MedPath

Neurovalens Launches FDA-Cleared Modius Sleep for Chronic Insomnia

• Neurovalens has launched Modius Sleep, an FDA-cleared device, available via prescription, for treating chronic insomnia. • The device uses electrical vestibular nerve stimulation (VeNS) to influence brain areas controlling circadian rhythm and sleep patterns. • Clinical trials showed that 95% of participants reported improved sleep after four weeks of using Modius Sleep. • Modius Sleep, a non-invasive, drug-free solution, is administered at home for 30 minutes nightly and retails for $1,185.

Neurovalens, a neurotechnology company, has launched Modius Sleep, a non-invasive medical device cleared by the FDA for the treatment of chronic insomnia. The device is available in the U.S. through physician prescription.

Modius Sleep: A Novel Approach to Insomnia Treatment

Modius Sleep employs electrical vestibular nerve stimulation (VeNS) to modulate brain regions responsible for regulating circadian rhythm and sleep patterns. The device, worn on the head for 30 minutes each evening, delivers a safe electrical pulse to the vestibular nerve, influencing the hypothalamus and brainstem.
"Sleep is critically important to our overall health," said Dr. Jason McKeown, CEO of Neurovalens. "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 Brain Stimulation demonstrated 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+.

How Modius Sleep Works

The Modius Sleep headset is designed for home use, with patients using the device for 30 minutes each evening. The VeNS technology stimulates the vestibular nerve, promoting natural sleep cycles without surgical intervention.
"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."

Availability and Cost

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

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

UNEEG Medical's Subcutaneous EEG Implant System Receives FDA Breakthrough Device Designation for Epilepsy Monitoring

UNEEG Medical's Subcutaneous EEG Implant System has received FDA Breakthrough Device Designation, expediting its review for treating severe epilepsy.
The system offers continuous 24/7 EEG recording via a small subcutaneous device, providing long-term brain activity data for physicians.

Tonix Pharmaceuticals Seeks FDA Approval for TNX-102 SL in Fibromyalgia

Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for TNX-102 SL, targeting sleep and pain relief in fibromyalgia patients.
Phase 3 trials demonstrated that TNX-102 SL significantly reduced daily pain and improved sleep quality compared to placebo in fibromyalgia patients.

SetPoint Medical's Neuroimmune Modulation Platform Receives FDA IDE Approval for Relapsing-Remitting MS Trial

SetPoint Medical received FDA approval for an IDE to study its neuroimmune modulation platform in relapsing-remitting MS patients.
The platform stimulates the vagus nerve to modulate the immune system, potentially promoting neuroprotection and remyelination.

Magnetic Pulses Show Promise in Treating Chronic Insomnia

Researchers are developing a handheld device that uses magnetic pulses to treat chronic insomnia by targeting the default mode network (DMN).
A $3 million grant from the Department of Defense is funding a study at the University of Arizona focusing on military personnel affected by sleeplessness.

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.

Neurovalens Launches FDA-Cleared Modius Sleep for Chronic Insomnia

Neurovalens has launched Modius Sleep, an FDA-cleared, non-invasive device, for treating chronic insomnia, offering a drug-free alternative.
Clinical trials showed that 95% of participants reported improved sleep after four weeks of using the Modius Sleep device.

SetPoint Medical's Vagus Nerve Stimulation Device Receives FDA IDE for Multiple Sclerosis Trial

SetPoint Medical received FDA IDE approval to begin a clinical trial of its neurostimulation platform in relapsing-remitting multiple sclerosis (RRMS) patients.
The pilot study, set to begin in 2025, will enroll 60 patients in the US and will assess the device's impact on remyelination.

Withings' Sleep Rx Mat Receives FDA 510(k) Clearance for OSA Diagnosis Assistance

The FDA has granted 510(k) clearance to Withings' Sleep Rx Mat, a device designed to aid in the diagnosis of sleep apnea in adults.
The under-mattress mat tracks sleep, breathing, and cardiovascular activity, providing users with a sleep quality score and detailed sleep data.

Withings Sleep Rx Receives FDA Clearance for Home Sleep Apnea Testing

Withings Sleep Rx has received FDA clearance, marking a significant advancement in sleep apnea diagnosis by offering a convenient alternative to traditional in-lab testing.
The device is non-intrusive, fitting under any mattress, and provides detailed analysis of sleep, breathing, and cardiovascular activity for accurate sleep apnea diagnosis.

Medtronic's Inceptiv Spinal Cord Stimulator Receives FDA Approval for Chronic Pain Relief

Medtronic's Inceptiv, a spinal cord stimulator, has gained FDA approval for managing chronic pain by automatically adjusting stimulation based on biological signals.
The device is implanted and works by sensing signals and blocking pain signals before they reach the brain, offering a potential alternative to traditional pain management.

Reference News

[1]
Product Launch: Modius Sleep FDA-Cleared Non-Invasive Device that Treats Chronic ...
finance.yahoo.com · Oct 28, 2024

Neurovalens launched Modius Sleep, an FDA-cleared, non-invasive device for chronic insomnia, improving sleep for 95% of ...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy