Neuronetics' NeuroStar Gets Regulatory Clearance In South Korea

Neuronetics, Inc. STIM announced that the Ministry of Food and Drug Safety (MFDS) in South Korea has approved multiple features of NeuroStar TMS (transcranial magnetic stimulation) for sale and distribution in the country.

The regulatory go-ahead includes expanding the indication to incorporate patients with major depressive disorder (MDD) that exhibit comorbid anxiety symptoms, the NeuroStar 3.7 platform, MT Cap, and D-Tect MT Accessory. 

This marks the first international market where NeuroStar has obtained marketing authorization for the expanded indication and cutting-edge technologies.

The NeuroStar 3.7 platform standardizes the NeuroStar hardware globally, designed to streamline a clinician's workflow, such as a touchscreen display with a biometric fingerprint reader.

"The regulatory milestone, which came several months ahead of schedule, is a notable achievement for NeuroStar," stated Keith J. Sullivan, President and CEO of Neuronetics Inc. 

Price Action: STIM shares are trading flat at $2.04 on the last check Monday.