NeuroMetrix (NSDQ:NURO) said today it won CE Mark approval in the European Union for its Quell wearable pain relief device, now cleared as a class IIa medical device in the region.
The Waltham, Mass.-based company said that recent studies indicate that 20-40% of the adult European population suffers from chronic pain, which costs the region approximately $250 billion annually. NeuroMetrix’s Quell is designed to treat chronic pain, which can help improve sleep, mental and general health.
“Europe is the natural market for initial international expansion of Quell sales. 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. Now that we have CE Certification, we will accelerate partnership and distribution discussions that will position us for market entry in 2017. We are pleased to have gained certification making Quell available in Europe,” CEO Dr. Shai Gozani said in a press release.
In September, NeuroMetrix said it launched a pilot study of its Quell wearable pain relief device for treating patients with fibromyalgia. NeuroMetrix said it is partnering with the Synovation medical group to carry out the study.
In June, NeuroMetrix said it is seeking CE Mark approval in the European Union for over-the-counter clearance for its Quell wearable chronic pain relief system. The company touted recent studies which indicate that 20-40% of the adult European population suffer fron chronic pain, with an annual financial cost exceeding $250 billion.
Earlier in June, NeuroMetrix said it closed a $21.3 million round of funding through the private placement of preferred stock and warrants to support its Quell device.
