electroCore, Inc. Announces Exclusive Distribution Agreement with Byond Healthcare Pty Ltd, South Africa
21 Fevereiro 2023 - 10:00AM
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a
commercial-stage bioelectronic medicine and wellness company, today
announced an agreement with Byond Healthcare Pty Ltd. to serve as
the exclusive distributor of gammaCore SapphireTM, non-invasive
vagus nerve stimulator (nVNS) in South Africa and
Namibia. “Access to exceptional medical technologies is key to
improving healthcare outcomes,” said David Loubser, Managing
Director of Byond Healthcare Pty Ltd. “It is a privilege for Byond
to provide clinicians in South Africa and Namibia with a
cutting-edge, clinically proven tool that we believe can help
combat the opioid crisis by treating a variety of pain conditions
with a non-pharmaceutical therapeutic option. Cleared by reputable
authorities such as the U.S. FDA, TGA, Health Canada, and EU,
gammaCore is a practical solution that aligns with Byond's focus on
making innovative pain management technologies accessible to both
patients and healthcare providers. As a first-line treatment option
for primary headache-related pain, gammaCore is a perfect fit for
Byond's mission.”“We are excited to be working with Byond in
expanding accessibility of our nVNS technology for headache
sufferers in South Africa and Namibia,” said Iain Strickland, SVP,
Global Sales and Strategy at electroCore. “Byond’s focus on
innovative pain management solutions makes them an ideal
distributor for us as we take gammaCore into Africa nations for the
first time. This agreement helps us to mobilize the response
to calls from patients and clinicians alike to make gammaCore
available in South Africa and Namibia.”The initial term of the
agreement is three years and contains customary terms and
conditions, and regulatory clearances are required before sales and
revenue can occur.
About Byond Healthcare Pty
Ltd.Byond Healthcare, a registered South African company
and licensed by the South African Health Products Regulatory
Authority (SAHPRA), is a distributor, importer, and exporter of
medical devices and accessories. We are a dedicated,
entrepreneurial team that operates out of the SADC region and
caters for end-users and healthcare providers operating in small
and large medical practices and theaters. The medical devices we
specialize in are novel medical technologies designed for pain
management to achieve better healthcare outcomes. We strive to help
as many patients as possible to gain access to these devices to
treat pain and other device-related conditions.For more
information, please visit www.byondhealthcare.com.
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 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 StatementsThis 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 the South Africa
or Namibia, 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 CockrellCG
Capital404-736-3838ecor@cg.capital
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