How Neurovalens moved to remote clinical trials during Covid-19

Kane Fulton, August 4, 2020 3 min read

With signs of a second wave of Covid-19 hitting Europe, there is a need for digital tech company founders to remain resilient. Amid the doom and gloom there is reason to be positive, with recent figures demonstrating that investors are continuing to back promising UK tech teams despite the challenges posed by the pandemic.

Belfast and San Diego-based Neurovalens, a Tech Nation Upscale 5.0 cohort member, is a case in point. Made in Northern Ireland, the company’s non-invasive neurostimulation devices – which resemble wearable headbands – solve global problems such as obesity; diabetes; anxiety and insomnia without the need for implanted electrodes.

In January, the healthtech raised £175k from 793 backers for its Modius SLEEP device on crowdfunding platform Indiegogo. Last month, it raised £5.1m in a follow-on Series A funding round led by IQ Capital, which included £2m from the Government’s coronavirus Future Fund loan scheme that was set up to help innovative companies facing financial difficulties due to the virus.

Neurovlens’ Modius SLEEP

Time trial

Critical to Neurovalens’ future are its clinical trials, conducted in the UK and abroad, which facilitate the development of Neurovalens’ tech – which is going through FDA and EU regulatory approvals – toward use as an approved medical treatment around the world. The company combines data from its clinical trials with real-world data (from users who purchase its devices) to shape its future products.

When Covid hit, participants on Neurovalens’ trials were suddenly restricted from entering hospitals to provide vital clinical data. In the case of Neurovalens’ obesity trials, which are currently drawing to a close in the US, that includes everything from fat loss and muscle mass to bone density. This left the company unable to recruit or finish its existing trials. The possibility of ending them and restarting in 2021 would lead to a “significant” amount of time being lost while incurring insurmountable cost, says cofounder and CEO Dr Jason McKeown.

“You can work out the cost of losing, say, 100 participants in a single trial, which is in itself really significant,” says Jason. “What you also lose, which is sometimes overlooked, is that you have to still run the company and pay wages for a period while nothing else is happening. You then need to pick up on the other side and run those trials again.”

He continues: “For us, we could have survived at our leanest, doing nothing for six months then returning, or we could take funding to take the pressure off. Thankfully, our investors are really passionate about what we do, and because we’re avoiding Covid-related catastrophe we were eligible to match £2m of private investment through the Future Fund.”

Remote opportunity

So, how do you continue to run an obesity trial during a pandemic? The answer came following a call to the Food and Drug Administration (or FDA) in the US, which is a key market for the company due to its huge private healthcare market, along with China.

“We have a really good relationship with the FDA and was on a conference call talking to them about our weight loss trial within an hour of them putting out national guidance for Covid,” he says. “From that, we were able to change things.”

An agreement was made, and within days Neurovalens had sent certain participants medical scales like ones found in bathrooms, only much more expensive. Despite multiple data points being lost, it meant that the most critical one – weight – would still be captured. “Though it wouldn’t be the gold standard, the FDA decided it would be good enough to allow us to continue running the trial remotely.”

Jason is confident that the decision has set a precedent for running other clinical trials remotely, of which he says there will be “far greater acceptance” in the future. Particpants could provide consent via electronic signatures while holding discussions over zoom before being randomly sent pre-packaged active (or placebo) devices without the company’s scientists knowing which they have received.

“At the end of a trial when everybody’s finished, you would get all of the devices back, break envelopes and find out who had what – so it’s all very doable,” he says. “I think [the pandemic] is going to force people to accept something like that now in clinical trials.”

Looking ahead, in addition to continuing its trials, Neurovalens will also be using its funding to hire new team members. A key aim for the company is securing approval for insomnia and anxiety devices in the next year, with diabetes trials planned for 2021.

Community, Northern Ireland