Neuronetics Settles Litigation Against BrainsWay

Rhea-AI Summary

Neuronetics, a medical technology company listed on NASDAQ under the ticker STIM, has settled its litigation against BrainsWay concerning unfair competition allegations. The settlement mandates BrainsWay to cease using specific efficacy data related to the treatment of anxious depression with NeuroStar Advanced Therapy. CEO Keith J. Sullivan reaffirmed the company's commitment to defending its data and the efficacy of NeuroStar. This therapy is FDA-cleared for major depressive disorder and has delivered over 5 million treatments, backed by extensive clinical data.

Positive

• Settlement reached with BrainsWay, reducing legal risks.
• NeuroStar therapy has delivered over 5 million treatments.

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• None.

MALVERN, Pa., Jan. 10, 2023 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a commercial stage medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, today announced that it has settled the litigation filed in the District of Delaware against BrainsWay Ltd. and BrainsWay USA Inc. for unfair competition under the Lanham Act and state law.

Under the terms of the settlement, BrainsWay agreed to stop the use of the efficacy data for the treatment of anxious depression with NeuroStar® Advanced Therapy for Mental Health that was at issue in the Complaint filed by Neuronetics. “As I said at the outset of this litigation, Neuronetics will vigorously defend our data and the efficacy of NeuroStar® Advanced Therapy for Mental Health,” said Keith J. Sullivan, President and Chief Executive Officer. The parties have agreed to keep the additional terms of the settlement agreement confidential.

About Neuronetics
Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience, Neuronetics is redefining patient and physician expectations with its NeuroStar Advanced Therapy for Mental Health. NeuroStar is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication hasn’t helped. NeuroStar is FDA-cleared for adults with major depressive disorder (MDD), as an adjunct for adults with obsessive-compulsive disorder (OCD), and to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression). NeuroStar Advanced Therapy is the leading transcranial magnetic stimulation (TMS) treatment for MDD in adults with over 5 million treatments delivered. NeuroStar is backed by the largest clinical data set of any TMS system for depression, including the world’s largest depression Outcomes Registry. Neuronetics is committed to transforming lives by offering an exceptional treatment that produces extraordinary results. For safety and prescribing information, www.neurostar.com.

Investor Contact:

Mike Vallie or Mark Klausner
ICR Westwicke
443-213-0499
ir@neuronetics.com

Media Contact:

EvolveMKD
646-517-4220
NeuroStar@evolvemkd.com

FAQ

What was the outcome of the Neuronetics and BrainsWay litigation?

Neuronetics settled the litigation with BrainsWay, who agreed to stop using contested efficacy data.

How does NeuroStar therapy impact patients?

NeuroStar is FDA-cleared for treating major depressive disorder and anxious depression, improving patient quality of life.

What is the significance of the settlement for Neuronetics?

The settlement reduces legal uncertainties and reinforces the validity of NeuroStar's efficacy data.

How many treatments of NeuroStar have been delivered?

Over 5 million treatments of NeuroStar Advanced Therapy have been delivered to patients.