Rule changes introduced by the US medical device regulator in 2019 to encourage innovation for insomnia and anxiety are now bearing fruit: Neurovalens, a Belfast-based startup it has been developing for nearly 10 years Technology that provides non-invasive electrical stimulation of the brain and nervous system. Its second head-mounted therapy device in ten years just received FDA approval.

Neurovalens currently has two medical devices approved for prescription by U.S. doctors, one for the treatment of generalized anxiety disorder (GAD) and the other for insomnia. Its GAD device was approved just last week. Last October, its device to treat insomnia received FDA approval. More products in development: The next product in development is a device to treat cardiometabolic risks associated with obesity, targeting brain messaging that affects harmful visceral fat storage.

CEO Dr. Jason McKeown told TechCrunch it hopes to gain FDA approval for a “de novo” classification of a third non-invasive neurostimulation device — for people diagnosed with obesity — later this year or early next year. The company is also developing another product targeting post-traumatic stress disorder (PTSD).

A growing number of startups are interested in applying neurostimulation to treat a range of problems and chronic conditions. Issues such as chronic pain, depression, anxiety or stress are often poorly addressed by low-resource traditional health services. Although pharmacological intervention has its own disadvantages, especially the risks associated with side effects.Non-invasive alternatives with proven effectiveness and safety Can Transformative. They can also be combined with medications for intervention. Therefore, although the field of non-invasive neurostimulation is still nascent and novel, it still holds great potential.

Neurovalens has intentionally chosen to focus on selling medical devices approved by regulatory agencies for specific conditions. This pathway would require it to conduct clinical trials to demonstrate significant results for specific use cases—i.e., rather than go straight to consumers with marketing claims containing vague “health” promises—but according to McKeown, this is a a differentiation strategy. “As a consumer device, we’re not allowed to make medical claims,” he noted, noting: “So it’s really about setting ourselves apart as a true medical service for very, very, very specific situations. “

“In 2019, the FDA actually updated their regulations and specifically addressed insomnia and anxiety because they knew neurotech had the potential to treat those issues. In both cases, we were actually allowed to do 510(k)s [FDA application]. But the limitation is that we have to conduct our own clinical trials,” he told us, explaining the process the first two prescription products went through.

510(k) clearance refers to a type of FDA application in which a medical device can be considered substantially similar to an existing device, rather than a more novel “de novo” classification, with future Neurovalens products targeting other conditions (i.e., non-anxiety and Insomnia) needs to be obtained.

“Normally, with a 510(k), you don’t do clinical trials—you’re imitating someone who’s done it before. Yet the FDA decided that we didn’t think anything that had gone before provided enough evidence. So we asked They redo the trial. So we took that guidance in 2019 and actually started our own trial. And, to my knowledge, we were the first in the world to go through the FDA process and get the first approval in this category company.”

McKeown said regulations in Europe are different and consumers can contact Neurovalens to purchase the device directly. But he confirmed that the company was also applying for medical device licenses in the UK and EU and said it expected to receive the first approval from European doctors as a treatment for its insomnia device later this year.

Neurovalens’ product takes the form of a head-mounted device that applies electrical nerve stimulation to the skin behind the ear (directly targeting the vestibular nerve) as a pathway to stimulate the hypothalamus and associated brainstem autonomic nuclei.

The startup says these brain regions are responsible for functions such as metabolic control, stress response and circadian rhythm regulation. The basic theory of how this mechanism works is that targeted stimulation can re-regulate the brain’s control centers when certain areas are not functioning properly. (McKeown also says the results can be long-lasting, and users can stop regular treatment and switch to supplemental treatments after noticing positive changes; he also recommends four weeks of initial use to determine individual results.)

Notably, this is a unique approach to some other neurostimulation startups, such as those applying transcranial direct current stimulation (TDCS) or magnetic stimulation.

“We’re applying minimal stimulation, but it’s very specific,” said McKeown, who believes TDCS is less specific because it applies electrical current to neurons on the surface of the brain rather than through the brainstem.

“We know that these nerve fibers carry signals deep into the brain, areas that were previously only accessible with implants,” he said. “It’s kind of like sending a signal through a USB cable or something… As long as the signal is getting from one end to the other, the cable itself almost doesn’t matter. So we can start at the surface and work our way down to stimulate the vestibular nerve, which we know activates something in the brainstem of neurons.”

The vestibular system is often associated with balance, but McKeown thinks it’s underestimated – saying it plays a key role in “overall homeostasis”; helping regulate everything from blood pressure to respiratory rate, heartbeat and even the amount of fat the body stores. .

Neurovalens is the first company to focus on non-invasive direct stimulation of the vestibular nerve, McKeown said. Although he noted that some startups are trying to develop non-invasive stimulation of the vagus nerve, another cranial nerve that connects the brain to other organs in the body and plays a role in regulating various sensory and motor functions. Neurovalens also looked at this area, but said they decided the target stimulation was too unreliable given the presence of more soft tissue, muscles, etc., and abandoned it. (And basically, the vestibular nerve is easier to reach.)

“Each cranial nerve stimulator is in our seam area,” he added. “So there are competitors in the general space, in the non-invasive space, [But] Specifically, we are not aware of anyone who has received device approval or regulatory approval for the treatment of anxiety. “

Monday, Nervous Valens It also announced an additional £2.1 million ($2.65 million) in its Series A funding round, with existing investors funding the launch of commercialization of the new device in the US market. McKeown said they will begin raising Series B funding directly – they are targeting about $40 million in the round and plan to close it before the end of the year.

so far Neurovalens has Raised a total of £23.1 million 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.

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