Company Announcements

CORAL SPRINGS, Fla. and NETANYA, Israel, Aug. 21, 2025 /PRNewswire/ -- Neurolief, a pioneering brain stimulation company specializing in non-invasive neuromodulation therapies, today announced a strategic investment from BrainsWay Ltd. (NASDAQ & TASE: BWAY), a publicly-traded global leader in non-invasive neurostimulation treatments for mental health disorders. This investment marks a significant milestone as Neurolief awaits FDA approval and prepares for commercial launch of its Proliv™Rx, designed for the treatment of Major Depressive Disorder (MDD). The partnership reflects an exciting strategic alignment between the two companies, both of which are dedicated to expanding access to innovative, clinically validated and non-invasive mental health treatments.

"We are on the brink of introducing an entirely new category in neuromodulation - bringing at-home treatment for major depressive disorder," said Scott Drees, Chief Executive Officer at Neurolief. "With BrainsWay's commercial expertise and the global reach of its proprietary Deep TMS system deployed in over 1,500 clinics globally, we are well-positioned to scale following our pending FDA approval and deliver a much-needed therapeutic solution for the millions affected by this debilitating condition."

Addressing the Urgent Need for Innovation in Depression Treatment
Major Depressive Disorder remains one of the most prevalent and burdensome mental health conditions worldwide. A significant subset of patients fails to respond adequately to traditional treatments such as antidepressant medications, resulting in prolonged illness, increased healthcare costs, and heightened risks of comorbidities including substance use disorders and suicide. The lack of adequately accessible therapies for these patients highlights a critical gap in mental health care, emphasizing the urgent need for innovative and effective treatment strategies. Proliv™Rx is designed to bridge this gap by offering a revolutionary, non-invasive brain neuromodulation therapy that can be administered at a mental health clinic or a patient's home. By delivering effective brain stimulation through a wearable at-home therapy, Neurolief offers a fundamentally different approach - one that has the potential to radically shift how major depressive disorder is treated and address the unmet needs of patients who did not achieve improvement with traditional treatments.

"So many depressed patients do not respond to medications and cannot access the office-based new brain stimulation therapies like TMS as they have child-care, jobs, or live too far from clinics," said Dr. Mark S. George, Professor of Psychiatry and Neurology at the Medical University of South Carolina. "Too many patients are left partially treated or untreated. Neurolief's technology offers a much-needed paradigm shift in how we approach depression care."

"The Proliv™Rx therapy represents an ideal solution for patients who have not experienced sufficient relief from antidepressants," said Dr. Linda Carpenter, Professor of Psychiatry at Brown University and Neuromodulation Program Director at Butler Hospital. "It's accessibility and at-home application offer a practical and effective alternative that could help prevent the progression to more severe and chronic illness. I'm excited about its potential to reshape how we treat depression."

About Neurolief
Neurolief is a pioneering neuromodulation company committed to developing breakthrough therapies for mental health and neurological disorders. The company has developed the world's first wearable, non-invasive, multi-channel brain neuromodulation system, that is designed for home use, engineered to simultaneously stimulate key neural pathways in the head in order to modulate brain regions involved in regulation of mood and pain. Neurolief's technology is currently FDA-cleared and CE-marked for the treatment of migraine, and the company is actively seeking regulatory approvals for Proliv™Rx, its flagship product for the treatment of Major Depressive Disorder. If granted, Neurolief will be the first medical device company to offer an FDA-approved MDD treatment that can be delivered outside of the clinic. Learn more at: www.neurolief.com

About BrainsWay
BrainsWay Ltd. is a global leader in advanced, non-invasive neurostimulation therapies for mental health conditions. The company's proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform is FDA-cleared for three indications: major depressive disorder (including anxious depression), obsessive-compulsive disorder (OCD), and smoking addiction - all supported by pivotal clinical studies demonstrating efficacy. BrainsWay is committed to transforming lives and advancing neuroscience through clinically proven technologies. Learn more at: www.brainsway.com

Logo - https://mma.prnewswire.com/media/2754768/Neurolief_Logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/neurolief-prepares-for-launch-of-its-prolivrx-system-for-major-depressive-disorder-with-strategic-investment-from-brainsway-302535866.html