electroCore, Inc. (Nasdaq: ECOR), a commercial-stage
bioelectronic medicine company, today announced the publication of
a peer-reviewed paper on June 10, 2021, entitled “Effects of
Transcutaneous Vagal Nerve Stimulation (tVNS/nVNS) on Cognitive
Performance under Sleep Deprivation Stress,” in the
journal Communications Biology, a Nature publication. The
paper reports the positive results of a randomized, double-blind,
sham-controlled trial conducted at Wright-Patterson Air Force Base
using gammaCore SapphireTM and sponsored by the United States Air
Force Research Laboratories (USAFRL).
Fatigue is a serious and unavoidable problem for many
professions such as medicine, transportation, and the military.
Fatigue induced by sustained wakefulness can cause slower reaction
times, reduced ability to multi-task, and increases in lapses of
attention which can lead to costly, even deadly mistakes.1 Studies
on the behavioral implications of repeated sleep deprivation in
humans have showed delayed reaction times, decreased accuracy and
attention, and negative alterations in mood.2 Although some
pharmacological fatigue countermeasures do exist, they vary in
their effectiveness, have a range of negative side effects, and may
lose effectiveness with repeated use.
The study, which treated 40 United States Air Force personnel,
investigated the use of nVNS as a fatigue countermeasure. This
study was the first to assess cognitive performance during nVNS,
and the first to do so under conditions of lengthy sleep
deprivation.
Study participants were awake for 34 consecutive hours and
tested at multiple time points assessing the effects of sleep
deprivation on their ability to multi-task. The group treated with
nVNS showed a statistically significant benefit in their throughput
capacity when compared to the sham group, with the nVNS treated
group’s throughput capacity decreasing by 5% from baseline vs. the
sham group, which fell 15% (p<0.001). Furthermore, six
stimulations of nVNS (12 minutes total) provided benefit to
multi-tasking performance up to 15 hours post-stimulation, when
performance should be at its worst. The study also found the nVNS
group had a significantly smaller increase in a subjective fatigue
rating when compared to sham participants (p<0.001).
Dr. Richard McKinley, of the Air Force’s 711th Human Performance
Wing, Human Effectiveness Directorate and an investigator of the
study, commented, “We are pleased to have successfully completed
the first randomized, double-blind sham-controlled trial
demonstrating the efficacy of nVNS as possible aid to cognitive
performance and as a tool to counter fatigue. Improvements in our
aviators’ ability to perform tasks during the study while feeling
less fatigue suggest a range of possible roles for nVNS in
combating these issues in both military and civilian settings.”
“We congratulate and thank Dr. McIntire, Dr. McKinley and their
team at the 711th Human Performance Wing,” commented Eric Liebler,
Senior Vice President of Neurology at electroCore. “Current options
for helping maintain performance and combating fatigue are very
limited and often come with unacceptable side effects and risks due
to excessive use. We look forward to the results of the ongoing
research at the USAFRL.”
The full publication is available
at: https://www.nature.com/articles/s42003-021-02145-7
About electroCore, Inc.
electroCore, Inc. is a commercial stage
bioelectronic medicine company dedicated to improving patient
outcomes through its platform non-invasive vagus nerve stimulation
therapy initially focused on the treatment of multiple conditions
in neurology. The company’s current indications are for the
preventative treatment of cluster headache and migraine and acute
treatment of migraine and episodic cluster headache.
For more information, visit
www.electrocore.com.
About
gammaCoreTM
gammaCoreTM (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 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. 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 pacemaker, hearing aid implant, or 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:
- 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 of age)
- Pregnant women
- Patients with
clinically significant hypertension, hypotension, bradycardia, or
tachycardia
Please refer to the gammaCore Instructions for
Use for all the important warnings and precautions before using or
prescribing this product.
Forward-Looking Statements
This 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; its pipeline or potential markets for its
technologies; the timing, outcome and impact of regulatory,
clinical and commercial developments; the availability and impact
of payer coverage, the potential of nVNS generally and gammaCore in
particular to treat fatigue or enhance cognitive performance caused
by sleep deprivation 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.
1 Perry, I.C. (Ed.) (1974). Helicopter aircrew fatigue. AGARD
(Advisory Rep. No. 69). Neuilly sur Seine, France: Advisory Group
for Aerospace Research and Development.2 Krueger G.P. (1989).
Sustained work, fatigue, sleep loss, and performance: a review of
the issues. Work Stress, 3(2):129e41.
Investors:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
or
Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com
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