Sanuwave Health, Inc. (OTCQB:SNWV) is developing non-invasive medical devices using its proprietary Pulsed Acoustic Cellular Expression (PACE) technology to aid in the body's repair and regeneration of tissue, musculoskeletal and vascular structures. PACE works by creating shock waves which, in-turn, elicit a biological response and help the healing process.
Recent clinical studies have indicated the company's lead product, dermaPACE, is more effective than current standard of care in the treatment of serious life-threatening diabetic foot ulcers (DFU). In July 2011 Sanuwave made the third and final module filing of a three-tiered PMA application seeking FDA approval of dermaPACE for the treatment of diabetic foot ulcers. Surprisingly, the FDA responded in December 2011 with a major deficiency letter,
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