FDA grants clearance to TMS device, NeuroStar as adjunct to first line depression treatment

The US Food and Drug Administration has cleared first transcranial magnetic stimulation (TMS) device, NeuroStar, adjunct to first-line treatment of major depressive disorder for individuals aged 15 to 21.

NeuroStar is the first and only transcranial magnetic stimulation (TMS) treatment FDA-cleared for this age group, making it the fourth FDA-cleared indication for NeuroStar.

"The prevalence of depression in adolescents and young adults has been accelerating since the COVID-19 pandemic. The current treatment options available for adolescents are extremely limited, compared to those available for adults," according to Dr. Kenneth Pages, Medical Director of TMS of South Tampa. "NeuroStar’s TMS therapy now offers a promising first-line treatment for adolescents, backed by real-world data and impressive response rates consistent with response rates for adults. This advancement has the potential to set a new treatment paradigm for how we address depression in our youth."

The FDA's decision to grant clearance for this new indication is based in part on analyzing real-world data collected through NeuroStar's proprietary TrakStar® platform. This platform provided crucial insights into the treatment's effectiveness and safety profile in adolescents. Among the 1,169 adolescents in the data analysis, 78% achieved clinically meaningful improvement in their depression severity. The FDA reviewed the comprehensive data set from TrakStar, along with clinical data from the published literature, and concluded that NeuroStar TMS was substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone in this population.

“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%.”

NeuroStar is harnessing the versatility of its coil design, enabling providers to address the treatment needs of adolescents with MDD symptoms immediately, all without requiring additional hardware upgrades or purchases.

About Adolescent Depression

Adolescent depression is a complex and challenging mental health condition that affects young individuals during the crucial period of adolescence. An estimated 4.3 million U.S. adolescents aged 15-21 are affected by MDD. Depression amongst adolescents can disrupt crucial aspects of development, such as academic performance, relationships with peers and family members, and overall emotional well-being.

NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of MDD in adolescent patients aged 15-21.