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

Core Insights - BrainsWay's strategic investment in Neurolief has led to the FDA granting Premarket Approval for the Proliv™Rx system, the first at-home neuromodulation device for major depressive disorder (MDD) patients who have not responded to previous antidepressants [1][2][3] Company Overview - BrainsWay is a leader in noninvasive brain stimulation technologies, focusing on advanced treatments for mental health disorders [5] - The company utilizes its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform to provide effective treatments for various mental health conditions, including MDD, obsessive-compulsive disorder, and smoking addiction [5] Neurolief Overview - Neurolief is a pioneering company in neuromodulation, known for developing the first wearable, non-invasive, multi-channel brain neuromodulation system designed for home use [4] - The Proliv™Rx device is indicated for adults with MDD who have not achieved satisfactory improvement from at least one prior antidepressant [4] Regulatory Milestone - The FDA's approval of Proliv™Rx marks a significant advancement in the treatment landscape for refractory MDD, allowing for treatment in both home and clinical settings [2][3] Strategic Positioning - BrainsWay's investment in Neurolief, which includes an option to acquire the company, aims to enhance its market value and expand its addressable market by providing access to patients who may struggle to visit clinics [3]