Neuronetics received FDA clearance for the device to treat depression in adolescents

During an August earnings call, Neuronetics announced submitting a 510(k) application to expand Neurostar transcranial magnetic stimulation (TMS) device's eligible population, withholding specifics for competitive reasons. Recently, the FDA cleared Neurostar as an adjunctive treatment for Major Depressive Disorder (MDD) in adolescents, making it the sole approved TMS device for this group.

In the fourth quarter, Neuronetics reported sales surpassing $20 million, a 12% increase year-over-year. The company shipped 59 Neurostar systems, generating $4.5 million, and recorded nearly $15 million in U.S. treatment session revenue. Neuronetics anticipates global revenues reaching $80 million this year, intending to enhance awareness and education with its expanded label.

While reimbursement establishment for younger adolescents may extend to year-end, Neuronetics' reimbursement team aims to educate major payers about Neurostar's potential as a primary add-on treatment, aiming to broaden coverage in subsequent quarters.