Neuronetics has secured a groundbreaking green light for its noninvasive transcranial magnetic stimulation technology, saying it is now the first to be cleared by the FDA as an add-on therapy for major depressive disorder in adolescent patients.
The regulatory clearance is the company’s fourth for its NeuroStar system, following a nod last year in obsessive-compulsive disorder, and previous OKs in the treatment of anxiety symptoms in adults suffering from MDD who have not seen success with antidepressant medications.
The drug-free approach uses magnetic coils to generate pulses, which aim to restart the activity of some dormant synapse pathways in the regions of the brain's cerebral cortex that govern mood and self-regulation. Therapy sessions take about 20 minutes per day.
The latest 510(k) clearance this week opens up NeuroStar therapy as a first-line adjunctive treatment in patients ages 15 to 21—a population of about 4.3 million people in the U.S., the company estimates—without the need for additional hardware upgrades or coil purchases.
The FDA based its decision in part on real-world data collected by Neuronetics through its TrakStar registry platform. According to the company, 78% of more than 1,100 adolescents in the dataset saw clinically meaningful improvements in the severity of their depression.
“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,” Neuronetics President and CEO Keith Sullivan said in a statement.
“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%,” Sullivan added.
In Neuronetics’ most recent full-year earnings report, published earlier this month, it logged $71.3 million in total revenue for a 9% gain over 2022, including $50.9 million from treatment sessions. Operating expenses topped $82.3 million, with other costs contributing to an annual net loss of $30.2 million.
The company said it aims to nearly close that gap this year, with worldwide 2024 revenues landing between $78 million and $80 million, and expenses totaling between $80 million and $84 million.