BASKING RIDGE, N.J., July 27, 2020 — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced more information about availability, distribution and pricing for gammaCore Sapphire™ CV non-invasive vagus nerve stimulation (nVNS) therapy under its Emergency Use Authorization (EUA). The EUA allows for the use of gammaCore Sapphire™ CV at home or in a healthcare setting to acutely treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief.
“We are pleased to be ready to make gammaCore Sapphire CV available to treat people with known or suspected COVID 19 who are experiencing exacerbation of asthma-related breathing difficulty,” said Dan Goldberger, Chief Executive Officer of electroCore. “Our goal is to make this process as simple as possible for all of the patients, physicians and hospitals that would like to use gammaCore Sapphire CV.”
Stephen Samuel, Chief Executive Officer of Premier Pharmacy Services, stated, “At Premier, our mission every day is to help our patients manage complex diseases, and we are pleased to partner with electroCore to offer gammaCore Sapphire CV therapy to COVID-19 patients in need. I am confident that we will be able to secure reimbursement for this novel treatment from both government and commercial payers alike.”
gammaCore Sapphire CV (nVNS) Logistical Information
About The EUA
The United States FDA has authorized use of the gammaCore Sapphire CV device for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive vagus nerve stimulation (VNS) on either side of the patient’s neck, available under an emergency access mechanism called an EUA.
The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of medical devices during the COVID-19 pandemic. This device has not undergone the same type of review as an FDA-approved or cleared device. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, or available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the device meets certain criteria for safety, performance, and labeling, and that it may be effective in treating patients with COVID-19.
The EUA for the gammaCore Sapphire CV device is in effect for the duration of the COVID-19 declaration justifying emergency use of these devices, unless terminated or revoked (after which the products may no longer be used). An FDA approved or cleared device should be used instead of the gammaCore Sapphire CV under EUA, when applicable and available. Further information is available at:
Authorization Letter: https://www.fda.gov/media/139967/download
Fact Sheet for Healthcare Providers: https://www.fda.gov/media/139968/download
Fact Sheet for Patients: https://www.fda.gov/media/139969/download
Instructions for gammaCore use https://www.fda.gov/media/139970/download
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 initial targets 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.
gammaCoreTM (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 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, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine 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), Bronchoconstriction and Medication Overuse Headache in adults.
About Premier Pharmacy Services
Premier Pharmacy Services is Southern California’s largest independent long-term care and specialty pharmacy, with satellite locations in Arizona, Missouri, Pennsylvania, and New Jersey. Premier Pharmacy Services is specialty pharmacy accredited by URAC, ACHC, and The Compliance Team and safe internet pharmacy practice site accredited by NABP VIPPS. The company offers clinical management nationwide, utilizing strategies that promote optimal outcomes for persons enduring debilitating diseases while delivering industry-leading patient care with integrity, compassion, and excellence. Premier Pharmacy Services opened in 2006 as a long-term care pharmacy with one mission, “do everything for every patient every day.” To this day, that mission continues- Premier Pharmacy Services works around the clock to provide patient centric support and care.