NI company Neurovalens have announced they have received approval for their first neuromodulation product in Europe and the UK.
The company received approval for Modius Sleep, its non-invasive system for treating insomnia.
Neurovalens designed its Modius technology to use low-level electrical signals to non-invasively stimulate areas of the brain known to regulate key functions, such as the management of sleep, anxiety and overall metabolic health. It stimulates key areas of the brain and nervous system without the need for surgically implanted electrodes. This method is known as vestibular system stimulation (VSS).
Neurovalens designed Modius Sleep to specifically help manage insomnia. It delivers a small, safe electrical pulse to the head for a period of 30 minutes before bed. During this period, users can perform other activities, like watching TV or reading.
Modius Sleep is already available in the U.S., having earned FDA approval in 2023 and launched the following year. The company also won FDA approval for Modius Calm, its anxiety-treating device, in 2024, then picked up de novo approval for Modius Lean, its weight management technology, in December 2025.
The company has also raised approximately £20 million (nearly $27 million) to date, including $8.1 million last year. It plans to target other conditions, next, with approvals pending for treating PTSD.
Dr Jason McKeown, CEO of Neurovalens, said:
“Receiving this approval for the Modius Sleep from EU and UK regulators is another significant landmark for Neurovalens as we continue on our mission to offer a low risk, non-invasive therapeutic alternative to the existing treatments for chronic health issues such as insomnia and anxiety. Most other sleep related products on the market measure the symptoms of insomnia, but Modius Sleep is a non-invasive device that actually treats the underlying issue, which can have a transformative impact on the lives of our patients. Neurovalens is currently focused on achieving continued growth in the US market but these approvals in closer to home markets create new opportunities, both for the business and for patients seeking new treatment options in those jurisdictions.”
