'Another significant landmark': Northern Ireland medical tech manufacturer granted EU and UK approval for innovative insomnia device
Modius Sleep, a non-invasive, prescription-only neurostimulation device, offers a new drug-free approach to treating insomnia across Europe, the UK, and the US
Northern Ireland medical technology manufacturer Neurovalens has had its first product approved for sale in Europe and the UK after achieving EU Medical Device Regulation (MDR) compliance for Modius Sleep, it’s prescribed treatment for insomnia.
Based in Belfast, Neurovalens, a global leader in non-invasive neuro-technology, is a pioneering medical device company which specialises in leveraging the power of neuroscience and advanced technology to address a variety of global health challenges across a range of at-home treatments in both metabolic and mental health.
The company’s Modius technology uses low-level electrical signals to non-invasively stimulate areas of the brain known to influence mental health. This technology is known as electrical vestibular system stimulation (VSS).
Modius Sleep is specifically designed to help people manage their insomnia by delivering a small and safe electrical pulse to the head for a period of 30 minutes before bed, during which users can do other activities, such as watching TV or reading.
EU MDR compliance requires medical device manufacturers to meet strict safety, clinical evaluation, and quality management system standards to place products on the EU market. Having achieved MDR compliance, the device has also been registered with the UK Medicines and Healthcare products Regulator Agency (MHRA), meaning Modius Sleep is now compliant for sale across both the EU and the UK.
Neurovalens has previously obtained medical device clearance from the US Food & Drink Administration (FDA) for its Modius Sleep device, as well as its Modius Calm device for managing anxiety. After clearing the regulatory process, the devices are now being prescribed by healthcare professionals in the US.
It is among the first Northern Ireland-based companies to achieve EU MDR certification, placing it alongside some of the world's leading medical device manufacturers.
Dr Jason McKeown, MD, PhD, 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.”
Modius Sleep is available via prescription in the US for $2265.00 and available to US veterans through the US Department of Veterans Affairs.
To date, Neurovalens has raised approximately £20m in equity and debt funding from UK investors including Wharton Asset Management, IQ Capital, Techstart Ventures, ACF Investors, Beltrae Partners, Investment Fund for Northern Ireland, Clarendon Fund Managers, Whiterock, Innovation Ulster Limited and British Business Bank.
The company continues to run clinical trials on the effectiveness of its drug-free non-invasive technology in treating other conditions and has approvals pending for the treatment of PTSD.