BrainsWay Announces FDA Approval of Neurolief's Proliv™Rx Neuromodulation System for Major Depressive Disorder (MDD)

Core Insights - The FDA has granted Premarket Approval for Neurolief's Proliv™Rx system, making it the first at-home neuromodulation treatment for patients with major depressive disorder (MDD) who have not responded to previous antidepressant medications [1][2] Group 1: FDA Approval and Market Impact - The approval signifies a major regulatory milestone, expanding treatment options for refractory MDD patients beyond traditional in-clinic care [2] - Proliv™Rx is now recognized as an adjunctive treatment for MDD, indicating its potential to improve patient access to care [4] Group 2: Strategic Positioning of BrainsWay - BrainsWay's investment in Neurolief, which includes an option to acquire the company, aims to enhance its market value and expand its total addressable market [3] - The FDA approval validates BrainsWay's investment strategy and reinforces its commitment to data-driven mental health care [3] Group 3: Company Backgrounds - Neurolief is focused on developing innovative therapies for mental health and neurological disorders, with its Proliv™Rx device designed for home use [4] - BrainsWay is a leader in noninvasive neurostimulation treatments, with a proprietary Deep TMS™ platform and multiple FDA-cleared indications for mental health disorders [5]