MALVERN, Pa. - Neuronetics , Inc. (NASDAQ:STIM), a medical technology company, has received U.S. Food and Drug Administration (FDA) clearance for its NeuroStar Advanced Therapy system as an adjunct treatment for major depressive disorder (MDD) in patients aged 15-21.
This marks NeuroStar as the first and only transcranial magnetic stimulation (TMS) therapy approved for this age group, expanding its indications within the mental health treatment field.
The FDA's decision was partly based on real-world data from NeuroStar's TrakStar platform, which showed that 78% of the 1,169 adolescent patients analyzed experienced clinically significant improvement in depression severity.
The review also considered clinical data from published literature, concluding that NeuroStar TMS is substantially equivalent in safety and effectiveness to antidepressant therapy alone for adolescents.
Dr. Kenneth Pages, Medical Director of TMS of South Tampa, highlighted the limited treatment options for adolescent depression, particularly since the rise of the condition post-COVID-19 pandemic. He expressed optimism that NeuroStar TMS therapy could establish a new treatment paradigm for addressing youth depression.
Keith J. Sullivan, President and CEO of Neuronetics, emphasized the importance of this FDA clearance, which he believes addresses a long-overdue need in the mental health industry. He noted that with the new approval, the company aims to increase awareness and education about NeuroStar, potentially growing their addressable market in MDD by 35%.
NeuroStar's technology, which does not require additional hardware upgrades for providers to treat adolescents, is now indicated for the treatment of MDD in patients aged 15-21 as an adjunct to traditional antidepressant therapy. This clearance could provide a new option for young people and their parents seeking alternative treatments for depression.
Neuronetics prides itself on improving the quality of life for patients with neurohealth disorders through non-drug, noninvasive treatments. The company's NeuroStar Advanced Therapy system is already a leading TMS treatment for adult MDD, with over 6.1 million treatments delivered to date.
This recent FDA clearance represents a significant development in the treatment of adolescent depression, a condition affecting an estimated 4.3 million U.S. adolescents. The information for this article is based on a press release statement from Neuronetics.
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