The Ins & Outs of nVNS: Non-Invasive Vagus Nerve Stimulation Device Prevents and Relieves Pain From Migraines, Cluster Headaches & Other Conditions

electroCore's nVNS device transformed the field of headache therapy and seeks to revolutionize other treatment areas like COVID-19 associated migraine, post-traumatic headache, stroke, Parkinson’s disease and other neurological, and inflammatory conditions

electroCore, a commercial stage bioelectronic medicine company, has developed a non-drug and non-invasive alternative to pharmaceuticals that safely and effectively stimulates the vagus nerve to communicate with the brain and help optimize the body’s own ability to control problems impacting its health. While vagus nerve stimulation (VNS) has been available for decades, electroCore has transformed the industry with non-invasive vagus nerve stimulation (nVNS) therapy which taps into the power and potential of the vagus nerve via a portable device.

“For quite awhile the scientific and medical research community has been captivated by the vagus nerve, the body’s longest nerve which connects information between the brain and important parts of the body including, the heart, lungs, voice box, stomach, ears, and other organs. By activating the vagus nerve with a safe and comfortable electrical stimulation through the skin, we believe we can neuromodulate, or adjust the brain signals to safely treat a variety of conditions,” says JP Errico, founder at electroCore.

Implanted Vagus Nerve Stimulation (iVNS), which involves the surgical implantation of a device, was one of the first major breakthroughs highlighting how electrical stimulation could be used to treat conditions such as depression, epilepsy, infectious disease, and heart disease. In 2008, electroCore joined this medical exploration and two years later created a non-invasive way of delivering VNS therapy. Between 2011 and 2017, nVNS received CE Marks, which means it fulfilled the requirements of relevant European product directives in addition to performance and safety standards, for the treatment of multiple conditions in neurology, psychiatry, and gastroenterology. In 2017, electroCore’s nVNS received its first FDA clearance for the acute treatment of episodic cluster headache. Since then, electroCore’s game changing nVNS therapy received four additional FDA clearances as well as growing acknowledgement from health care providers and patients as a front-line, non-drug option for the treatment and prevention of migraine and cluster headache.

“nVNS has not only transformed the way healthcare providers treat migraine and cluster headache but has also advanced how doctors treat veterans, adolescents, athletes, and long haul COVID-19 patients with migraine. nVNS is a safe, convenient, effective treatment for people who wish to avoid both the short and long term side effects and inconveniences that can be associated with injectable, inhaled, or pill-based medicine,” states Dr. Peter Staats, chief medical officer of electroCore.

The creation of a safe, patient-controlled way of activating the vagus nerve has opened the door for the research and clinical community to study the vagus nerve’s potential to treat several conditions more easily and safely.

At the forefront of medicine, electroCore and other organizations are expanding research on the vagus nerve with clinical studies of nVNS’s effectiveness on conditions including COVID-19, post-traumatic headache, traumatic brain injury, post-traumatic stress disorder, Parkinson’s disease, epilepsy, stroke, sub-arachnoid hemorrhage and addiction as well as a number of gastrointestinal and inflammatory conditions.

“At electroCore, we are looking into treating some of the most challenging diseases in the world with nVNS. What makes non-invasive nerve stimulation so exciting is the ability for the patient to self-administer the treatment,” says Dr. Staats. “Because the device is portable, it is empowering patients to literally take control of their condition into their own hands.”

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.

About gammaCore^TM

gammaCore^TM (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)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Forward-Looking Statements

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.

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