Medical Device Network

Neuronetics’s NeuroStar wins FDA clearance for adolescents with depression

Teenagers aged 15-21 years in the US are eligible to use the treatment alongside antidepressant therapy.

The US Food and Drug Administration (FDA) has granted clearance to Neuronetics for its NeuroStar device as an add-on therapy to antidepressant therapy in adolescent patients with major depressive disorder (MDD).

The transcranial magnetic stimulation (TMS) device is cleared for use as an adjunct treatment in patients aged 15-21 years with MDD.

NeuroStar is a non-invasive therapy for MDD patients, providing an option for patients with the condition who do not respond to antidepressant medications. The treatment works by stimulating neurons in the brain that regulate mood.

The FDA based its decision on data from NeuroStar’s TrakStar – a patient data management and reporting system – and clinical data. Neuronetics said the device led to a 78% improvement in depression severity in an analysis of 1,169 adolescents. Neuronetics also conducted a clinical trial (NCT02586688) evaluating the safety and efficacy of daily NeuroStar treatment compared with sham.

US-based Neuronetics said the FDA cleared the technology in adolescents as it is “substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone”.

According to Neuronetics, NeuroStar is the only TMS cleared by the FDA for this age group. Along with antidepressant medication, teenagers have access to other non-drug options such as video game treatment. Adults are eligible for neuromodulation devices such as Magnus Medical’s SAINT system.

NeuroStar is already FDA-cleared for adults with MDD who meet certain criteria. The device also has clearance as an adjunct for adults with obsessive-compulsive disorder (OCD).

Also in the TMS space is BrainsWay, which has several FDA clearances for its system in MDD and anxious depression. Earlier this year, the company launched two feasibility studies to investigate a new type of transcranial magnetic stimulation (TMS) technology.

Neuronetics has a market cap of $140m and BrainsWay has a market cap of $94m. The TMS market is becoming more crowded, with Mag & More, Magstim, and Nexstim all companies with FDA-cleared devices.

The global neuromodulation device market, which includes brain stimulation devices, is expected to grow to $11.4bn by 2033, according to GlobalData. Medtronic holds the biggest share in the global market.