CEO and co-founder Jason McKeown. Image: Neurovalens
The Belfast-based medical device company founded in 2015 just received two FDA approvals in five months.
Brain implants that can treat a range of issues such as insomnia, anxiety and even obesity may seem like a futuristic fancy of science fiction enthusiasts, but it’s also the kind of future that Jason McKeown, co-founder of Neurovalens, is trying to prevent.
The idea is that while brain implants could be an effective way to solve many health problems, one that does not require surgery or medication is even better. Based in Belfast, Neurovalens has been working on exactly that for nearly a decade.
McKeown, a medical doctor by background, co-founded the medical device start-up with Paul McGeoch in 2015. Medtechs often take time to get the business up and running, but for Neurovalens, the time has come – it has received two regulatory nods from the US Food and Drug Administration (FDA) within the space of five months.
“Neurovalens [has] developed a non-invasive technique that allows stimulation of the deep parts of the brain,” explains McKeown, who is CEO of the company and a visiting scholar at the University of California, San Diego.
“Previously, this was only possible by surgical implantation. However, when using Neurovalens’ technology, stimulation can be delivered to the skin at the back of the head.”
How it works
The first FDA approval came last October when its Modius Sleep product was given the green light to be prescribed by US doctors treating patients with insomnia. According to the National Council on Aging, nearly one-third of US adults have symptoms of the condition that makes it hard to fall asleep. Around 10pc have insomnia severe enough to negatively impact their daily life.
Modius Sleep treats chronic insomnia by taking aim at the underlying issue instead of solely attempting to alleviate symptoms. The device delivers a small electrical pulse to the head for a period of 30 minutes. Patients wear the device right before they go to bed, and they can perform activities such as reading or watching television while they receive the treatment.
The Modius Sleep device. Image: Neurovalens
And just last week, Neurovalens got its second approval from the FDA, this time for its device that treats generalised anxiety disorder (GAD), a long-term condition where a person feels a heightened sense of anxiety in a wide range of situations.
“Almost a third of adults suffer from chronic insomnia at some point, and in the US alone, there are approximately 7m people who suffer from generalised anxiety disorder,” says McKeown, who’s passion not just for medicine but also electronics and computers led him to start his entrepreneurial journey with Neurovalens. “The ability to impact these diseases using a drug-free, non-invasive treatment is a very exciting opportunity.”
The Modius range of products are wearable neurostimulators that activate very specific nerves at the back of the head. “During this period, a very small electrical current is used to activate the vestibular nerves just below the skin. The reason this is important is that that the vestibular nerves offer a pathway from the surface directly into the brainstem and other deep regions of the brain,” McKeown explains.
“Using these nerves allows the device to operate non-invasively, and therefore we can avoid the need for surgical implantation. This allows the devices to be considered as much lower risk, and therefore can be offered much earlier in the treatment pathway.”
Expansion plans
Now, McKeown and the team of 20 based in Belfast have their eyes set on their next milestone on both sides of the Atlantic: to be fully covered by US health insurance companies and the NHS in the UK. McKeown said that this will allow Neurovalens to treat these conditions much earlier, ahead of sleeping pills and mental health drugs.
The company also plans to raise $50m in Series B funding later this year, which McKeown said will help it not only overcome “commercial challenges” in the US but also bag more regulatory wins across the world while it stays put with a home based on the island of Ireland.
“One challenge typical with medical devices is that the clinical trials often take longer to recruit, which leads to both cost and time overruns,” he says. “In Northern Ireland, we have a strong history of collaboration with Ulster University and have been able to work closely with them to ensure we navigate through the research as efficiently as possible.”
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