulated presentation of these results misled clinicians and patients about NeuroStar’s efficacy. In the litigation, Neuronetics is seeking injunctive relief as well as monetary damages.
“Neuronetics views strong, high-quality data as the cornerstone of driving TMS as a mainstream treatment for mental health disorders. We have made a significant investment to develop a robust body of clinical evidence and believe that we have the best data in the industry,” said Keith J. Sullivan, President and Chief Executive Officer. He added, “We will vigorously defend against the mischaracterization of the efficacy of NeuroStar TMS, the damage it causes to our business and the confusion it causes medical professionals and their patients. We look forward to pursuing this case through the federal courts and to begin to correct this grievous mischaracterization of our efficacy data beginning later this week during the Clinical TMS Society annual meeting in Chicago.”
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