New Data at AHS Annual Meeting Demonstrate Substantial Results for Patients Using Neurolief's Digital Therapeutics Technology to Treat Migraine

2023-06-20

临床结果

TAMPA, Fla., June 20, 2023 /PRNewswire/ -- Neurolief, a medical neurotechnology innovator, today announced new data released at the 65th Annual Scientific Meeting hosted by the American Headache Society (June 15-18, 2023, Austin, TX). The real-world, open label analysis presents clinically meaningful data on both the acute treatment and prevention of migraine. Relivion MG is a novel wearable digital therapeutic neurostimulation system, intended to treat migraine and reduce the need for drug therapies.

"This real-world data is extremely promising," says Roni Sharon, a board-certified neurologist and headache specialist, and assistant professor of neurology at Tel Aviv University's Slackler School of Medicine. "The remarkable results achieved in this subset of more difficult to treat patient population underscore the immense potential of Relivion's innovative technology in helping millions of people living with migraine."

"At the heart of our mission lies a deep dedication to our patients," said Scott Drees, Neurolief's CEO. "We will continue to partner with the migraine community to expand access to Relivion and together, we will embark on a journey to help shape the future of migraine care."

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Neurolief's eCOT-NS technology is the first external, combined occipital and trigeminal neurostimulation system (eCOT-NS) which applies electrical impulse to 6 major nerve branches in the head associated with migraine. Combined occipital and trigeminal neurostimulation was previously possible only by an invasive high-risk procedure.

Poster 1: Initial Efficacy and Safety Evidence of Long-Term Migraine Preventive Treatment Using External Combined Occipital and Trigeminal Nerve Stimulation (poster #: P-252)

This post-hoc analysis included sixteen subjects with high frequency episodic or chronic migraine who self-administered daily treatments with Relivion MG for a 9-month period.

Mean Monthly Migraine Days (MMD) decreased by 75%, from 17.8 days per month at baseline to 4.8 days at the end of the third treatment month (p

Poster 2:

Real-world Efficacy of Abortive Migraine Treatment with External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) in High-Frequency Episodic and Chronic Migraine by treatment initiation timing

(poster #P-255)

This post-hoc analysis included analysis of 497 migraine attacks across 56 subjects who self-administered abortive treatment sessions with the eCOT-NS system upon the onset of a migraine and record their migraine outcomes as well as the timing of treatment initiation from migraine onset (1 hour after pain onset).

78% of treatments which were initiated less than 1 hour after migraine onset achieved relief of migraine pain and 40% of treatments were pain-free. 62% of treatments which were initiated more than 1 hour after migraine onset achieved relief of migraine pain and 25% of treatments were pain-free. There were no reported serious adverse events.

"At the heart of our mission lies a deep dedication to our patients" said Scott Drees, Neurolief's CEO. "We will continue to partner with the migraine community to expand access to Relivion and together, we will embark on a journey to help shape the future of migraine care."

Relivion MG is cleared by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine for patients 18 years of age and older and has received CE Mark. Neurolief will pursue an expanded indication for the preventive treatment of episodic and chronic migraine.

For more information on Relivion MG, visit Relivion.com.

About Neurolief

Neurolief is a neuromodulation company, dedicated to improving the lives of patients suffering from Neurological and Neuropsychiatric disorders such as migraine and depression. The company has designed and manufactures the Relivion device which is the world's first neuromodulation system designed to concurrently stimulate the occipital and trigeminal nerve branches to modulate brain regions associated with migraine and depression. Currently FDA and CE approved for the acute treatment of migraine, Relivion is intended to provide a highly effective alternative to pharmaceutical therapies. The system also incorporates a patient mobile app and clinical software with cloud enabled data-tracking feature sets, enabling next generation AI incorporation. The company is currently pursuing additional FDA and CE mark approvals for migraine prevention and for treatment of major depression (MDD).

SOURCE Neurolief Inc.