Neurolief News
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BrainsWay Targets Expansion of its Total Addressable Market through a Strategic Investment in Neuromodulation Systems Developer, Neurolief Ltd.
/PRNewswire/ -- Neurolief, a leader in brain stimulation for mental health and neurological disorders, is pleased to announce the appointment of Owen Scott...
Neurolief, a leader in brain stimulation for mental health and neurological disorders, has appointed Dr. Owen Scott Muir as its fractional Chief Medical Officer. Dr. Muirs expertise in psychiatry and FDA-regulated medical devices will be instrumental in advancing Neuroliefs mission to deliver effective brain stimulation therapy for treatment-resistant depression. The company is preparing to launch Proliv™Rx, an FDA-Breakthrough Designated therapy, which is the first at-home brain stimulation solution to show clinical success for patients unresponsive to traditional therapies. Proliv™Rx integrates advanced neuromodulation technology with a mobile app and cloud-enabled data tracking, allowing for personalized treatment and improved outcomes. Neuroliefs Relivion®MG therapy is already approved in the USA, Europe, and Japan for migraine treatment.
Management Changes
/PRNewswire/ -- Neurolief, a leading pioneer in neuromodulation technology, recently unveiled its pivotal multicenter RCT clinical study results for its...
Neurolief, a leader in neuromodulation technology, presented promising results for its Proliv™Rx brain neuromodulation therapy at the 7th Annual Neuropsychiatric Drug Summit. The therapy aims to treat major depressive disorder (MDD), especially in patients unresponsive to traditional treatments. Proliv™Rx is a non-invasive therapy that can be administered in clinics or at home, utilizing adaptive output channels to stimulate brain regions associated with mood regulation. The presentation generated significant interest from major pharmaceutical executives, highlighting the industrys focus on innovative mental health solutions. Neurolief anticipates FDA approval for Proliv™Rx by 2025, further solidifying its position in the mental health treatment landscape.
Neurolief Announces Publication of the RIME Pivotal Study for Relivion MG - a Digital Therapeutics Platform for Migraine
Neurolief announces the publication of the RIME US pivotal trial results for Relivion MG, a non-drug therapy for migraine. The study demonstrates the safety and efficacy of the neurostimulation system and its potential as an alternative to medication treatments. The results show significant pain relief and freedom from migraine symptoms in patients. The technology, which uses mild electrical impulses, targets the neural pathways responsible for migraines. The study was conducted with 131 patients and met all its endpoints. Neurolief aims to be widely accepted as a first-line therapy for migraine. The companys remote monitoring capabilities allow healthcare providers to optimize treatment for patients. Relivion MG is FDA cleared and CE marked, and the commercialization process has begun in the US.
Customers
Neurolief's Digital Therapeutics Neuromodulation System May Challenge Medication Therapies for the Treatment of Migraine
Neurolief announces the publication of a study demonstrating the safety and efficacy of their wearable neuromodulation system, Relivion MG, for the treatment of migraine. The study shows that 76% of patients achieved headache relief within 2 hours compared to 31.6% in the sham group. The results are promising, providing patients with an effective and safe non-drug therapy they can use at home. Relivion MGs clinical results compare favorably with previous studies for oral triptans. Neurolief aims to revolutionize the management of migraine disease with their technology. Relivion MG is FDA cleared and has CE mark, and the company has started its commercialization process in the United States.
Customers
Neurolief Announces Exclusive Licensing Agreement with NeuroFront for Development and Commercialization of Relivion® in Greater China and South Korea
Relivion® Wearable Brain Neuromodulation Technology Cleared by FDA for the Treatment of Migraine
Neurolief and Sawai Enter into Exclusive Development and Marketing Agreement for Relivion®
Neurolief Ltd. has entered into an exclusive agreement with Sawai Pharmaceutical Co., Ltd. for the development and marketing of Relivion®, a non-invasive digital medical device for migraine and depression, in Japan. The agreement widens treatment options for patients suffering from migraine or depression. Neurolief plans to submit applications for regulatory approval in Japan by 2022 for migraine and 2023 for depression. If approved, Relivion® will be the only brain neuromodulation device available for home treatment in Japan. Neurolief has already obtained CE Mark certification in Europe and has filed an application with the FDA in the US. The company is dedicated to bringing relief to patients with chronic neurological and neuropsychiatric disorders.
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Neurolief Announces Positive Results From RIME Clinical Study of Its Brain Neuromodulation System for Treating Acute Migraine
Neurolief Awarded Breakthrough Device Designation from FDA for Wearable Technology to Address Major Depression
This Headset Could Treat Migraines
Israel-based Neurolief has received European approval for its noninvasive, adjustable electronic headset that uses nerve stimulation to control pain. The companys product, Relivion, stimulates occipital and trigeminal nerves to affect brain networks associated with pain control. The device is meant for home use and has shown positive results in a clinical investigation, with 76% of the treatment group reporting relief compared to 31% in the control group. Neurolief plans to develop a mobile app for personalized treatment. Migraine affects one in 10 people worldwide, and current treatments are not effective for everyone.
Customers
Neurolief's neuromodulation digital treatment for migraine gets CE mark
Neurolief has received the CE mark for its Relivion non-invasive, adaptive digital treatment for migraine. The CE mark allows Neurolief to market, sell, and distribute the Relivion device as an over-the-counter therapy within the European Union and countries that participate with Agreements on Mutual Recognition of Conformity Assessment. The Relivion system is a comfortable and adjustable headset that provides precise modulated pulses to the occipital and trigeminal nerves. It connects to a proprietary mobile phone app and learns over time to deliver personalized treatment for each patient. The CE mark was granted based on data from a clinical trial showing high efficacy and safety of the Relivion in treating migraine headaches.
Customers
Neurolief Receives CE Mark for Relivion™ - First Non-Invasive, Adaptive Neuromodulation Digital Treatment for Migraine
Neurolief's Relivion™ Digital Therapeutics Brain Neuromodulation Technology Highlighted at 4th Annual International Headache Symposium in Israel
Migraine relief from an Israeli neuro-modulation device
Neurolief is developing a noninvasive neuro-modulation device for migraine treatment that could be available for purchase in pharmacies for less than $500. The device stimulates six different nerve branches in the brain to regulate pain and mood. One study showed an average 80% reduction in pain symptoms. Neurolief has raised $5 million in funding and is currently conducting trials. The company plans to expand its product line to include treatment for depression in the future.
Customers
Neurolief develops non-invasive migraine treatment
Israeli company Neurolief has developed a non-invasive brain neuro-modulation interface system to treat migraines and depression. The company aims to offer significant improvement in a market dominated by large companies offering invasive implant therapies. A small-scale controlled study of the product demonstrated an average 80% reduction in pain symptoms, with half the patients reporting migraine pain had disappeared during the trial. Neurolief has raised initial capital from Terralab Ventures Incubator and closed a $5 million Series A financing round from US investors and Terra Venture Partners. The company plans to file for marketing clearance in Europe and the US pending the outcomes of further trials.
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