BrainsWay’s strategic investment in Neurolief paved the way for the first and only FDA approved at-home neuromodulation device with Class III Premarket Approval labeling for MDD patients who failed one or more prior antidepressantsBURLINGTON, Mass. and JERUSALEM, Jan. 12, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that the U.S. Food and Drug Administration (FDA) has gran ...

BURLINGTON, Mass. and JERUSALEM, Jan. 12, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for Neurolief's Proliv™Rx system, a Class III device, as an adjunctive treatment for adult patients suffering from major depressive disorder (MDD) who have failed to achieve satisfactory improvement fro ...

Core Insights - BrainsWay has made a strategic investment of $5 million in Neurolief, which is developing the Proliv™Rx device pending FDA approval for treating Major Depressive Disorder (MDD) outside of clinical settings [1][2][4] - Neurolief's technology aims to address the significant gap in accessible therapies for treatment-resistant MDD patients, who often face prolonged suffering and higher healthcare costs [3][4] - The partnership is expected to enhance both companies' market presence and expand access to innovative mental health treatments [2][4] Company Overview - BrainsWay is a leader in non-invasive neurostimulation treatments for mental health disorders, with its Deep TMS™ platform technology having three FDA-cleared indications [6][7] - Neurolief is a pioneering company focused on developing wearable, non-invasive neuromodulation systems for mental health and neurological disorders, with its Relivion®MG therapy already approved for migraine treatment [8] Financial Aspects - The investment agreement includes potential milestone-based funding, with a second tranche of up to $6 million contingent on FDA approval of Neurolief's Proliv™Rx system, and a third tranche of up to $5 million based on revenue milestones [4] - The strategic investment is seen as a validation of Neurolief's technology and vision, aiming to reshape the treatment landscape for depression [4]