Regenerative medicine firm Sanuwave Health (OTC:SNWV) will run another clinical trial of its dermaPace foot ulcer treatment, after the FDA determined that its initial pre-market approval bid failed to meet its primary endpoint.
New trials may take up to 2 years before the company re-submits its device for FDA review, according to a press release.
The Alpharetta, Ga.-based regenerative medicine company decided to launch another study rather than attempt to push its pre-market application to panel review after the FDA in December 2011 issued a “major deficiency letter. The watchdog agency recommended that Sanuwave run another clinical trial "using the findings from any subgroup(s) that may support the safety and effectiveness of the dermaPace device."
"We feel strongly that dermaPace is clinically effective in treating diabetic foot ulcers and that our Phase III clinical trial results would potentially support a positive panel review recommendation for approval to the FDA if an amended pre-market approval application submission by Sanuwave is permitted to go to a panel meeting," president & CEO Christopher Cashman said in prepared remarks. "However, that process could take 12-18 months, and the FDA may not follow a potentially positive panel review recommendation."
The federal watchdog agency spiked Sanuwave’s PMA bid when clinical trials of the extra-corporeal shock wave technology showed no statistically significant difference after 12 weeks between sham treatment and actual treatment with dermaPace.
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, data that was also submitted in the original PMA.
The FDA’s December rejection sent SNWV shares plummeting nearly 81% from $1.30 to 25¢ in 24 hours. Shares have recovered from that loss, and were frozen at 46¢ today as of about 10:40 this morning.