Neuronetics Nabs FDA Clearance for NeuroStar Treatment in Adolescents

Neuronetics, a medtech company focused on neurohealth disorders, today announced the FDA clearance of its NeuroStar Advanced Therapy for use as an adjust for the treatment of major depressive disorder (MDD) in adolescents aged 15 to 21. It’s fourth FDA-cleared indication for the device, NeuroStar is the first and only transcranial magnetic stimulation (TMS) treatment for the 15 to 21 age group, according to the company.

TMS is a non-drug treatment for major depression, using focused magnetic pulses, similar to an MRI, to reignite dormant synapses in the brain and help the brain function normally. The device is not a shock therapy or surgery and is non-invasive.

“There are specific areas in your brain that control mood. When synapses in those mood-regulating areas are underactive, connections are broken, and depression can result,” according to the NeuroStar website. “NeuroStar revitalizes those dormant synapses, ‘waking up’ the brain to function as it was meant to.”

Medical treatments for depression are usually centered around antidepressants which rely on the systems in the body to deliver relief. NeuroStar goes to the source of depression, the brain, through an outpatient treatment that takes as little as 19 minutes per day. 

"NeuroStar's breakthrough non-drug TMS therapy uses an MRI-strength magnet to target the underactive areas of the brain responsible for the symptoms of depression," Keith J. Sullivan, president and CEO of Neuronetics, told MD+DI. "NeuroStar addresses the source of depression directly. To-date Neurostar has treated 170,000 patients with over 6.2 million treatments. NeuroStar is the first and only FDA-cleared, first-line add-on treatment for adolescents aged 15-21, which signifies a critical advancement in providing an effective, safe, and non-invasive therapy for the 4.3 million adolescents struggling from depression.”  

During each treatment, a cushioned “figure-8” coil is placed against the patient’s head while magnetic pulses deliver therapy to the location which regulates mood in the brain. Patients may feel a tapping, tingling, or warming sensation where the coil is positioned but it is usually temporary and subsides with subsequent treatments. Patients remain awake and alert during the treatment and can resume regular activities immediately afterwards.

Usually a six-week treatment course, NeuroStar patients could start to see improvements within two to three weeks, according to the company.

FDA’s decision to grant clearance for the new indication was reportedly based, in part, on its analysis of real-world data collected through the company’s proprietary TrakStar platform which provides crucial insights into the treatment’s effectiveness and safety profile in adolescents. According to the data, among the 1,169 adolescents analyzed, 78% achieved clinically meaningful improvement in their depression severity. After reviewing the data from TrakStar, along with clinical data from the published literature, FDA concluded that NeuroStar was “substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone in this population,” according to the company press release.