electroCore, Inc. Announces Exclusive Distribution Agreement with Byond Healthcare Pty Ltd, South Africa
electroCore, Inc. (NASDAQ: ECOR) has secured an agreement with Byond Healthcare Pty Ltd. to distribute its gammaCore Sapphire™ non-invasive vagus nerve stimulator in South Africa and Namibia. This partnership aims to enhance access to innovative pain management solutions amid the opioid crisis. The gammaCore device is FDA-cleared and CE-marked for treating various headache-related conditions and can be self-administered by patients. The three-year exclusive distribution agreement requires regulatory clearances before sales commence.
- Secured exclusive distribution agreement with Byond Healthcare for gammaCore in South Africa and Namibia.
- gammaCore is FDA-cleared and CE-marked for treating migraine and cluster headaches.
- The agreement aligns with addressing the opioid crisis through non-pharmaceutical pain management.
- Sales and revenue are contingent on regulatory clearances.
ROCKAWAY, N.J., Feb. 21, 2023 (GLOBE NEWSWIRE) -- 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 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 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 Cockrell
CG Capital
404-736-3838
ecor@cg.capital
FAQ
What is the recent development for electroCore regarding distribution?
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