SNWV news from Dec 1 ~
SANUWAVE Enrolls 130th Patient in Its dermaPACE Clinical Trial Treating Diabetic Foot Ulcers
ALPHARETTA, Ga., Dec 01, 2014 (GLOBE NEWSWIRE via COMTEX) -- SANUWAVE Health, Inc. (OTCQB:SNWV) today announced that the Company has enrolled its 130 patient in the Phase III supplemental clinical trial using dermaPACE for treating diabetic foot ulcers (DFU's), which represents the number of patients the Company must enroll for the second interim analysis by the independent Data Monitoring Committee (DMC). The Company has suspended further enrollment in the study until the Data Monitoring Committee provides feedback on the 130 patients.
Kevin Richardson, II, Chairman of the board of directors of SANUWAVE, stated, "We are very pleased to have reached this enrollment milestone in the supplemental clinical trial of dermaPACE to treat diabetic foot ulcers. We anticipate having the feedback from the Data Monitoring Committee regarding the 130 patients in the first quarter of 2015 and look forward to updating shareholders at that time."
The DMC will perform an analysis on the entire 130 patient population once the patients have completed the twelve week efficacy analysis period. This is expected to be completed in the first quarter of 2015. After their review of the 130 patients, the DMC may recommend: 1) stopping enrollment because the dermaPACE has met the minimum success criteria as compared to sham-control, 2) increasing enrollment to 170 patients which is the next predefined patient analysis point, or 3) stopping the trial due to poor results.
