22 Apr Neurovalens closes £2.1m funding round
Neurovalens, a Belfast-headquartered specialist in non-invasive neuro-technology, has closed a £2.1m funding round with existing investors in preparation for a $40m-$50m Series B fundraising round. The firm has also received clearance from the US Food & Drug Administration (FDA) for its Modius Stress device.
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The company, whose 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, said it expects to launch the Series B round later this year.
It 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 Managers and British Business Bank.
The firm’s Modius Stress device 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. 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.
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.
Dr Jason McKeown, chief executive 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 per cent 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.”
Neurovalens 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.