DermaPACE: Phase III start

This quarter, Sanuwave will begin a double-blind, U.S. Phase III trial to evaluate dermaPACE in combination with standard of care in >=90 patients with diabetic foot ulcers. Patients will receive 4 treatments with dermaPACE or sham during the first 2 weeks and up to 4 additional treatments during weeks 4-10. Sanuwave plans to submit a PMA to FDA for dermaPACE as early as the end of 2014.

In December 2011, Sanuwave received a major deficiency letter from FDA regarding a previous PMA for dermaPACE. According to Sanuwave, the agency cited a number of deficiencies, including that dermaPACE missed that primary endpoint of 100% wound closure in the supporting clinical trial. The agency recommended that Sanuwave conduct an additional trial. ...