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Neurovalens Launches FDA-Cleared Modius Sleep for Chronic Insomnia

• Neurovalens has launched Modius Sleep, an FDA-cleared, non-invasive device, to treat chronic insomnia, offering a drug-free alternative. • The Modius Sleep headset uses electrical vestibular nerve stimulation (VeNS) for 30 minutes nightly to influence brain areas controlling sleep patterns. • Clinical trials showed that 95% of participants reported improved sleep after four weeks of using Modius Sleep, as published in Brain Stimulation. • Patients can purchase Modius Sleep, priced at $1,185, after qualifying through an online questionnaire and physician consultation via Neurovalens' platform.

Neurovalens, a health-tech company specializing in neurostimulation, has released Modius Sleep, a non-invasive medical device designed to treat chronic insomnia. The device, cleared by the FDA in October 2023, is now available in the U.S. by prescription.

Modius Sleep: A Non-Invasive Approach to Insomnia

Modius Sleep is a headset worn for 30 minutes each evening that delivers a low-level electrical pulse to the vestibular nerve. This stimulation influences areas of the brain, specifically the hypothalamus and brainstem, responsible for regulating circadian rhythms and sleep patterns. The device aims to improve sleep without the use of drugs.
Dr. Jason McKeown, CEO of Neurovalens, stated, "Sleep is critically important to our overall health, and I was deeply concerned by the amount of sleeping pills and sedatives my patients were relying on to get it. The truth is these medications weren't working, and I knew there was a better way to treat chronic insomnia and other sleep disorders through my research and training in neurotechnology."

Clinical Trial Results

A clinical trial published in the journal Brain Stimulation indicated that 95% of participants experienced improved sleep after four weeks of using Modius Sleep. Individual results may vary, and the device is indicated for adults 22 and older.

How to Obtain Modius Sleep

Patients interested in Modius Sleep must complete a questionnaire on the Neurovalens website to determine eligibility. Qualified patients will then be connected with a physician through the Neurovalens online platform. The device retails for $1,185 and can be purchased using HSA/FSA funds. Neurovalens also provides a toolkit to help patients seek insurance reimbursement.

About Neurovalens

Neurovalens is a global health-tech company focused on developing non-invasive neurostimulation products to address significant health challenges. Headquartered in Belfast, UK, the company's Modius technology aims to enhance health by using low-level electrical signals to stimulate the vestibular nerve, regulating key functions like sleep, stress, and overall well-being. Modius Stress, another product from Neurovalens, received FDA clearance in March 2024 but is not yet available for purchase.
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Clinical trials showed that 95% of participants reported improved sleep after four weeks of using the Modius Sleep device.

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Reference News

[1]
Product Launch: Modius Sleep FDA-Cleared Non-Invasive Device that Treats ... - PR Newswire
prnewswire.com · Oct 29, 2024

Neurovalens launched Modius Sleep, an FDA-cleared, physician-prescribed device for chronic insomnia, improving sleep for...

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