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."
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.
