NeuroMetrix announced that they have received the Certificate for Quell from TUV SUD Product Service GmbH who are basically responsible for reviewing and approving new products. As defined by the Medical Device Directive, in the European Union, the certificate allows sales and marketing of Quell as a class IIa medical device. The certificate will grant access for Quell to be marketed directly to consumers within the European Union. And so now with the certificate on wearable nerve-stimulating device for chronic pain, it is opening the gates to both the OTC and prescription pain markets in Europe.
Speaking of the device, it is engineered for people with nerve pain, sciatica, osteoarthritis and fibromyalgia, among other things. According to the company, it’ll be worn on the upper calf of the patient and upon doing that, the device will stimulate sensory nerves that’ll carry neutral pulses to the brain. And as to how it’ll alleviate pain, these pulses will then prompt a very natural response that’ll block pain signals from the body and ultimately pain away from you.
The wearable device can be connected to a dedicated app via Bluetooth. With this the wearer can control and track their progress and make amends based on their needs. As per Business Wire, Quell users can start, stop, and adjust therapy discreetly by using the app. The device offers advanced sleep tracking that provides feedback on eight dimensions of sleep including sleep duration, quality, body position, repetitive leg movements, time out of bed, throughout the night.
“Europe is the natural market for initial international expansion of Quell sales. 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,” said Neurometrix CEO Dr. Shai Gozani, in a statement.
Around 20% to 40% Europeans suffer from chronic pain, according to Neurometrix. As per reports from the Institute of Medicine of The National Academies, chronic pain is something that haunts 100 million Americans. “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,” Gozani said. And in the US, the impact of chronic pain extends beyond the direct effects of pain and includes general poor health, cardiovascular disease, disturbed sleep, low activity, mental health issues, among other things.
As per Fierce Biotech, back in 2014, when Quell earned FDA clearance, Gozano said that it’s nature made several innovations possible that usually aren’t possible with a prescription device. Such devices have “to fit into a very narrow channel between what physicians want, what insurers are willing to pay for, and what works clinically.”
It’s worth noting that Quell was the winner of the 2016 SXSW (South by Southwest) Innovation Award for Best Wearable Technology. Neurometrix raised almost $400,000 in a crowdfunding campaign that sold the Quell device for $199 in 2015. And with stocks and warrants, they reeled in some $14.7. NeuroMetrix combines bioelectrical and digital medicine to address issues like chronic health conditions including chronic pain, diabetes, and sleep disorders.