Neurovalens gets FDA approval for insomnia device

Belfast health-technology company Neurovalens has been given approval by US authorities for its non-invasive chronic insomnia treatment.

The move, which will open up the US market, comes ahead of the company’s plans to raise a Series B funding round next year.

The company uses electrical stimulation delivered to key areas of the brain and nervous system through its non-invasive Modius Sleep band to help improve chronic insomnia. The device, which is used for 30 minutes before bed, can be worn while watching TV or reading.

The FDA clearance means Modius Sleep can be sold directly to patients suffering from the sleep disorder with a prescription from a doctor.

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“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,” said Dr Jason McKeown, chief executive of Neurovalens.

“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.”

The company also has approvals in the works for using the technology to treat anxiety and obesity.

Established in 2015 by Dr McKeown and neuroscientist Paul McGeoch, Neurovalens has been investigating the use of its technology for a range of medical applications. It has raised around £11 million to date in equity funding from a range of investors that include Wharton Asset Management, IQ Capital, Techstart Ventures, Angel Co Fund, Beltrae Partners, Clarendon Fund Management and British Business Bank. It is expected to raise a Series B funding round next year.