Interim Phase III data for dermaPACE in Diabetic Foot Ulcers does not meet endpoint-Sanuwave Health

Sanuwave Health has announced that the independent Data Monitoring Committee (DMC) has performed an interim analysis on the efficacy and safety results in the Phase III supplemental clinical trial using the dermaPACE for treating diabetic foot ulcers. The DMC performed an analysis of the primary efficacy endpoint of the rate of 100% complete wound closure at the 12-week endpoint for the dermaPACE treated patients as compared to the sham-control patients and the safety data. The DMC has completed its review and noted there were no safety issues.

The DMC reported the Monitoring Success Criterion for the primary efficacy endpoint of 100% complete wound closure at 12 weeks has not been met and, assuming similar trends for any additional patents enrolled, will likely not be met at the next predefined analysis point of 170 patients. The Monitoring Success Criterion is a predictive probability of dermaPACE achieving statistical significance in the rate of 100% complete wound closure at 12 weeks as compared to the rate for sham-control.

The DMC has requested to the Company the ability to review complete closure rates at later points in the study, as patients were followed for up to 24 weeks and the DMC noted the Company had positive results at the 20-week endpoint in the first study of 206 patients completed in 2011. The Company expects to have feedback from the FDA by the end of this quarter.