electroCore, Inc. Announces Johns Hopkins University School of Medicine Study of Non-Invasive Vagus Nerve Stimulation (nVNS) ...
26 Abril 2021 - 9:00AM
-- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage
bioelectronic medicine company, today announced that Johns Hopkins
University School of Medicine is starting an investigator-initiated
trial of non-invasive vagus nerve stimulation (nVNS) using the
Company’s proprietary gammaCore device to treat symptomatic
exacerbation of nausea in patients with gastroparesis and related
disorders (NCT04857281).
Many gastrointestinal disorders can cause nausea
and vomiting, of which the most well-known is gastroparesis, a
digestive disorder in which the stomach empties slowly.1 The
symptoms of gastroparesis can range from mild to severe, requiring
prolonged hospitalizations and interventions, and causing
life-threatening complications which can significantly affect the
quality of life in affected individuals. It is estimated that close
to 6 million Americans suffer from gastroparesis which is more
common in women than men.2 The economic impact of gastroparesis can
be substantial, with studies reporting 11% of patients disabled due
to their gastroparesis symptoms, while another 28.5% reported a
loss of yearly income. 3
Nausea without slow gastric emptying may be even
more common and has been referred to by many names, including
chronic unexplained nausea and vomiting (CUNV), gastroparesis-like
syndrome (GLS), functional vomiting, and vomiting of unexplained
etiology (VUE). Many of these patients can be classified as having
functional dyspepsia (FD) which is a disorder that may affect 10%
of the US population.4
“The vagus nerve plays a key role in the regulation
of nausea and vomiting,” commented Dr. Jay Pasricha, Professor
of Medicine and Neurosciences and Director of the Johns Hopkins
Center for Neurogastroenterology and principal investigator of the
study. “Vagal modulation is currently thought to be a major
component of the treatment benefit from an implanted gastric
electrical stimulation (GES) device in patients with symptoms of
gastroparesis and the planned proof of concept study explores
whether a non-invasive hand-held device for vagal modulation can
also be effective in reducing the need for traditional rescue
medications for patients with unexplained nausea and vomiting.”
“We appreciate Dr. Pasricha and his team selecting
gammaCore (nVNS) for their study,” said Eric Liebler, Senior Vice
President of Neurology at electroCore, Inc. “gammaCore (nVNS) is
the first non-invasive, handheld medical device proven to activate
the vagus nerve by providing a patented mild electrical stimulation
through the skin, and offers a potential alternative to GES that
could eliminate significant risks of injury or illness associated
with implantation.”
For more information, visit clinicaltrials.gov.
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 symptomatic exacerbation of nausea in patients
with gastroparesis 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 Camilleri, M; Parkman HP; Shafi MA; Abell T;
Gerson L. Clinical guideline: management of gastroparesis. 2013
Jan; 108 (1): 18-37. 2 Rey E, Choung RS, Schleck CD, Zinsmeister
AR, Talley NJ, Locke GR III. Prevalence of hidden gastroparesis in
the community: the gastroparesis“iceberg”. J Neurogastroenterol
Motil. 2012;18:34–42.3 Lacy BE, Crowell MD, Mathis C, Bauer D,
Heinberg LJ. Gastroparesis: quality of life and health care
utilization. J Clin Gastroenterol. 2018; 52: 20–24.4 Harer, K;
Pasricha PJ. Chronic Unexplained Nausea and Vomiting or Gastric
Neuromuscular Dysfunction (GND) An Update on Nomenclature,
Pathophysiology and Treatment and Relationship to Gastroparesis.
2016 Dec; 14 (4): 410-419.
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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