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electroCore, Inc.. a commercial-stage bioelectronic medicine company, today announced that the Official Journal of the European Union (OJEU) has published a Voluntary ex-ante Transparency Tender Notice on behalf of NHS England, citing electroCore as the sole supplier of non-invasive vagus nerve stimulation therapy to patients within NHS England. The award will provide further funding for the continued use of gammaCore for the treatment of cluster headache for patients who respond to the therapy. The proposed contract will run for 6 months from October 1, 2020 to March 31, 2021. The proposed contract includes the option to extend for up to 3 years beyond March 31, 2020.<\/p>\n
“gammaCore is rapidly becoming an established treatment option for clinicians and patients managing cluster headache in England. This continuation of funding shows a real commitment from NHS England to provide cost-effective and clinically beneficial innovations to patients who need them the most,” said Iain Strickland, VP of European Operations, electroCore, Inc. “Importantly, gammaCore remains the only medical technology recommended by the National Institute for Health and Care Excellence (NICE) for use in patients with cluster headaches, fulfilling an important unmet need.”<\/p>\n
In 2019, NICE published an evidence-based Medical Technology Guidance document recommending the use of gammaCore for cluster headache within NHS England.<\/p>\n
About gammaCore™<\/strong><\/p>\n 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. <\/p>\n 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. In 2019, NICE published an evidence-based Medical Technology Guidance document recommending the use of gammaCore for cluster headache within NHS England.<\/p>\n 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.<\/p>\n Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.<\/p>\n gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.<\/p>\n gammaCore Sapphire CV has been authorized for the above emergency use by FDA under an Emergency Use Authorization.<\/p>\n gammaCore Sapphire CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.<\/p>\n Please refer to gammaCore Sapphire CV (nVNS) Instructions for Use for all of the important warnings and precautions before using or prescribing gammaCore Sapphire CV (nVNS).<\/p>\n About electroCore, Inc.<\/strong><\/p>\n 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.<\/p>\n For more information, visit www.electrocore.com.<\/p>\n Investors: or<\/p>\n Media Contact: Tags:<\/b> Investors:\n
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Hans Vitzthum
LifeSci Advisors
617-430-7578
hans@lifesciadvisors.com<\/p>\n
Jackie Dorsky
electroCore
973-290-0097<\/p>\nSee Campaign: <\/strong>http:\/\/www.electrocore.com.<\/a>
Contact Information:<\/b>
Investors:
\nHans Vitzthum
\nLifeSci Advisors
\n617-430-7578
\nhans@lifesciadvisors.com<\/p>\n
<\/a>, Wire<\/a>, Disclosure Newswire<\/a>, United States<\/a>, English<\/a><\/p>\n<\/div>\n
\nContact Information:<\/h3>\n
\nHans Vitzthum
\nLifeSci Advisors
\n617-430-7578
\nhans@lifesciadvisors.com<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"electroCore, Inc.. a commercial-stage bioelectronic medicine company, today announced that the Official Journal of the European Union (OJEU) has published a Voluntary ex-ante Transparency Tender Notice on behalf of NHS England, citing electroCore as the sole supplier of non-invasive vagus nerve stimulation therapy to patients within NHS England. The award will provide further funding for … Continue reading electroCore, Inc. Announces Publication of a Voluntary ex-ante Transparency Tender Notice Award by NHS England to Fund Continued Use of gammaCore™ in England<\/span><\/a> Continue Reading