ROCKAWAY, NJ, April 21, 2022 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that Frontiers in Neurology published the results of an investigator-initiated trial, SAVIOR-1, a prospective, randomized, controlled study evaluating noninvasive vagus nerve stimulation (nVNS) using gammaCore Sapphire™ in patients admitted to the hospital for the treatment of COVID-19.
The SAVIOR-1 trial was conducted by Principal Investigator Dr. Carlos Tornero, Head of Department of Anaesthesiology, Resuscitation and Pain Therapy at 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 demographics and medical history and constituted the evaluable population. The study assessed the safety and feasibility of nVNS when given in addition to the then current standard of care in patients hospitalized with active SARS-CoV-2 infection versus standard of care only.
The study identified significant treatment differences for some inflammation biomarkers. Decreases from baseline in C-reaction protein (CRP) levels were significantly greater in the nVNS treatment group compared to the control group throughout the combined five-day period (p=0.011) and on day 5 compared to the reference period of day 1 alone (p=0.015). On day 1, CRP levels were very high for 90% of all subjects, but on days 3 and 5, the percentage of subjects with normal CRP levels improved markedly in the nVNS group with lower CRP levels. on day 3 at 17.9% against 52.2% in the control (p=0.010). Additionally, the nVNS group had a significantly greater decrease in procalcitonin level at day 5 (p=0.012) compared to the control group. Increased levels of CRP, procalcitonin, and d-dimers 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 treatment to potentially improve a patient’s outcome. ‘ Symptoms of covid19.
The nVNS was well tolerated with no major device-related adverse events, and treatment was administered three times daily to most patients as indicated in the study protocol.
“We are delighted that the SAVIOR-1 article has been peer reviewed and published in the Frontiers in Neurology journal,” said Dr. Peter Staats, chief medical officer at electroCore. “We are encouraged by this publication as Frontier’s rigorous process for peer review of articles further strengthens and validates our nVNS technology and its relevance and potential to alleviate 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 noninvasive vagus nerve stimulation therapy platform, initially focused on treating 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 migraine in adolescent, paroxysmal hemicrania and continuous hemicrania in adults.
For more information, visit www.electrocore.com.
gammaCore™ (nVNS) is the first non-invasive manual medical therapy applied to the neck to treat migraine and cluster headache through the use of mild electrical stimulation of 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 medications. When placed on a patient’s neck above the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may result in reduced pain for patients.
gammaCore (nVNS) is cleared by the FDA in the United States for adjunctive use for the preventive treatment of cluster headaches in adult patients, the acute treatment of pain associated with episodic cluster headaches in adult patients, and the acute treatment and preventive of migraine in adolescents (12 years and older) and adult patients, and paroxysmal hemicrania and continuous hemicrania 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 headache 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 other implanted electronic device
- Having a metal device, such as a stent, bone plate, or bone screw, implanted at or near the neck
- Use another device at the same time (eg TENS unit, muscle stimulator) or any portable electronic device (eg cell phone)
The safety and efficacy of gammaCore have not been evaluated in the following patients:
- Adolescent patients with congenital heart problems
- 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 (under 12 years old)
- 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, insider trial results by investigators, its sales and marketing and product development plans, future cash flow projections, expected costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS in general and gammaCore in particular to address COVID-19, and other statements that are not historical in nature, particularly those that use terms such as “anticipates”, “s ‘expects’, ‘believes’, ‘intends’, other words of similar meaning, derivations of these words and the use of future dates. Actual results could differ from those projected in the forward-looking statements due to many factors. These factors include, among others, the ability to obtain additional financing necessary to pursue 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 market 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 the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements. , unless necessary. by the law. Investors should refer to all information contained herein and should also refer to the disclosure of risk factors set forth in reports and other filings by electroCore with the SEC, available at www.sec.gov.