A Belfast company has received clearance in the United States to sell a medical device it has developed to treat anxiety with electrical pulses to the brain.
The decision by the Food and Drug Administration (FDA) means Neurovalens can now sell its Modius Stress headset to people to people with generalised anxiety disorder (GAD) who have a prescription from their doctor.
GAD is a long-term condition that causes sufferers to feel anxious about a wide range of situations and issues.
It comes six months after the FDA cleared Neurovalens’ Modis Sleep headset for treating insomnia.
Set up by Dr Jason McKeown, the Belfast health-tech firm is seeking to become a global leader in non-invasive neuro-technology.
Its headsets are designed to deliver electrical stimulation to parts of the brain and nervous system without the need for surgically implanted electrodes.
The latest device to hit the US market - Modius Stress - is designed to treat anxiety via electrical pulses for a period of 30 minutes.
It follows two 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).
Neurovalens’ chief executive, Dr Jason McKeown said having Modius Stress as a certified medical device for the treatment of GAD represents the next meaningful step for the company as it focuses 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,” he said.
“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.”
The Belfast company also announced on Monday that it had 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 the 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.
