Neuronetics has earned U.S. Food and Drug Administration (FDA) clearance for its NeuroStar advanced therapy’s use as an adjunct to treat major depressive disorder (MDD) in adolescent patients aged 15-21.

Neuronics因其NeuroStar advanced therapy作为治疗15-21岁青少年重度抑郁症（MDD）的辅助手段而获得美国食品和药物管理局（FDA）的批准。

According to the company, NeuroStar is the first, only transcranial magnetic stimulation (TMS) treatment FDA-cleared for this age range. It is the fourth FDA-cleared indication for NeuroStar, the next most recent being the NeuroSite coil placement accessory earlier this month.

据该公司称，NeuroStar是FDA批准的第一个，也是唯一一个针对该年龄段的经颅磁刺激（TMS）治疗。这是FDA批准的第四个NeuroStar适应症，下一个最新的适应症是本月早些时候的NeuroSite线圈放置附件。

The FDA nod was based in part on real-world data collected from NeuroStar’s TrakStar platform, which offered insights into the treatment’s effectiveness and safety in adolescents. 78% of the 1,169 adolescents in the data analysis reached clinically meaningful improvement in their depression severity, according to the data. .

FDA的点头部分基于从NeuroStar的TrakStar平台收集的真实数据，该平台提供了对青少年治疗有效性和安全性的见解。数据显示，在数据分析中，1169名青少年中有78%的抑郁严重程度有临床意义的改善。

The FDA concluded NeuroStar TMS was substantially equivalent when used as an adjunct to antidepressant therapy, over antidepressants alone in this population, based on TrakStar’s data set and data from the published literature.

根据TrakStar的数据集和已发表文献的数据，FDA得出结论，NeuroStar TMS作为抗抑郁药治疗的辅助手段，与该人群中单独使用抗抑郁药相比，基本相当。

Dr. Kenneth Pages, Medical Director of TMS of South Tampa said depression’s prevalence has grown since the COVID-19 pandemic, and current treatment options for adolescents are very limited compared to adults.

南坦帕州TMS医学主任KennethPages博士说，自新型冠状病毒大流行以来，抑郁症的患病率一直在上升，与成年人相比，目前青少年的治疗选择非常有限。

'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,” Dr. Pages told the press. “This advancement has the potential to set a new treatment paradigm for how we address depression in our youth.' .

佩奇博士告诉媒体：“NeuroStar的TMS疗法现在为青少年提供了一种有前途的一线治疗方法，有现实世界的数据和令人印象深刻的反应率，与成人的反应率一致。这一进步有可能为我们如何应对青少年抑郁症建立一种新的治疗模式。”

Neuronetics said NeuroStar is using the versatility of its coil design for providers to address adolescents’ treatment needs for MDD symptoms immediately, without needing further hardware upgrades or purchases.

Neuronetics表示，NeuroStar正在利用其线圈设计的多功能性，为供应商立即解决青少年对MDD症状的治疗需求，而无需进一步的硬件升级或购买。

“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.

Neuronetics总裁兼首席执行官基思·J·沙利文（KeithJ.Sullivan）表示：“接受FDA批准治疗15岁及以上的青少年是心理健康行业早就该有的治疗方案。我们很高兴能为年轻人和那些努力寻找自己可以信任的治疗方法的关心父母提供NeuroStar TMS治疗，作为一种新的选择。

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%.” .

作为一家公司，我们将专注于提高对NeuroStar的认识和教育，因为这一新的许可使我们在MDD的总目标市场增长了35%。”