Clearance covers the use of NeuroStar as an adjunct treatment of major depressive disorder (MDD) in adolescent patients aged 15-21. Neuronetics said clearance makes NeuroStar the first and only transcranial magnetic stimulation (TMS) treatment cleared for this age group. It also marks the fourth FDA-cleared indication for NeuroStar, according to a news release.
Malvern, Pennsylvania-based Neuronetics develops products aimed at improving the life of patients with neuro health disorders. NeuroStar utilizes a coil-based design for the immediate treatment of MDD symptoms through TMS. It requires no additional hardware upgrades or purchases.
The company said the new indication is based in part on real-world data highlighting safety and effectiveness in adolescents. Among 1,169 adolescents in a data analysis, 78% achieved clinically meaningful improvement in their depression severity.
“Receiving FDA clearance to treat the adolescent segment aged 15 and up is a treatment solution that is long overdue in the mental health industry,” said Keith J. Sullivan, president and CEO of Neuronetics. “We are excited to offer NeuroStar TMS therapy as a new option for young people and for their concerned parents who have struggled to find a treatment they can be confident in. As a company, we will be focused on driving even more awareness and education about NeuroStar given that this new clearance grows our total addressable market in MDD by 35%.”
