electroCore, Inc. Announces Study of gammaCore Sapphire™ for the Treatment of Post-COVID Syndrome
Study to be initiated with Mayo Clinic’s Post-COVID Care Clinic subjects
ROCKAWAY, N.J., July 07, 2022 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced Mayo Clinic is initiating an investigator-initiated study to assess the efficacy of gammaCore Sapphire non-invasive vagus nerve stimulation (nVNS) in patients with post-COVID syndrome. Post-COVID syndrome, also known as Long COVID, is a collection of symptoms that persist greater than 28 days after the initial onset of symptoms of SARS-CoV-2 (COVID) infection1,2. These symptoms, such as headache, brain fog, fatigue and gastric distress can bear a striking resemblance to the “central sensitization syndromes,” a group that includes fibromyalgia, chronic fatigue syndrome, and postural orthostatic tachycardia syndrome (POTS). Post-COVID syndrome is likely to occur in upwards of 10% of the population who has been infected with COVID, likely affecting hundreds of millions across the world.
The study entitled “Outcomes of treatment with non-invasive vagal nerve stimulation (nVNS) in post-COVID syndrome: A Pilot Study,” is a randomized, single-center, controlled trial enrolling up to 20 subjects recruited from the Post-COVID Care Clinic at Mayo Clinic in Rochester, Minnesota. Endpoints of the study include a number of clinical questionnaires including the Post-COVID Functional Status Score, as well as an analysis of blood samples for certain chemokines, and positron emission tomography-computed tomography (PET-CT) of the brain to evaluate brain metabolism.
“Long-COVID represents a significant ongoing medical challenge that can extend long after the acute phase of COVID,” said Dr. Peter Staats, Chief Medical Officer at electroCore, Inc. “We believe the decision to use gammaCore Sapphire is consistent with its demonstrated mechanisms of action and its use in acute-COVID under an Emergency Use Authorization granted by the Food and Drug Administration.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.
For more information, visit www.electrocore.com.
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 (nVNS) 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, and paroxysmal hemicrania and hemicrania continua in 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:
- Adolescent patients with congenital cardiac issues
- 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
For more information, please visit gammaCore.com
This press release and other written and oral statements made by representatives of electroCore 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; the Company’s business prospects with and resulting from work in conjunction with the Mayo clinic; business prospects around treatment of Post-COVID Syndrome or other new markets 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.
1 Bierle, D.M., et al., Central Sensitization Phenotypes in Post Acute Sequelae of SARS-CoV-2 Infection (PASC): Defining the Post COVID Syndrome. J Prim Care Community Health, 2021. 12: p. 21501327211030826.
2 Soriano, J.B., et al., A clinical case definition of post-COVID-19 condition by a Delphi consensus. The Lancet Infectious Diseases, 2022. 22(4): p. e102-e107.