Sanuwave files for de novo FDA nod for DermaPace wound care device

Sanuwave Health (OTC:SNWV) said last Thursday it filed a de novo petition with the FDA as it seeks approval for its DermaPace system designed for treating diabetic foot ulcers. Sanuwave said it expects to hear a response from the FDA within 120 days, and is hopeful that evidence from over 336 patients across 2 trials are enough to “quantify the safety and effectiveness of the non-invasive procedures with the DermaPace system.” “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,” board chair Kevin Richardson II said in prepared remarks. The company said it chose the de novo pathway as it was the “most appropriate regulatory pathway for the DermaPace for diabetic foot ulcers because of the continued, strong evidence of safety when using the device.” In July, Sanuwave said it met with the FDA to ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Diabetes Food & Drug Administration (FDA) SANUWAVE Health Inc. Source Type: news