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Next Generation nVNS Therapy gammaCore Sapphire™ Now Available for Patients with Migraine and Episodic Cluster Headache in United States
BASKING RIDGE, N.J., Aug. 01, 2018 -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced gammaCore Sapphire™, the next generation of gammaCore (non-invasive vagus nerve stimulator or nVNS), is now available in the United States. gammaCore is the first U.S. Food and Drug Administration (FDA) cleared, nVNS device for the acute treatment of pain associated with migraine and episodic cluster headache.
gammaCore Sapphire is the next generation of gammaCore nVNS therapy, which is designed as a portable, easy-to-use technology. gammaCore Sapphire can be self-administered by patients as needed for the pain associated with migraine and episodic cluster headache without the potential side effects associated with commonly prescribed medicines. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s fibers, resulting in the reduction of pain. The improved design features of gammaCore Sapphire include:
- A sleeker, smaller handheld device that is easy for patients to grip
- Smoother stimulation surfaces for easy placement over the vagus nerve
- Intensity buttons positioned on the side of the device to facilitate therapy adjustments
- A larger, brighter display to communicate status information, even in the dark
Additionally, gammaCore Sapphire includes added functionality intended for multi-year use, with a rechargeable function and reloadable refill capability. It can be activated monthly through the input of a unique, prescription-only authorization code, delivered via a radio-frequency identification (RFID) card that is mailed directly to the patient.
“gammaCore Sapphire offers more convenience to patients with an enhanced designed and added functionalities that make the therapy application more seamless and even more patient-centric than the device’s previous generation,” said Dan Duhart, Chief Commercial Officer of electroCore. “Constantly innovating to deliver the next-generation device is just one example of our commitment to providing relief to patients suffering from the debilitating pain of migraine and episodic cluster headache.”
gammaCore is prescribed by a physician and each device allows for treatment of multiple headaches per day up to 24 stimulations per day. If experiencing migraine or episodic cluster headache pain, patients should talk to their physician, or visit http://gammaCore.com to help find a local physician.
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck that acutely treats the pain associated with episodic cluster headache and migraine in adult patients 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 released/cleared in the U.S. for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.
IMPORTANT SAFETY INFORMATION REGARDING GAMMACORE
- The safety and effectiveness of the gammaCore (nVNS) have not been established in the acute treatment of chronic cluster headache.
- gammaCore has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache or migraine headache.
- 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 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 important warnings and precautions before using or prescribing this product.
gammaCore is available by prescription only. U.S. Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.
About electroCore, Inc.
electroCore, Inc. is a commercial-stage bioelectronic medicine healthcare company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation (nVNS) platform therapy initially focused on the treatment of multiple conditions. The company’s initial commercial focus is on the acute treatment of pain associated with migraine and episodic cluster headache in adults.
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 and product development plans, its pipeline or potential markets for its technologies, 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™, 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.