The U.S. medical device regulator’s 2019 rule changes aimed at encouraging innovation targeting insomnia and anxiety are bearing fruit. Belfast-based startup Neurovalens has been developing technology to deliver non-invasive electrical stimulation to the brain and nervous system for over a decade. A second head-mounted therapy device has been approved by the FDA.
Neurovalens currently has two medical devices approved for prescription by U.S. physicians. One is for treating generalized anxiety disorder (GAD) and the other is targeting insomnia. The GAD device was approved just last week, and the insomnia device received FDA approval last October. More products are on the way, including devices to treat obesity-related cardiometabolic risks that target brain messages that may influence the storage of harmful visceral fat. This is the next step in the pipeline.
CEO Dr. Jason McKeown told TechCrunch that Neurovalens hopes to receive “novel” classification from the FDA for its third non-invasive neurostimulation device for people diagnosed with obesity later this year or early next year. We are also developing other products for PTSD.
Issues such as chronic pain, depression, anxiety or stress are often poorly addressed by under-resourced traditional healthcare, and a growing number of startups are interested in applying neurostimulation to treat a variety of problems and chronic diseases. I have it. However, pharmaceutical interventions have their own drawbacks, especially risks associated with side effects. Noninvasive alternatives that can demonstrate efficacy and safety can be innovative and even work in conjunction with drugs to scale up interventions. Therefore, although the field of non-invasive neurostimulation is nascent and new, it has tremendous potential.
Neurovalens has intentionally chosen to focus on selling medical devices that have been approved by regulatory agencies for specific conditions. This route requires conducting clinical trials to demonstrate significant results for specific use cases rather than, for example, directing to consumers with marketing pitches consisting of vague “wellness” promises, but it is a differentiation strategy, McKeown says. “As a consumer device, we cannot make any medical claims,” he points out. “So what we do is differentiate ourselves as a true medical treatment for very, very, very specific conditions.”
“In 2019, the FDA actually updated their regulations and specifically mentioned insomnia and anxiety because they knew that neurotechnology could potentially treat these problems. In both of these cases, we were actually allowed to do 510(k)s. [FDA application]. “However, there was a restriction that we had to conduct our own clinical trials,” he said, referring to the process that the first two products that could be prescribed had to go through.
510(k) clearance refers to a type of FDA application in which a medical device may be considered substantially similar to an existing device, while future Neurovalens products may need to be obtained for other conditions (e.g., anxiety and insomnia).
“Normally, a clinical trial is not required for a 510(k). You’re copying someone who was there before,” he said. “The FDA said, ‘We don’t think anything that has come before has provided sufficient evidence. So we are asking them to retry the trial.’ So we took the guidance in 2019 and actually started doing our own testing. And as far as I know, we are the first company in the world to go through the FDA process and get the first approval in that category.”
According to McKeown, consumers in Europe, where regulations are different, can contact Neurovalens to purchase the device directly. However, he confirmed that the company is also applying for medical device approval in the UK and EU, and said he expected to receive the first stamp of approval for European doctors to prescribe the insomnia device as a treatment later this year.
Neurovalens’ product takes the form of a head-mounted device that applies electrical nerve stimulation to the skin behind the ear, targeting the vestibular nerve directly in a pathway that stimulates the hypothalamus and associated autonomic nuclei of the brainstem.
The startup says this is a brain region responsible for functions such as metabolic regulation, stress response, and circadian regulation. The basic theory of how the mechanism works is that targeted stimulation can re-regulate the brain’s control centers when certain areas are not functioning normally. (McKeown also says that once users notice positive changes, they can discontinue their regular treatment and switch to an additional treatment so the effects can last. Four weeks of initial use is suggested to determine individual efficacy.)
It is worth noting that this is a distinct approach to other neurostimulation startups, such as applying transcranial direct current stimulation (TDCS) or magnetic stimulation.
“We are applying minimal stimulus, but it is very specific,” McKeown said. He argues that TDCS is less specific because it supplies electricity to neurons on the surface of the brain rather than through the brainstem.
“We know that these nerve fibers carry signals to deep areas of the brain that were previously only accessible through implants,” he said. “This is similar to sending a signal over a USB cable or something like that. The cable itself is of little relevance as long as the signal passes from one end to the other. “So we can start at the surface and push stimulation down the vestibular nerve, and we know that this activates neurons in the brainstem.”
The vestibular system is commonly associated with balance, but McKeown suggests it is underestimated, saying it plays an important role in “overall homeostasis.” That means it helps regulate everything from blood pressure to breathing rate, heart rate or the amount of fat your body stores.
According to McKeown, Neurovalens is the first company to focus on non-invasive direct stimulation of the vestibular nerve. Although, he notes, there are startups trying to develop non-invasive stimulation of the vagus nerve, another cranial nerve that connects the brain to other organs of the body and is responsible for regulating various sensory and motor functions. This was an area that Neurovalens also looked at, but it was decided that targeting stimulation would be too unreliable because there is more soft tissue, muscle, etc. The vestibular nerve is inherently easier to access.
“All the cranial nerve stimulators are in our seam area,” he said. “So in the general space, there are competitors in the non-invasive space; [But] “No one has ever received device approval or regulatory approval specifically for the treatment of anxiety.”
Neurobalance on Monday It also announced it would add £2.1 million ($2.65 million) to its Series A funding round, with existing investors joining to begin commercialization of the new device in the US market. McKeown said it will begin the process of raising a direct Series B, targeting approximately $40 million for the round and aiming to complete it by the end of the year.
until now, Neuro Balance is It has raised a total of £23.1 million in equity funding from UK-based investors including Wharton Asset Management, IQ Capital, Techstart Ventures, Angel Co Fund, Beltrae Partners, Clarendon Fund Management and British Business Bank.