WALTHAM, Mass.--(BUSINESS WIRE)--NeuroMetrix, Inc. (Nasdaq: NURO) announced today that a CE (Conformité Européenne) Technical File Application for Quell® has been submitted to TŰV SŰD Product Service GmbH, which is one of the Notified Bodies responsible for reviewing and approving new products. This regulatory filing seeks Quell CE certification in the European Union as a class IIa medical device, as defined by the Medical Device Directive (93/42/EEC). CE certification or “CE Marking” will allow Quell to be marketed directly to consumers within the European Union.
Recent epidemiological studies indicate that 20-40% of the adult European population suffers from chronic pain, with an annual financial cost exceeding US $250B. As in the US, the impact of chronic pain extends beyond the direct effects of pain to include disturbed sleep, low activity, mental health issues, cardiovascular disease and generally poor health.
“Europe is the natural market for initial international expansion of Quell sales,” said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix. “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 filed for CE Marking, we will accelerate partnership and distribution discussions that will position us for market entry in 2017. We are pleased to have taken this first step towards making Quell available in Europe.”
Quell is designed for millions of people suffering from chronic pain. The advanced wearable device is lightweight and can be worn during the day while active, and at night while sleeping. It has been cleared by the FDA for treatment of chronic pain without a prescription. In a recent study, 81% of Quell users reported an improvement in their chronic pain. Quell users can start, stop, and adjust therapy discreetly via the optional Quell Relief app. Quell also offers advanced sleep tracking that provides feedback on eight dimensions of sleep including sleep duration, quality, body position, time out of bed, and repetitive leg movements throughout the night. Quell was the winner of the 2016 SXSW (South by Southwest) Innovation Award for Best Wearable Technology. Quell is available at select healthcare professionals and retailers. To find a Quell retailer near you, visit the Store Locator at QuellRelief.com.
NeuroMetrix is an innovative health-care company that develops wearable medical technology and point-of-care tests that help patients and physicians better manage chronic pain, nerve diseases, and sleep disorders. The company is located in Waltham, Massachusetts and was founded as a spinoff from the Harvard-MIT Division of Health Sciences and Technology in 1996. For more information, please visit www.NeuroMetrix.com.