This study marks a historic milestone as the first ever Randomized Controlled Trial (RCT) to demonstrate success in a non-pharmacological home therapy for Treatment Resistant Major Depression.

TAMPA, Fla., June 25, 2024 /PRNewswire/ -- Neurolief, a leading developer of innovative brain neuromodulation technologies, announces the groundbreaking topline results from its pivotal clinical trial evaluating the efficacy and safety of its revolutionary brain neuromodulation therapy for patients suffering from Treatment Resistant Depression (TRD). Neurolief's non-invasive medical technology, designed for clinic and at-home treatment, marks a significant advancement in the management of TRD, offering new hope for millions of patients worldwide who have previously not responded, or not sufficiently responded, to pharmaceutical treatments.

The double-blind, randomized, placebo-controlled, multi-center clinical trial enrolled 124 participants across leading medical centers in the United States and Israel. The study's primary endpoint was a reduction in depression severity as measured by the Hamilton Depression Rating Scale (HDRS17). Key findings from the trial include:

• Significant Reduction in Depression Symptoms: Patients receiving Neurolief's brain neuromodulation therapy showed a statistically significant reduction in HDRS17 scores compared to the control group.
• High Remission Rate: A substantial proportion of patients achieved full remission from depression symptoms (HDRS17 score ≤7), demonstrating the therapy's profound impact.
• Favorable Safety Profile: The therapy was well-tolerated, with no serious adverse events related to the treatment, underscoring its safety.
• High Adherence to the Treatment Protocol: Approximately 95% of patients fully complied with the daily treatment regimen throughout the 16-week treatment period.

Dr. Linda Carpenter, Professor of Psychiatry and Human Behavior at the Warren Alpert Medical School at Brown University and the principal investigator of the trial, stated,

"So many of my patients do not get relief from their antidepressant medications and struggle to find effective treatment options for their depression. I want them to get better without adding more medications to their regimen, but many of them simply cannot manage daily trips to the clinic for other offered treatments. I am thrilled that I will soon be able to prescribe Neurolief's therapy for my patients to treat at home!

The results of this clinical trial not only show this technology is safe and effective for relieving depression symptoms, but also that patients can self-administer their therapy in a time and place when it is convenient for them and get better! This will have a tremendous impact on the approach for treating major depressive disorder."

Dr. Mark George, Distinguished Professor of Psychiatry, Radiology, and Neuroscience and Director of the Medical University of South Carolina (MUSC) Brain Stimulation Division, who was an investigator in the study, commented, "This is such an important study as it shows that patients with depression can effectively treat their depression using Neurolief's brain stimulation technology at home, under a doctor's supervision. This will greatly expand access to therapy for people who live far away from medical centers, who are working, have children or cannot travel long distances to the clinic. This non-medication medical technology has no drug-drug interactions or other side effects common with medications. This is a great day for patients with depression!"

Scott Drees, CEO of Neurolief, added, "We are dedicated to addressing the unmet needs of patients and their families affected by the debilitating impacts of depression. The success of this pivotal trial not only brings us closer to making this groundbreaking therapy widely available but also highlights the transformative potential of our technology in revolutionizing depression treatment."

Neurolief's technology treats major depression by stimulating the release of neurotransmitters in the brainstem and modulating brain networks associated with mood regulation. Utilizing three adaptive output channels, the device non-invasively transfers electrical pulses to the brainstem via major neural pathways in the head. These pathways conduct the electrical stimulation to the brainstem and higher brain regions involved in depression. Designed for at-home treatment, the system incorporates a patient mobile app and a physician interface with cloud-enabled data-tracking features and AI integration. This setup allows physicians to monitor patients, analyze their data, and personalize treatment, thereby enhancing therapy outcomes.

Neurolief previously received Breakthrough Device designation from the FDA for its technology targeting Major Depression. The company plans to submit the pivotal trial results to regulatory authorities in the coming months, with the goal of securing approval and moving towards commercialization.

About Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD)

Major depressive disorder (MDD) and treatment resistant depression (TRD) exert a profound global impact, affecting millions and significantly contributing to disability, economic burden, and reduced quality of life. MDD is the leading cause of disability worldwide, and the challenge is exacerbated in TRD, where patients fail to respond to standard treatments, leading to prolonged suffering, higher healthcare costs, and increased risk of comorbid conditions such as anxiety, substance abuse, and suicide. The lack of adequately accessible therapies for TRD highlights a critical gap in mental health care, emphasizing the urgent need for innovative and effective treatment strategies to alleviate the global burden of these debilitating disorders and improve patient outcomes.

About Neurolief

Neurolief is a neuromodulation company dedicated to bringing relief to patients suffering from mental health and neurological disorders. The company consists of highly experienced professionals with a proven track record in neuroscience, neuromodulation technology, and the neurotech industry. Neurolief has developed a disruptive platform technology, the world's first and only non-invasive, multi-channel brain neuromodulation system designed to concurrently neuromodulate major neural pathways in the head and thereby affect brain regions involved in the control and modulation of mood and pain. Neurolief's technology is currently approved by the FDA and CE for the treatment of migraine, and the company is presently seeking regulatory approvals for the treatment of Resistant Major Depression.

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SOURCE Neurolief