The US Food & Drug Administration (FDA) granted 510(k) clearance to Neurovalens’ Modius Sleep noninvasive neurostimulator to treat chronic insomnia.
Based in Belfast, Neurovalens is a health-tech company that specializes in combining neuroscience and technology to tackle health challenges. The company’s medical devices have been designed to deliver noninvasive electrical stimulation to key areas of the brain and nervous system without the need for surgically implanted electrodes.
Modius Sleep is designed to improve insomnia by delivering a small and safe electrical pulse to the head for 30 minutes before bed, during which users can do other activities, such as watching TV or reading.
With FDA 510(k) clearance, the Modius Sleep device can now be sold directly to people with from chronic insomnia across the US who have a prescription from their doctor.
The decision by the FDA was secured following a phase 3 pivotal clinical trial carried out in the UK and Ireland by Ulster University and in Hong Kong by PolyU University. Neurovalens now plans to enter discussions with insurance providers to achieve reimbursement status, so patients can access the treatment on their medical insurance.
“Having the Modius Sleep technology as a certified medical device for the treatment of chronic insomnia is a landmark step for the company as we focus on future growth in the US market,” says Jason McKeown, PhD, CEO of Neurovalens, in a release. “Most other products on the market measure symptoms of insomnia, but Modius Sleep is a non-invasive device that actually treats the underlying issue, improving the lives of our patients.
He continues in the release, “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, having carried out extensive clinical trials in the US and Northern Ireland, we’re really excited to be moving to this next stage.”
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 anxiety and obesity.
Photo caption: Modius Sleep
Photo credit: Neurovalens