ROCKAWAY, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that Health Improvement Scotland (“HIS”) has published a Scottish Health Technology Group (“SHTG”) adaptation for NHS Scotland on the use of gammaCore for cluster headache. The SHTG publication is based on guidance produced in 2019 by the U.K. National Institute for Health and Care Excellence (“NICE”), which states that gammaCore, when used alongside standard of care, can reduce the frequency and intensity of cluster headache attacks, leading to significant quality of life benefits for people living with this condition and can save an average of £450 per patient in the first year of treatment through a reduction in acute rescue medication use, and with electroCore offering no-cost evaluations for all patients. The SHTG publication recommends that gammaCore should be available for a 3-month trial period for use in treating NHS Scotland patients suffering from cluster headache and the SHTG adaptation will now be disseminated across NHS Scotland health boards by HIS, to inform the use of gammaCore for cluster headache.
“We are delighted by the recommendation from the Scottish Health Technology Group to consider the application of the medical technology guidance produced by NICE in 2019 to NHS Scotland,” said Iain Strickland, electroCore’s VP of European Operations. “We welcome the opportunity to provide our proven and established therapy to more patients in Scotland suffering from the debilitating condition of cluster headache. I would like to thank the Scottish experts who worked on this assessment and arrived at the conclusion that an equivalent recommendation to the one in effect in England and Wales was also needed in Scotland. The publication notes the devastating impact that cluster headaches can have on the lives of sufferers and the desperation that can result from ineffective treatment, so the further ratification of gammaCore as an effective treatment option is great to see.”
The SHTG adaptation can be viewed at:
About Scottish Health Technology Group
The Scottish Health Technologies Group (SHTG) is a national health technology assessment (HTA) agency. They provide evidence support and advice to NHS Scotland on the use of new and existing health technologies which are not medicines and which are likely to have significant implications for people’s care.
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.
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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, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine 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.
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
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
Patients should not use gammaCore 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 their neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
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 anticipated government support provided by the HIS, SHTG, NHS and NICE; 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 Eastern 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.