-- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage
bioelectronic medicine company, today announced the U.S. Department
of Veterans Affairs is starting an investigator-initiated study of
the use of gammaCore SapphireTM non-invasive vagus nerve
stimulation (nVNS) for the treatment of post-traumatic headache
(PTH). PTH accounts for approximately 4% of all symptomatic
headache disorders1 and is one of the most common consequences of
mild traumatic brain injury (mTBI),2,3 also known as concussion.
Estimates suggest that 69 million people per year experience a
traumatic brain injury (TBI) worldwide.4 In addition, patients with
PTH commonly suffer from comorbidities such as anxiety and
depression,5 both of which are among the leading causes of
disability worldwide.6
The study (GAP-PTH) is a randomized, multi-center, double-blind,
parallel, sham-controlled trial enrolling up to 100 veterans and
directed by the Veterans Health Administration’s Headache Center of
Excellence (HCoE) at the West Haven VA Medical Center in West
Haven, CT. PTH is a critical area of concern for the VA and it is
estimated that more than 350,000 service members
have headaches resulting from TBIs sustained in combat.
PTH in veterans is most often caused by the kind of
TBIs experienced during combat, including blast wave injuries
“PTH is one of the most common presentations among veterans who
come to our VA Headache Centers of Excellence around the United
States. Last year the Veterans Health Administration was caring for
more than 140,000 veterans diagnosed with headache related to head
trauma,” commented Dr. Jason Sico, National Director of the VA
Headache Centers of Excellence Program and Associate Professor of
Neurology (Headache Medicine and Vascular Neurology) and Internal
Medicine (General Medicine) Yale School of Medicine.
“We have been using gammaCore nVNS successfully in veterans
suffering from cluster headache and migraine at our center,”
commented Dr. Emmanuelle Schindler, Medical Director of the HCoE at
VA Connecticut Healthcare System, Assistant Professor of Neurology
at Yale School of Medicine, and primary investigator of the GAP-PTH
study. “This will be among the first Randomized Controlled Trials
(RCTs) for PTH and we look forward to demonstrating how gammaCore
nVNS can help our veterans with PTH.”
“We appreciate the opportunity to work with Dr. Schindler, Dr.
Sico and their team to evaluate the potential of gammaCore as an
acute and/or preventive option for PTH” said Eric Liebler, Senior
Vice President of Neurology at electroCore, Inc. “gammaCore is
being used across the Department of Veterans Affairs and Department
of Defense for both cluster and migraine headache and we believe
that the same mechanisms of action that support the efficacy of
gammaCore in primary headaches could also provide relief to our
servicemen, servicewomen, and veterans suffering from
post-traumatic headache.”
About electroCore, Inc.
electroCore, Inc. is a commercial stage
bioelectronic medicine company dedicated to improving patient
outcomes through its platform non-invasive vagus nerve stimulation
therapy initially focused on the treatment of multiple conditions
in neurology. The company’s current indications are for the
preventative treatment of cluster headache and migraine and acute
treatment of migraine and episodic cluster headache.
For more information, visit
www.electrocore.com.
About
gammaCoreTM
gammaCoreTM (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 skin. 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 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. 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 with:
- An active
implantable medical device, such as a pacemaker, hearing aid
implant, or any implanted electronic device
- A metallic device,
such as a stent, bone plate, or bone screw, implanted at or near
the neck
- An open wound, rash,
infection, swelling, cut, sore, drug patch, or surgical scar(s) on
the neck at the treatment location
- Safety and efficacy
of gammaCore have not been evaluated in the following patients:
- 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
(younger than 12 years)
- Pregnant women
- Patients with
clinically significant hypertension, hypotension, bradycardia, or
tachycardia
Please refer to the gammaCore Instructions for
Use for all of the important warnings and precautions before using
or prescribing this product.
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; its pipeline or potential markets for its
technologies; the timing, outcome and impact of regulatory,
clinical and commercial developments; the availability and impact
of payer coverage, the potential of nVNS generally and gammaCore in
particular to treat post-traumatic headache or traumatic brain
injury and related disorders 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 Seifert, T. D. & Evans, R. W. Posttraumatic headache: a
review. Curr. Pain Headache Rep. 14, 292–298 (2010).2
Nampiaparampil, D. E. Prevalence of chronic pain after traumatic
brain injury: a systematic review. JAMA. 300, 711–719 (2008).3
Mullally, W. J. Concussion. Am. J. Med. 130, 885–892 (2017).4
Dewan, M. C. et al. Estimating the global incidence of traumatic
brain injury. J. Neurosurg. 27, 1–18 (2018)5 Minen, M. T., Boubour,
A., Walia, H. & Barr, W. Post-concussive syndrome: a focus on
post- traumatic headache and related cognitive, psychiatric, and
sleep issues. Curr. Neurol. Neurosci. Rep. 16, 100 (2016). A review
that details the clinical characteristics and associated
comorbidities of PTH.6 GBD 2015 Disease and Injury Incidence and
Prevalence Collaborators. Global, regional, and national incidence,
prevalence, and years lived with disability for 310 diseases and
injuries, 1990–2015: a systematic analysis for the global burden of
disease study 2015. Lancet. 388, 1545–1602 (2016).
Investors:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
or
Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com
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