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electroCore to Present Additional Research for Non-invasive Vagus Nerve Stimulation in Headache Disorders at the 17th Biennial Migraine Trust International Symposium
BASKING RIDGE, N.J., Sept. 05, 2018 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that seven abstracts and an oral presentation featuring non-invasive vagus nerve stimulation (nVNS) across two primary headache disorders will be presented at the 17th Migraine Trust International Symposium (MTIS) (September 06-09, 2018, London). Presentations at the meeting will highlight data for migraine and cluster headache patient populations.
“Together with our partners, electroCore is proud to continue to share evidence that highlights the role of non-invasive vagus nerve stimulation in the treatment of patients with primary headache disorders,” said Peter S. Staats, M.D., Chief Medical Officer, electroCore.
Data will demonstrate the ability of nVNS to impact some of the key symptoms associated with cluster headache. This finding is discussed further in the Late Breaking Oral presentation showing the effect of nVNS in the brain based on functional magnetic resonance imaging (fMRI). Additionally, there will be a digital poster presentation of the PREMIUM study, a randomized, double-blind, sham-controlled study evaluating the efficacy, safety and tolerability of gammaCore for the preventive treatment of episodic migraine.
The nVNS-related research to be presented at the 17th biennial MTIS meeting includes:
- Oral Presentation:
- Vagus nerve stimulation modulates the cranial trigeminal-autonomic reflex - A comparison trial of different sham-conditions [September 08, 2018, 16:00-16:45 p.m. BST]
- Digital Poster Presentations:
- Modulation of the Trigeminal Autonomic Reflex by Non-invasive Vagal Nerve Stimulation (nVNS): an fMRI Study [MTIS2018-165, Saturday 08, 2018, 3:00-3:05 p.m. BST]
- Non-invasive Vagus Nerve Stimulation (nVNS) for the Preventive Treatment of Episodic Migraine: The Multicentre, Double-blind, Randomised, Sham-Controlled PREMIUM Trial [MTIS2018-076, September 07, 2018, 2:50-2:55 p.m. BST]
- Poster Presentations (on display from 7:30 a.m.- 6:00 p.m. BST in the Monarch Suite):
- Effects of Non-invasive Vagus Nerve Stimulation (nVNS) on Resting-State EEG and Laser-Evoked Potentials in Migraine: Findings from a Subgroup of Patients Enrolled in the Randomised, Sham-Controlled, Double-blind PRESTO Study [MTIS2018-061, September 08, 2018, 2:15-3:30 p.m. BST]
- Practical and Clinical Utility of Non-invasive Vagus Nerve Stimulation (nVNS) for the Acute Treatment of Migraine: Post Hoc Assessment of the Randomized, Sham–Controlled, Double-blind PRESTO Trial [MTIS2018-059, September 08, 2018, 2:15-3:30 p.m. BST]
- Additional Findings from the Randomised, Sham-Controlled, Double-blind PRESTO Study of Non-invasive Vagus Nerve Stimulation (nVNS) for the Acute Treatment of Episodic Migraine [MTIS2018-060, September 07, 2018, 2:30-4:00 p.m. BST]
- Evaluating the Benefits of More Frequent Non-invasive Vagus Nerve Stimulation (nVNS) for Patients with Chronic Cluster Headache: A Post Hoc Analysis of the PREVA Trial [MTIS2018-142, September 07, 2018, 2:30-4:00 p.m. BST]
- Peripheral Vagal Nerve Stimulation Attenuates Migraine Aura: A Case Report [MTIS2018-064, Friday 07, 2018, 2:30-4:00 p.m. BST]
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck that acutely treats the pain associated with migraine and episodic cluster headache in adult patients through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. 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 released/cleared in the U.S. for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients. gammaCore is currently available outside of the U.S., including in the European Economic Area, where it is CE-Marked.
IMPORTANT SAFETY INFORMATION REGARDING GAMMACORE
- The safety and effectiveness of the gammaCore (nVNS) have not been established in the acute treatment of chronic cluster headache.
- gammaCore has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache or 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 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 important warnings and precautions before using or prescribing this product.
gammaCore is available by prescription only. U.S. Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.
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. The company’s initial targets are the acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
This 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 about electroCore's business prospects and product development plans, its pipeline or potential markets for its technologies, 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™, 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.
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