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."
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160622005132/en/
NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
SVP and
Chief Financial Officer
neurometrix.ir@neurometrix.com
Source: NeuroMetrix, Inc.
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