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Belfast tech firm’s medical device to treat anxiety wins US regulator approval

Published on 8 April 2024

A health tech firm in Belfast has received medical device clearance in the US for a headset adapted to treat anxiety.

Neurovalens has been given the green light by the US Food and Drug Administration (FDA) to treat anxiety using its Modius Stress device.

The company combines neuroscience and technology to tackle health problems like stress, obesity and insomnia.

Company founder Dr Jason McKeown, an NHS-trained doctor, developed the idea for the devices, which work by delivering non-invasive electrical stimulation to key areas of the brain and nervous system, averting the need for surgically implanted electrodes.

Modius Stress is designed to treat anxiety by delivering an electrical pulse to the head for 30 minutes before bed, during which users can do other activities, such as watching TV or reading.

Regulatory approval from the FDA means the Modius Stress device can be sold directly to people suffering from Generalised Anxiety Disorder (GAD) across the US who have a prescription from their doctor.

According to Neurovalens, “GAD is a long-term condition that causes people to feel anxious most days about a wide range of situations and issues, rather than a specific event”.

The FDA regulates the development, manufacturing, authorisation, distribution and sale of medical devices in the US.

It has given approval to the device following clinical trials in mid-2023 in the UK and Ireland, carried out by Ulster Universitym and in India by the Indian Center of Neurophysiology (ICN).

It follows the company receiving clearance from the FDA in October 2023 for its Modius Sleep device, which can be used to treat insomnia.

Dr McKeown, the company’s chief executive, said: “Having the Modius Stress technology as a certified medical device for the treatment of generalised anxiety disorder is the next meaningful step for the company as we focus on continued growth in the US market.

“GAD affects an estimated 6.8 million adults in the US, over 3% of the population, with women twice as likely to be affected as men, according to the American Depression and Anxiety Association. Modius Stress is a non-invasive device that treats the underlying issue to improve the lives of 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 this latest clearance moves us further towards that goal.”

Neurovalens also announced that it has closed a £2.1m ($2.65m) funding round with existing investors ahead of a $40m-$50m Series B fundraising round, which the company expects to launch later this year.

Neurovalens has previously raised around £11m in equity funding from UK investors including Wharton Asset Management, IQ Capital, Techstart Ventures, Angel Co Fund, Beltrae Partners, Clarendon Fund Management and British Business Bank.

The company continues to run clinical trials on the effectiveness of its drug-free technology in treating other conditions and has approvals pending for the treatment of post-traumatic stress disorder (PTSD) and obesity.

Dr McKeown, an NHS-trained doctor and past pupil of Ballymena Academy, came up with the idea of the Modius as a device to treat brain-activated disorders and habits like insomnia, over-eating and anxiety.

The Modius Sleep is available to buy in the UK as a health technology device.

Source: Belfast Telegraph (link opens in new window)