electroCore, Inc. Announces Regulatory Approval in Canada
gammaCore Sapphire products approved for prevention and therapeutic treatment of migraine and cluster headache
ROCKAWAY, NJ, April 05, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that Health Canada has granted regulatory approval for the promotion and sale of the gammaCore Sapphire family of products in Canada for prevention and therapeutic treatment of migraine and cluster headache, as outlined in the registration application with Health Canada.
gammaCore Sapphire will be distributed in Canada by RSK Medical Inc., pursuant to an exclusive distribution agreement announced on January 26, 2021. The initial term of the agreement is three years, and the agreement contains customary terms and conditions, including minimum purchase commitments. “Patients and clinicians in Canada have been waiting years for this novel migraine and cluster headache therapy. RSK Medical Inc. is delighted to bring another breakthrough medical device technology to the Canadian marketplace. We look forward to working towards provincial healthcare funding for this patient group” said Scott Kadwell, President of RSK Medical Inc.
“Migraine Canada is pleased to learn that a new device to treat migraine and cluster headaches has been approved by Health Canada. Timely and equitable access to diverse and affordable treatment options and devices are essential for patients living with these painful and debilitating diseases” said Dr. Elizabeth Leroux, president of the Canadian Headache Society and the founder and chair of Migraine Canada.
“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.
About RSK Medical, Inc.
Headquartered in Ontario, RSK Medical Inc. brings a wealth of experience, knowledge and keen responsiveness as a medical device supplier and is dedicated to providing innovative and disruptive medical device technologies to the Canadian clinical and patient community.
For more information, visit www.rskmedical.com
About Migraine Canada
Migraine Canada is an alliance of patients and health care providers working together to improve the lives of people living with migraine and other headache disorders in Canada, through awareness, support, education, advocacy and research
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 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 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 Canada 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 CockrellCG Capital 404-736-3838 firstname.lastname@example.org or Media Contact: Summer Diaz electroCore 816-401-6333 email@example.com