FDA approved Neurolief's ProlivRx System on December 31 under P250010. The company announced it on January 12. The label is adjunctive treatment of major depressive disorder in adults who failed at least one antidepressant. It is prescription-only, for use at home or in clinic. FDA received the PMA on March 26, 2025, a 280-day review.
ProlivRx is a headset that delivers what Neurolief calls external combined occipital and trigeminal afferent stimulation through three output channels. It is a cranial electrotherapy stimulator, product code JXK, under 21 CFR 882.5800, the same code Flow Neuroscience's FL-100 took three weeks earlier. Neurolief's label requires a prior antidepressant failure, which Flow's does not. Support came from the MOOD study, a randomized, controlled, multicenter trial. The company's Relivion MG migraine device already sells in the US, Europe and Japan.
The approval trips a milestone in Neurolief's August 2025 deal with BrainsWay. BrainsWay put in a $5 million convertible loan and committed up to $6 million more on FDA approval. A further $5 million in equity follows a revenue milestone, for up to $16 million in all. BrainsWay also holds a call option to buy the company outright, priced off the greater of a set enterprise value or a revenue multiple. CEO Scott Drees, working from Coral Springs, Florida and Netanya, Israel, expects US availability in early 2026 through prescribers.
A tranche tied to the approval order plus an option to acquire is a financing many founders would sign. It is also a ceiling on the exit price, agreed before the label existed.