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Monday, April 12, 2010

SANUWAVE : Enrollment in dermaPACE Phase III Pivotal IDE Clinical Trial for the Treatment of Diabetic Foot Ulcers

SANUWAVE HealthApril 6, 2010 – SANUWAVE Health, Inc., (OTC BB: SNWV), an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, announced that patient enrollment was completed in March in its dermaPACE™ Phase III pivotal, randomized, double-blinded, sham controlled, multicenter clinical trial comparing its Pulsed Acoustic Cellular Expression (PACE™) technology, utilizing the dermaPACE™ tissue regeneration device, to sham control for the treatment of diabetic foot ulcers (DFU).
The primary study goal is to establish superiority in diabetic foot ulcer healing rates using the dermaPACE™ treatment compared to sham control, when both are combined with the current standard of care. The standard of care includes wet-to-dry dressings, the most widely used primary dressing material in the United States, and offloading with a walking boot... [PDF] SANUWAVE Health's Press Release -