By Chris Wack


Neuronetics Inc. said it received clearance from the U.S. Food and Drug Administration for a new indication for its transcranial magnetic stimulation system, NeuroStar Advanced Therapy for Mental Health, to treat anxiety symptoms for adult patients who suffer from major depressive disorder, also known as anxious depression.

The company said study results from 664 anxious depression patients demonstrated that 65.5% achieved a clinically meaningful response, which exceeded the pre-established overall study success criteria of a minimum 50% response rate.

NeuroStar data from more than 1,300 patients showed safety and efficacy in relieving both depression and anxiety symptoms in patients with anxious depression, the company said.

This clearance follows after Neuronetics' announcement of an obsessive compulsive disorder indication, which received FDA clearance in May of this year.

Neuronetics shares were up 25% to $4.55 in premarket trading.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

07-19-22 0728ET