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electroCore, Inc. Announces Product Registration in Indonesia, Malaysia and South Africa

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electroCore, a commercial-stage bioelectronic medicine company, announced on April 6, 2023, that it received a license to import, distribute, and market its gammaCore Sapphire™ device in Indonesia. This is part of a broader strategy to expand its global presence, which includes earlier license approvals in Malaysia and South Africa. Iain Strickland, SVP of Global Sales and Strategy at electroCore, stated that these approvals not only validate their clinical evidence but also enhance geographical access for patients. The new registrations cover regions with a combined population of 367 million, presenting significant market opportunities and establishing new clinician networks in these territories.

Positive
  • Received license for gammaCore Sapphire™ in Indonesia, expanding market access.
  • Validates clinical evidence portfolio and enhances geographical footprint.
  • Regions approved have a combined population of 367 million, indicating a large market opportunity.
Negative
  • None.

ROCKAWAY, N.J., April 06, 2023 (GLOBE NEWSWIRE) -- electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the receipt of a license to import, distribute and market gammaCore Sapphire™, non-invasive vagus nerve stimulator (nVNS) in Indonesia. This follows the equivalent license approvals received in Malaysia in September 2022 and in South Africa in March 2023.

“Gaining wider global approvals and opening supply routes for gammaCore further validates the clinical evidence portfolio we have behind our technology, and more importantly, broadens the geographical access for patients and clinicians,” said Iain Strickland, SVP, Global Sales and Strategy at electroCore. “The product registration in Indonesia, South Africa and Malaysia represent the first registrations we have in both the Far East and the African continent.”

Mr. Strickland continued, “It’s an exciting time to be building new clinician networks and we look forward to supporting our distributors Kromax South Asia and Byond Healthcare as they launch in their respective territories. These regions have a combined population of 367 million and represent a significant market opportunity supported by local key opinion leaders, to whom we are grateful for their ongoing support and desire to include gammaCore nVNS, in their treatment considerations for headache patients.”

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving outcomes 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 as a potential alternative to opioids for pain management; its pipeline or potential markets for its technologies including treatment as a non-pharmaceutical therapeutic option for a variety of pain conditions; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in Indonesia, Malaysia and South Africa, and other new markets 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 recent license did electroCore receive for gammaCore Sapphire™?

electroCore received a license to import, distribute, and market gammaCore Sapphire™ in Indonesia.

What is the significance of the license obtained by electroCore for gammaCore in Indonesia?

The license represents an expansion of gammaCore's market access and validates the clinical evidence behind the technology.

Which countries have approved gammaCore Sapphire™ before Indonesia?

gammaCore Sapphire™ was previously licensed in Malaysia in September 2022 and South Africa in March 2023.

What populations do the new licenses cover for gammaCore?

The licenses in Indonesia, Malaysia, and South Africa cover regions with a combined population of 367 million.

electroCore, Inc.

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