ElectroCore Announces Publication of PREMIUM II Trial of gammaCore (Noninvasive Vagus Nerve Stimulation; nVNS) for Migraine Prevention

ROCKAWAY, NJ, January 10, 2022 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed article, “Noninvasive Vagus Nerve Stimulation for Migraine Prevention: The Multicenter, Randomized , double-blind, controlled PREMIUM II trial” in Headache, the official journal of the International Headache Society (IHS). The article reports the results of a randomized, double-blind, simulation-controlled trial conducted at twenty-seven sites across United States. Originally designed and powered to randomize 400 patients, the study was terminated prematurely due to COVID-19 after recruiting 231 subjects.

Study results showed a decrease in monthly headache days of 4.6 versus -3.0 for simulations (p=0.05) with 44.87% of subjects in the gammaCore group having a greater reduction 50% of the number of migraine days. per month against 26.81% for the fictitious group (p=0.05). Quality of life, measured by the HIT-6 (Headache Impact scale), improved by -4.9 points against -2.3 for sham (p 100% compared to the simulacrum. These results are consistent with previous reports on mechanisms of action that suggest that nVNS may be particularly effective in patients with migraine with aura.

Dr. Umer Najib, Associate Professor, Headache Medicine Fellowship Program Director at West Virginia University and the first author of the paper commented, “We are pleased to have added to the data that helps suggest the types of migraine patients who would likely benefit most from nVNS. The safety and tolerability of nVNS are such that it can be used as a stand-alone or adjunctive therapy, depending on the patient’s needs, and its flexibility allows healthcare providers to consider it for a large number of their patients. .

“We congratulate and thank all the investigators, site personnel and subjects who conducted this study throughout United States despite the challenges that have come with COVID-19,” commented Eric Liebler, senior vice president of neurology at electroCore. “With seven different FDA indications, gammaCore is safe and effective for many primary headache patients, and the results of this study highlighting potential benefits in patients with migraine with aura are particularly compelling.”

The full publication is available at: https://journals.sagepub.com/doi/10.1177/03331024211068813

About electroCore, Inc.
electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its noninvasive vagus nerve stimulation therapy platform, initially focused on treating multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraine in adolescent, paroxysmal hemicrania and continuous hemicrania in adults.

For more information, visit www.electrocore.com.

About gammaCore^MT
gammaCore^MT (nVNS) is the first non-invasive manual medical therapy applied to the neck as an adjunct therapy to treat migraine and cluster headache through the use of mild electrical stimulation of the vagus nerve which crosses 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 medications. When placed on a patient’s neck above the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may result in reduced pain for patients.

gammaCore (nVNS) is cleared by the FDA in United States for adjunctive use in 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 adolescents (12 years and older) and adult patients, and paroxysmal hemicrania and hemicrania continuum in adult patients. gammaCore is CE marked in the European Union for the acute and/or prophylactic treatment of primary headaches (migraine, cluster headache, trigeminal autonomic headaches and hemicrania continuum) and medication overuse headaches in adults.

gammaCore is contraindicated for patients if they:

Have an active implantable medical device, such as a pacemaker, hearing aid implant, or other implanted electronic device
Having a metal device, such as a stent, bone plate, or bone screw, implanted at or near the neck
Use another device at the same time (eg TENS unit, muscle stimulator) or any portable electronic device (eg cell phone)

The safety and efficacy of gammaCore have not been evaluated in the following patients:

Adolescent patients with congenital heart problems
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 (under 12 years old)
Pregnant women
Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia

Please refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.

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 activities of electroCore. clinical and product development prospects and plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, results and impact of regulatory, clinical and commercial developments; the issuance of we and international patents providing extended IP coverage; the possibility of future business models and revenue streams from the potential of the company using nVNS for symptoms associated with migraine with aura, the potential of nVNS in general and gammaCore in particular and other statements that are not historical in nature, especially those that use terminology such as “anticipates”, “will”, “expects”, “believes”, “intends”, other words of similar meaning, derivations of these words and the use of future dates. Actual results could differ from those projected in the forward-looking statements due to many factors. These factors include, among others, the ability to obtain additional funds necessary to pursue plans for business and product development of electroCore, the inherent uncertainties associated with the development of new products or technologies, the ability to commercialize gammaCore™, the impact and effects on of COVID-19 on electroCore’s business, results of operations and financial performance of electroCore, and any actions electroCore has and may take in response to COVID-19 and any expectations that electroCore may have in this regard, competition in the industry in which electroCore operates and general market conditions. All forward-looking statements are made as of the date of this press release, and electroCore undertakes 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. , unless required by law. Investors should review all information contained herein and should also refer to the disclosure of risk factors set forth in reports and other documents filed by electroCore with the SECOND available at www.sec.gov.

Investors:rich roosterCG Capital
404-736-3838
ecor@cg.capital

Where

Media Contact:Jackie DorskyelectroCore
908-313-6331
jackie.dorsky@electrocore.com