electroCore, Inc. (Nasdaq: ECOR), a commercial-stage
bioelectronic medicine company, today announced enrollment has been
completed for the TRANSIT study of non-invasive vagal nerve
stimulation (nVNS) to reduce ileus after colorectal surgery. This
randomized, participant blinded, sham-controlled study is being
sponsored by the United Kingdom’s National Institute for Health
Research (NIHR). The 97-patient study is led by Dr. Stephen
Chapman, Clinical Research Fellow in the University of Leeds School
of Medicine. The study is conducted at St. James Hospital in Leeds,
England and Bradford Royal Infirmary in Bradford, England.
Ileus occurs in 10-20% of patients who have undergone elective
colorectal surgery. Ileus is a distressing condition characterized
by abdominal distension, persistent vomiting, and delayed return of
bowel function after surgery. For patients, it prolongs the length
of hospital stays and increases the risk of serious complications
such as pneumonia and venous thromboembolic events. For healthcare
systems, ileus increases per-patient costs by up to 71%,
particularly those associated with nursing care, laboratory
investigations, and medications.
Clinical endpoints in the TRANSIT study include the number of
postoperative days to first flatus, first stool, first oral intake,
hospital discharge, and the GI-2 composite outcome, a common
clinical measure of return of bowel function. The amount of daily
oral morphine equivalent requirements, as well as a number of
safety and feasibility outcomes to inform potential future clinical
research and use, will also be assessed. Study results are expected
later this year and will be presented at an appropriate medical
congress.
"We are excited by the completion of enrollment in the TRANSIT
study and are a step closer to potentially providing patients an
alternative option to treat post-operative ileus, while reducing
recovery time and costs," commented Dr. Peter Staats, Chief Medical
Officer of electroCore, Inc.
About the National Institute for Health
Research (NIHR)The mission of the National Institute
for Health Research (NIHR) is to improve the health and wealth of
the nation through research, accomplished by:
- Funding high quality, timely research that benefits the
National Health Service (NHS), public health and social care.
- Investing in world-class expertise, facilities, and a skilled
delivery workforce to translate discoveries into improved
treatments and services.
- Partnering with patients, service users, carers and
communities, improving the relevance, quality and impact of our
research.
- Attracting, training, and supporting the best researchers to
tackle complex health and social care challenges.
- Collaborating with other public funders, charities, and
industries to help shape a cohesive and globally competitive
research system; and
- Funding applied global health research and training to meet the
needs of the poorest people in low- and middle-income
countries.
NIHR is funded by the Department of Health and Social Care. Its
work in low- and middle-income countries is principally funded
through UK Aid from the UK government.
About University of LeedsThe University of
Leeds is one of the largest higher education institutions in the
UK, with more than 38,000 students from more than 150 different
countries and is renowned globally for the quality of their
teaching and research.
The University of Leeds is a values-driven university that
harness expertise in research and education to help shape a better
future for humanity, working through collaboration to tackle
inequalities, achieve societal impact and drive change.
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; 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 for the acute treatment of stroke
and hemorrhagic brain injury, 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
electroCore (NASDAQ:ECOR)
Gráfico Histórico do Ativo
De Jun 2024 até Jul 2024
electroCore (NASDAQ:ECOR)
Gráfico Histórico do Ativo
De Jul 2023 até Jul 2024