Health Canada Approves AVACEN 100 to Treat Pain in Fibromyalgia Patients

Health Canada Approves AVACEN 100 to Treat Pain in Fibromyalgia Patients
Avacen Medical recently announced that its Avacen 100 Class II medical device, previously licensed for treating joint pain associated with arthritis, is now licensed by Health Canada to treat generalized pain associated with fibromyalgia. Unlike previously approved treatments for the widespread pain associated with fibromyalgia, which Lyrica (pregabalin) or Savella (milnacipran), Avacen 100 uses the "Avacen Treatment Method" to offer drug-free muscular relaxation. The Avacen device infuses heat, non-invasively, into the circulatory system to create muscular relaxation, while increasing microcirculation throughout the body. Health Canada’s decision follows the recent CE Mark approval for Avacen 100 – a regulatory status that means a drug or product is aligned with the European Commission’s standards and can be marketed in any of the European Union’s 28 member states. Avacen 100 was evaluated in a Phase 2 clinical trial (NCT01619579) it sponsored in 22 fibromyalgia patients. The 28-day follow-up study showed a statistically significant reduction of more than 40 percent in widespread pain index among participants, and a reduction in average tender point counts from approximately 15 to 9, a
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