Neuronetics (Nasdaq:STIM) announced today that the FDA cleared a new indication for its transcranial magnetic stimulation (TMS) system.
The new indication for the NeuroStar advanced therapy for mental health allows the system to treat anxiety symptoms for adult patients who suffer from major depressive disorder (MDD), also known as anxious depression.
NeuroStar is a non-drug, non-invasive treatment that can improve the quality of life for people suffering from neuro health conditions when traditional medication hasn’t helped.
Malvern, Pennsylvania-based Neuronetics said in a news release that the FDA accepted its use of real-world data analyzed from its proprietary TrakStar platform, with that database containing digital data from patients treated with NeuroStar at over 1,000 centers, providing a large sample from a diverse patient group treated in a clinical practice setting.
“Today, we celebrate a big win for NeuroStar patients and providers,” Neuronetics President and CEO Keith J. Sullivan said in the release. “Many people suffering from MDD also experience anxiety symptoms, and these patients with anxious depression are more likely to be severely depressed and to have more thoughts of suicide. This new indication means providers can now describe to MDD patients the benefit of NeuroStar for improving their anxiety symptoms.”
TrakStar results from 664 anxious depression patients demonstrated that 65.5% achieved a clinically meaningful response, exceeding the pre-established overall study success criteria of a minimum 50% response rate.
“We would like to acknowledge the contributions of healthcare providers across the country who have partnered with us to help build the world’s largest database of depression outcomes,” said Cory Anderson, VP R&D and clinical. “Not only do we have MDD outcomes, but we also receive data on anxiety outcomes from patients with anxious depression, and these real-world results in anxious depression were an important piece of the FDA clearance.”
BTIG analyst Marie Thibault wrote in a report that the FDA clearance represents a “positive update” that, when combined with recent clearance for the treatment of obsessive-compulsive disorder (OCD), enhances the value proposition of owning a NueroStar system. The analyst reiterates the position of “neutral” on the company while awaiting its second-quarter earnings results.