electroCore Announces Publication of Investigator-Initiated Trial Data for SAVIOR-1 in COVID-19 Patients in Frontiers in Neurology
21 Abril 2022 - 9:00AM
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic
medicine company, today announced that Frontiers in Neurology has
published results from an investigator-initiated trial, SAVIOR-1, a
prospective, randomized, controlled study evaluating non-invasive
vagus nerve stimulation (nVNS) using gammaCore Sapphire™ in
patients admitted to the hospital for treatment of COVID-19.
The SAVIOR-1 trial was conducted by principal investigator Dr.
Carlos Tornero, Head of the Department of Anesthesiology,
Resuscitation and Pain Therapeutics of the Hospital Clínico
Universitario de Valencia, Spain, between April 2020 and February
2021. The trial targeted patients over 18 years of age and enrolled
110 patients, randomly assigned, with 55 patients in each group. Of
the 110 patients, 97 patients (47 in the nVNS treatment group, 50
in the control group) provided baseline demographic and medical
history data and were the evaluable population. The study evaluated
the safety and feasibility of nVNS when administered in addition to
the then-standard of care in patients hospitalized with active
SARS-CoV-2 infection compared with the standard of care alone.
The study identified significant treatment differences for
certain biomarkers of inflammation. Decreases from baseline in
C-reaction protein (CRP) levels were significantly greater in the
nVNS treatment group as compared to the control group throughout
the five-day period combined (p=0.011) and on day 5 compared to the
day 1 baseline period alone (p=0.015). On day 1, CRP levels were
highly elevated for 90% of all subjects, but by days 3 and 5, the
percentage of subjects with normal CRP levels improved markedly in
the nVNS group with day 3 CRP levels at 17.9% vs. 52.2% in the
control (p=0.010). Additionally, the nVNS group had a significantly
greater decrease from baseline in procalcitonin level at day 5
(p=0.012) as compared to the control group. Increased levels of
CRP, procalcitonin, and d-dimer have all been reported to be
associated with more severe disease and the lower levels of these
markers in the nVNS treated group may represent the initial impact
of nVNS therapy to potentially improve the course of a patients’
COVID-19 symptoms.
nVNS was well tolerated with no major device-related adverse
events and the therapy was administered three times daily to most
patients as outlined in the study protocol.
“We are thrilled that the SAVIOR-1 article has been
peer-reviewed and published in the Frontiers in Neurology journal,”
mentioned Dr. Peter Staats, Chief Medical Officer at electroCore.
“We are encouraged by this publication as Frontier’s rigorous
process for peer-reviewing articles further strengthens and
validates our nVNS technology and its relevancy and potential to
mitigate some of the symptoms associated with COVID-19.”
The Frontiers in Neurology publication is available here.
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 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
is 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.comForward-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 regarding electroCore's business prospects, the results
from investigator-initiated trials, its sales and marketing and
product development plans, future cash flow projections,
anticipated costs, its product portfolio or potential markets for
its technologies, the availability and impact of payor coverage,
the potential of nVNS generally and gammaCore in particular to
treat COVID-19, and other statements that are not historical in
nature, particularly those using terminology such as "anticipates,"
"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 obtain additional financing necessary to
continue electroCore's business, sales and marketing and product
development plans, the uncertainties inherent in the development of
new products or technologies, the ability to successfully
commercialize gammaCore™, competition in the industry in which
electroCore operates and general market conditions. All
forward-looking statements are made as of the date of this press
release, and electroCore undertakes no obligation to update
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 refer to
all information set forth in this document and should also refer to
the disclosure of risk factors 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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