Neurovalens receives FDA clearance for medical device to treat anxiety

Modius Stress becomes company’s second product cleared for use in US

Neurovalens, a global leader in non-invasive neuro-technology, has received medical device clearance from the US Food & Drug Administration (FDA) to treat anxiety with its Modius Stress device.

Based in Belfast, Neurovalens is a health-tech company that specialises in combining neuroscience and technology to tackle a range of global health challenges.

The company’s medical devices have been designed to deliver non-invasive 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 a period of 30 minutes before bed, during which users can do other activities, such as watching TV or reading.

The FDA regulates the development, manufacturing, authorisation, distribution and sale of medical devices in the US across multiple product categories. Achieving regulatory approval via 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 decision by the FDA 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.”

Neurovalens also announced today that it has closed a £2.1m ($2.65m) funding round with existing investors in preparation for 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 PTSD and obesity.