electroCore, a Basking Ridge, New Jersey company co-founded in 2005, is developing non-invasive Vagus Nerve Stimulation (nVNS) therapies which can be delivered using their proprietary gammaCore technology to treat various neurologic, psychiatric, gastric motility, and respiratory conditions. Founded on the pioneering concept of using vagal neuromodulation to acutely treat patients with severe bronchoconstriction during an asthma attack, electroCore has used this concept to expand beyond the acute emergency indications and produce a prophylactic vagus nerve stimulation therapy option. Their initial focus on asthma expanded quickly into migraine and cluster headaches, based on patient feedback from their early studies, and new trials are continuing to investigate new uses for nVNS for gastric motility, pain, and sleep disorders, as well as depression and anxiety. I asked co-founder and CEO J.P. Errico about their gammaCore product, the technology behind it, and his role at electroCore.
Tom Fowler, Medgadget: Tell us how you progressed from being an MIT aeronautical engineering student to a patent attorney to leading a medical device company.
J.P. Errico: I was strongly influenced by my parents, one who was a practicing physician, and the other who had a law degree, to go, professionally, beyond my initial training as an engineer,. So, after graduating from MIT, I went to Duke Law School, where I branched out and simultaneously received a graduate degree in engineering. Because of my focus on patent law, after graduation I was approached by a family member who was a prominent spine surgeon, and within a very short time, our inventive and entrepreneurial bent had us building the first of several healthcare companies. The ventures were largely centered on inventions that could be licensed to market leading companies. The next stage was to begin the clinical development of more innovative technologies, but again these were purchased away from us by the same sort of market leaders. These ventures were successful in generating more than $500 million for our close network of investors. With electroCore, and nVNS, we are committed to building a ground breaking, paradigm-shifting product line. And with recent developments in our clinical and product design programs, I am increasingly confident of our ability to do just that.
Medgadget: How do you foresee gammaCore transforming the standard of care for headache treatment?
J.P. Errico: I foresee physicians, who have as their first obligation to do no harm, offering gammaCore as a first line treatment for their patients. As one of the world leading headache specialist said; “Why would you not use gammaCore first?” I think he is spot on. Through everything we have done, nVNS with gammaCore has been consistently safe, and it is easy for patients to use. Patients can continue with their existing treatments and if it does not work for some of them (nothing works for everyone), they can stop using it. Medications flood the entire body with exogenous chemicals, and thus, invariably have side effects. GammaCore uses the body’s own neural pathways to carry our nVNS therapy, which some refer to as an “electroceutical”, directly to the areas in the brain that release the endogenous chemicals many drug therapies try to modulate. SSRIs, SNRIs, and GABA analogues are some of the largest classes of drugs on the market, and they are designed to alter brain chemistry, and specifically serotonin, GABA, and norepinephrine (also known as noradrenalin). nVNS modulates these same neurotransmitters, but does so without requiring the patient’s liver, kidneys, and other organs to be exposed to foreign chemicals. The other huge benefit, from a patient’s perspective, is that he or she can likely continue with existing medication(s) if they choose, as there have been no observed interactions of nVNS with other treatments, For these reasons and others, electroceuticals is, and will continue to be a rapidly expanding area of healthcare, with GSK starting a new division and investing in multiple bioelectronics companies, and Merck investing in electroCore. I expect many other pharma and medical device companies will follow suit and become involved in this exciting space, and their traditional drugs will, we believe, will slide to the second or third choice… I also believe that patients will demand a non-invasive option that has fewer and more benign side effects than medications as a first option. We expect payors, as well, will appreciate the fact that nVNS can be used both prophylactically and acutely to manage headaches, and with innovative payment options, we hope to make patients and those who hold the purse strings champions of gammaCore.
Medgadget: What is the technology behind gammaCore therapy and are there any risks involved in having patients self administer the nVNS therapy?
J.P. Errico:Vagus Nerve Stimulation was pioneered, twenty-five years ago, by our friends at Cyberonics (Houston, Tx). They were the first to introduce gentle electrical stimulation of the vagus nerve and show that it can selectively stimulate the subset of the nerves in the vagus that have the ability to quiet the surge of activity associated with epileptic seizures. They have recently announced that more than 100,000 patients, world-wide have received their implants, and the profile of safety of their device has been very positive In fact, I believe that the only reason that this therapy option hasn’t climbed the continuum of care from a last resort to front line therapy is the cost and requirement for surgery. GammaCore offers the best of both worlds, the same underlying mechanism of action, without the requirement for surgery and the astronomical cost. In terms of putting it in the hands of patients, I can only say that it takes less time to train a patient to use gammaCore than it takes to train a person to use inhaled medications, and with over 500,000 doses administered to date, we haven’t found any device related adverse events. If the patient doesn’t like it, the therapy can be discontinued in a fraction of a second. In the modern world, we put oxycontin in the hands of patients for headaches, and we feed amphetamines to children with ADHD. Once those pills are ingested, it takes near-heroic efforts to clear those chemicals from the body.
Medgadget: Surgically implanted VNS has been used for some time in the treatment of refractory epilepsy and depression. What is the cost and effect comparison of implants vs. electroCore’s nVNS?
J.P. Errico: Last I heard, Cyberonics was selling their implantable device for over $24,000 in the US. I am not aware of the price point in the EU, or other markets around the world, but of course, that doesn’t include cost of the neurosurgeons’ time, the operating room staff, the anesthesiologist, the long-term maintenance, adjustments, battery replacement, and explanation of the device, if necessary. All of these costs add up to well over $30,000 in the US. Most importantly, VNS doesn’t work for everyone, so the cost for gaining benefits in those for whom it works have to include all the patients in whom it doesn’t (Cyberonics doesn’t give a rebate if the therapy doesn’t work). Reports indicate that 5 years out from the implantation of the device, close to 60% of patients have experienced significant benefit. That means, the real cost for gaining a patient with significant benefit is over $50,000. With gammaCore, while the final pricing of the therapy hasn’t been established, I am very confident to say that we don’t expect payors to commit anywhere near the same amount just to determine in whom the therapy will work. Our goal is to limit the cost of therapy for the payors as closely as can be to just the patients who are gaining the benefit. We are much more like a pharmaceutical in this way, i.e., think of the gammaCore as a bottle of pills containing 300 treatments. When it is used up, it is disposed of and you get another one. Of course, that isn’t quite as socially responsible to the environment – to be tossing things into the garbage all the time – so we intend to introduce reload-able devices that can be refilled with a new prescription, and the fee structure for this would be just like a chronic medication.
Medgadget: You are a named inventor on more than 125 issued US patents, and more than 100 pending patents. What are three tips for those of us that are applying for patents, particularly in the medical device field?
J.P. Errico: This is going to sound corny, but I would say the first thing you want to do is to make sure that whatever it is that you are trying to patent is actually innovative and has potential value to the world. It is an honor to receive a patent, and it is certainly something to be proud of, but they are expensive to obtain, and cost many thousands of dollars to maintain once you’ve gotten them. Make sure it is going to be worth the effort. Second, I would advise people to get an attorney to help. They really do an important service for inventors, and I would NOT suggest to anyone to do it alone. The scope of the patent, and its enforceability are critical to the value they have, so having a professional working with you is critical. Third, and this is specific to the medical field, which is invariably very crowded and intimidating, I would advise anyone with a good idea to commit yourself to your belief. So long as you are not violating the laws of physics, the only thing that stands between you and success is the energy you are willing to expend to make it happen.