gammaCore Sapphire™ Non-Invasive Vagus Nerve Stimulator (nVNS) Receives Unique National Product Code Number by the Belgian Pharmaceutical Association
November 18 2022 - 8:00AM
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a
commercial-stage bioelectronic medicine company, today announced
that gammaCore Sapphire has been issued a National Code Number
(CNK) in Belgium.
CNK numbers are unique product code identifiers allocated by the
Belgian Pharmaceutical Association (APB) for products and medicines
commercially available from pharmacies throughout Belgium and
enables product recognition throughout the pharmaceutical
network.
“This positive news will allow us to provide patients with a
convenient way to easily access gammaCore at their local pharmacy,”
mentioned Iain Strickland, Senior Vice President Global Sales and
Strategy at electroCore. “We have taken a big step forward in
making our therapy more widely available throughout Europe. The
publication of the CNK code, makes gammaCore recognized within the
Belgian pharmaceutical database and therefore available via any
pharmacy in Belgium.”
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 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 (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 StatementsThis 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 including online, e-commerce,
direct-to-consumer channels, telehealth portal, and cash pay
initiatives; 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
across Belgium or other territories across Europe, 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.
Contact:Rich CockrellCG
Capital404-736-3838ecor@cg.capital
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