ElectroCore–Digital Health’s Big Secret – Forbes
Digital health moves to digital therapy
We all know about them. We all wear them. The trackers and recorders that, in many ways, define digital health. And beyond that, the scanners–from ECGs to ultrasounds–add another dimension to this important and evolving movement. But there’s another interesting aspect to digital health that takes us from observer status directly to a therapeutic intervention. It’s a company called electroCore and their new device may be an important step forward for both medicine and digital health. electroCore has developed a device that externally stimulates the vagus nerve in the neck. The vagus nerve is the 10th cranial nerve, or the wandering nerve (vagus is Latin for wandering) extending from the brain stem all the way to the viscera with a number of branching nerves to the heart, lungs, voice box, stomach, and ears, among other organs. It contains motor and sensory fibers and, because it passes through the neck and thorax to the abdomen, has the widest distribution in the body. Because it is so important, it is often referred to as the neural superhighway. And it’s exactly for this reason that stimulation of the vagus nerve may have far-reaching clinical implications. Preliminary data suggest that this intervention can be helpful in a variety of conditions from migraine to asthma. Currently, electroCore’s lead indication is for the treatment of primary headache disorders including migraine and cluster headaches.
While vagus nerve stimulation (VNS) is not a new treatment modality, it still lives in the shadows. And this may be more a function of complicated delivery, not the data. Currently approved stimulators are internally implanted and carry all the baggage associated with these type of “internal” devices. The key differentiator for electorCore is its simplified external stimulator that is about the size of a smart phone and very simple to use. Additionally, the company’s ambitious clinical development plan looks to expand the role of VNS to a wide variety of conditions, including anxiety, epilepsy, and depression as well as for the immune/inflammatory conditions of gastroparesis, COPD, and asthma.
A simple, hand-held device
gammaCore is a portable handheld device that transmits electrical impulses to the vagus nerve without direct contact but through the skin on the right or left side of the patient’s neck. The device is designed to be easy to use – it is turned on and off with a simple switch – and allows the patient to control the intensity of the stimulation themselves. One “dose” of VNS therapy delivered by gammaCore is equivalent to approximately 90 seconds of stimulation, with each device “preloaded” with 50, 150, or 300 doses. For prophylactic use against cluster headache, patients are recommended to administer two doses in the morning and two doses in the evening. Based on this prophylactic protocol alone, each gammaCore device would last about 2-3 months. To treat acute episodes, patients could deliver one to three additional doses of VNS therapy in succession at the onset of pain. Each dose is only 90 seconds but the effects of the treatment have been found to last 5-8 hours.
Current vagus nerve stimulation has been found to be a safe and effective therapy. However, it’s been limited to only a small group of patients with epilepsy. To date, it’s generally reserved for only the most refractory patients due to the hight cost of the device and implantation and used only as a last resort due to the requirement of invasive neurosurgery. It also has significant limitations related to the present inability to pre-identify who will be a responder to therapy. Simply put, no one–doctor or patient–wants an implanted device without a realistic expectation of success.
The brave new world of digital medicine
gammaCore may be a revolution in the brave new world of electronic medicine that some have labeled “electroceuticals.” It places an established therapy squarely in the hands of the patient, who, with a doctor’s authorization and no more than a few minutes of training, can self-administer VNS doses as needed, acutely, or on a fixed daily regimen. The price point, according to electroCore, will be very approachable and they believe a large percentage of the indicated population should be in a position to trial the therapy for a month to 6 weeks before ever needing to commit to long-term treatment. Others may chose to use the device only acutely. Importantly, if benefit isn’t realized within 4-6 weeks, it is unlikely to be effective. Additionally, electroCore is working to develop a screening tool that will tell if a patient is likely to respond with a meaningful degree of accuracy that will further reduce the risk of non-responders being placed on therapy. It’s fair to say that electricity is the air at electroCore. And there’s no bigger advocate than CEO J.P. Errico, who expresses this optimism with a voice of both knowledge and excitement.
The breadth of this therapy’s potential applicability is intriguing. We are starting with the advantage of decades of work by researchers who have mapped the vagus nerve, but who were limited by the challenges of an implanted delivery system. The non-invasive device has allowed us to begin mapping the startling neural pathways that connect depression and headaches, widespread pain to irritable bowel syndrome, anxiety and insomnia to asthma. Researcher we are collaborating with have microdialyzed neurotransmitters from deep with the brain, conducted fMRI studies with active vagus stimulation for the first time with a non-invasive device, and demonstrated how potent and long-lasting VNS can be. The most gratifying part of all of our work is that we aren’t just pointing out the problems, we are poised to demonstrate to the world that VNS, coming out of a hand-held device the size of a cell-phone, may be able to fix many these problems. The biggest secret in digital health? Well, maybe not in a few years. If our work succeeds, many people suffering with a number of related medical conditions will be able to grab a single medical device in their hands and deliver the relief they want in a short burst of non-invasive VNS. While it might not all work out, our data lead us to believe the contrary, and we expect that the secret will soon be out!
The gammaCore is CE marked for cluster headache, migraine and medication overuse headache. The firm has already initiated commercialization in several countries via a hybrid direct/indirect sales model. The gammaCore has received the CE-Mark in the EU for use in multiple indications, including epilepsy, headache, anxiety and depression, as well as gastric motility disorders like IBS. The gammaCore was granted a Medical Device Licence by HealthCanada for use in the treatment of cluster headache and migraines in adults. The gammaCore is also approved for sale in Australia for the treatment of primary headaches (migraine, cluster headache, and hemicrania continua) and medication overuse headache in adults. The product is not yet available for human use in the United States; however, electroCore, LLC has begun the process necessary to gain FDA approval or clearance to market the gammaCore.
Today, we’re seeing the movement of digital fitness to digital health to digital medicine. Technology is changing the way to understand and treat various medical conditions. electroCore is another great example of potentially important advances that improve medicine, empower patients and may result in an improved quality of life. I don’t expect that it will be a secret for long.