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electroCore Announces First Patient Enrollment in Investigator-Led Study of gammaCore™ nVNS for PTSD

electroCore (ECOR)electroCoreFDA / regulatory

electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, announced today the enrollment of the first eight patients in a clinical study being conducted by Acacia Clinics in collaboration with the Vagus Nerve Society.

As previously announced, the study is designed to evaluate the safety and effectiveness of electroCore’s gammaCore™ non-invasive vagus nerve stimulation (nVNS) device as an adjunctive treatment for symptoms associated with PTSD. The study is expected to enroll up to 40 adult participants and will assess outcomes over a 12-week treatment period.

The primary safety endpoint is the incidence of treatment-related serious adverse events, and the primary efficacy endpoint is the change from baseline in the Clinician-Administered PTSD Scale (CAPS-5) total score at 12 weeks. Secondary endpoints include changes in PTSD Checklist (PCL-5) scores and Clinical Global Impression (CGI) ratings.

“The enrollment of the first eight patients marks an important milestone in advancing research into non-invasive neuromodulation as a potential adjunctive treatment for PTSD,” said Dr. Peter Staats, Chief Medical Officer of electroCore and President of the Vagus Nerve Society. “We are encouraged by the growing interest in bioelectronic approaches that may offer patients additional therapeutic options beyond standard of care, particularly for PTSD, where effective treatment options remain limited.”

The study is led by Danielle DeSouza, MSc, PhD, Vice President of Research at Acacia Clinics, and Noah DeGaetano, MD. The study is sponsored by the Vagus Nerve Society, with electroCore providing an educational grant and gammaCore devices.

“We are pleased to initiate patient enrollment in this study evaluating nVNS in PTSD,” said Dr. DeSouza. “There remains a significant unmet need for effective adjunctive therapies, and this research will help further our understanding of the role vagus nerve stimulation may play in addressing both the neurological and physiological components of PTSD.”

The study is anticipated to run for approximately 10 months and is intended to generate preliminary safety and effectiveness data to inform future research in neuropsychiatric applications of nVNS.

About Acacia Clinics

Acacia Clinics is a recognized leader in precision neuromodulation and advanced mental health services, drawing on nearly a decade of experience in fMRI-guided TMS. Founded in 2018 by Dr. David Carreon and Dr. Nathan Meng, Acacia is led by an experienced executive team that also includes Mr. David Ling, Dr. Noah DeGaetano, and Dr. Danielle DeSouza. Acacia integrates patient-focused care, rigorous clinical research, and industry-leading partnerships to deliver exceptional, evidence-based treatment.

About electroCore, Inc.

electroCore, Inc. is a bioelectronic technology company whose mission is to improve health and quality of life through innovative non-invasive bioelectronic technologies. The Company’s two leading prescription products, gammaCore ® non-invasive vagus nerve stimulation (nVNS) and Quell ® neurostimulator, treat chronic pain syndromes through non-invasive neuromodulation technology. Additionally, the company commercializes its handheld, and personal use Truvaga™ and TAC-STIM™ nVNS products utilizing bioelectronic technologies to promote general wellness and human performance.

For more information, visit www.electrocore.com .

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 the anticipated results from the study using gammaCore nVNS for adjunctive treatment of symptoms associated with PTSD, the Company’s relationship with the Vagus Nerve Society and Acacia Clinics, the anticipated timeline and enrollment of the clinical study, the Company’s future business strategies, growth opportunities, prospects, product development, and market expansion, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” "may," "potential," and 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, inherent uncertainties associated with clinical studies, including the ability to enroll sufficient numbers of patients, the ability of the Company to develop and commercialize new products or technologies, its ability to obtain regulatory clearance or approval for new indications, electroCore’s results of operations and financial performance, inflation and currency fluctuations, and any expectations electroCore may have with respect thereto, as well as competition in the industry in which electroCore operates and overall economic and 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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electroCore

Noninvasive Neuromodulation electroCore develops handheld bioelectronic devices that stimulate the vagus nerve without surgery. Its products are used across prescription and consumer channels. gammaCore gammaCore is a prescription noninvasive vagus-nerve-stimulation device used for headache disorders. A major commercial channel is the...

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