24-Week Trial Data Announced / Final Module Filed…
In early July SANUWAVE (SNWV) announced that they had made the third and final module filing to the FDA for dermaPACE in the treatment of diabetic foot ulcers.
Also announced was 24-week data from SANUWAVE's Phase III IDE study. The data, along with the 12-week results, which were announced in December 2010, will serve as support for FDA approval and were included in the third module filing.
The recent data demonstrated that at week 20 dermaPACE did show a statistically significant greater rate of wound closure compared to sham-control. As a reminder, while the 12-week data showed a higher percentage (21% for dermaPACE and 15% for sham-control) of dermaPACE treated patients achieved full closure, the difference was not statistically significant.
Relative to the 24-week data, in the Intent-to-Treat population (ITT – which included all 206 patients in both cohorts) 36% (39 of 107) of dermaPACE patients achieved complete wound closure compared to 23% (23 of 99) of sham-control at 20 weeks. The difference was statistically significant (p = 0.047). In the Efficacy Evaluable population (EE – which excluded a few patients who fell outside the study parameters) 38% (38 of 101) of dermaPACE patients achieved complete wound closure compared to 22% (20 of 93) of sham-control at 20 weeks. The difference was also statistically significant (p = 0.018).
The difference in rates of wound closure between dermaPACE and sham treatment in both the ITT and EE populations continued to be statistically significant and in favor of dermaPACE out to the final 24 week evaluation date.
Also noteworthy is that the recurrence rate at 24 weeks among those patients that achieved full closure at 12 weeks remained very low, at 4.5% with dermaPACE patients compared to 20% in the sham-control group.
24-Week Top Line Data from Phase III IDE Study
Despite statistical significance not being achieved until week 20, we again believe the rigorous study design (double-blinded, surgery not permitted, larger ulcers with dermaPACE cohort, etc.) was likely a factor and will be taken under consideration in FDA's analysis of SANUWAVE's regulatory package. Similar to the 12-week data, safety was comparable among all cohorts through 24 weeks.
We continue to model dermaPACE to launch in the U.S. in the Q2 – Q3 2012 timeframe and expect it to be highly competitive with other advanced DFU treatments including skin substitutes and Kinetic Concepts' (KCI) VAC devices. See below for access to a free copy of our full 27 page report on SANUWAVE.
For a free copy of the full research report, please email scr@zacks.com with SNWV as the subject.
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