Pre-clinical trial demonstrates the ability of nVNS to decrease the amount of brain injury, decrease anxiety and improve motor function post injury
ROCKAWAY, N.J., March 23, 2023 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the publication of a paper entitled “Non-Invasive Vagus Nerve Stimulation Improves Brain Lesion Volume and Neurobehavioral Outcomes in a Rat Model of Traumatic Brain Injury” in the peer-reviewed Journal of Neurotrauma. The lead author is Dr. Afshin Divani of the University of New Mexico, who is the primary investigator leading the study.
Traumatic brain injury (TBI) is a significant cause of death and disability worldwide. The Center for Disease Control estimates approximately 2.5 million people sustain a TBI each year, resulting in 283,000 hospitalizations, 52,000 deaths, and an estimated annual direct and indirect cost of $56 billion.1,2 It is estimated that 3.2 million Americans live with long-term disabilities attributable to TBI, which is roughly 1.1% of the US population.3 Although the underlying pathophysiology of TBI has been extensively studied, no therapy has been able to significantly improve clinical outcomes.
The study design included low dose non-vagus nerve stimulation (nVNS), high dose nVNS, and control arms, and stimulated 5 (low dose nVNS) or 10 (high dose nVNS) times over an hour, beginning 30 minutes post-TBI in a rodent model. Magnetic Resonance Imaging (MRI) studies on Day 1 and 7 revealed smaller brain lesion volume (damage) among the nVNS groups compared with the control group. On Day 1, these abnormal volume changes were 13% and 55% (p<0.05) smaller in the lower dose and higher dose nVNS groups, respectively, as compared with the control group. By Day 7, nVNS decreased the size of the cortical lesion (injury) by 35% and 89% (p<0.05) in the low dose and high dose nVNS groups, respectively, as compared with the control group. The control group showed significant deficits in three common neurobehavioral assessments including rotarod, anxiety, and modified beam walking performances. All these deficits were significantly reduced (p<0.05) in the high dose nVNS group on Day 1 and the two anxiety indices were also reduced on Day 7 post-injury as compared with the control group. MRI data suggest that the benefits may be caused by a decrease in the deformation and swelling of brain tissue after TBI.
Additional work on the potential benefits of nVNS on TBI will be funded by an Exploratory/Development Research Grant (R21) from the National Institute of Neurological Disorders and Stroke (NINDS).
“We are pleased to have successfully published this study of nVNS as a possible treatment for TBI and believe our data suggest that nVNS could be a feasible treatment for TBI/concussion,” commented Dr. Afshin Divani, Associate Professor Neurology at the University of New Mexico. “We are delighted that NINDS has recognized the potential of nVNS as a treatment for TBI and has agreed to fund our ongoing efforts through a R21 grant to the University of New Mexico.”
Peter Staats, MD, Chief Medical Officer for electroCore, commented, “The impact of TBI and concussion is seen every day from the soccer fields where our children play to the National Football League, as well as those that serve in the military. The data suggest nVNS could be an important new approach to the treatment of TBI, for which there are very few treatment options, and would represent an important new opportunity for nVNS that would extend the use of gammaCore beyond the current Food and Drug Administration clearances for most forms of headache. We appreciate the efforts of Professor Divani and his team as well as the support of NINDS for their funding of this ongoing effort.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.
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 adolescents (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 the results from investigator-initiated trials, anticipated results and timing of clinical trials being conducted with gammeCore (nVNS), 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 Traumatic Bain Injury, 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. The results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials, or commercial success. 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.