Neurotech startup Neurovalens receives FDA approval for non-invasive anxiety treatment

A 2019 rule change by the U.S. medical device regulator aimed at spurring innovation targeting insomnia and anxiety is bearing fruit. Belfast-based startup Neurovalence has been developing technology to deliver non-invasive electrical stimulation to the brain and nervous system for almost a year. The 10-year-old company just received FDA approval for its second head-mounted therapy device.

Neurovalens currently has two medical devices approved for prescription by physicians in the United States. One is for the treatment of generalized anxiety disorder (GAD) and the other is aimed at insomnia. The company’s GAD device was approved just last week. The company’s insomnia treatment device received FDA approval in October last year. More products on the way. Next in the pipeline are devices to treat obesity-related cardiometabolic risks that target brain messaging that can influence the accumulation of harmful visceral fat.

CEO Dr. Jason McCune told TechCrunch that he expects the FDA to grant “de novo” classification for a third non-invasive neurostimulation device for people diagnosed with obesity later this year or early next year. . Another product for PTSD is also in development.

A growing number of startups are interested in applying neurostimulation to treat a variety of problems and chronic diseases. Issues such as chronic pain, depression, anxiety and stress are often not adequately addressed by traditional medical services, which lack resources. Pharmaceutical interventions have their own drawbacks, especially risks associated with side effects.Non-invasive alternatives with proven efficacy and safety did it Be transformative. It can also work in conjunction with drugs to enhance the intervention. Therefore, although the field of non-invasive neurostimulation is still in its infancy and novel, it holds great potential.

Neurovalens has intentionally chosen to focus on selling medical devices that have regulatory approval for specific conditions. This pathway requires conducting clinical trials to demonstrate significant results for specific use cases. That is, rather than communicating directly to consumers with a marketing pitch made up of vague “health” promises, he says McKeown, but this is a differentiation strategy. “As a consumer device, you’re not allowed to make medical claims,” ​​he said, “so the purpose is to differentiate it as a genuine medical treatment for a very, very, very specific condition.” That’s what it is.”

“In 2019, the FDA actually updated their regulations and called out insomnia and anxiety specifically because they knew they could potentially be treated with neurotechnology. In these two cases, they actually I was allowed to do a 510(k). [FDA application]. But the constraint was that we had to do our own clinical trials,” he said, explaining the process his first two prescriptible products went through.

510(k) clearance refers to a type of FDA application in which a medical device is deemed to be substantially similar to an existing device. Rather than the more novel “de novo” classification, future Neurovalens products will target other symptoms (other than anxiety and anxiety). insomnia).

“Typically, a 510(k) doesn’t require a clinical trial; it’s more like a copy of someone who existed before. On the other hand, the FDA feels that nothing has been provided with sufficient evidence so far. So we’re asking them to redo the trial. So we received guidance in 2019 and actually started our own trial. And as far as I know, we’re asking them to restart the trial. We are the first company in the world to go through that process and receive first approval in that category.”

Consumers in Europe, where regulations are different, can contact NeuroValence to purchase the device directly, McCune said. However, he confirmed that the company is also applying for medical device approval in the UK and EU, with European doctors receiving first approval to prescribe the company’s insomnia treatment device as a treatment later this year. He said it was planned.

Neurovalens’ products take 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 route to stimulating the hypothalamus and related autonomic nuclei in the brainstem.

According to the company, these are brain regions responsible for functions such as metabolic control, stress response, and circadian regulation. The basic theory of how this mechanism works is that targeted stimulation can re-regulate the brain’s control centers when areas are not functioning properly. (McKeown also notes that the effects may be long-lasting, and users can discontinue regular treatments and switch to additional treatments after noticing positive changes, but judge effectiveness for individuals.) We recommend using it for 4 weeks for the first time.)

It’s worth noting that this is a different approach than other neurostimulation startups that apply transcranial direct current stimulation (TDCS) or magnetic stimulation.

“We’re giving a minimal stimulus, but it’s very specific,” McCune said, adding that TDCS is less specific because it delivers electricity to neurons on the surface of the brain rather than through the brainstem. claim.

“We now know that these nerve fibers carry signals to deep regions of the brain that were previously accessible only through implants,” he says. “It’s similar to transmitting a signal over a USB cable or something. The cable itself is of little value as long as the signal goes from one end to the other. So you start at the surface and then it goes to the vestibular nerve. We know that we can push a stimulus in, which activates neurons in the brainstem.”

The vestibular system is usually associated with balance, but McCune suggests it is underappreciated, saying it plays an important role in “overall homeostasis.” It helps regulate everything from your blood pressure to your breathing rate, heart rate, and even 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. He also notes that there are startup companies trying to develop non-invasive stimulation of the vagus nerve, which connects the brain with organs in other parts of the body and is responsible for a variety of sensory functions and It is another cranial nerve that plays a role in regulating motor functions. This was an area that Neurovalence had also considered, but they decided that targeting stimulation would be too unreliable given that there was more soft tissue, muscle, etc., so they moved away from it. It is said that (On the other hand, the vestibular nerve is basically easier to stimulate.) )

“All neurostimulators are in the seams like we are,” he added. “So in the general space, we have competitors in the non-invasive space as well. [But] Specifically, we are not aware of anyone with device approval or regulatory approval for anxiety treatment. ”

Monday, Neurovalence has also announced a maximum Series A funding round of £2.1 million ($2.65 million), with existing investors working together to begin commercializing the new device in the US market. McCune said he plans to begin the Series B funding process directly. They are targeting about $40 million in that round and aim to close by the end of the year.

so far Neurobalance is A total of £23.1m from UK-based investors including Wharton Asset Management, IQ Capital, Techstart Ventures, Angel Co Funds, Beltray Partners, Clarendon Fund Management and British Business Bank. raised equity funds.