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gammaCore (Non-Invasive Vagus Nerve Stimulation; nVNS) Improves Attention and Memory in Patients with Posttraumatic Stress Disorder (PTSD)

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ROCKAWAY, N.J., July 25, 2023 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the publication of a peer reviewed manuscript, Effect of Transcutaneous Cervical Vagus Nerve Stimulation on Declarative and Working Memory in Patients with Posttraumatic Stress Disorder (PTSD): A Pilot Study, in the Journal of Affective Disorders. The study was conducted with the support of Emory University, The Georgia Institute of Technology and the Atlanta Veteran’s Affairs Medical Center and was sponsored by a Department of Defense Small Business Technology Transfer grant (DoD STTR).

PTSD is an extreme mental health condition associated with changes in multiple neurophysiological systems such as inflammation and the autonomic nervous system and contributing to deficits in memory. Many patients have limited or no response to currently available treatments for PTSD symptoms and associated cognitive dysfunction. According to the American Psychiatric Association, exposure to traumas including accidents or other life-threatening incidents can initiate the development of PTSD, a complex syndrome involving core symptoms of hyperarousal, avoidance and re-experiencing symptoms, and associated decreases in concentration and memory1,2 (Hou et al., 2007; Williams and First, 2013).

Vagus Nerve Stimulation (VNS) has been shown in preliminary studies to enhance function when paired with cognitive and motor tasks. The randomized double-blinded study enrolled fifteen patients (nVNSActive = 8; nVNSSham =7), was conducted over the course of three months of twice daily home-based nVNS self-administered treatments and assessed the effectiveness of nVNS on declarative and working memory in patients with PTSD. The study concluded the active group developed better attention and recall of paragraphs encoded with stimulation as well as for working memory tasks as compared to sham. The improvement in working memory for patients with PTSD who used nVNS compared to sham was statistically significant at 4 weeks (57.1%; p=0.01) and continued to improve through 8 weeks (91.4%; p=0.03).

Dr. Douglas Bremner, Professor of Psychiatry and Radiology at Emory University School of Medicine and the primary investigator for the study, commented, “nVNS continues to demonstrate its potential as a safe, convenient and potentially effective treatment for people suffering from PTSD. The improvements in memory seen in this study, complement our previous research which has shown the beneficial effects of nVNS on some of the basic mechanisms that lead to, and can exacerbate, PTSD3,4.This longitudinal study shows benefit for cognitive symptoms associated with PTSD and suggests that nVNS may improve work and social functioning for patients with PTSD.”

“We congratulate and thank Dr. Bremner, Dr. Inan, Dr. Choudhary and the clinical and research teams at Emory University, Georgia Tech University and the Atlanta VA for their support of this study,” commented Dan Goldberger, Chief Executive Officer at electroCore. “We look forward to the results of several larger on-going government sponsored studies of nVNS as a treatment for PTSD and other future indications.”

The full publication is available at: https://www.sciencedirect.com/science/article/abs/pii/S0165032723008625

The content of the paper is solely the responsibility of the authors and does not necessarily represent the official views of study sponsors.

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.

About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck 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 is 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 intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck for preventive treatment of migraine and the acute treatment of pain associated with migraine in patients 12 and older. gammaCore is also indicated for adjunctive use for preventive treatment of cluster headache, acute treatment of episodic cluster headache, and treatment of hemicrania continua and paroxysmal hemicrania in adult patients. gammaCore should not be used by people with an active implantable medical device. Please refer to gammaCore.com or the Instructions for Use for complete safety information, including indications, contraindications, warnings, cautions, and instructions.

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 Company’s business prospects in cognitive symptoms associated with PTSD 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.

Contact:
ECOR Investor Relations
(973) 302-9253
investors@electrocore.com

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1 Hou, C., Liu, J., Wang, K., Li, L., Liang, M., He, Z., Liu, Y., Zhang, Y., Li, W., Jiang, T., 2007. Brain responses to symptom provocation and trauma-related short-term memory recall in coal mining accident survivors with acute severe PTSD. Brain Res. 1144, 165–174. https://doi.org/10.1016/j.brainres.2007.01.089
2 Williams, J.B.W., First, M., 2013. Diagnostic and Statistical Manual of Mental Disorders [WWW Document]. Encycl. Soc. Work. https://doi.org/10.1093/acrefore/9780199975839.013.104
3 Bremner, J.D., Wittbrodt, M.T., Gurel, N.Z., Shandhi, M.H., Gazi, A.H., Jiao, Y., Levantsevych, O.M., Huang, M., Beckwith, J., Herring, I., Murrah, N., Driggers, E.G., Ko, Y.-A., Alkhalaf, M.L., Soudan, M., Shallenberger, L., Hankus, A.N., Nye, J.A., Park, J., Woodbury, A., Mehta, P.K., Rapaport, M.H., Vaccarino, V., Shah, A.J., Pearce, B.D., Inan, O.T., 2021b. Transcutaneous Cervical Vagal Nerve Stimulation in Patients with Posttraumatic Stress Disorder (PTSD): A Pilot Study of Effects on PTSD Symptoms and Interleukin-6 Response to Stress. J. Affect. Disord. Rep. 6, 100190. https://doi.org/10.1016/j.jadr.2021.100190
4 Wittbrodt, M.T., Gurel, N.Z., Nye, J.A., Shandhi, M.M.H., Gazi, A.H., Shah, A.J., Pearce, B.D., Murrah, N., Ko, Y. A., Shallenberger, L.H., Vaccarino, V., Inan, O.T., Bremner, J.D., 2021. Noninvasive Cervical Vagal Nerve Stimulation Alters Brain Activity During Traumatic Stress in Individuals With Posttraumatic Stress Disorder. Psychosom. Med. 83, 969. https://doi.org/10.1097/PSY.0000000000000987


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