Belfast firm receives 'landmark step' with FDA clearance for medical device to treat insomnia

A Belfast medical technology manufacturer has received medical device clearance from the US Food & Drug Administration (FDA) to treat chronic insomnia with its Modius Sleep device.

Based in Belfast, Neurovalens is a health-tech company that specialises in combining neuroscience and technology to tackle a range of global health challenges.

The company’s medical devices have been designed to deliver non-invasive 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 a period of 30 minutes before bed, during which users can do other activities, such as watching TV or reading.

The FDA regulates the development, manufacturing, authorisation, distribution and sale of medical devices in the US across multiple product categories. Achieving regulatory approval via FDA 510(k) clearance means the Modius Sleep device can now be sold directly to people suffering from chronic insomnia across the US who have a prescription from their doctor.

The decision by the FDA was secured following a robust Phase III / 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.

Dr Jason McKeown, CEO of Neurovalens, said: “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.

“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.”

Vicky Kell, Invest NI director of innovation research development, explained: “Our R&D support has assisted Neurovalens to develop its product through clinical trials and validation to achieve this FDA clearance. The company has also secured investment via our Access to Finance funds, and trade support to help it identify export opportunities.

“This clearance from the FDA for their Class II Medical Device will allow the company to move to commercialisation and take advantage of business opportunities globally. This kind of industry cutting edge innovation in Life Sciences is exactly the kind of project that will enable Northern Ireland to achieve economic success, as outlined in the Department for the Economy’s 10X Economic Vision.”

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.

Last year Neurovalens took part in the MedTech Innovator competition, a globally renowned accelerator programme and showcase for innovative medical device, digital health and diagnostic start-ups.

To date, Neurovalens has raised around £11m in equity funding from UK investors including Wharton Asset Management, IQ Capital, Techstart Ventures, Angel Co Fund, Beltrae Partners, Clarendon Fund Management and British Business Bank. A Series B funding round is being planned for 2024.