Device therapy milestone for depression
BrainsWay completed an additional $6 million milestone investment in Neurolief after the FDA approved Neurolief's Proliv™Rx System for major depressive disorder—part of a growing wave of device‑based, noninvasive mental‑health treatments. Companies say further trials are underway to expand uses across psychiatric and neurologic indications (biospace.com)
The FDA granted Premarket Approval (PMA) for Neurolief’s Proliv™Rx system under the Class III pathway on January 12, 2026, labeling it as an adjunctive treatment for adults with major depressive disorder who failed to achieve satisfactory improvement with at least one prior antidepressant. (prnewswire.com) The MOOD pivotal trial that supported the approval was a prospective, multi‑center, randomized, double‑blind, parallel‑group sham‑controlled study (ClinicalTrials.gov NCT04279522) with an official primary completion date of June 7, 2024 and an actual enrollment listed as 124 participants. (clinicaltrials.gov) Neurolief’s corporate release describes the MOOD manuscript as involving 160 patients across 13 U.S. and international sites and cites investigators Linda L. Carpenter, Mark S. George, and Andrew F. Leuchter as lead authors on the study accepted for publication in Brain Stimulation (DOI: 10.1016/j.brs.2025.08.022). (prnewswire.com) The Proliv™Rx platform delivers focal external Combined Occipital and Trigeminal Afferent Stimulation (eCOT‑AS) through a wearable, multi‑channel device with adaptive stimulation, a clinician‑directed prescription model, and app/cloud‑based remote monitoring to support at‑home self‑administration under medical oversight. (neurolief.com) BrainsWay’s strategic investment structure with Neurolief began with an initial $5 million convertible loan in August 2025, has left BrainsWay invested to the tune of $11 million to date, includes a call option to acquire Neurolief under specified valuation windows, and provides for a potential third equity tranche of up to $5 million contingent on revenue targets. (biospace.com) Following regulatory clearance, Neurolief reported it has begun scaling commercial operations and expanded provider access via an authorized reseller’s inclusion in the U.S. Department of Veterans Affairs Federal Supply Schedule (FSS), with FSS pricing established for both Proliv™Rx and the company’s migraine platform, Relivion® MG. (biospace.com)
