SNWV .18 lottery ticket
This one has retraced from the .25 range over the past week on small volume. Last year, the stock was based in the .40 range before falling to .05. It has begun to climb out of the cellar over the past few weeks. The next catalyst is an update on their supplemental trial for their dermaPACE product that treats diabetic foot ulcers. From the Dec 1 press release:
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.
If the DMC recommends #1, SNWV should easily blow past the old base of the .40's
Encouraging results from the phase 3 IDE trial in 2011:
Patients treated with dermaPACE showed a strong positive trend in the primary endpoint of 100% wound closure. Treatment with dermaPACE increased the proportion of diabetic foot ulcers that closed within 12 weeks by 36%, although the rate of complete wound closure between dermaPACE and Sham-control at 12 weeks in the intention-to-treat (“ITT”) population was not statistically significant at the 95% confidence level used throughout the study (p=0.363). There were 22 out of 107 (21%) dermaPACE subjects who achieved complete wound closure at 12 weeks compared with 15 out of 99 (15%) Sham-control subjects.
In addition to the originally proposed 12-week efficacy analysis, the FDA expressed interest in seeing the efficacy analysis carried over the full 24 weeks of the study. In response, we conducted a series of secondary analyses of the primary endpoint of complete wound closure at 12 weeks and at each subsequent study visit out to 24 weeks. The primary efficacy endpoint of complete wound closure reached statistical significance at 20 weeks in the ITT population with 36% of dermaPACE subjects achieving complete wound closure compared with 23% of Sham-control subjects (p=0.047); in the efficacy evaluable (“EE”) population 38% of dermaPACE subjects achieved complete wound closure beginning at 20 weeks, compared with 21% of Sham-control subjects (p=0.018).
Subjects treated with dermaPACE achieved a significant increase in the rate of complete and/or =90% wound closure. We analyzed a clinically relevant = 90% wound closure endpoint that demonstrated statistical significance (p=0.0161) in favor of dermaPACE subjects (51/107, 48%) compared to patients randomized to receive Sham-control (31/99, 31%).
Within 6 weeks following the initial dermaPACE treatment, and consistently throughout the 24-week period, dermaPACE significantly reduced the size of the target ulcer compared with subjects randomized to receive Sham-control (p<0.05).
Of the subjects who achieved complete wound closure at 12 weeks, the recurrence rate at 24 weeks was only 4.5% in the dermaPACE group compared with 20.0% in the Sham-control group.
Importantly, there were no meaningful statistical differences in the adverse event rates between the dermaPACE treated patients and the Sham-control group. There were no issues regarding the tolerability of the treatment which suggests that a second course of treatment, if needed, is a clinically viable option.
