Neurovalens Debuts Newly FDA-Cleared Insomnia Neurostim Headband

Neurovalens, a Belfast-based maker of non-invasive neurotechnology, recently earned U.S. Food and Drug Administration (FDA) clearance to treat insomnia using its Modius sleep device. The company is showcasing the newly cleared device in the ABHI UK Pavilion, Hall 16, K32, at this year’s MEDICA trade fair.
 
Modius delivers non-invasive electrical stimulation to key brain and nervous system areas with the aim of improving insomnia. Treatment consists of an electrical pulse administered for 30 minutes before bed, during which users can do other activities, Neurovalens said.
 
The FDA’s nod was based on an Phase II/pivotal trial in the U.K. and Ireland by Ulster University and PolyU University in Hong Kong. Neurovalens said it plans to begin discussions with insurance providers to secure reimbursement status.
 
“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. 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,” Neurovalens CEO Dr. Jason McKeown told the press. “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 is currently conducting clinical trials assessing effectiveness of its tech to treat other conditions, and has approvals pending to treat anxiety and obesity. It has also participated in the MedTech Innovator competition.