electroCore Announces Completion of Enrollment in SAVIOR-1 Study of Non-Invasive Vagus Nerve Stimulation (nVNS) in COVID-19 Patients Exhibiting Respiratory Symptoms
Spain-based study has enrolled 110 patients over 18 years of age with respiratory failure secondary to SARS-CoV-2 infection, and is designed to evaluate the incidence of relevant clinical events in patients with active SARS-CoV-2 infection
ROCKAWAY, N.J., Feb. 11, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the completion of patient enrollment in SAVIOR-1, a prospective, randomized, controlled study evaluating vagus nerve stimulation in patients who exhibit respiratory symptoms due to COVID-19. This study is being conducted at the Hospital Clínico Universitario de Valencia, Spain.
The SAVIOR-1 study enrolled 110 patients over 18 years of age with respiratory failure secondary to SARS-CoV-2 infection. The study is designed to evaluate the incidence of relevant clinical events in patients with active SARS-CoV-2 infection. Study subjects were randomized to either the study group receiving non-invasive vagus nerve stimulation (nVNS; gammaCore Sapphire) together with conventional treatment, or the control group receiving conventional treatment alone. The study is also evaluating the safety of gammaCore Sapphire in patients hospitalized for COVID-19, in addition to the blood levels of proinflammatory cytokines in these patients. Preliminary results will be reported once available and full results will be published in a peer-reviewed scientific journal later this year.
The principal investigator of the study, Dr. Carlos Tornero, Head of the Department of Anesthesiology, Resuscitation and Pain Therapeutics of the Hospital Clínico Universitario de Valencia, Spain, commented, “We are very pleased to have successfully completed the enrollment of patients in this trial evaluating the clinical benefit of nVNS in patients suffering from COVID-19 respiratory distress. We look forward to seeing the data from this study in the hope that nVNS may provide clinical benefit to many of those suffering from COVID-19.”
“The ability of nVNS to decrease respiratory distress, and possibly limit inflammatory cytokine levels, has previously been demonstrated in several preclinical models. This preclinical work provided the basis for studying nVNS in COVID-19 patients suffering respiratory distress,” said Dr. Peter Staats, Chief Medical Officer of electroCore.
Complete details on the study design can be found at the following link: NCT04368156
gammaCore™ (nVNS) is the first non-invasive manual medical therapy delivered to the neck as adjunctive therapy to treat migraine and cluster headache using mild electrical stimulation of 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 medications. When placed on the patient’s neck over the vagus nerve, gammaCore stimulates afferent nerve fibers, which can lead to a reduction in pain for patients.
gammaCore is cleared by the FDA in the United States for adjunctive use in 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 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 Continuous Hemicrania) and Drug Use Headache in adults. In 2019, NICE published an evidence-based Medical Technology Guidance document recommending the use of gammaCore for cluster headache within the NHS in England.
- The 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 undergone surgery for resection of the vagus nerve in the neck (cervical vagotomy).
- Pediatric patients
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia
- Patients should not use gammaCore if:
- Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- Has a metallic device such as a stent, bone plate, or bone screw implanted in or near the neck
- You are using another device at the same time (e.g. TENS unit, muscle stimulator) or any portable electronic device (e.g. cell phone).
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 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, available under an emergency access mechanism called EUA.
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 cleared by the FDA for the above emergency use under an emergency use authorization.
The 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), unless 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
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 and the acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
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 regarding electroCore’s business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat COVID-19, and other statements that are not historical in nature, particularly those using terminology such as “anticipates,” “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 obtain additional financing necessary to continue electroCore’s business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the SEC, available at www.sec.gov.