Neuronetics wins FDA clearance for device to treat adolescents with depression
The FDA has granted Neuronetics 510(k) approval to treat major depressive disorder (MDD) in adolescents by using its transcranial magnetic stimulation (TMS) device. Following Neuronetics' release of real-world data that connected their device to 78% of patients experiencing clinically substantial improvements in the severity of their depression, the FDA broadened the label to include people aged 15 to 21. In the TMS market, Neuronetics is in competition with Brainsway, Apollo TMS, Magstim, Magventure, CloudTMS, and Nexstim. According to Neuronetics, Neurostar is now the only TMS device authorized for use in patients. The clearance, according to CEO Keith Sullivan, increases the company's whole addressable market share in MDD by 35%. Analysts at William Blair greeted the announcement with enthusiasm, noting that approval as a first-line treatment for this patient group represents a significant advancement for the business and the prospect. Neuronetics shipped 59 Neurostar systems, bringing approximately $4.5 million in revenue, and announced fourth-quarter revenues of more than $20 million, up 12% year over year. Now that it has an enlarged label, neuronetics will concentrate on raising awareness and educating people. The business will create reimbursement education to support current procedures that require prior authorization for patients who are younger than eighteen. Over the next few quarters, the company's reimbursement team will try to increase coverage by educating major payers about Neurostar's status as a first-line add-on treatment for the population.
