Dr Jason McKeown, CEO of Neurovalens, reveals the exciting announcement that their latest non-invasive device which treats anxiety, Modius Stress, has received FDA clearance.
Dr Jason also reveals his career path into health-tech any why it is so important for him and his team to help mothers in the post-natal period who are breastfeeding have access to non-invasive treatment for anxiety as well as Neuovalen’s exciting plans for the future.
Dr Jason, reveals to Sync NI he was “very fortunate early in my career as a junior doctor I was given a job in neurosurgery.” This was “closely followed by an invitation to carry out research at the University of California, San Diego (UCSD).”
RELATED: Belfast-based company receives FDA clearance for medical device to treat anxiety
Dr Jason explains: “This allowed me to better understand the complexity of how the brain and nervous system work, and also why neurological diseases are commonly treated with drugs, even though drug-free approaches are available.
“The concept of using electrical stimulation to replace drugs has been around for some time but it is less common in the UK. In short, a neurostimulator can be surgically implanted in the chest and a wire is connected to nerves at the base of the brain. Unfortunately, that makes it very risky and expensive and so it tends to be used as a last resort.”
But Dr Jason explains he pursued a non-invasive way to achieve this, explaining to Sync NI: “At UCSD, we looked at this type of technology and wanted to explore if it always needed to be surgically implanted. Once we had developed a non-invasive way to achieve this, I established Neurovalens in Belfast, and we built up a small team there.
“For the last few years, we have been testing this technology in clinical trials to clearly establish the safety and efficacy, and to work through regulatory approval.”
Amazingly, Neurovalens now have their first and second approvals from the FDA, an are moving into the “exciting” stage of commercialisation.
And Dr Jason was conscious from the offset that women are twice as likely to be affected as men by Generalised Anxiety Disorder, explaining: "The higher prevalence of anxiety in woman is something we factored into our primary clinical trial that was used for the anxiety regulatory approval, but also into our ongoing clinical trial that looks at PTSD.
“Most people assume that PTSD is associated with veterans, but it’s actually another example of an anxiety related disease that presents more commonly in woman.
“Interestingly, in our UK and Ireland trials, 75 per cent of the participants were female. One of areas we are really interested in is the post-partum period, where mental health issues can often become more significant.
“The Modius Stress device will provide new mothers with a drug-free solution to manage their anxiety without needing to worry about mental health medication transferring when breastfeeding.
“The core technology behind our devices is quite similar regardless of what we are using them to treat. However, they all have a different configuration of electrical impulses that are used to activate key areas in the brain,” Dr Jason explains.
“This presents some challenges when it comes to regulatory approval, as not only do we have to create a piece of hardware to a medical device standard, but we also then must take that piece of hardware through Phase III (Pivotal) trials so that the FDA can review both the safety and efficacy when used as a medical treatment.
“In the earlier years of Neurovalens, we spent a lot of our time making the medical device hardware. This transitioned into clinical trials looking at insomnia, anxiety and obesity, and more recently PTSD and Type Two diabetes.
“Now, after a long period of research, these trials have finished, and our approvals have started to come through. The first approval was the Modius Sleep device that is used to treat Chronic Insomnia.
“This was a huge milestone for the company as it took us from an R&D company to a certified medical device company that can now issue Modius devices on prescription.
“We were able to use our knowledge from the original submission when working the second time with the FDA on the anxiety approval. This is why the two approvals for Modius Sleep and Modius Stress have come through so close together,” he explains.
When asked about what it is like to a part of Neuovalens, particularly its amazing Belfast team, Dr Jason explains: “Neurovalens is a team of 20 very hardworking and intelligent people, who enjoy a culture that is built on an extremely high level of performance.
“We are always keen to speak with individuals who have a similar mindset for potential job opportunities.
“Keeping the team small while focusing on elevated performance and high levels of efficiency has allowed us to achieve our milestones quickly and at a fraction of the expected cost.”
Neurovalens 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 the likes of PTSD and obesity.
Dr Jason explains: “The Modius technology has a wide range of issues that it can potentially treat, so we are always keen to partner with universities and clinics who want to look at other diseases. Our obesity trials have been completed, with very positive results, and we are now working through what will hopefully be the third approval.
“This is closely followed by our PTSD and Type Two Diabetes trials that are scheduled to reach completion later in 2024. Just recently we have started our initial work in depression, but this is still at the very early stages of development.”
Neurovalens also recently announced it has closed a £2.1m ($2.65m) funding round with existing investors in preparation for a $40m-$50m Series B fundraising round, which the company expects to launch later this year.
Neurovalens has previously 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.
