Belfast-based neurotechnology company Neurovalens has received approval for its prescribed insomnia treatment from authorities in the European Union (EU) and the UK, clearing the way for its sale in both markets.
Neurovalens’s technology uses low-level electrical stimulation in areas of the brain and nervous system to address challenges such as insomnia, anxiety and post-traumatic stress disorder.
Modius Sleep delivers a small, safe electrical pulse to the head for 30 minutes before bed. Users can carry out other activities, such as watching TV or reading, while the treatment is under way.
This is the first of Neurovalens’ products to be approved for sale in the UK and EU markets, with the company already receiving approval for the device in the US.
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Chief executive and founder of Neurovalens Dr Jason McKeown said the approval was a “significant landmark” for Neurovalens.
“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,” he said.
“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 $2,265 (€1,957.75), and to US veterans through the US department of veterans affairs. Its Modius Calm device, which is used to manage anxiety, is also on sale there.
Established in 2015 by McKeown and neuroscientist Paul McGeoch, Neurovalens has been investigating the use of its technology for a range of medical applications.
The company is running clinical trials on the effectiveness of its non-invasive technology in treating other conditions, with approvals pending for the treatment of PTSD.
Neurovalens has raised approximately £20 million (€23 million) in funding, with a mix of debt and equity from UK investors that include Wharton Asset Management, IQ Capital, Techstart Ventures, Angel Co Fund, Beltrae Partners, Co-Fund NI managed by Clarendon Fund Managers, Innovation Ulster Limited and British Business Bank.
