Mr. Goldberger: GammaCore differs from prescription medications and IV treatments for migraines because it is a nerve stimulator, not a pharmaceutical, and has a tremendous safety profile. It is a very safe technology that can be used instead of or in addition to traditional pharmaceutical solutions to treat headaches and migraines. It does not suffer from the limitations of various pharmaceuticals in terms of dosing and contraindications, drug interactions, and side effects.
Most of our patients tell us they get relief within moments of energizing the device instead of waiting for 30 minutes to an hour when they take a pill. So, no pills, no injections—just relief. Our e-commerce platform and telehealth solutions offer a portable handheld personal use device. It fits in well with the trends toward telehealth and self-care.
Medical Device News Magazine: Your device is based upon the use of the Vagus Nerve. What does the Vagus Nerve offer for patient therapy?
Mr. Goldberger: Our device delivers a safe amount of electrical energy non-invasively. The vagus nerve travels with the carotid artery through the neck, so we instruct people to place our device over the carotid artery. The nerve stimulation is programmed to take two minutes. The method of action has to do with how the vagus nerve transmits information to the brain which determines pain and the management of pain. It also transmits signals differently to the body’s major organ systems and regulates the inflammatory response, which is an essential component of what we perceive as headache pain.
Medical Device News Magazine: Is the gammaCore device scalable for additional therapies?
Mr. Goldberger: In January of this year, we announced that the FDA had granted us breakthrough designation for treating post-traumatic stress disorder (PTSD). We are collaborating with the VA hospital system and DARPA, THE Defense Research Grant facility, to bring our PTSD therapy to the market. Not far behind that, NIDA, the National Institute for Drug Abuse, has been sponsoring work using our technology to treat the symptoms of withdrawal from substance abuse, especially for the first week or two of an inpatient substance abuse program. We are excited about applying our technology that is being pulled forward by NIDA and its various initiatives to respond to the opioid epidemic in this country.
Last year, there was data published about treating the symptoms of Parkinson’s disease and the ability of the therapy to support an earlier discharge of patients after abdominal surgery. We also had data published in February of this year about using our technologies in acute stroke treatment. So, we have a robust pipeline, and I look forward to bringing these additional indications to market in 2023 and beyond.
Medical Device News Magazine: How will your next-generation digital platform advance your med-tech to patients?
Mr. Goldberger: Most recently, we have expanded our patent portfolio to talk about connectivity with a mobile device and digital health applications. We are now working on a next-generation platform that will be app-enabled, communicate to our therapeutic device through an app, and collect remote patient monitoring and therapy data. That could ultimately be part of the reimbursement process for prescribing physicians, which will create a much more encompassing user experience for our patients.
For the first time, consumers can go to our e-commerce site. We always recommend interested patients speak with their physicians first. But if that is not convenient, they can go to our website and click on the button that says “Try gammaCoretm” There’s a simple questionnaire that gets routed to a telehealth professional who will interact with the patient and write a prescription if the patient is a suitable candidate. Thus, we have dramatically improved access to our therapy through the e-commerce platform.
We also have a large and growing number of prescribers, both traditional headache specialists in neurology and a growing number of primary care physicians offering therapy. Parallel with that; we have started to invest in direct-to-consumer awareness campaigns, initially through paid search and social media. We have a few social media influencers now that are talking about us. You will see more of that as we go through the second half of 2022 and into 2023.
Medical Device News Magazine: What promise does electroCore and your gammaCore device hold for the capital markets?
Mr. Goldberger: Although our stock has been negatively affected by the market turmoil, the company is stronger than ever and accelerating.
We have a healthy balance sheet with almost $30 million in current assets as of March 31, 2022. Revenues are growing more than 50% annually, and gross margins have expanded to about 80%. I am very proud of what our team has accomplished in terms of growing the business and being good stewards of the stockholders’ cash. We are fortunate that we have a solid balance sheet. We have more than enough resources to continue to execute our plan for several years to come.