Neurolief has recently received European approval for their non-invasive, digital migraine treatment. The device, Relivion, is a wearable headset that delivers therapeutic neurostimulation that was previously only available through implanted devices. This innovative system allows consumers to combat the symptoms of migraine at home for a much lower cost than the surgical implant. After receiving the CE mark, Neurolief can now market, distribute, and sell their solution over the counter in both the European Union and countries that participate with Agreements on Mutual Recognition of Conformity Assessment.
“This CE mark for the Relivion system marks a vital step in providing patients with alternative, non-drug technology-driven treatments,” said Shmuel Shany, co-founder and CEO, Neurolief. “We designed the Relivion to be a self-administered, safe and attainable alternative to high-cost and high-risk surgical implants, accelerating migraine relief for migraine sufferers in a non-invasive manner. We believe the Relivion will be instrumental in giving patients more rapid relief, increased productivity, and the ability to get back to their lives.”
The Relivion headset is designed for comfort, with adjustable size features for each user’s head. Stimulation is delivered simultaneously to six branches of the trigeminal and occipital nerves using three adaptive channels. This technology was granted the CE mark based on a successful clinical trial, in which Relivion was tested in treating migraines. 76% of the participants were relieved of their headache symptoms after one treatment and none displayed serious side effects.
These patients began using Relivion at the beginning of their migraine episode and wore the device for one hour. The device was also found to be superior to pharmaceutical intervention without presenting any side effects, toxicity, or limitation on treatment quantity. The full study was presented at the American Headache Society’s 61st Annual Scientific Meeting on Saturday, July 13, 2019 in Philadelphia.
“I believe that the Relivion device from Neurolief has great potential to improve acute migraine therapy,” said Alan Rapoport, M.D., clinical professor of neurology at The David Geffen School of Medicine at UCLA and former president of the International Headache Society. “Not only is it designed to stimulate both the trigeminal and occipital nerves simultaneously to help alleviate migraine without having to worry about side effects from medications, but it does so via a comfortable headset that is different from anything available today. These attributes combine to offer a therapy that migraine sufferers can feel good about using – and in turn receive consistent treatment to help them live a more disability-free, productive, fulfilling life.”
The Relivion device is connected to the e-Relief smartphone app as well, which connects the patients’ information to the cloud database. In the cloud, each user’s data is gathered and analyzed via artificial intelligence (AI), allowing for treatments to be optimized to the individual patient. This learning system continues to improve customized treatments over time, offering countless treatment combinations using its three channels and targeting six nerve branches.
With 80% of migraine sufferers currently unhappy with existing treatment options, Relivion has the potential to help countless sufferers. Over 900 million people worldwide suffer from migraine, and by offering an affordable, non-invasive solution, Neurolief may be taking a huge step in providing migraine care. The company also claims that their neuromodulation device can serve as therapy to those with other neurological and psychiatric disorders, including depression, ADHD, and insomnia. The anti-depressant therapy of Relivion was evaluated in an open-label clinical study, in which 90% of patients showed improvements in their depression scores and 37% reached remission.
Neurolief also has plans to expand upon Relivion’s current AI capabilities and therapeutic capabilities.
“Future generations of Neurolief’s innovative technology will include embedded AI and machine learning algorithms, which will provide powerful capabilities to analyze the data collected from each user and from multiple users along with accurate migraine prediction,” says Amit Dar, Neurolief’s co-founder and chief technology officer. “This will integrate in a seamless fashion to enable updates of the closed-loop personalized brain neuromodulation treatment that improves over time, providing a tailored, precise treatment for each patient. Furthermore, Neurolief is advancing toward implementation of its groundbreaking technology for additional neurological and neuropsychiatric disorders with great unmet need such as major depression.”
MESH™ Incubator at Massachusetts General Hospital@meshincubatorRelivion Headset for Migraines Cleared in Europe: Neurolief, an Israeli company, has won European regulatory clearance (CE Mark) for its Relivion system to treat migraines. Intended as an over-the-counter product, the non-invasive… http://dlvr.it/R8JlTm @medgadget @medtech
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