SANUWAVE Health Inc. announced today that a de novo petition has been submitted to the U.S. Food and Drug Administration (FDA) asking for the review and classification of the dermaPACE System to be used in the treatment of Diabetic Foot Ulcers (DFU) as a Class II device.
The petition was submitted coming off the company’s two 24-week trials evaluating the safety and efficiency of the dermaPACE system, which included 336 patients. The trials were double-blind, parallel group, sham controlled and conducted over multiple centers.
“We are confident that the compelling clinical outcomes demonstrated in this rigorous double-blinded, sham controlled clinical trial provide credible, unbiased evidence that the dermaPACE System combined with current standard of care significantly and positively impacts wound healing in these clinically challenging diabetic foot ulcers compared with standard of care alone,” Kevin A. Richardson II, SANUWAVE’s chairman of the board, said. “We are pleased to submit this strong package of clinical evidence to the FDA in support of our dermaPACE System to treat diabetic foot ulcers. We look forward to a positive response from the agency so we can bring this novel, promising treatment to the millions of patients who suffer from these debilitating, recalcitrant wounds.”
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