FDA Approves Neurovalens’ Modius Sleep Headset for Insomnia

FDA Approves Neurovalens' Modius Sleep Headset for Insomnia

The FDA has granted clearance to Neurovalens’ Modius Sleep device, offering a novel, drug-free solution for chronic insomnia in the United States. This marks a significant development for the Northern Ireland-based company, allowing them to expand their presence in the US, according to CEO Jason McKeown, Ph.D.

“Having the Modius Sleep technology as a certified medical device for the treatment of chronic insomnia is a landmark step for the company as we focus on future growth in the US market. Most other products on the market measure symptoms of insomnia, but Modius Sleep is a non-invasive device that actually treats the underlying issue, improving the lives of our patients. We believe that the low risk, non-invasive therapeutic intervention offered by Neurovalens technology will be truly transformative for a range of serious medical conditions and, having carried out extensive clinical trials in the US and Northern Ireland, we’re really excited to be moving to this next stage.”

– Dr Jason McKeown, CEO of Neurovalens

The Modius Sleep device is a wearable headset designed to employ neuromodulation technology, delivering small electrical pulses through an electrode placed behind the ear. Its purpose is to stimulate specific areas of the brain’s hypothalamus associated with the sleep-wake cycle and circadian rhythm.

Users are recommended to wear the headset for a 30-minute session before bedtime, during which they can engage in activities such as watching TV or reading as they wind down for the night.

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The neurostimulation provided by the device aims to enhance both the quality and duration of sleep. In a pilot study conducted in 2020, 20 adults used the neurostimulation headset every night before sleep for two weeks. At the end of the study period, participants reported significant reductions in their Insomnia Severity Index (ISI) scores, as well as an improvement in how rested they felt throughout the day.

Notably, participants initially had an average baseline ISI score indicating “moderate insomnia,” which significantly decreased after two weeks of regular Modius Sleep treatment, falling below the threshold for a clinical diagnosis of insomnia. Additionally, their scores for restfulness on a scale of zero to four improved from an average of 1.6 before the study to 2.67 after the two-week Modius Sleep treatment.

Neurovalens’ FDA clearance was supported by the results of a robust pivotal clinical trial conducted in the UK, Ireland, and Hong Kong, although the full results have not yet been published.

The company’s future plans include working with insurance providers to secure reimbursement for US users of the Modius Sleep device. Simultaneously, Neurovalens is in the process of adapting its neurostimulation technology for various other medical indications, including Type 2 diabetes, obesity, anxiety, and post-traumatic stress disorder, with the latter subject to an upcoming clinical trial that is currently recruiting participants.

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