Key clinical research trials carried out by Ulster University researchers have played a crucial role in securing clearance from the US Food & Drug Administration (FDA) for Neurovalens’ pioneering medical device known as ‘Modius Sleep,’ a novel, non-invasive treatment for chronic insomnia.
Combining neuroscience and technology, the innovative ‘Modius Sleep’ device is a significant development for those suffering from sleep disorders as it has been designed to deliver non-invasive electrical stimulation to key areas of the brain and nervous system without the need for surgically implanted electrodes or for tablets, therefore reducing pressure on an already stretched health service.
The new device delivers 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.
Research highlighted the 'Modius Sleep' device's pioneering approach and non-invasive nature harnessed through digital technology provides a prescription free solution within the UK/EU which alleviates concerns linked with prescription medicines, including the added benefit of portability allowing users to easily integrate this treatment into their daily lives.
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 is a real breakthrough and means the Modius Sleep device can now be prescribed directly to people suffering from chronic insomnia across the US.
The decision by the FDA was secured following intense scrutiny of 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.
This is one of three trials that Ulster University has partnered with the Belfast based health-tech company, Neurovalens, to provide evidence-based research and knowledge to advance healthcare innovation. FDA approvals are pending for submissions using data from the other two trials, one using a medical device for anxiety and the other for obesity.
State of the art research facilities
Clinical trials were conducted within the Human Interventions Studies Unit (HISU) based at the state-of-the-art Centre for Molecular Biosciences (CMB) at Ulster University Coleraine. Other human trials ongoing in the unit include the role of diet in different types of cancer, heart disease, obesity and diabetes.
The bespoke, purpose-built unit is dedicated to carrying out intervention trials on human volunteers and has specialist facilities and equipment including a residential suite accommodating up to 11 volunteers to stay for days or weeks at a time.
Leading the clinical trials research at Ulster University, Dr Julie Sittlington, School of Biomedical Sciences said: "This project at the School of Biomedical Sciences has been very rewarding, and we are delighted to support local company, Neurovalens, in securing a safe, patient-centered, effective solution backed by our evidence-based research. Our research and testing sheds light on the remarkable benefits that patients can experience when using the innovative 'Modius Sleep' device.
"This new non-drug, non-invasive treatment signifies a sizeable breakthrough for individuals grappling with sleeping disorders, offering the promise of an improved quality of life. Insomnia can be an overwhelming burden, impacting both physical and mental health, leading to fatigue, frustration, anxiety, and depression. The 'Modius Sleep' device has the potential to alleviate these struggles and enhance overall well-being.
"Moreover, at a time when waiting lists within the health service have reached unprecedented lengths, this non-invasive solution provides an alternative option that can advance the path to improvement for those in need."
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.”
This news follows Ulster University’s latest announcement committing to a new five-year Research and Innovation Strategy aiming to focus its contribution to global challenges such as climate change, inequality, and social deprivation and ensure its research aligns with societal needs – both locally, here on the Island of Ireland and on a global scale.
Learn more about the new strategy: Ulster University Supercharges Research and Innovation with Launch of New Five Year Strategy