electroCore, Inc. Provides Update on Global Distribution Partners
electroCore, Inc. (NASDAQ: ECOR) has secured exclusive distribution agreements for its gammaCore Sapphire™ non-invasive vagus nerve stimulator in several territories. The agreements are with Melidonia Health Services for Cyprus, Cyrus Medical Technologies for the UAE and Oman, and Express Medical Solutions LLC for Saudi Arabia and Bahrain. The agreements with Melidonia, Cyrus, and Medexsol have initial terms of three to five years.
These partnerships are part of electroCore's global expansion strategy to enhance accessibility to its therapeutic product for headache patients. Regulatory clearances are pending before sales can commence.
- New distribution agreements in multiple Middle Eastern territories may increase market access for gammaCore.
- Partnerships with reputable healthcare companies potentially bolster credibility and market penetration.
- Regulatory clearances are required before sales and revenue can be recognized, introducing uncertainty.
- The timing for obtaining regulatory clearances is uncertain, which may delay revenue generation.
ROCKAWAY, NJ, Dec. 16, 2021 (GLOBE NEWSWIRE) -- electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced it has entered into agreements with Melidonia Health Services (Melidonia), Cyrus Medical Technologies (Cyrus), and Express Medical Solutions LLC. (Medexsol) to serve as the exclusive distributors of the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) in Cyprus, the United Arab Emirates and Oman, and Saudi Arabia and Bahrain, respectively.
“Melidonia works to improve the availability of novel and state-of-the-art health care products that facilitate the role of physicians, and in doing so, improve the lives of their patients,” commented Loannis Kouis, General Manager of Melidonia. “Melidonia is a partner of choice for pharmaceutical and other health care companies, and we are excited to add electroCore to our network. As experts within the neurological and cardiology fields, gammaCore compliments Melidonia’s existing portfolio of products and expertise.”
“Cyrus is dedicated to offering the latest technology and medical devices across the Middle East,” commented Tamer Farouk, General Manager of Cyrus Medical Technologies. “We endeavour to partner with outstanding medical technologies that contribute to alleviating challenging healthcare conditions across the region. The gammaCore non-invasive vagus nerve stimulator is a proven therapy for patients with primary headache disorders. We are excited to represent this product to help healthcare professionals and patients in their management of various headache conditions in the United Arab Emirates and Oman.”
“Medexsol embraces disruptive medical technologies believing in quality, efficiency and innovation. Our ambition is to contribute and to facilitate healthcare services development,” commented Hasan Zaini, Owner of Medexsol. “We are excited to add gammaCore to our portfolio of products focused on the management of chronic diseases. Our company’s vision is to provide healthcare transformation by striving towards an advanced healthcare sector that combines medicine and modern technology. We are pleased to partner with electroCore to help achieve this goal.”
“We are delighted to announce these three new commercial partnerships as part of our global expansion plan in making gammaCore accessible to primary headache patients around the globe,” stated Iain Strickland, VP of Global Sales and Strategy at the Company. “We welcome Melidonia, Cyrus, and Medexsol to the electroCore family of partners and look forward to building a business with them based on their strong commitment to improving the quality of life for patients.”
The initial term of the Melidonia agreement is three years while the Cyrus and Medexsol agreements have an initial term of five years. The new agreements contain customary terms and conditions, and regulatory clearances are required before sales and revenue can occur. The timing for any such potential clearances is uncertain at this time.
Beginning December 2020, the Company executed on its plan to expand international distribution by onboarding ten exclusive distribution partners outside the United States and United Kingdom (Table 1).
Table 1: International Distributor List
| Territory | Distributor | Country |
| North America | RSK Medical | Canada |
| Eastern Europe | Pro Medical Baltic | Lithuania, Latvia, Belarus, Kazakhstan, and Ukraine |
| Western Europe | Silvert Medical Nv-Sa. | Belgium, Luxembourg, the Netherlands, and France |
| Australia | Medistar2 PTY Ltd | Australia |
| Asia | Kromax International Corp. | Taiwan and China |
| Kromax South Asia Pte Ltd. | Malaysia, Singapore, and Indonesia | |
| Middle East | East Agency | Qatar |
| Melidonia | Cypress | |
| Cyrus | United Arab Emirates and Oman | |
| Medexsol | Saudi Arabia and Bahrain |
The Company has received initial stocking orders from many of these partners and will provide updates on additional territory expansion in future quarters.
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 gammaCoreTM
gammaCoreTM (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
Please refer to the gammaCore Instructions for Use for all of the 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 electroCore's business prospects and clinical and product development plans; its pipeline or potential markets for its technologies including Cyprus, United Arab Emirates and Oman, and Saudi Arabia and Bahrain; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams, 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.
FAQ
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