Product Launch: Modius Sleep FDA-Cleared Non-Invasive Device that Treats Chronic Insomnia is Now Available for Purchase
95 percent of clinical trial participants reported better sleep in four weeks
BELFAST, Northern Ireland, Oct. 28, 2024 /PRNewswire/ -- Neurovalens, a global health-tech leader in neurotechnology, has launched its first product, Modius Sleep, to treat chronic insomnia. Neurovalens received medical device clearance from the U.S. Food & Drug Administration (FDA) for two of its products: Modius Sleep (in October of 2023), which is available now in the U.S. through a physician prescription, and Modius Stress (in March of 2024), which is not yet available for purchase.
The company's Modius technology is non-invasive and taps into the body's natural processes. It enhances health by using low-level electrical signals that stimulate the vestibular nerve in the brain to regulate key functions like sleep and anxiety.
Modius Sleep Treats Chronic Insomnia
Modius Sleep, winner of the 2024 SleepTech® Award from the National Sleep Foundation, is Neurovalens' first FDA-cleared physician-prescribed medical device. It is a non-invasive and drug-free solution to help improve sleep for patients with chronic insomnia. Featured in the prestigious medical journal Brain Stimulation, a recent clinical trial showed that after four weeks, Modius Sleep improved sleep for 95 percent of trial participants (Individual results may vary. Indicated for Adults 22+).
"Sleep is critically important to our overall health," said Dr. Jason McKeown, CEO of Neurovalens, "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."
How It Works
Modius Sleep is a headset used in the comfort of a patient's home for 30 minutes each evening. The device uses electrical vestibular nerve stimulation (VeNS) which is a non-invasive therapeutic method shown to improve chronic insomnia. The device sends a safe electrical pulse into the vestibular nerve, influencing the areas of the hypothalamus and brainstem that control circadian rhythm and sleep patterns.
"It was important to us to develop a non-surgical option for patients with chronic insomnia," said Dr. McKeown. "By non-invasively tapping into the brain's natural sleep cycles, Modius Sleep allows you to fall asleep faster and stay asleep longer."
Patients Must Qualify to Purchase
Patients interested in purchasing Modius Sleep must visit www.Neurovalens.com to fill out a questionnaire. If the patient qualifies, they will be connected to a physician through the Neurovalens online platform.
Modius Sleep retails for $1,185. The device can be purchased with HSA/FSA funds and a tool kit is available on the Neurovalens website for patients to submit information to their insurance provider to see if reimbursement is available.
About Neurovalens
Neurovalens is a global health-tech company that creates non-invasive neurostimulation products to solve some of the world's most significant health challenges. The company's Modius technology is FDA-cleared, non-invasive, and taps into the body's natural processes. It enhances health by using low-level electrical signals that stimulate the vestibular nerve in the brain to regulate key functions like sleep, stress, and overall well-being. The company is headquartered in Belfast, United Kingdom.
Contact: Kate Willis
[email protected]
+1 513-532-2378
SOURCE Neurovalens
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