Sanuwave Health (OTC:SNWV) today released 24-week data from the pivotal trial of its dermaPace, saying it missed its 12-week primary efficacy endpoint but returned a greater reduction in wound size and lowered amounts of subjects with increased wound size compared to the control treatment at 24 weeks.
Data came from 2 24-week studies at 39 centers across the U.S., studying a total of 336 subjects treated with either the dermaPace and conventional therapy or sham dermaPace and conventional therapy, Alpharetta, Ga.-based Sanuwave said.
The primary efficacy endpoint for the studies were the incidence of complete wound closure at 12 weeks post-initial treatment with dermaPace or the sham dermaPace. The primary safety endpoint of the trial was the overall rate of adverse events throughout 24 weeks, the company said.
Sanuwave reported that while the primary endpoint was not met in the trials, results from the 1st trial reported superiority in complete wound healing rates at 20 and 24 weeks post-initial application, though the results were not statistically significant.
Data from the 2nd trial didn’t indicate superiority at 20 and 24 weeks, the company reported, but did return a 35.4% rate of wound closure in patients treated with dermaPace over 26.2% for patients treated in the sham control.
The rate of complete wound closure for patients treated with dermaPace in both studies were not significant, though Sanuwave said that “subsequent visits a trend towards significance was shown resulting in a significant difference by the 20 week endpoint that was maintained through the end of the study,” according to a press release.
At 24 weeks, the rate of wound closure in the dermaPace group was 37.8% versus 26.2%.
Though the overall rate of adverse events between both groups was not statistically different at 24 weeks, patients in the dermaPace cohort exhibited lower rates of serious adverse event and lower rates of target ulcer recurrence and amputations.
“The dermaPace device demonstrates a positive benefit-risk ratio based on the outcome of the two clinical studies performed. A significantly greater percentage of dermaPace subjects were considered a success at 20 weeks and out to final follow-up at 24 weeks. While, the data did not demonstrate superiority at 12 weeks, a trend is clearly demonstrated toward superior effectiveness when using dermaPACE to treat diabetic foot ulcers,” CEO Kevin Richardson, said in a press release.
Data from the trial was submitted along with the company’s FDA pre-submission package, Sanuwave said. The company added that it hopes to meet face-to-face with the FDA to review the application in late-April or early-May.
Sanuwave said the goal of the meeting is to “bring dermaPACE to market in the most expeditious possible manner,” according to a press release. The company said a final product submission to FDA in is slated for the Q2 this year.