Migraine Market Promising Despite Two Device Failures
by James Cavuoto, editor
October 2020 issue
The neurotechnology market for treating migraine continues to show promise, despite some uncertainties caused by the demise of two early entrants in the space. While the commercial failures have caused concern in some patient advocacy groups, the wealth of product alternatives will likely keep this product segment on an upward trajectory.
In August, eNeura Inc., a manufacturer of a handheld TMS device for treating migraine, filed for Chapter 7 bankruptcy and no other vendor has yet emerged to continue marketing their device. And Autonomic Technologies, the manufacturer of a minimally invasive SPG stimulation device, was forced to close its doors last year as a result of regulatory fraud [NBR Jan20 p3]. A firm called Unity HA has acquired ATI’s IP and intends to revive the product.
Ironically, both eNeura’s single-pulse sTMS mini and ATI’s implanted Pulsante device were effective in treating migraine. A promising study of 93 patients with cluster headache treated with Pulsante was published in Lancet Neurology shortly after ATI’s demise. The eNeura device was approved in the U.S., Europe, Australia, and Singapore for both the acute treatment of migraine and migraine prevention for patients 12 and older. The eNeura bankruptcy caused consternation among many customers who had achieved good results from the device but found themselves locked out by the now-bankrupt company’s subscription model.
Meanwhile, another migraine vendor, Cefaly Technology, earlier this month announced that the FDA has cleared their noninvasive trigeminal nerve stimulation system as an over-the-counter product for the acute and preventative treatment of migraine headaches in adults 18 years and older.
Cefaly’s Dual device is placed on the forehead to modify pain sensation in the area research identifies as a center for migraine pain, the trigeminal nerve. The device offers two distinct treatment options—a 60-minute acute setting that serves as an abortive treatment for pain relief at the onset of a migraine, which is clinically proven to stop or reduce migraine pain during an attack; and a 20-minute prevent setting for daily use to help prevent future episodes.
Another player in the neurotech migraine market is electroCore Medical, which offers a surface VNS stimulation device that is FDA-cleared for migraine and cluster headache. Although the device is currently selling through VA and DoD channels, electroCore restructured its commercial distribution channel earlier this year amid reports that its Sapphire device was underperforming in the migraine market. The company expects third quarter 2020 revenue to be about $1 million, with a $4 million cash burn. They announced that the NHS in the U.K. recently renewed its reimbursement of the device for cluster headache, which could yield an additional revenue of $4.6 million over the next three years.
Two other vendors of migraine devices, Theranica and Neurolief, seem to be doing well in the market. Theranica’s Nerivio device received CE mark last month and recently announced expanded labeling from the FDA. Nerivio now has clearance for use in acute treatment of migraine with or without aura in patients 18 years of age or older, without limitation to episodic migraine. Nerivio uses remote electrical neuromodulation to activate the brain’s conditioned pain modulation to treat pain and accompanying migraine symptoms. Neurolief’s Relivion stimulation device, which activates occipital and trigeminal nerves, received CE mark last year.