Christopher M. Cashman, President and CEO of SANUWAVE, said, "I am encouraged and deeply grateful for the dedication and passionate commitment of our study sites. Enrollment in 2010 has been strong, and we reached our target patient enrollment earlier than expected in the first quarter of this year. This significant milestone will allow us to unblind and analyze the data and report on it, with our expectation to file our regulatory submission in 2010. We will continue to be aggressive with our timelines, as the medical need is well-documented, urgent and growing. In the U.S. alone, there are up to 3 million foot ulcers in any given year. And with 27 million diabetics in the U.S. and 54 million that are pre-diabetic, this disease state is only getting worse. Unfortunately, the occurrence of diabetes onset is also on the rise in many other countries, making our mission one of global importance. The United States diabetic foot ulcer market is estimated to be approximately a $2 billion portion of the estimated $10 billion global advanced wound care market."

Mr. Cashman continued, "Foot complications are the most frequent reason for hospitalization in patients with diabetes, accounting for up to 25 percent of all diabetic admissions in the U.S. This places a tremendous burden on available healthcare resources and seriously diminishes quality of life for patients and their families. Early detection and appropriate treatment of diabetic foot ulcers may eliminate the vast majority of amputations. As shown in our complete body of clinical work, dermaPACE?„? has been able to efficiently promote wound closure, and to provide treatment in a convenient, flexible and cost-effective manner that encourages both the caregiver and the patient to adopt dermaPACE?„? into their standard of care. Our high enrollment of 207 patients in the dermaPACE?„? multicenter diabetic foot ulcer trial is another positive indicator that dermaPACE?„? treatment can be successfully incorporated into the clinical care system."

Study Design

The objective of the dermaPACE?„? clinical trial is to compare the safety and effectiveness of the dermaPACE?„? device to sham control, when administered in conjunction with the standard of care, in the treatment of diabetic foot ulcers. It is a randomized, double-blind, sham controlled, multicenter, 26-week, parallel assignment study design with a primary endpoint of diabetic foot ulcer closure at 12 weeks following the first treatment application. Secondary endpoints include time to closure, reduction in total wound surface area and volume, long-term safety, and skin appearance and pain assessments.

SOURCE SANUWAVE Health, Inc.