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Neuronetics Takes on Anxious Depression with New Indication

The Malvern, PA-based company said FDA cleared its NeuroStar Advanced Therapy for Mental Health for Major Depressive Disorder.

Neuronetics has won a new indication for its transcranial magnetic stimulation system to take major depressive disorder or anxious depression, head-on. The Malvern, PA-based company said this is a big win for the NeuroStar Advanced Therapy for Mental Health and for patients.

FDA accepted Neuronetics’ use of real-world data analyzed from NeuroStar’s proprietary TrakStar platform in granting clearance for this new indication. The TrakStar database contains digital data from patients treated with NeuroStar at over 1,000 centers. Real-world data from TrakStar is particularly valuable because it provides a large sample from a diverse patient group being treated in a clinical practice setting.

Marie Thibault, an analyst with BTIG and former MD+DI managing editor, commented on the market opportunity for the new indication.

“This is a large market opportunity, as more than 50% of the estimated 13.9 million people in the U.S. with MDD undergoing treatment have anxious depression, according to Neuronetics, Thibault said. “We think this is a positive update that, along with the company's recent clearance in obsessive compulsive disorder (OCD), further enhances the value proposition of owning a NeuroStar system.”

The market to treat depression using neuromodulation has been heating up. Earlier this month, Abbott Laboratories won breakthrough device designation for its deep brain stimulation system to be investigated in the use of treatment-resistant depression (TRD).

Previously, the technology had been used to help control symptoms for people with movement disorders, such as Parkinson’s disease and essential tremor.

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