NeuroMetrix Receives CE Mark Certification for Quell Wearable Pain Relief Device
WALTHAM, Mass.–(BUSINESS WIRE)–$NURO #chronicpain–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.
Contacts
NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
SVP and
Chief Financial Officer
neurometrix.ir@neurometrix.com
