Neurolief, a leading developer of innovative brain neuromodulation technologies, has announced significant topline results from its pivotal clinical trial assessing the efficacy and safety of its novel brain neuromodulation therapy for patients suffering from Treatment Resistant Depression (TRD).

This non-invasive medical technology, designed for both clinic and home use, represents a major advancement in TRD management, providing new hope for millions who have not responded, or not sufficiently responded, to pharmaceutical treatments.

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

• Significant Reduction in Depression Symptoms: Patients receiving Neurolief's therapy showed a statistically significant reduction in HDRS17 scores compared to the control group.
• High Remission Rate: Many 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, highlighting 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.

"Many of my patients do not get relief from their antidepressant medications and struggle to find effective treatment options. I want them to improve without adding more medications, but many cannot manage daily clinic visits.

Thrilled that I will soon be able to prescribe Neurolief's therapy for home use! The trial results show this technology is safe and effective for relieving depression symptoms, and patients can self-administer their therapy at their convenience and get better! This will significantly impact the treatment approach for major depressive disorder."

"This study is crucial as it shows that patients can effectively treat their depression using Neurolief's technology at home under a doctor's supervision.

This greatly expands therapy access for those who live far from medical centers, work, have children, or cannot travel long distances. This non-medication technology has no drug interactions or side effects common with medications. This is a great day for patients with depression!"

Committed to addressing the unmet needs of patients and their families affected by the debilitating impacts of depression.

The success of this pivotal trial brings us closer to making this groundbreaking therapy widely available and highlights the transformative potential of our technology in revolutionizing depression treatment.

Neurolief's technology treats major depression by stimulating neurotransmitter release in the brainstem and modulating brain networks associated with mood regulation. Using three adaptive output channels, the device non-invasively delivers electrical pulses to the brainstem via major neural pathways in the head.

These pathways conduct the stimulation to the brainstem and higher brain regions involved in depression. Designed for at-home treatment, the system includes 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, 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, aiming for approval and commercialization.


 

Source: prnewswire.com

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