Avacen Medical recently announced that its product Avacen 100, an over-the-counter (OTC) medical device designed to treat widespread fibromyalgia pain and increase blood circulation, has received CE Marking.
The CE Mark means the product meets the requirements of all relevant medical device directives in the European Union and can now be marketed in the 28 member countries of the E.U.
Avacen 100 treats chronic pain differently from other therapies by using a noninvasive method of infusing heat into the circulatory system to induce muscle relaxation while increasing microcirculation — the movement of blood in the smallest blood vessels throughout the body.
Rather than providing pain relief only in one area, increased microcirculation allows for the relief of widespread pain, according to Avacen Medical.
The CE Mark was based on a Phase 2 study of Avacen 100 in 22 people with fibromyalgia at VA San Diego, a veterans healthcare facility in California. The Avacen study showed positive results in all participants. The 28-day trial (NCT01619579) showed a statistically significant reduction of more than 40 percent in the widespread pain index and a reduction in average tender point counts from approximately 15 to 9 (11 is the clinically meaningful threshold).
The study’s findings, titled “Effects of a 4-week AVACEN Treatment on Pain Perception in Fibromyalgia: An Open Label Study,” were published in Fibromyalgia: Open Access.
“The only OTC medical device on the market today is able to provide non-invasive, rapid whole body treatment, using a single point of contact,” Thomas Muehlbauer, CEO of Avacen Medical, said in a press release. “It is the ideal drug-free and safe alternative for relief of muscle and joint pain while increasing microcirculation.”
“The most exciting aspect of CE approval is that the E.U. market has shown high demand and acceptance for innovative new alternatives to pharmaceuticals for treating chronic pain,” Muehlbauer added.
The U.S. Food and Drug Administration (FDA) has approved Avacen 100 for the temporary relief of joint pain associated with arthritis, among other indications. Avacen 100 is not for sale in the U.S. or the E.U. for any non-cleared or non-approved indication.