electroCore, Inc. Announces Regulatory Approval in Canada
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that
gammaCore Sapphire will be distributed in
“Migraine Canada is pleased to learn that a new device to treat migraine and cluster headaches has been approved by
“We are pleased to achieve another significant regulatory milestone as we expand our global business,” said Iain Strickland, electroCore’s Vice President of European Operations. “We are looking forward to supporting the growth of our Canadian distribution partner, RSK Medical Inc.”
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 the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
For more information, visit www.rskmedical.com
About Migraine Canada
For more information, visit www.migrainecanada.org
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 is FDA cleared in
gammaCore contraindications include but are not limited to:
- Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- Patients with a metallic device, such as a stent, bone plate or bone screw, implanted at or near the neck
- Patients who 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:
- 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 of age)
- 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.
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 business, operating or financial impact of such studies; the commercial potential of nVNS generally and gammaCore in particular in
Rich Cockrell CG Capital404-736-3838 firstname.lastname@example.org or Media Contact: Summer DiazelectroCore 816-401-6333 email@example.com