electroCore, Inc. Announces Exclusive Distribution Agreement with Silvert Medical Nv-Sa. For Western Europe
Silvert Medical will serve as exclusive distributor of gammaCore Sapphire™ in Belgium, Luxembourg, the Netherlands, and France
ROCKAWAY, N.J., March 23, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced it has entered into an agreement with Silvert Medical Nv-Sa. (“Silvert Medical”) whereby Silvert Medical will serve as the exclusive distributor of the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) to patients suffering from primary headache disorders in Belgium, Luxembourg, the Netherlands, and France.
“Silvert Medical is proud and excited to represent electroCore’s non-invasive and drug-free medical treatment for chronic migraine and cluster headache. gammaCore Sapphire matches our mission of ’Innovation and Solutions for Better Patient Care’ perfectly,” said Eric Silvert, Owner and Managing Director of Silvert Medical. “Our long-term expertise in pain management and neuromodulation combined with our access to key opinion leaders within our territories such as Belgium, Luxembourg, the Netherlands, and France will help establish a solid and lasting business relationship.”
“We are delighted to collaborate with Silvert Medical as we continue to expand the geographical coverage of our nVNS therapy amongst patients suffering with migraine and cluster headache,” said Iain Strickland, electroCore’s Vice President of European Operations. “Silvert Medical is an experienced medical device supplier and we look forward to supporting them in our common goal of introducing our nVNS therapy, gammaCore Sapphire, in new Western European territories.”
The initial term of the agreement is three years, and it contains customary terms and conditions, including minimum purchase commitments.
About Silvert Medical Nv-Sa.
Belgium, Silvert Medical Nv-Sa brings a wealth of experience, knowledge and keen responsiveness as a medical device supplier and provides innovative and disruptive medical device technologies to the Belgium, Luxembourg, the Netherlands, and France clinical and patient community.
For more information, visit http://www.silvertmedical.com/
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
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 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. 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 with:
- An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
- An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
Safety and efficacy of gammaCore have not been evaluated in the following patients:
- 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 (younger than 12 years)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
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; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in Western Europe 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.