Neurovalens has secured clearance from the US Food and Drug Administration (FDA) for its Modius Stress device, designed to treat generalised anxiety disorder (GAD).
This marks the company’s second FDA-approved product, following the Modius Sleep device for insomnia.
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Neurovalens can now market the non-invasive device to individuals with GAD in the US, provided they have a prescription.
The Modius Stress device operates by delivering a small and safe electrical pulse to the head for 30 minutes before bedtime, allowing users to engage in other activities simultaneously.
The company said that the approval was granted after two Phase III / pivotal clinical trials conducted by Ulster University in the UK and Ireland and the Indian Center of Neurophysiology.
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Neurovalens CEO Dr Jason McKeown 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.
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By GlobalData“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.”
Recently, the company closed a funding round of £2.1m ($2.65m) with existing investors for a substantial Series B fundraising effort projected to be between $40m-$50m later in the year.
Investment in Neurovalens has reached approximately £11m, with contributions from UK investors such as IQ Capital, Techstart Ventures, Wharton Asset Management, Angel Co Fund, Beltrae Partners, Clarendon Fund Management, and the British Business Bank.
