SANUWAVE Health, Inc. announced that it has submitted to the U.S. Food and Drug Administration (FDA) a de novo petition requesting Agency review and classification of the dermaPACE System for treating Diabetic Foot Ulcers (DFU) as a Class II device. Through the course of two trials, 336 patients were randomized in double-blind, parallel group, sham controlled, multicenter, 24-week pivotal clinical trials that were designed to quantify the safety and effectiveness of the noninvasive procedures with the dermaPACE System (dermaPACE®).
Working with Musculoskeletal Clinical Research Associates (MCRA), SANUWAVE submitted to FDA a de novo petition. Due to the extremely strong safety profile of the dermaPACE System and the efficacy of the data showing statistical significance for wound closure for dermaPACE subjects at 20 weeks and out to 24 weeks, SANUWAVE believes that dermaPACE should appropriately be considered for classification into Class II.
SANUWAVE chose the de novo pathway because we believe it is the most appropriate regulatory pathway for the dermaPACE for diabetic foot ulcers because of the continued, strong evidence of safety when using the device.
Should FDA determine that guidance and evaluation criteria are met, FDA can grant the de novo, in which case the dermaPACE will be classified as Class II and may be marketed immediately. SANUWAVE expects to hear feedback from the FDA within 120 days.
Commenting on today’s announcement, Kevin A. Richardson II, SANUWAVE’s Chairman of the Board, said, “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.”
“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,” concluded Mr. Richardson.
