Neurometrix has received a CE mark for the over-the-counter version of its wearable nerve-stimulating device for chronic pain, opening the gates to both the OTC and prescription pain markets in Europe.
The Quell device is designed for people with nerve pain, sciatica, osteoarthritis and fibromyalgia, among other conditions. It is worn on the upper calf and stimulates sensory nerves, which carry neural pulses to the brain, according to the company. These pulses then prompt a natural response that blocks pain signals in the body and thereby alleviate pain, the company said. It connects to an optional app via Bluetooth, which patients may use to control and track their therapy.
“Europe is the natural market for initial international expansion of Quell sales,” said Neurometrix CEO Dr. Shai Gozani, in a statement. “Today we are focused on North America; however, our longer term strategy is to make Quell available in all markets with a high prevalence of chronic pain.”
Chronic pain is estimated to affect 100 million Americans, according to the Institute of Medicine of The National Academies. And anywhere between 20% and 40% of the European population suffers from chronic pain, Neurometrix said in the statement. With the CE mark in the bag, the company plans to “accelerate” partnership and distribution discussions with eyes on a market launch next year, Gozani said.
When the Quell device earned FDA clearance in 2014, Gozano said its over-the-counter nature allows for innovations that aren’t possible with a prescription device. Such devices have “to fit into a very narrow channel between what physicians want, what insurers are willing to pay for, and what works clinically,” he said.
In 2015, Neurometrix raised almost $400,000 in a crowdfunding campaign that sold the Quell device for $199 before reeling in $14.7 million through stocks and warrants. And in August, the company tapped Advantage Consumer Healthcare to lead Quell’s retail launch after initially offering the device through selected healthcare professionals and on the internet.