Nerivio, created by Theranica, is the first FDA-cleared, smartphone-controlled prescribed wearable device for the acute treatment of migraine.
Theranica says it has demonstrated clinical evidence equivalent to commonly prescribed medications and serves more than 25,000 people with migraine, including adolescents and adults, in the USA.
Health Tech World speaks with Alon Ironi, CEO of Theranica, to learn more about the wearable that’s got big pharmaceutical companies worried.
HTW: How does Nerivio work?
AI: There is a mechanism in the brain stem that decides whether a certain sensation is actually pain or not and if it’s putting us in danger and therefore requires us to take action.
It has the power of to cancel the sensation by releasing certain neurotransmitters, which are chemicals that travel along our neurons to the synapses, that abort these pain messages.
However, research has found that this mechanism doesn’t always trigger when it should in some people. And these people tend to suffer from certain neurological diseases, particularly migraine.
Typically migraine starts with aura, nausea or sometimes with pain. But that signal should have been interpreted as something that’s not dangerous, it should have been avoided, but it was not because the mechanism is deficient.
We have developed a device that provides a secondary conditioning stimulus. When activated, it sends an elliptical waveform through the upper arm. The wave has been designed to trigger the nerve fibres that are responsible for transferring pain messages and get them to transfer a message that is just below the pain threshold. And for most patients, this stimulus triggers that mechanism in the brain stem to send out the neurotransmitters that have the power to cancel pain signals.
This helps ease migraine pain because the mechanism is global so the neurotransmitters it releases spread over the entire central nervous system. This enables them to reach the Trigeminocervical Complex, which is the junction where all the migraine symptoms breakthrough.
Once those neurotransmitters arrive, they abort the sensation and the migraine attack is either completely stopped or at least brought down to a level that is bearable. The majority of patients start feeling relief anywhere between 20 to 40 minutes after the beginning of the treatment.
HTW: Who can use Nerivio?
AI: The device has been approved by the FDA for use on adults, but also for adolescence. This is important because people typically start suffering from migraines during their teen years, sometimes even younger. And most of the medications on the market isn’t available to this age range because of the side effects.
And so while adults have a pretty wide personnel toolkit of medication for migraine, there aren’t many options for adolescents. Our FDA approval was extended to include adolescents at the beginning of the year and we’re now at a point where about 30 per cent of our patients fall into this age range.
HTW: How does it integrate with the smartphone?
AI: Control of the device is managed from a smartphone app. When we started the company, quite a few people advised us not to use an app because a lot of people don’t have the state of mind to do anything on a smartphone during a migraine attack. Luckily we did not take this advice.
From a patient standpoint, it’s really very easy. They download the app and sign up for an account. It takes a few minutes and then when they need the treatment, it’s just a matter of pushing start. They don’t have to watch the phone or even look at the phone. The treatment will continue all the way through and then terminate automatically.
The patient can control the intensity of the electrical waveform that is applied by the device and the app guides them during the first 60 seconds of the treatment. It starts with a pretty low default intensity. And then the patient is guided to gradually increase the intensity.
HTW: How does the migraine diary work and why is it such an important part of the treatment?
AI: We’ve added a number of digital features to the app that help patients manage their disease. These collect data from the patient, including their geographical location, weather, barometric pressure and air pollution. The app also asks the patient to log the variety and severity of their symptoms, such as sensitivity to smell and sound and things like nausea, neck stiffness and, of course, headache.
This information is transferred to a HIPAA-compliant server that processes the information and produces the migraine diary.
The diary shows the patient when they usually experience an attack. This is incredibly helpful for the patient because if it shows that most of their migraine attacks happen on a Tuesday afternoon, for example, they may be able to relate this to a particular activity.
The migraine diary can also be shared with the patient’s healthcare provider from the app. So they can discuss it and make decisions about treatment, such as what medications to try and what lifestyle changes may be required.
HTW: How is Nerivio different from other pain management wearables?
Other electrical stimulation devices are based on a different mechanism. The nerve fibres that are in charge of transferring those deceptive, painful messages we discussed earlier share the same intermediate neurons en route to the brain as the nerve fibres that are in charge of transferring touch sensations.
Other devices apply an electrical waveform which triggers a touch sensation, which stimulates touch nerve fibers. These fibers share the same intermediate neurons with nociceptive (pain) fibers, so there’s no room for the pain messages to flow through. So it actually blocks the pain, which is why a lot of these devices are pretty effective at reducing certain types of pain.
The problem is, the moment you stop the stimulation, the pain messages start again and the pain returns.
Also, other devices usually have to be placed exactly where the pain is because they need to block the signals. In our case, it’s the other way around. Patients need to place the device away from the painful location so it can create that secondary conditioning stimulus somewhere else. This means Nerivio is more discreet than other devices.
HTW: Is there a potential for it to be expanded and applied to other pain issues?
Absolutely. There’s a very high correlation between that pain mechanism deficiency and the prevalence of certain diseases, such as fibromyalgia, irritable bowel syndrome and chronic fatigue. The development process is very long, you have to go through rigorous clinical studies and meet the regulatory requirements. It takes a lot of time and money, but we have other diseases on our radar.
HTW: Have you had any issues with big pharmaceutical companies who worry that you’re going to put them out of business?
They’re sensitive about it. We were invited to be the co-sponsor of a seminar on treatments for migraines, organised by a group of headache experts from the US. The organiser called us one day and told us they wouldn’t be able to include us in the conference and that they had to reject our sponsorship.
They said one of the large pharmaceutical companies that was also sponsoring the event had heard that we were involved and threatened to pull their sponsorship. Theirs was five times bigger than ours so the organiser had no choice.
I think pharmaceutical companies are worried but, at the end of the day, no one can stop good technology, especially technology that is helpful. Pharma companies are starting to understand that you can provide pain therapy to a person in different ways. More companies are opening digital health divisions so they’re starting to learn about non-pharmacological solutions.
Eventually, everyone’s going to understand that there are a range of tools for fighting pain. Nobody is putting a ban on medication, including us. Medication is still very important, but there is room for other things.