Suwanee, GA – January 2, 2018 – SANUWAVE Health, Inc. (OTCQB: SNWV) has announced that the US Food and Drug Administration (FDA) has issued its decision on the de novo submission for the dermaPACE® System. Their decision, dated December 28, 2017, permits the marketing of the dermaPACE System as a Class II medical device used for the treatment of Diabetic Foot Ulcers (DFU) in the U.S., the world’s largest medical device market. This order by FDA is the culmination of intensive clinical studies by SANUWAVE and diligent work by both SANUWAVE employees and their regulatory partners, Musculoskeletal Clinical Regulatory Advisers (MCRA) in successfully submitting documentation and interacting with FDA during the clearance process.
The dermaPACE system was evaluated using two studies under an FDA approved IDE. The studies were designed as prospective, randomized, double-blind, parallel-group, sham-controlled, multi-center 24-week studies at 39 centers. A total of 336 subjects were enrolled and treated with either active dermaPACE plus conventional therapy or sham dermaPACE plus conventional therapy (a.k.a. standard of care). Conventional therapy included, but was not limited to, debridement, saline-moistened gauze, and pressure reducing footwear. The objective of the studies was to compare the safety and efficacy of the dermaPACE System to sham-control application. The prospectively defined primary efficacy endpoint for the dermaPACE System studies was the incidence of complete wound closure at 12 weeks post-initial application of the dermaPACE system (active or sham). Complete wound closure was defined as complete skin re-epithelialization without drainage or dressing requirements, confirmed over two consecutive visits within 12-weeks. If the wound was considered closed for the first time at the 12-week visit, then the next visit was used to confirm closure. Investigators continued to follow subjects and evaluate wound closure through 24 weeks ….
