electroCore Announces Encouraging Research Supporting Key Areas of Clinical Development for its Non-Invasive Vagus Nerve Stim...
14 Março 2019 - 9:00AM
electroCore, Inc. (Nasdaq: ECOR), a global commercial-stage
bioelectronic medicine company, today announced new preclinical and
clinical research supporting the potential therapeutic benefit of
its non-invasive vagus nerve stimulator (nVNS), gammaCoreTM, for
the treatment of mild traumatic brain injury (mTBI) and rheumatoid
arthritis (RA). Data from studies evaluating these potential
additional therapeutic targets for gammaCore were presented at the
3rd International Brain Stimulation Conference Feb. 24-27, 2019 in
Vancouver, British Columbia.
“The recent results are very encouraging as they
support the broad therapeutic potential of nVNS therapy,” said
Francis Amato, chief executive officer of electroCore. “Based on
these data, gammaCore could represent a safe and effective non-drug
treatment option for patients with mild traumatic brain injury and
rheumatoid arthritis. We look forward to further validating nVNS
for treatment of these conditions as we remain committed to
leveraging our unmatched expertise and proprietary technology to
expand the applicability of nVNS and provide patients with an
effective, non-drug treatment option for a growing number of
diseases and disorders.”
Results from a preclinical study evaluating nVNS
for the prevention and treatment of comorbid mTBI and
post-traumatic stress disorder (PTSD) demonstrate the potential use
of therapeutic nVNS following blast-induced mTBI, a condition for
which there is currently no effective treatment option. electroCore
plans to initiate a pilot trial to further evaluate the effects of
nVNS on the prevention of post-traumatic headache in 2H 2019.
Results from electroCore’s first human trial
evaluating the effect of short-term transcutaneous nVNS on disease
activity and pro-inflammatory cytokines in RA provide preliminary
support for an anti-inflammatory effect. The Company also plans to
initiate a randomized controlled trial to further evaluate the
efficacy of nVNS for the treatment of RA in 2H 2019.
About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical
therapy FDA-cleared as an adjunctive therapy for the preventative
treatment of cluster headache and as an acute treatment for pain
associated with episodic cluster headache and migraine headache in
adult patients. 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 leading to a
modulation of neurotransmitters and a reduction in pain.
gammaCore is the only therapy FDA cleared for the prevention of
cluster headache.
gammaCore is available by prescription only and patients should
speak with their doctor about whether gammaCore is right for
them.
gammaCoreTM (non-invasive vagus nerve stimulator) is
intended to provide non-invasive vagus nerve stimulation (nVNS) on
the side of the neck. gammaCore is indicated 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.
- The acute treatment of pain associated with migraine headache
in adult patients.
- The safety and effectiveness of gammaCore (nVNS) have not been
established in the acute treatment of chronic cluster headache
- gammaCore has not been shown to be effective for the preventive
treatment of migraine headache
- The long-term effects of the chronic use of gammaCore have not
been evaluated
- Safety and efficacy of gammaCore have not been evaluated in the
following patients, and therefore it is NOT indicated for:•
Patients with an active implantable medical device, such as a
pacemaker, hearing aid implant, or any implanted electronic
device• 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• Pregnant women• Patients with clinically
significant hypertension, hypotension, bradycardia, or
tachycardia
- Patients should not use gammaCore if they:• Have a
metallic device such as a stent, bone plate, or bone screw
implanted at or near their neck• Are using another device at
the same time (e.g., TENS Unit, muscle stimulator) or any portable
electronic device (e.g., mobile phone)
NOTE: This list is not all inclusive. Please refer to the
gammaCore Instructions for Use for all of the important warnings
and precautions before using or prescribing this product.
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 and rheumatology. The company’s
initial targets are the preventative treatment of cluster headache
and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
Media ContactSara ZelkovicLifeSci Public
Relations(646) 876-4933Sara@lifescipublicrelations.com
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