electroCore Announces Publication Reviewing the Prescribing of gammaCore for the Treatment of Cluster Headache in England
20 Outubro 2021 - 9:00AM
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage
bioelectronic medicine company, today announced the publication of
a peer-reviewed paper entitled “Non-invasive vagus nerve
stimulation for treatment of cluster headache: a retrospective
review of prescribing in England,” in the British Journal of
Healthcare Management. The paper reviews the prescribing
trends of gammaCore in England from April 2019 through the end of
2020. gammaCore was listed on NHS England and Improvement’s
‘Innovation Technology Payment’ program beginning 1st April 2019,
which provided for the reimbursement of gammaCore for cluster
headache patients in England. This program followed the National
Institute for Health and Care Excellence recommendation for the use
of gammaCore in cluster headache.
The study is one of the largest clinical audits of patients with
cluster headache and highlights that of the 655 patients who
started on gammaCore, 46.3% of patients were prescribed at least
one refill and 30.9% were prescribed two or more refills. These
real-world results suggest a durable benefit for patients utilizing
gammaCore’s non-invasive vagus nerve stimulation (nVNS) for cluster
headache in England.
Dr. Nick Silver, Consultant Neurologist at The Walton
Centre NHS Foundation Trust and lead author of the paper commented,
“Clinically, our goal is to find a treatment that works well and
works consistently for our patients with cluster headache. This
study demonstrates our patients’ ability to maintain gammaCore
treatment through multiple 3-month refill cycles, showing that
non-invasive vagus nerve stimulation is efficacious, tolerable, and
practical for patients with cluster headache.”
“We congratulate and thank the authors, NHS Centers, and
patients who contributed to this study,” commented Iain
Strickland, Vice President of Global Sales and Strategy at
electroCore. “After using gammaCore for 3 months, nearly 50% of
patients continue treatment highlighting nVNS’ practical benefit in
a condition with limited therapeutic options. Furthermore, adoption
and successful use of gammaCore in cluster headache patients has
been shown to deliver cost savings as recommended by the NHS.”
The full publication is available
at: https://www.magonlinelibrary.com/journal/bjhc
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
gammaCoreTMgammaCoreTM (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, the acute and
preventive treatment of migraine in adolescent (ages 12 and older)
and adult patients, and paroxysmal hemicrania and hemicrania
continua in adults. 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
Please refer to the gammaCore Instructions for Use for all of
the important warnings and precautions before using or prescribing
this product.
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 about electroCore’s expectations for revenue and cash
used in operations during the third quarter of 2021, its
expectations for future performance, as well as electroCore's
business prospects and clinical and product development plans for
2021 and beyond, its pipeline or potential markets for its
technologies, additional indications for gammaCore, the timing,
outcome and impact of regulatory, clinical and commercial
developments (including human trials for the study of headache,
PTH, mTBI, Parkinson’s diseases and sleep deprivation stress and
the business, operating or financial impact of such studies),
further international expansion, and statements about anticipated
distribution arrangements, government and payor funding
arrangements (including those relating to Canada, Western Europe,
Qatar, Taiwan, and China) 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™, 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
or
Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com
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