Sanuwave Completes Minimum Enrollment in Dermapace Trial

Alpharetta, Ga.-based Sanuwave Health Inc. has enrolled the 90th patient in its phase III supplemental clinical trial using Dermapace for treating diabetic foot ulcers (DFUs), which represents the minimum number of patients the company must enroll for the first interim analysis.

“We are very pleased to have reached this major milestone for minimum enrollment in the supplemental clinical trial of Dermapace to treat diabetic foot ulcers,” said Chairman of the Board Kevin Richardson. “We anticipate having the feedback from the data monitoring committee regarding the first 90 patients in the third quarter and look forward to updating shareholders at that time.”

The goal of the trial is to demonstrate that the healing rate of Dermapace is statistically superior to that of sham at 12 weeks post initial device application. Patients enrolled in the study receive four non-invasive procedures (Dermapace or sham) during the first two weeks. In addition, up to four additional non-invasive procedures (Dermapace or control) are delivered bi-weekly, between weeks 4 and 10. After the 12-week efficacy evaluation, patients are followed for an additional 12 weeks for safety. The study will continue to enroll new patients while 12-week efficacy data are collected on the first 90 patients.

“I would like to give credit and thanks to our study investigators and their dedicated staff. They have done an outstanding job in recruiting high quality patients in a relatively short timeframe,” said Chief Medical Officer Daniel Jorgensen, M.D. “Assuming positive study results, Dermapace could transform the way diabetic foot ulcers are treated.”

The first interim analysis will be performed by an independent data monitoring committee shortly after the 90th patient has completed the 12-week efficacy visit. If success criteria are met, the committee will recommend to Sanuwave that further enrollment can be stopped.

Sanuwave is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures.