Sanuwave Health (OTC:SNWV) said Monday it closed a $1.5 million round of equity financing to help support the FDA submission of Phase III clinical trial data to support the clearance of its dermaPACE device designed for treating diabetic foot ulcers.
The company said it expects to close another round with an additional amount under the same terms by March 31.
“With the support from new investors and continued support from existing shareholders and our entire staff, we have improved our balance sheet. This funding increases our financial stability and sets up a clear path towards obtaining FDA approval for our dermaPACE product. These additional financial resources should provide us with the financial flexibility to continue our operations as we prepare our FDA filing and prepare to market dermaPACE upon approval. Thanks to the support and perseverance of our existing shareholders, we are now in position to achieve our primary goal,” SanuWave CEO Kevin Richardson II said in a press release.
The company floated 25 million shares of common stock at 6¢ per share for the round. During the round, Sanuwave also issued warrants to purchase up to 25 million shares of common stock at 8¢ per share, which would bring in an additional $2 million for the company. The warrants are immediately exercisable and expire on March 17.
Last July, said it met with the FDA to discuss the progress of a pre-market approval trial of its Dermapace diabetic foot ulcer treatment.
The 130-patient study completed enrollment in November 2014 and each patient has completed a full-24-week follow-up, the Alpharetta, Ga.-based company said.
Sanuwave said it is completing an audit of the clinical documentation of each study site, which will be followed by a final review and locking of the study database. After the lock the data can be analyzed, and checked to see if the trial met primary endpoints, the company said.
A month earlier in June, Sanuwave said the oversight board for the clinical trial of its DermaPace wanted more data after determining that the trial was unlikely to meet its primary endpoint.
An interim analysis by the trial’s independent Data Monitoring Committee found that if the trend holds the endpoint “will likely not be met at the next predefined analysis point of 170 patients,” the company said.
