gammaCore Non-Invasive Vagus Nerve Stimulation (nVNS) Improves Neurobehavioral Outcomes in a Model of Traumatic Brain Injury
Pre-clinical trial demonstrates ability of nVNS to decrease amount of brain injury, decrease anxiety and improve motor function post injury
ROCKAWAY, N.J., Oct. 20, 2022 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced data from an oral presentation at Neurocritical Care Society’s (NCS) 20th Annual Meeting held in San Antonio, Texas on October 17 – 21, 2022 on the possible role of gammaCore (nVNS) in the acute treatment of Traumatic Brain Injury (TBI). The presentation is being given by Dr. Afshin Divani, of the University of New Mexico, who is the primary investigator leading the program.
The study design included low dose 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 (damage) volume 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, 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, compared with the control group. The control group showed significant deficits in 3 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 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).
Dr. Afshin Divani, Associate Professor Neurology at the University of New Mexico commented, “We are pleased to have successfully completed 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. We are pleased 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.”
Traumatic brain injury 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.
Eric Liebler, Senior Vice President of Neurology 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. This pre-clinical study suggests nVNS could be a significant new approach to the treatment of TBI. This 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 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 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 neck. 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, 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 and other written and oral statements made by representatives of electroCore 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 about electroCore’s business prospects and clinical and product development plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential use of nVNS for the acute treatment of traumatic brain injury and concussion, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “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 raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes 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, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.
1 Corps, K.N., Roth, T.L. and McGavern, D.B. (2015). Inflammation and neuroprotection in traumatic brain injury. JAMA Neurology 72, 355-362.
2 (2014). Centers for Disease Control and Prevention. Report to congress on traumatic brain injury in the United States: epidemiology and rehabilitation. Atlanta: National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention.
3 Summers, C.R., Ivins, B. and Schwab, K.A. (2009). Traumatic brain injury in the United States: an epidemiologic overview. The Mount Sinai Journal of Medicine, New York 76, 105-110.