The US Food and Drug Administration (FDA) has granted 510(k) clearance to Neurovalens’s Modius Sleep, a device used to treat chronic insomnia.
The Belfast-based company has developed a non-invasive device that delivers electrical stimulation to the vestibular nerve of the brain. This modulates the hypothalamus and brainstem nuclei, regions of the brain important in regulating sleep patterns and the circadian rhythm – the internal body clock in humans.
The therapy involves 30 minutes of stimulation before bed. Neurovalens state that patients can carry on with their usual pre-bed routine, such as reading or watching television, whilst receiving the pulses.
The FDA based the clearance on data from a Phase III/pivotal clinical trial. The trial was carried out in the UK and Ireland by Ulster University and in Hong Kong by PolyU University.
A study, published in the Journal of Basic Clinical Physiology Pharmacology, assessing the insomnia severity index (ISI) score of patients using the device found that there was a significant improvement after two weeks of therapy comprising 30 minutes of stimulation once a day.
Neurovalens said it has planned discussions with insurance providers for reimbursement status for the device.
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The company added it is also seeking FDA authorisation for its technology in anxiety and obesity indications.
Neurovalens CEO Dr Jason McKeown said: “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.
Neurovalens has raised around £11m ($13.35m) in funding and has a Series B funding round planned for 2024.
A market model by GlobalData forecasts that the global neuromodulation device market will be worth $14.3bn by 2033.