ROCKAWAY, NJ, Sept. 29, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the original author manuscript from the SAVIOR-1 study; a prospective, randomized, controlled study evaluating non-invasive vagus nerve stimulation (nVNS) using gammaCore Sapphire
TM
in patients admitted to the hospital for treatment of COVID-19; is available on MedRxiv and has been submitted for peer review. This study was an investigator-initiated trial conducted at the Hospital Clínico Universitario de Valencia, Spain.
The SAVIOR-1 study enrolled 110 patients over 18 years of age between April 2020 and February 2021. A total of 97 patients comprised of 47 treatment subjects and 50 control subjects provided baseline demographic and medical history data. The study was designed to evaluate 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 standard of care alone.
The analyses identified significant treatment differences for certain biomarkers of inflammation. Decreases from baseline in C-reaction protein (CRP) levels were significantly greater for the nVNS treatment group as compared to the control group throughout the five-day period combined (p= 0.010) and on day 5 compared to the day 1 baseline period alone (p= 0.012). At 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=0.004) 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 on most patients as outlined in the study protocol.
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, “Our results suggest that nVNS may contribute to our efforts in combating the ongoing COVID-19 disease process and its long-term effects through the modulation of biomarkers that are typically associated with a more severe prognosis.”
“The ability of nVNS to potentially affect the progression of COVID-19 in these hospitalized patients is encouraging.” said Dr. Peter Staats, Chief Medical Officer of electroCore. “As the pandemic continues to evolve, we believe that nVNS could be an appropriate treatment for patients suffering from the long-term effects of COVID-19 by helping combat the increased levels of inflammation.”
The manuscript is available at:
https://www.medrxiv.org/content/10.1101/2021.09.24.21264045v1
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.
About
gammaCoreTM
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 (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, the treatment of paroxysmal hemicrania and hemicrania continua in adults, 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 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
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 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/1399
67/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
Forward-looking statement
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, including its long-term effects, 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.
Investors: Rich Cockrell CG Capital 404-736-3838 [email protected] or Media Contact: Jackie Dorsky electroCore 908-313-6331 [email protected]
