Neurolief Prepares for Launch of its Proliv™Rx System for Major Depressive Disorder with Strategic Investment from BrainsWay

Rhea-AI Summary

BrainsWay (NASDAQ: BWAY) has made a strategic investment in Neurolief, a brain stimulation company developing non-invasive neuromodulation therapies. The investment comes as Neurolief awaits FDA approval for its Proliv™Rx system, designed to treat Major Depressive Disorder (MDD).

The Proliv™Rx system represents a breakthrough in depression treatment, offering at-home brain neuromodulation therapy for patients who haven't responded adequately to traditional antidepressants. BrainsWay's commercial expertise and global presence, with Deep TMS systems in over 1,500 clinics worldwide, positions Neurolief for significant market penetration post-FDA approval.

The partnership aims to address a critical gap in mental health care, particularly for patients who have limited access to clinic-based treatments due to factors such as childcare, employment, or geographical constraints.

Positive

• Strategic partnership with BrainsWay provides access to established commercial infrastructure across 1,500 clinics globally
• Innovative at-home treatment solution addresses significant market gap in depression therapy
• Pending FDA approval for Proliv™Rx system could open new revenue streams
• Technology offers treatment alternative for patients unresponsive to traditional antidepressants

Negative

• FDA approval still pending and not guaranteed
• Will face competition from established depression treatments including traditional TMS
• Market adoption of new treatment modality may take time

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

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SOURCE Neurolief

FAQ

What is the strategic investment between BrainsWay and Neurolief?

BrainsWay (NASDAQ: BWAY) has made a strategic investment in Neurolief to support the launch of Proliv™Rx, a non-invasive neuromodulation system for treating Major Depressive Disorder (MDD). The partnership leverages BrainsWay's commercial expertise and global presence.

What is Neurolief's Proliv™Rx system and how does it treat depression?

Proliv™Rx is a non-invasive brain neuromodulation therapy system that can be administered at mental health clinics or in patients' homes. It's designed to treat Major Depressive Disorder, particularly for patients who haven't responded adequately to traditional antidepressants.

When will Neurolief's Proliv™Rx system receive FDA approval?

The system is currently awaiting FDA approval, with the exact approval date not specified in the announcement. The company is preparing for commercial launch following potential approval.

How many clinics currently use BrainsWay's Deep TMS system?

BrainsWay's proprietary Deep TMS system is currently deployed in over 1,500 clinics globally, demonstrating the company's extensive commercial reach.

What advantages does Proliv™Rx offer over traditional depression treatments?

Proliv™Rx offers the unique advantage of at-home treatment accessibility, making it suitable for patients who cannot access clinic-based therapies due to childcare, work commitments, or geographic location. It provides an alternative for patients who haven't responded well to antidepressants.