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.
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
For more information, please visit gammaCore.com.
Forward-Looking Statements
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.
Investors: Rich Cockrell CG Capital
404-736-3838 ecor@cg.capital
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.
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