NeuroMetrix Submits CE Mark Application for Quell Wearable Pain Relief Device
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.”
About Quell
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.
About NeuroMetrix
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.
NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
SVP and Chief Financial Officer
neurometrix.ir@neurometrix.com
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