Neurovalens can now market the non-invasive device in the US. Credit: Neurovalens.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.