electroCore Announces Publication of Investigator-Initiated Trial Data for SAVIOR-1 in COVID-19 Patients in Frontiers in Neurology
ROCKAWAY, N.J., April 21, 2022 (GLOBE NEWSWIRE) -- electroCore Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that Frontiers in Neurology has published results from an investigator-initiated trial, SAVIOR-1, a prospective, randomized, controlled study evaluating non-invasive vagus nerve stimulation (nVNS) using gammaCore Sapphire™ in patients admitted to the hospital for treatment of COVID-19.
The SAVIOR-1 trial was conducted by principal investigator Dr. Carlos Tornero, Head of the Department of Anesthesiology, Resuscitation and Pain Therapeutics of the Hospital Clínico Universitario de Valencia, Spain, between April 2020 and February 2021. The trial targeted patients over 18 years of age and enrolled 110 patients, randomly assigned, with 55 patients in each group. Of the 110 patients, 97 patients (47 in the nVNS treatment group, 50 in the control group) provided baseline demographic and medical history data and were the evaluable population. The study evaluated the safety and feasibility of nVNS when administered in addition to the then-standard of care in patients hospitalized with active SARS-CoV-2 infection compared with the standard of care alone.
The study identified significant treatment differences for certain biomarkers of inflammation. Decreases from baseline in C-reaction protein (CRP) levels were significantly greater in the nVNS treatment group as compared to the control group throughout the five-day period combined (p=0.011) and on day 5 compared to the day 1 baseline period alone (p=0.015). On day 1, CRP levels were highly elevated for 90% of all subjects, but by days 3 and 5, the percentage of subjects with normal CRP levels improved markedly in the nVNS group with day 3 CRP levels at 17.9% vs. 52.2% in the control (p=0.010). Additionally, the nVNS group had a significantly greater decrease from baseline in procalcitonin level at day 5 (p=0.012) as compared to the control group. Increased levels of CRP, procalcitonin, and d-dimer have all been reported to be associated with more severe disease and the lower levels of these markers in the nVNS treated group may represent the initial impact of nVNS therapy to potentially improve the course of a patients’ COVID-19 symptoms.
nVNS was well tolerated with no major device-related adverse events and the therapy was administered three times daily to most patients as outlined in the study protocol.
“We are thrilled that the SAVIOR-1 article has been peer-reviewed and published in the Frontiers in Neurology journal,” mentioned Dr. Peter Staats, Chief Medical Officer at electroCore. “We are encouraged by this publication as Frontier’s rigorous process for peer-reviewing articles further strengthens and validates our nVNS technology and its relevancy and potential to mitigate some of the symptoms associated with COVID-19.”
The Frontiers in Neurology publication is available here.
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 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, the results from investigator-initiated trials, 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.