The FDA wants Sanuwave Health (OTC:SNWV) to run another clinical trial of its dermaPACE diabetic foot ulcer treatment, after a review of the company’s pre-market approval bid found that the initial trial failed to meet its primary endpoint.
Designed to show whether the extra-corporeal shock wave technology could deliver 100% wound closure after 12 weeks, the data showed no statistically significant difference between sham treatment and actual treatment with the device. DermaPACE uses high-energy acoustic "shock" waves to stimulate cells to heal.
Further evaluation of the data showed that complete wound closure occurred at 20 weeks and that the rate of healing was sustained after 24 weeks, according to a press release. That data was also included with Sanuwave’s PMA submission, according to the release.
That evidently wasn’t good enough for the federal watchdog agency, which issued a "major deficiency letter" to Sanuwave recommending another clinical trial "using the findings from any subgroup(s) that may support the safety and effectiveness of the dermaPACE device."
"The company is evaluating the comments in the FDA’s letter and is considering its formal response, which may include submitting answers to the deficiencies based on further analysis of the existing data," according to the release. "The company anticipates that its evaluation of its response to the letter and its associated interactions with the FDA will take place in the first quarter of 2012."
"We believe our submission provided clinical data which demonstrates that dermaPACE positively impacts wound healing in these clinically challenging diabetic foot ulcers," added president & CEO Christopher Cashman in prepared remarks. "We will continue to work toward our goal of a positive approval decision from the FDA so we can bring this novel, promising treatment to the millions of patients who suffer from these debilitating, recalcitrant wounds."
Sanuwave’s share price got a lift when other trial results went public in October, in the online edition of the journal Diabetes Research and Clinical Practice, comparing dermaPACE with hyperbaric oxygen therapy. Shares gained more than 12% in the week following the study’s release, closing at $2.14 Oct. 13.
SNWV shares lost 80.8 percent after it announced the FDA letter, falling from a close of $1.30 Dec. 21 to finish at 25 cents yesterday. Shares were trading at nearly 19 cents as of about 1:30 today, down another 26%.