BASKING RIDGE, N.J., April 08, 2020 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that England’s National Health Service (NHS) has exercised its option to extend the Innovation and Technology Payment (ITP) Program for the use of gammaCore in the treatment of cluster headache in adults. The extension will run through September 2020 and via this program, which started in April 2019, gammaCore will continue to be reimbursed for those patients in England who suffer from cluster headache and respond to our therapy.
“We are pleased to have NHS England maintain their ITP program to fund and support bringing our gammaCore therapy to patients suffering from cluster headache. gammaCore remains the only device approved by the National Institute for Health and Care Excellence (NICE) for use in patients with drug resistant cluster headaches,” said Iain Strickland, VP of European Operations, electroCore, Inc.
The ITP Program is designed to support the adoption of innovations and technologies in the NHS market through the removal of significant financial barriers for both commissioners and providers. The program provides funding to these MedTech products and promotes a broader set of activities with Academic Health Science Networks (AHSNs) in order to deliver improvements in the quality and efficacy of patient care.
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy FDA-cleared for the prevention of migraine headache, as an adjunctive therapy for the preventative treatment of cluster headache and as an acute treatment for pain associated with episodic cluster headache and migraine headache in adult patients. 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 leading to a modulation of neurotransmitters and a reduction in pain.
gammaCore is the only therapy FDA-cleared for the prevention of cluster headache.
gammaCore is available by prescription only and patients should speak with their doctor about whether gammaCore is right for them.
gammaCore™ (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:
- The preventive treatment of migraine headache in adult patients.
- The acute treatment of pain associated with migraine headache in adult patients.
- 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 long-term effects of the chronic use of gammaCore have not been evaluated
- Safety and efficacy of gammaCore have not been evaluated in the following patients, and therefore it is NOT indicated for:
• Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• 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 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)
NOTE: This list is not all inclusive. Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
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 and rheumatology. The company’s initial targets are the preventative treatment of cluster headache and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
This press release 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, sales and marketing, and product development plans, future cash flow projections, anticipated costs , its pipeline or potential markets for its technologies, the availability and impact of payer coverage, the potential product use for other indications, 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, sales and marketing, and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to successfully commercialize gammaCore™, 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.