In 2019, the U.S. medical devices regulator made a change that aimed to inspire innovations in the treatment of insomnia and anxiety. Now, we see this change bearing fruit as Neurovalens, a startup based in Belfast, has received FDA clearance for their second head-mounted treatment device. This device utilizes noninvasive electrical stimulation of the brain and nervous system, a technology that Neurovalens has been working on for over a decade.
Neurovalens now has two FDA-approved medical devices for prescription by doctors in the U.S.: one to treat generalized anxiety disorder (GAD) and another for insomnia. The GAD device was just approved last week, while the insomnia device received clearance in October of last year. There are more products in the works, such as a device targeting brain messaging that can influence the storage of harmful visceral fat, aimed at treating obesity-related cardiometabolic risk.
According to CEO Dr. Jason McKeown, Neurovalens hopes to receive “de novo” classification from the FDA for a third noninvasive neurostimulating device for individuals with obesity, later this year or early next year. They are also working on a device to treat PTSD.
Many conditions, such as chronic pain, depression, anxiety, and stress, are often inadequately managed by traditional healthcare services. As a result, multiple startups are turning to neurostimulation as a potential solution. However, pharmaceutical interventions carry their own set of risks and drawbacks. Noninvasive alternatives, with the ability to demonstrate both efficacy and safety, could be a game changer in conjunction with drug treatments. The field of noninvasive neurostimulation is still relatively new and novel, but the potential is vast.
Unlike other neurostimulation startups that focus on applying Transcranial Direct Current Stimulation or magnetic stimulation, Neurovalens has deliberately chosen to sell FDA-cleared medical devices for specific conditions. This requires them to conduct clinical trials to prove effectiveness for targeted use-cases, rather than simply marketing their products as “wellness” solutions. According to McKeown, this is a differentiating strategy for Neurovalens.
Dr. McKeown explained, “In 2019, the FDA updated their regulations and specifically called out insomnia and anxiety as conditions that could potentially be treated with neurotechnology. In these two cases, we were able to apply through the 510(k) process. However, we still had to conduct our own clinical trials.”
Obtaining a 510(k) clearance means that a medical device is considered similar to an existing device, as opposed to the more novel “de novo” classification that future Neurovalens products targeted at other conditions will require.
McKeown noted, “Typically with a 510(k), clinical trials are not necessary, as you are essentially copying someone who has been there before. However, the FDA felt that previous evidence was not significant enough, and requested that we redo our trials. So we took their guidance and started our own trials in 2019. As far as I know, we are the first company globally to have gone through this process with the FDA and receive approval in this category.”
Consumers in Europe, where regulations differ, can purchase Neurovalens’ devices directly. However, the company is also seeking medical device clearance in the UK and EU, with expectations of receiving approval for doctors to prescribe their insomnia device later this year.
Neurovalens’ devices are worn on the head and deliver electrical neurostimulation to the skin behind the ear, targeting the vestibular nerve. This nerve connects to the hypothalamus and associated autonomic nuclei of the brainstem, responsible for functions such as metabolic control, stress response, and circadian regulation. The basic theory behind the device is that targeted stimulation can re-regulate these control centers when they are not functioning normally. According to McKeown, the effects can be long-lasting, as users can stop regular treatment after experiencing positive changes and switch to top-up treatments. The recommended initial use is four weeks to determine individual efficacy.
It’s worth noting that this approach differs from other neurostimulation startups that use methods such as Transcranial Direct Current Stimulation or magnetic stimulation.
McKeown explained, “We apply minimal stimulation, but it is extremely specific. TDCS is less specific because it applies electricity to neurons on the surface of the brain, rather than penetrating the brainstem.”
He added, “We know that the vestibular nerve carries signals to deep areas of the brain, which were previously only accessible through implants. It’s like sending a signal through a USB cable; the type of cable is irrelevant as long as the signal reaches its destination. Our device starts at the surface and pushes stimulation down the vestibular nerve, activating neurons in the brainstem.”
While the vestibular system is typically associated with balance, McKeown suggests that its significance has been underestimated. He claims that it plays a critical role in overall homeostasis, regulating functions such as blood pressure, breathing rate, heart rate, and even the body’s fat storage.
Neurovalens is the first company to focus on noninvasive direct stimulation of the vestibular nerve. While there are other startups attempting to develop noninvasive stimulation of the vagus nerve, another cranial nerve that also regulates various sensory and motor functions, Neurovalens decided it was too unreliable to target due to the presence of more soft tissue and muscle. The vestibular nerve, on the other hand, is more accessible.
Dr. McKeown stated, “Every cranial nerve stimulator is in our field. In this general space, there are competitors in the noninvasive category. However, we are not aware of any company that has received FDA or regulatory approval for an anxiety treatment.”
On Monday, Neurovalens announced a top-up of £2.1 million ($2.65 million) to their Series A funding round, with existing investors contributing to kickstart commercialization of the new device in the U.S. market. McKeown shared that they will soon begin raising a Series B, with a target of $40 million by the end of the year. To date, Neurovalens has raised a total of £23.1 million from U.K-based investors, including Wharton Asset Management, IQ Capital, Techstart Ventures, Angel Co Fund, Beltrae Partners, Clarendon Fund Management, and British Business Bank.
