Neurolief Secures Additional $6 Million Investment Following FDA Approval of Proliv™Rx, Expanding Access to Brain Neuromodulation Therapy for Patients with Inadequate Response to Antidepressants

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Neurolief Secures Additional $6 Million Investment Following FDA Approval of Proliv™Rx, Expanding Access to Brain Neuromodulation Therapy for Patients with Inadequate Response to Antidepressants

PR Newswire

Investment accelerates U.S. rollout of a scalable, at-home brain neuromodulation therapy for patients with depression and inadequate response to at least one antidepressant

CORAL SPRINGS, Fla., March 30, 2026 /PRNewswire/ -- Neurolief, a medical technology company developing neuromodulation therapies for mental health conditions, today announced a $6 million milestone-based investment from BrainsWay Ltd., following FDA Premarket Approval (PMA) of its Proliv™Rx brain neuromodulation system. The investment reflects growing recognition of the need for accessible, clinically validated treatment options for adults whose depression has not adequately improved with antidepressant medication.

Neurolief Proliv™Rx: First at-home FDA approved depression therapy for inadequate response to medication

Millions of adults in the United States live with depression and do not achieve adequate response to antidepressant therapy. While several next-step treatment options exist, real-world access remains limited due to clinic-dependent delivery models, infrastructure requirements, referral delays, and logistical barriers that limit patient uptake.

Proliv™Rx is a brain neuromodulation therapy designed for at-home use, addressing this critical treatment gap. FDA-approved in December 2025, the system is prescribed and supervised by a physician while being self-administered by the patient at home. This model expands access to next-step depression care for patients who are unable to reach specialized treatment centers, while maintaining the clinical oversight expected of prescription therapy.

"This investment enhances our ability to bring clinically validated brain stimulation therapy to patients who have not achieved adequate improvement with antidepressants," said Scott Drees, Chief Executive Officer of Neurolief. "Proliv™Rx was developed to close a critical access gap at a pivotal point in the depression care journey. With FDA approval and early commercial traction, we are scaling a model that delivers rigorous, evidence-based care in a way that is accessible and built for real-world adoption."

"As health systems shift toward value-based care, reaching high-need depression patients faster and more effectively is becoming increasingly critical," said Owen Muir, MD, Chief Medical Officer of Neurolief. "Proliv™Rx was developed with this reality in mind - delivering clinically supervised brain neuromodulation in the home, enabling clinicians to expand access, reduce treatment delays, and overcome the limitations of facility-based care."

About Proliv™Rx
Proliv™Rx is the first and only FDA-approved, prescription brain neuromodulation system for adults with major depressive disorder who have not achieved adequate response to at least one antidepressant medication. The therapy is prescribed and managed under physician supervision, while being self-administered by the patient at home, enabling access to advanced neuromodulation therapy without the need for specialized treatment facilities.

About Neurolief
Neurolief is a neuroscience-driven medical technology company developing non-invasive neuromodulation therapies for mental health and neurological disorders. The company is focused on bridging critical gaps in care by delivering clinically validated treatments that combine scientific rigor with scalable, real-world accessibility.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The company advances neuroscience through its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology, which is designed to improve health outcomes and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications supported by pivotal clinical studies demonstrating efficacy, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The company continues to expand its clinical research across psychiatric, neurological, and addiction disorders and is committed to increasing global awareness of and access to neurostimulation therapies.

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SOURCE Neurolief Inc.