WALTHAM, Mass.--(BUSINESS WIRE)--NeuroMetrix, Inc. (Nasdaq: NURO, NUROW) announced today that the CE (Conformité Européenne) Certificate for Quell® has been received from TŰV SŰD Product Service GmbH, which is one of the Notified Bodies responsible for reviewing and approving new products. This certification in the European Union allows sales and marketing of Quell as a class IIa medical device, as defined by the Medical Device Directive (93/42/EEC). CE certification or “CE Marking” allows 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 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.”
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 in the US at select healthcare professionals and retailers. Visit QuellRelief.com for more information.
NeuroMetrix is a commercial stage, innovation driven healthcare company combining bioelectrical and digital medicine to address chronic health conditions including chronic pain, sleep disorders, and diabetes. The company's lead product is Quell, an over-the-counter wearable therapeutic device for chronic pain. Quell is integrated into a digital health platform that helps patients optimize their therapy and decrease the impact of chronic pain on their quality of life. The company also markets DPNCheck®, a rapid point-of-care test for diabetic neuropathy, which is the most common long-term complication of Type 2 diabetes. The company maintains an active research effort and has several pipeline programs, including a therapeutic device for restless leg syndrome. 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.