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 gammaCoreTMgammaCoreTM (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.
Investors:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
or
Media Contact:
Jackie Dorsky
electroCore
908-313-6331
jackie.dorsky@electrocore.com
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