NeuroMetrix Receives CE Mark Certification for Quell Wearable Pain Relief Device
November 29 2016 - 7:00AM
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.”
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 in the US at select
healthcare professionals and retailers.
Visit QuellRelief.com for more information.
About NeuroMetrix
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161129005162/en/
NeuroMetrix, Inc.Thomas T. Higgins, 781-314-2761SVP and Chief
Financial Officerneurometrix.ir@neurometrix.com
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