electroCore Reports Results of Pre-Clinical Trial in a Model of Traumatic Brain Injury
23 March 2023 - 11:00PM
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.
About gammaCore™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.Forward-Looking StatementsThis 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. Contact:Rich
CockrellCG Capital404-736-3838ecor@cg.capital
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