electroCore, Inc. (Nasdaq: ECOR), a commercial-stage
bioelectronic medicine company, today announced that its
gammaCore™ nVNS device has received Breakthrough Designation
from the U.S. Food and Drug Administration (FDA) for the
treatment of posttraumatic stress disorder (PTSD) after showing a
reduction of symptoms of PTSD by 31% when compared to sham.
PTSD is a highly prevalent and disabling disorder
with limited approved treatment options. According to the U.S.
Department of Veterans Affairs National Center for PTSD,
approximately 15 million adults in the U.S. experience PTSD each
year. In the Military and Veterans Administration alone, PTSD is
reported to affect between 10-20% of veterans who served in each
Operations Iraqi Freedom (OIF) and Enduring Freedom (OEF), the Gulf
War (Desert Storm), and the Vietnam War. More than half of all
patients with PTSD report severely impaired quality of life in
areas including mood, social and family relationships, leisure
activities, sense of well-being and life satisfaction.
The Breakthrough Device Designation was supported,
in part, by research from an Emory-Georgia Tech team led by J.
Douglas Bremner, M.D., in the Departments of Psychiatry and
Radiology at the Emory University School of Medicine, and Omer T.
Inan, Ph.D., from the School of Electrical and Computer Engineering
and the Coulter Department of Biomedical Engineering at the Georgia
Institute of Technology in Atlanta, Georgia. Their research, built
upon a strong mechanistic rationale and animal studies, shows nVNS
blocks sympathetic and inflammatory responses to memories of
traumatic events in patients with PTSD, modulates brain responses
to traumatic memory, and reduces symptoms of PTSD by 31% when
compared to a sham stimulation.
Dr. Douglas Bremner commented, “Current
treatments for PTSD involving medication and psychotherapy have
limitations due to limited efficacy, possible side effects, and the
unwillingness of many PTSD patients to engage in therapies that
involve reliving traumatic memories. gammaCore represents a new
class of treatment separate from medication or psychotherapy that
is safe, relatively free of side effects, and does not involve
costly and invasive procedures for implantation, like previous VNS
devices approved by the FDA for treatment of refractory
depression.”
“We appreciate the thorough and timely review by
the FDA of our Breakthrough Device Request for gammaCore for the
treatment of PTSD,” commented Eric Liebler, Senior Vice
President of Neurology at electroCore. “The ability of nVNS to
target several of the underlying causes of PTSD such as autonomic
dysfunction, stress and inflammation, safely and effectively
supports its potential as a breakthrough treatment for PTSD.”
The Breakthrough Devices Program is a voluntary
program for certain medical devices and device-led combination
products for more effective treatment or diagnosis of
life-threatening or irreversibly debilitating diseases or
conditions.
The goal of the Breakthrough Devices Program is to
provide patients and health care providers with timely access to
critical medical devices by speeding up their development,
assessment, and review, while preserving the statutory standards
for premarket approval, 510(k) clearance, and De Novo marketing
authorization, consistent with the FDA’s mission to protect and
promote public health.
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
The U.S. FDA has cleared the gammaCore
Sapphire CV device under an emergency use authorization for acute
use at home or in a healthcare setting to treat adult patients with
known or suspected COVID-19 who are experiencing an exacerbation of
asthma-related dyspnea and reduced airflow, and for whom approved
pharmacologic therapies are not tolerated or provide insufficient
symptom relief as assessed by their healthcare provider, using
noninvasive vagus nerve stimulation (nVNS) on either side of the
patient's neck.
gammaCore Sapphire CV has been authorized only for
the duration of the statement that circumstances exist that warrant
authorization of the emergency use of medical devices under section
564(b)(1) of the Act, 21 U.S.C. § 360bbbb-3(b)(1), until the
authorization is terminated or revoked.
More information can be found at:
Letter of
authorization: https://www.fda.gov/media/139967/download
Fact sheet for healthcare
workers: https://www.fda.gov/media/139968/download
Patient information
sheet: https://www.fda.gov/media/139969/download
Instructions for use of
gammaCore: https://www.fda.gov/media/139970/download
Please refer to the gammaCore Instructions for Use
for all 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
Posttraumatic 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 CockrellCG
Capital404-736-3838ecor@cg.capital
or
Media Contact:Jackie
DorskyelectroCore908-313-6331jackie.dorsky@electrocore.com
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