In August 2010 the FDA accepted SANUWAVE's shell application for dermaPACE?„? proposing a modular PMA submission plan containing three sections or "modules." A modular submission divides the PMA document into modules filed at different times that together form the complete application. This modular approach allows the FDA to review each module separately as soon as it is received, making it possible for manufacturers to receive timely feedback during the review process, and perhaps shortening the time to a final regulatory determination.

The Company will submit the first two modules containing the preclinical data, prior clinical testing and a quality manufacturing system review to the FDA in October 2010. The Company plans to submit the third and final module containing the PMA application, clinical trial data, proposed product labeling and summary of safety and effectiveness late in 2010 or early in 2011.

Mr. Cashman concluded, "Initiating the dermaPACE?„? PMA submission is an important milestone for SANUWAVE, as it brings us one step closer to our goal of introducing dermaPACE?„? to stimulate wound healing and closure. Our diligent efforts to achieve a Class III PMA approval for dermaPACE?„?, the most stringent approval level granted in the U.S., will allow SANUWAVE to establish clinical credibility, differentiate our technology and create a significant barrier to entry for potential competitors. These factors, along with our extensive patent portfolio, provide a high degree of market protection and should enhance shareholder value. We look forward to working with the FDA to facilitate the review of this novel regenerative technology."

Source SANUWAVE Health, Inc.