Neurovalens raises £2.1M and gains FDA approval for anxiety treatment wearable device

Belfast-based healthtech company Neurovalens announced today that it has received medical device clearance from the US Food & Drug Administration (FDA) to treat anxiety with its Modius Stress device.

Neurovalens also announced today that it has closed a £2.1 million funding round with existing investors. The company has previously raised around £11 million in equity funding from UK investors.

Neurovalens specialises in combining neuroscience and technology to tackle a range of global health challenges. 

Its medical devices are designed to deliver noninvasive electrical stimulation to key areas of the brain and nervous system without the need for surgically implanted electrodes.

Modius Stress is designed to treat anxiety by delivering a small and safe electrical pulse to the head for 30 minutes before bed. During this time, users can do other activities, such as watching TV 

Achieving regulatory approval via the FDA 510(k) clearance means the Modius Stress device can now be sold directly to people suffering from Generalised Anxiety Disorder (GAD) across the US who have a prescription from their doctor.

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. GAD can cause both psychological and physical symptoms, including feeling restless or worried, having trouble concentrating or sleeping, dizziness and heart palpitations. 

The FDA's decision was secured following two Phase III / Pivotal clinical trials carried out in mid-2023 in the UK and Ireland by Ulster University 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. The Modius Sleep is now available for sale and is being actively promoted by doctors.

Dr Jason McKeown, CEO of Neurovalens, 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.”

Lead image: Neurovalens. Photo: uncredited.