Neurovalens announced today that it received FDA clearance for its Modius Stress device for treating anxiety and raised $2.65 million.
Belfast, Northern Ireland-based Neurovalens designed Modius Stress to deliver non-invasive electrical stimulation. It stimulates key areas of the brain and nervous system without the need for surgically implanted electrodes.
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Modius Stress treats anxiety with a small and safe electrical pulse delivered to the head for 30 minutes before bed. During this time, users can perform other activities, like watching TV or reading. People with generalized anxiety disorder (GAD) across the U.S. with a prescription can utilize this device now.
Clearance follows an FDA nod for the Modius Sleep device for treating insomnia last October. The company also closed a £2.1m ($2.65m) funding round with existing investors. This comes in preparation for a Series B funding round, expected to launch later this year. Neurovalens expects to raise between $40 million and $50 million.
Dr. Jason McKeown, CEO of Neurovalens, said in a news release: “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.”
