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FDA approves neurotech startup Neurovalens’ non-invasive anxiety treatment

by Kabir Khan
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FDA

The U.S. medical devices regulator’s 2019 rule change, which encouraged innovations addressing anxiety and insomnia, is beginning to pay off: The FDA has just cleared Neurovalens’ second head-mounted treatment device. The Belfast-based startup has been developing technology to deliver noninvasive electrical stimulation of the brain and nervous system for over ten years.

FDA
A doctor doing a girl’s brain scan procedure in a scientific lab. Brain waves scanning the helmet

Both of Neurovalens’ medical devices—one for treating generalized anxiety disorder (GAD) and the other for treating insomnia—are currently authorized for prescription by physicians in the United States. Not too long ago, the FDA cleared its device for anxiety disorders, and last October, it approved its GAD device as well. A device that targets brain messaging that can affect the storage of harmful visceral fat is one of the upcoming products intended to treat obesity-related cardiometabolic risk. That is what’s coming up next.

As first reported by Shuttech, Neurovalens’ CEO, Dr. Jason McKeown, hopes to receive an FDA “de novo” classification for a third noninvasive neuro-stimulating device later this year or early next year, for use by patients diagnosed with obesity. Additionally, it is developing a different PTSD product.

FDA
Laboratory doctor experiencing virtual reality using vr goggles in medical neurological research lab. Physician therapists using medical innovation equipment device glasses, analyzing brain scan

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A growing amount of startups are interested in using neurostimulation to treat a variety of problems and chronic conditions. Problems like chronic pain, depression, anxiety, or stress are frequently poorly managed by resource-constrained traditional healthcare services. However, using pharmaceutical interventions has its own set of disadvantages, not the least of which are side effect risks. In addition to having the potential to revolutionize treatment, noninvasive substitutes that can prove their efficacy and safety may also complement pharmaceuticals in intensifying interventions. Thus, even though noninvasive neurostimulation is still a relatively new and developing field, there is a lot of potential.

Neurovalens has made a conscious decision to concentrate on marketing medical devices that have received regulatory clearance for particular ailments. It’s a differentiating strategy, according to McKeown, but this pathway requires it to carry out clinical trials to show meaningful results for specific use cases rather than going straight to consumers with a marketing pitch made of fuzzier “wellness” promises, for example. He notes, “As a consumer device, we wouldn’t be allowed to make medical claims.” “Our goal is to set ourselves apart as a legitimate medical provider for extremely specific conditions.”

FDA

As they were aware that neurotechnology may be able to treat these conditions, the FDA actually revised its regulations in 2019 and specifically mentioned anxiety and insomnia. We were able to submit a 510(k) [FDA application] in those two instances. He mentioned the procedure that the first two prescription drugs had to go through when he said, “But the restriction was that we had to do our own clinical trials.”Instead of requiring the more innovative “de novo” classification—which is required for future Neurovalens products targeting conditions other than anxiety and insomnia—a 510(k) clearance is a type of FDA application where a medical device can be considered substantially similar to an existing device.

“Generally, a 510(k) allows you to kind of copy someone who has already been there; clinical trials are not necessary,” he explained. On the other hand, the FDA stated that they did not believe that the evidence presented thus far was sufficient. We are thus requesting that they retake their trials. We therefore started our own trials in 2019 after taking the guidance. Furthermore, to the best of my knowledge, we are the first company in the world to have applied for and been approved in that category by the FDA through that process.

According to McKeown, customers in Europe, where laws vary, can get in touch with Neurovalens to buy devices directly. Though he acknowledges that the business is also applying for medical device clearances in the EU and the UK, he says the company anticipates receiving its first approval later this year so that physicians in Europe will be able to prescribe its insomnia device as a treatment.

According to the startup, these brain regions are in charge of circadian regulation, stress response, and metabolic regulation. The basic idea behind the mechanism’s operation is that when certain parts of the brain aren’t working properly, focused stimulation can help restore normal function to those areas. (McKeown adds that effects can last a long time and that users can switch to top-up treatments after noticing a positive change in their condition; it recommends four weeks of initial use to determine individual efficacy.)

McKeown claims that the first company specializing in noninvasive direct stimulation of the vestibular nerve is Neurovalens. The vagus nerve, another cranial nerve that connects the brain to organs throughout the body and is involved in the regulation of several sensory and motor functions, is being studied by startups, he notes. Although Neurovalens examined this area as well, they concluded that, given the greater amount of soft tissue, muscle, etc., it was too unpredictable to target stimulation there. In essence, it is simpler to access the vestibular nerve.

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