Chronic conditions (both neurological and systemic) often originate from dysfunctions of the brainstem or hypothalamus. For example, downregulation of the hypothalamus can cause insulin resistance and therefore lead to type two diabetes and obesity. Similarly, dysfunction in the circadian regulation centre of the hypothalamus can lead to insomnia.
Whilst medications can influence neurons of the hypothalamus, they will also lead to cross-activation of similar receptors in other areas leading to significant side effects (such as increased mental health issues or cardiovascular disease). By stimulating the required neurons directly using electricity, the patient has a much greater outcome with significantly reduced side effects.
This where Neurovalens comes in. The Northern Ireland-based company makes non-invasive technology that can stimulate the deep parts of the brain and brainstem.
The company’s CEO, Dr Jason McKeown, told Omnia Health Insights: “Our technology, which is worn like a headband, is typically used for 30 minutes each day and is user-controlled via connection to their mobile phone. Our main focus is our insomnia and anxiety treatments (US FDA approval is pending) and our longer-term work is in the area of metabolic disease (Currently at Phase 3 trials). Ultimately, we would like to offer a drug-free treatment for four diseases – insomnia, anxiety, type 2 diabetes, and obesity.”
McKeown highlights that the company’s good relationship with the U.S. FDA allowed it to have early meetings designed to ensure clinical trial participants were able to complete the trials safely and effectively, despite the challenges posed by COVID-19. “Most of this was via our remote-trial plan, which we were able to action with the FDA directly,” he added.
Separately, outside of the U.S. market, Neurovalens have noticed a significant increase in the sales of its CE certified Sleep & Stress technology. These devices can be issued without a prescription and non-U.S. customers can have their device sent directly from Neurovalens via online orders.
At the upcoming ‘Northern Ireland: Providing innovative solutions to the world’s healthcare challenges’ webinar, Neurovalens will shed light on its two expected medical device approvals (insomnia and anxiety treatment) in the coming months.
“We are hoping to subsequently register these products in several Middle East regions,” he said. “At this stage, we are keen to highlight this novel technology and discuss with distributors and healthcare networks about integration into their treatment offering.”
Dr Jason McKeown
McKeown concluded: “Although Neurovalens’ immediate focus is on the neurological treatments; we are aiming to have approval for diabetes and obesity technology by early 2021. Therefore, we would also be happy to speak with anyone who has a more specific focus of type 2 diabetes or metabolic disease.”
Join the webinar: Northern Ireland: Providing innovative solutions to the world’s healthcare challenges
Tuesday 9th February – 3PM GST
You can hear more from Neurovalens at this webinar hosted by Invest Northern Ireland, the economic development agency for Northern Ireland, UK. With expertise across a range of specialisms, including respiratory products, diagnostics, medical devices, e-health and medtech, companies from Northern Ireland are enabling treatments that transform lives across the globe.
Register for free >>