Avacen Medical has received Conformite Europeene (CE) Mark approval for its Avacen 100, Class-Ila, an over-the-counter medical device for treating pain associated with fibromyalgia.
With the CE mark, the company now sell its Avacen 100 in European Union’s 28 member countries for treating fibromyalgia pain.
Fibromyalgia is a medical condition characterised by widespread pain and heightened pain response to pressure.
About 200 to 400 million people worldwide are affected with the condition, as per the National Fibromyalgia Association and about 14 million people in Europe are affected according to European Network of Fibromyalgia Associations (ENFA).
Avacen claims that its new product Avacen 100 takes a completely new route for treating fibromyalgia. It is an OTC medical device which is non-invasive and safely infuses heat into the circulatory system that helps muscles relax, while increasing microcirculation throughout the body.
AVACEN Medical CEO Thomas Muehlbauer said: "AVACEN 100 is the only OTC medical device on the market today able to provide non-invasive, rapid whole body treatment, using a single point of contact. It is the ideal drug-free and safe alternative for relief of muscle and joint pain."
"The most exciting aspect of CE approval is that the EU market has shown high demand and acceptance for innovative new alternatives to pharmaceuticals for treating chronic pain."
CE approval of Avacen 100 was based on a 22 person fibromyalgia study. Avacen claims that the study showed 100% positive results for the full therapeutic treatment group.
The study was conducted under a Cooperative Research Development Agreement with the US Department of Veterans Affairs at the University of California San Diego Center for Pain Medicine, Perlman Medical Center and the VA Medical Center, San Diego.
Image: Avacen 100 receives CE approval for sale in the European Union member countries. Photo: Courtesy of PR Newswire Association LLC.