electroCore, Inc. Provides Update on nVNS to Treat Post Traumatic Stress Disorder
14 Dezembro 2021 - 10:00AM
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a
commercial-stage bioelectronic medicine company, today provided an
update on the ongoing clinical research to assess the potential of
gammaCore (non-invasive vagal nerve stimulation; nVNS) to treat
Post Traumatic Stress Disorder (“PTSD”).
PTSD is a debilitating disorder triggered by experiencing or
witnessing a traumatic event that is increasingly common.
Approximately 15 million adults in the US will have PTSD
during a given year and it is particularly concerning to the
Military and Veteran’s Administration (VA).
In a study published on December 6th, 2021, in the Journal of
Affective Disorders Reports, 20 patients suffering from PTSD were
exposed to personalized traumatic scripts followed by an immediate
stimulation by an active or sham non-invasive vagus nerve
stimulator (“nVNS”). The results showed that three-months of
treatment with nVNS led to a 31% reduction (p<0.013) in PTSD
symptoms compared to sham on the PTSD Checklist (“PCL”), as well as
a significant decrease in hyperarousal symptoms (p=0.008) and a
decrease in overall and somatic (gastric) anxiety. At the
conclusion of the study, patients who continued using nVNS for a
further 3 month open-label period showed significant improvement in
their overall symptoms reported by the Clinical Global Index
(p=0.003). Furthermore, nVNS effectively blocked the increase in
the levels of the inflammatory cytokine IL-6 that is overexpressed
in patients with PTSD who are exposed to a traumatic script
(p<0.05).
electroCore is currently collaborating with investigators on two
Randomized, sham-controlled clinical trials to further confirm the
efficacy of nVNS as a treatment for PTSD. (Table 1)
Table 1. Ongoing Studies of nVNS in PTSD and
Related Disorders |
Study |
Size |
Location |
nVNS in posttraumatic stress |
88 |
VA San Diego Healthcare System, San Diego, CA |
Sympathetic overactivity in PTSD |
100 |
Atlanta VA Medical Center, Decatur, GA |
|
“PTSD is a devastating condition that affects family and
individuals across the United States. Whether it affects our
active-duty service men and women, our Veteran’s, or friends and
family, there are very few treatments that can decrease the signs
and symptoms of nVNS” said Dan Goldberger, CEO of electroCore.
“gammaCore, which is currently cleared by the FDA for most forms of
primary headache, offers the potential to provide a safe,
convenient and effective treatment for people with PTSD. We look
forward to reporting on our clinical and regulatory progress in
2022.”
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, 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
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
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; 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 utilizing nVNS for symptoms associated with
Post Traumatic Stress Disorder (PTSD), 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.
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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