Neuronetics, Inc. announced 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. NeuroStar is the leader in patient-focused TMS therapy having treated over 134,000 patients who completed more than 4.8 million treatment sessions. The 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. The TrakStar 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.