electroCore, a neuroscience and technology company, announced the commercial launch of gammaCore (non-invasive vagus nerve stimulator) for the acute treatment of pain associated with episodic cluster headache in adult patients in the United States. gammaCore is the first non-invasive, hand-held medical device applied at the neck and sends gentle, patented electrical stimulation through the skin to activate the vagus nerve, resulting in the reduction of pain.
"We are proud to bring gammaCore to the US market, as it provides episodic cluster headache sufferers with a much-needed treatment option for this rare and often debilitating condition," said Francis R. Amato, chief executive officer of electroCore. "The commercial launch also signifies an important milestone for electroCore, marking the first marketed product for the company in the US."
Patients can receive the device by enrolling in gammaCore Patient Registry (GPR), a non-research registry intended to examine the patient experience with gammaCore. As part of the registry, those eligible may receive two months of gammaCore treatment at no cost to the patient, in return for sharing information about their experience with the device along with periodic quality-of-life, self-reported outcomes.
Additional key offerings of GPR include: An interactive, online tracker to record information about cluster attacks as they occur; Hands-on training for how to use gammaCore from a GPR coordinator; Access to online and in-person support from a care specialist throughout the duration of treatment; Co-pay assistance for up to one year.
GPR will be offered through a select group of headache centers across the country. In order to participate in GPR, adult patients must be diagnosed with episodic cluster headache and selected by their participating healthcare provider (HCP) as appropriate candidates.
Cluster headache is a rare but extremely painful primary headache disorder characterized by recurring unilateral attacks.i The condition is the least common type of headache disorder, occurring in approximately one to two out of 1,000 individuals. Cluster headache predominantly affects males, with symptoms typically manifesting by the age of 30. Frequently nicknamed "suicide headache" due to the severity of pain associated with their occurrence, cluster headache bouts occur rapidly and with variable frequency but often at the same time each year or day and are often more frequent at night. Those at greater risk of cluster headache include heavy smokers and those with a family history of the condition.
gammaCore (nVNS) is the first non-invasive, hand-held medical device applied at the neck that acutely treats the pain associated with episodic cluster headache in adult patients through the transmission of a mild electrical stimulation to the vagus nerve 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 standard of care. 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 US for the acute treatment of pain associated with episodic cluster headache in adult patients. gammaCore is currently in use outside of the US, including in the European Union, where it is CE-Marked.
electroCore, LLC is a US-based neuroscience and technology company dedicated to improving patient outcomes through technological advancement and focused on developing non-invasive vagus nerve stimulation therapy for the treatment of multiple conditions in neurology, inflammation, and metabolic syndrome.