June is Migraine and Headache Awareness Month (MHAM) and according to The Migraine Research Foundation migraine disease affects 39 million men, women and children in the U.S. and 1 billion worldwide. This public health issue leaves 90% of sufferers unable to work during their migraine attacks. Employers must manage a loss of 157 million workdays, associated insurance and health care provider costs, and a financial loss of $36 billion annually in the U.S.
gammaCore Sapphire™ (nVNS) is the first non-invasive, hand-held medical therapy to receive 510(k) clearance for the acute treatment and prevention of cluster headache in adults and acute treatment and prevention of migraine in adolescents and adults. gammaCore can help ease the economic burden for employers and enable patients to self-administer discrete doses of safe and effective migraine and cluster headache therapy at home and in the workplace or school without the potential side effects associated with prescribed drugs.
“People oftentimes are affected by migraine headaches during their peak earning potential, between ages 25 and 55,” says Peter Staats, M.D., the Chief Medical Officer of the National Spine and Pain Centers, co-founder and Chief Medical Officer of electroCore, Inc. and current president of the World Institute of Pain. “Migraine sufferers not only live with debilitating headache attacks, which can be accompanied by gastrointestinal issues including nausea and vomiting, but also may incur the cost of lost wages due to the inability to work, and the expense of medical visits and medications. Moreover, many patients are dissatisfied with their current treatments, citing unwanted side effects, overuse of medication, inconsistent relief, and drug aversion. gammaCore is proven to both reduce the number of migraine headache attacks per week and decrease the need for other acute treatments, helping sufferers take control of their lives and wallets with a safe, effective therapy.”
Successful treatment with gammaCore may generate savings for patients and provide overall benefit by preventing attacks, reducing pain intensity and frequency. In the UK, the National Institute for Health and Care Excellent stated in their published guidance that adding gammaCore to the standard care for cluster headache patients can offer a cost savings by an average of £450 per person when compared with standard care alone in the first year of treatment, with a no cost evaluation period. gammaCore may also help reduce medical costs for migraine including frequent doctor’s visits and pharmaceuticals or other treatments.
“With the uptick of telemedicine and the absence of in-person medical visits for migraine or cluster headaches, at-home therapies have become crucial to patients for the management of pain,” adds Staats. “Once migraine and cluster headache sufferers can get their debilitating pain under control, we believe there is potential for the economy to see an uptick of work productivity and a decrease in healthcare costs. For example in 2015, more than $5.4 billion was spent in treating chronic migraine sufferers and $41 billion on treating their entire range of conditions.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.
gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.
gammaCore is contraindicated for patients if they:
- Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
- Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Pediatric patients (less than 12 years of age)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and clinical and product development plans, its pipeline or potential markets for its technologies, the timing, outcome and impact of regulatory, clinical and commercial developments including commercialization of, and potential reimbursement for, its nVNS technology and products, the business, operating or financial impact of any clinical trials or studies, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.