gammaCore Sapphire™ Non-Invasive Vagus Nerve Stimulator (nVNS) Receives Unique National Product Code Number by the Belgian Pharmaceutical Association

Rhea-AI Summary

electroCore, Inc. (NASDAQ: ECOR) announced that its gammaCore Sapphire device has received a National Code Number (CNK) in Belgium. This unique identifier, issued by the Belgian Pharmaceutical Association, will facilitate the availability of gammaCore in pharmacies across Belgium. Iain Strickland, Senior Vice President at electroCore, emphasized that this development enhances patient access to their innovative vagus nerve stimulation therapy, which is used to treat various headache conditions. gammaCore is FDA cleared in the U.S. and CE-marked in the EU for several indications.

Positive

• gammaCore Sapphire receives CNK number in Belgium, enhancing market presence.
• Increased accessibility for patients to obtain gammaCore at local pharmacies.

Negative

• None.

ROCKAWAY, N.J., Nov. 18, 2022 (GLOBE NEWSWIRE) -- electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced that gammaCore Sapphire has been issued a National Code Number (CNK) in Belgium. 

CNK numbers are unique product code identifiers allocated by the Belgian Pharmaceutical Association (APB) for products and medicines commercially available from pharmacies throughout Belgium and enables product recognition throughout the pharmaceutical network. 

“This positive news will allow us to provide patients with a convenient way to easily access gammaCore at their local pharmacy,” mentioned Iain Strickland, Senior Vice President Global Sales and Strategy at electroCore. “We have taken a big step forward in making our therapy more widely available throughout Europe. The publication of the CNK code, makes gammaCore recognized within the Belgian pharmaceutical database and therefore available via any pharmacy in Belgium.” 

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of 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 migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore™
gammaCore™ (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 (nVNS) 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, and paroxysmal hemicrania and hemicrania continua in 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 if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)

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

• Adolescent patients with congenital cardiac issues
• 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 (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

For more information, please visit gammaCore.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 electroCore's business prospects and clinical and product development plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments including online, e-commerce, direct-to-consumer channels, telehealth portal, and cash pay initiatives; the issuance of U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential use of nVNS across Belgium or other territories across Europe, the potential of nVNS generally and gammaCore in particular 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:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital

FAQ

What does the CNK number mean for gammaCore Sapphire in Belgium?

The CNK number is a unique identifier that allows gammaCore Sapphire to be recognized and sold in Belgian pharmacies, improving patient access.

When was the CNK number issued for gammaCore in Belgium?

The CNK number was issued on November 18, 2022.

What conditions does gammaCore treat?

gammaCore treats cluster headache, migraine, and other headache disorders through non-invasive vagus nerve stimulation.

How does receiving a CNK number impact electroCore's business?

It enables electroCore to expand its distribution and accessibility for gammaCore in Belgium, potentially leading to increased sales.

Is gammaCore available in other countries?

Yes, gammaCore is FDA cleared in the U.S. and CE-marked in the EU for various headache conditions.