electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company and the Hospital Clínico Universitario de Valencia in Spain, announced the completion of patient enrollment in SAVIOR-1, or “Prospective, Randomized, Controlled Study to Evaluate the Effect of Non-Invasive Electrical Vagus Nerve Stimulation on Respiratory Symptoms due to COVID-19.” This study was supported in part by electroCore. Closing enrollment for this study is an important step to better understanding the clinical benefit of non-invasive vagus nerve stimulation (nVNS) and how it can help patients suffering from COVID-19 respiratory distress.
“Vagus nerve stimulation offers potential promise for the medical and scientific community studying COVID-19 as an effective treatment to assist with respiratory function,” says the principal investigator of the Savior study, Dr. Carlos Tornero, Head of the Department of Anesthesiology, Resuscitation and Pain Therapeutics of the Hospital Clínico Universitario de Valencia, Spain. “We look forward to studying the clinical benefit of nVNS in COVID-19 patients suffering from respiratory distress.”
Identifying novel therapies to treat COVID-19 respiratory symptoms remains top of mind in the medical community. In fact, the most downloaded 2020 article in the Journal of Neuromodulation was The Use of Non‐invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated With COVID‐19: A Theoretical Hypothesis and Early Clinical Experience. “The concept and article’s popularity not only suggests interest in nVNS and its role in treating breathing difficulties seen in COVID-19 patients, but also emphasizes the medical community is still looking for answers that can help address various COVID-19 symptoms,” says Peter S. Staats, MD, Chief Medical Officer of electroCore. “gammaCore SapphireTM CV (nVNS) is unique in it’s ability to be used early in the course of disease, at home or in a health care setting. Research should be focused on identifying novel therapies with strong clinical rationale that can be used throughout the course of disease.”
gammaCore SapphireTM CV (nVNS) received Emergency Use Authorization from the FDA in July of 2020 to treat patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow.
“Because the virus is novel we began with almost no information whatsoever. Mobilizing COVID-19 survivors to support all medical, scientific and academic research is part of Survivor Corps’s fundamental mission,” according to Diana Berrent, founder of Survivor Corps, a grassroots group of over 150,000 COVID-19 survivors, the largest in the world, that has become a hub for facilitating medical and scientific research on the Coronavirus. “We applaud all research conducted to study potential treatments that could bring relief to those who are suffering.”
“We eagerly await the results of SAVIOR-1 as the outcome will increase our knowledge regarding potential treatments for respiratory symptoms associated with COVID-19 that hospitals, healthcare professionals, and patients struggle to treat and endure,” says Dr. Staats.
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.
gammaCoreTM (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 with:
- An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
- An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
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 (younger than 12 years)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
In the United States, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders, such as COVID-19-associated acute respiratory stress disorder. Refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.
The U.S. FDA has cleared the gammaCore Sapphire CV device under an emergency use authorization for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved pharmacologic therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (nVNS) on either side of the patient's neck.
gammaCore Sapphire CV has not been cleared or approved for acute use in the home or healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved pharmacologic therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (nVNS) on either side of the patient's neck during pandemic Coronavirus Disease 2019 (COVID-19).
gammaCore Sapphire CV has been authorized only for the duration of the statement that circumstances exist that warrant authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbbb-3(b)(1), until the authorization is terminated or revoked.
More information can be found at:
Letter of authorization: https://www.fda.gov/media/139967/download
Fact sheet for healthcare workers: https://www.fda.gov/media/139968/download
Patient information sheet: https://www.fda.gov/media/139969/download
Instructions for use of gammaCore https://www.fda.gov/media/139970/download
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; including trials for the study of nVNS in COVID-19 patients in Spain, the U.S., or elsewhere, the business, operating or financial impact of such studies; the potential of nVNS generally and gammaCore in particular for the acute and preventative treatment of migraine in adolescence 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.