electroCore, Inc. Announces U.S. Department of Veterans Affairs Study of gammaCore Sapphire™ (Non-Invasive Vagus Nerve Stimulator) for the Treatment of Post-Traumatic Headache
Randomized, multi-center, double-blind, parallel, sham-controlled trial enrolling up to 100 veterans and directed by the Veterans Health Administration’s Headache Center of Excellence at the West Haven VA Medical Center (Connecticut)
ROCKAWAY, NJ, May 04, 2021 (GLOBE NEWSWIRE) — — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the U.S. Department of Veterans Affairs is starting an investigator-initiated study of the use of gammaCore SapphireTM non-invasive vagus nerve stimulation (nVNS) for the treatment of post-traumatic headache (PTH). PTH accounts for approximately 4% of all symptomatic headache disorders1 and is one of the most common consequences of mild traumatic brain injury (mTBI),2,3 also known as concussion. Estimates suggest that 69 million people per year experience a traumatic brain injury (TBI) worldwide.4 In addition, patients with PTH commonly suffer from comorbidities such as anxiety and depression,5 both of which are among the leading causes of disability worldwide.6
The study (GAP-PTH) is a randomized, multi-center, double-blind, parallel, sham-controlled trial enrolling up to 100 veterans and directed by the Veterans Health Administration’s Headache Center of Excellence (HCoE) at the West Haven VA Medical Center in West Haven, CT. PTH is a critical area of concern for the VA and it is estimated that more than 350,000 service members have headaches resulting from TBIs sustained in combat. PTH in veterans is most often caused by the kind of TBIs experienced during combat, including blast wave injuries
“PTH is one of the most common presentations among veterans who come to our VA Headache Centers of Excellence around the United States. Last year the Veterans Health Administration was caring for more than 140,000 veterans diagnosed with headache related to head trauma,” commented Dr. Jason Sico, National Director of the VA Headache Centers of Excellence Program and Associate Professor of Neurology (Headache Medicine and Vascular Neurology) and Internal Medicine (General Medicine) Yale School of Medicine.
“We have been using gammaCore nVNS successfully in veterans suffering from cluster headache and migraine at our center,” commented Dr. Emmanuelle Schindler, Medical Director of the HCoE at VA Connecticut Healthcare System, Assistant Professor of Neurology at Yale School of Medicine, and primary investigator of the GAP-PTH study. “This will be among the first Randomized Controlled Trials (RCTs) for PTH and we look forward to demonstrating how gammaCore nVNS can help our veterans with PTH.”
“We appreciate the opportunity to work with Dr. Schindler, Dr. Sico and their team to evaluate the potential of gammaCore as an acute and/or preventive option for PTH” said Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “gammaCore is being used across the Department of Veterans Affairs and Department of Defense for both cluster and migraine headache and we believe that the same mechanisms of action that support the efficacy of gammaCore in primary headaches could also provide relief to our servicemen, servicewomen, and veterans suffering from post-traumatic headache.”
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.
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 with:
- An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
- An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
- 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 (younger than 12 years)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
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 post-traumatic headache or traumatic brain injury and related disorders 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 Seifert, T. D. & Evans, R. W. Posttraumatic headache: a review. Curr. Pain Headache Rep. 14, 292–298 (2010).
2 Nampiaparampil, D. E. Prevalence of chronic pain after traumatic brain injury: a systematic review. JAMA. 300, 711–719 (2008).
3 Mullally, W. J. Concussion. Am. J. Med. 130, 885–892 (2017).
4 Dewan, M. C. et al. Estimating the global incidence of traumatic brain injury. J. Neurosurg. 27, 1–18 (2018)
5 Minen, M. T., Boubour, A., Walia, H. & Barr, W. Post-concussive syndrome: a focus on post- traumatic headache and related cognitive, psychiatric, and sleep issues. Curr. Neurol. Neurosci. Rep. 16, 100 (2016). A review that details the clinical characteristics and associated comorbidities of PTH.
6 GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the global burden of disease study 2015. Lancet. 388, 1545–1602 (2016).
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