Data Highlighting Non-Invasive Vagus Nerve Stimulation (nVNS) for Treatment of Acute Neurological Injury Presented at 2023 World Stroke Congress
10 Ottobre 2023 - 2:00PM
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic
medicine and wellness company, today announced top line data from
two abstracts being presented at the 15th World Stroke
Congress held October 10-12, 2023, in Toronto, Canada on
the possible role of nVNS in the treatment of acute neurological
injuries.
The nVNS research presented at the 2023 World Stroke
Congress covers two recently completed trials as follows:
1. Non-Invasive Vagus Nerve
Stimulation Is Safe and Efficacious In The Treatment Of Headache
Associated With Subarachnoid Hemorrhage (VANQUISH)
In this study conducted at Northwell Health in New York, there
was a significant reduction in the overall pain score with a
therapeutic gain of − 0.5 points in favor of nVNS. (P<0.005).
There was a 14% decrease in the Average Morphine Equivalent Dosage
after two weeks of treatment as well as a trend towards a 3 day
decrease in average hospital stay (p = 0.14) that did not reach
significance, possibly due to the size of the study.
Dr. Tania Rebeiz, the primary investigator of the VANQUISH study
and Assistant Professor, Donald and Barbara Zucker School of
Medicine at Hofstra/Northwell commented, “We are pleased to
have successfully completed this first trial of nVNS as a possible
treatment for the acute treatment of Subarachnoid Hemorrhage. Our
data suggests that nVNS is safe and effective in reducing pain and
potentially the use of other acute pain medications, including
opioids in the immediate aftermath of a SAH. The potential for nVNS
to help decrease the overall length of the hospital stay after SAH
could offer significant patient and health care benefits.”
Subarachnoid hemorrhage (SAH) is a devastating condition, most
commonly due to trauma and aneurysm rupture, and carries
significant mortality and morbidity. About half of the survivors
are left with some disability. Some of the known complications are
aneurysm re-rupture, seizures, central fever, delayed cerebral
ischemia (DCI), headache and hydrocephalus.
2. Non-invasive Vagus Nerve
Stimulation in Acute Ischemic Stroke (NOVIS)
NOVIS is a prospective randomized clinical trial with blinded
outcome assessment being conducted at the Leiden University
Medical Center (Leiden, The Netherlands). 150 patients
with ischemic stroke are being randomly allocated (1:1) to nVNS for
five days in addition to standard treatment versus standard
treatment alone. The primary endpoint is the final infarct volume
on day five as assessed with MRI. Dr. Anne van der Meij, from
the Leiden University Medical Center, who is presenting the
poster at the World Stroke Congress commented, “Our study
will complete enrollment before the end of 2023 and our efficacy
endpoints should provide greater definition, and possibly
confirmation, of the efficacy of nVNS for the acute treatment of
ischemic stroke.”
Stroke is ranked as the second leading cause of death worldwide
with an annual mortality rate of about 5.5 million. The burden of
stroke lies not only in its high mortality rate, but in the high
morbidity rate as well with up to 50% of stroke survivors being
chronically disabled.
Peter Staats, MD, Chief Medical Officer for electroCore,
commented, “We congratulate all the investigators, patients and
sites that supported this research into the role of nVNS as an
acute treatment for SAH and Ischemic Stroke. The strong mechanistic
rational for nVNS as a potentially neuroprotective and
anti-inflammatory treatment for acute neurological injury is
further supported by this data showing the continued efficacy of
nVNS for the treatment of pain. The ability of nVNS to potentially
decrease the daily use of other acute pain medications and
potentially even shorten the length of the hospital stay after a
SAH is very exciting.”
About electroCore, Inc.electroCore, Inc. is a
commercial stage bioelectronic medicine and wellness company
dedicated to improving health through its non-invasive vagus nerve
stimulation (“nVNS”) technology platform. Our focus is the
commercialization of medical devices for the management and
treatment of certain medical conditions and consumer product
offerings utilizing nVNS to promote general wellbeing and human
performance in the United States and select overseas markets.
For more information, visit www.electrocore.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 potential commercial
applications of gammaCore and nVNS for treatment of headache and
pain associated with Subarachnoid Hemorrhage and the acute
treatment of ischemic stroke; 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, including patents related to non-invasive
nerve stimulation with mobile devices, providing expanded IP
coverage; the possibility of future business models, 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," "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:ECOR Investor
Relations(973) 302-9253investors@electrocore.com
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