U.S. Department of Veterans Affairs sites begin prescribing Proliv^®Rx for major depressive disorder and Relivion®MG for migraine, expanding veterans’ access to non-invasive, physician-supervised neuromodulation therapy at home

CORAL SPRINGS, Fla., Aug. 11, 2026 /PRNewswire/ — Neurolief, a neuroscience-driven medical technology company developing brain neuromodulation therapies for mental health and neurological conditions, is bringing two prescription therapies to U.S. veterans through a new Department of Veterans Affairs contract, including Proliv®Rx for adults with major depressive disorder (MDD) who have not achieved adequate relief from antidepressant medication, and Relivion®MG for the acute treatment of migraine.

Multiple VA medical centers across the U.S. are prescribing the therapies within the Veterans Health Administration, the largest integrated health system in the U.S. serving nine million enrolled veterans annually.

Proliv Rx received FDA approval in December 2025 as the first and only prescription at-home brain neuromodulation therapy for adults with MDD who have not achieved adequate improvement with antidepressant medication. These patients, often classified as having treatment-resistant depression, comprise approximately 30% of the overall MDD population¹ and represent a significant unmet medical need.

“Too many people I treat have carried depression for years, moving from one antidepressant to the next without relief, and many have lost hope that anything will help,” said Mark George, M.D., a world expert in brain stimulation and depression and distinguished professor of psychiatry, radiology and neurosciences at the Medical University of South Carolina (MUSC). “Proliv Rx gives us a rigorously studied, non-drug therapy that individuals can use at home under our care, and it lets us reach those who have run out of other answers and offer them a real chance to feel like themselves again.”

Depression and migraine are among the most common conditions treated in the VA health system, with roughly one in three veterans in VA primary care having symptoms of depression², and more than half a million veterans have been diagnosed with migraine in the VA.³ By allowing effective treatment to continue outside the clinic under clinical oversight, these therapies extend care to veterans who face barriers to frequent in-clinic visits, including those in rural and underserved areas.

“Veterans have earned access to the most advanced, evidence-based care available, and too often the therapies that could help them remain out of reach,” said Scott Drees, chief executive officer of Neurolief. “Making both Proliv Rx and Relivion MG available through the VA is a meaningful step toward closing that gap for the men and women who served our country.

“We see this as the start of a broader shift in how depression and migraine are treated, and as we grow, our mission is to bring proven brain neuromodulation out of specialized centers and into the everyday lives of patients,” continued Drees. “There is no group we are prouder to serve than the veterans who have given so much, and we will keep working until we reach everyone who has been left waiting for this therapy.”

Both therapies are supported by randomized controlled trials. Proliv Rx was evaluated in the pivotal MOOD study, a multi-center, double-blind, sham-controlled clinical trial of 124 participants with prior inadequate response to antidepressant treatment. At eight weeks, remission rates were significantly higher with active therapy than with sham stimulation, 21.3% versus 6.0% (p=0.027), and a clinically substantial improvement was achieved by 61.7% of patients receiving active therapy compared with 32.0% of the sham group (p=0.0034). Remission rose to 32% with continued treatment, while the proportion of participants with severe depression decreased from 81% at baseline to 15%. The findings were published in the peer-reviewed journal Brain Stimulation.

Relivion MG for the acute treatment of migraine was studied in the pivotal RIME study, a multicenter, double-blind, sham-controlled clinical trial of 131 participants, published in Headache: The Journal of Head and Face Pain. Two hours after treatment initiation, 46% of those treated with the active therapy were pain-free compared with 11.8% of those who received sham stimulation (p<0.0001), and 47.2% were free of all migraine symptoms compared with 11.1% in the sham group (p=0.0003), with no serious adverse events reported.

About Proliv Rx

Proliv Rx is the first and only FDA-approved prescription at-home brain neuromodulation therapy for adults with major depressive disorder who have not achieved an adequate response to at least one antidepressant medication. Based on External Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS), the non-invasive therapy uses three independent stimulation channels and six electrodes to stimulate branches of the occipital and trigeminal nerves across the forehead and back of the head, sending signals to brain networks involved in mood regulation without penetrating the skull. The treatment is prescribed and managed under physician supervision and self-administered by the patient at home, supported by a digital platform for remote monitoring.

About Relivion MG

Relivion MG is an FDA-cleared and CE-marked brain neuromodulation system for the treatment of migraine in adults. The non-invasive system uses three adaptive stimulation channels to simultaneously target branches of the occipital and trigeminal nerves, engaging pain-processing networks in the brain associated with migraine. The therapy is designed for patient use at home under physician supervision, providing a drug-free treatment option for people living with migraine.

About Neurolief

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

¹ https://www.psychiatrist.com/jcp/prevalence-national-burden-treatment-resistant-depression-major-depressive-disorder-in-us/

² https://www.research.va.gov/pubs/docs/va_factsheets/depression.pdf

³ https://pubmed.ncbi.nlm.nih.gov/36100439/

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SOURCE Neurolief Inc.