gammaCore Non-Invasive Vagus Nerve Stimulation (nVNS) Improves Neurobehavioral Outcomes in a Model of Traumatic Brain Injury

electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced data from an oral presentation at Neurocritical Care Society’s (NCS) 20^th 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 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.

About gammaCore™
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