Industry News May 2010

Net Health Partners with KCI to Provide V.A.C.® Therapy Integration

  Net Health Systems Inc (Pittsburgh, PA) announced the release of new functionality in the WoundExpert software enabling physicians to pre-populate V.A.C.® Therapy authorization forms, electronically sign, and transmit by means of a secure link directly to Kinetic Concepts Inc ([KCI] San Antonio, Tex). The inclusion of this functionality is another step forward in Net Health’s continuing to provide new efficiencies, improve ease of use, and reduce errors in wound care. The inclusion of V.A.C. Therapy ordering through WoundExpert provides:

• Seamless creation of the KCI V.A.C. Therapy Order Form, pre-populated with WoundExpert data
• Automatic Error checking for form compliance
• Inclusion of electronic signatures on the KCI V.A.C. Therapy Order Form
• Direct transmission for approval from WoundExpert to KCI
• Integration with WoundExpert’s electronic documentation

The introduction of V.A.C Therapy order functionality within WoundExpert will become available in May 2010.

  Visit www.woundexpert.com or www.KCI1.com for more information.

Sanuwave Completes Enrollment in dermaPACE Phase III Pivotal IDE Clinical Trial

  Sanuwave Health Inc (Alpharetta, GA) announced that patient enrollment was completed in March 2010 in its dermaPACE Phase III pivotal, randomized, double-blinded, sham controlled, multicenter clinical trial comparing its Pulsed Acoustic Cellular Expression (PACE) technology, utilizing the dermaPACE tissue regeneration device, to sham control for the treatment of diabetic foot ulcers (DFU).
  The primary study goal is to establish superiority in DFU healing rates using the treatment compared to sham control, when both are combined with the current standard of care. The standard of care includes wet-to-dry dressings, which is the most widely used primary dressing material in the United States, and offloading with a walking boot.
A total of 207 patients have entered the study at 24 sites, including Boston Medical   Center, Phoenix VA, Northwestern University in Chicago, VA Long Beach, California, The Ohio State University Medical Center in Columbus, King's College Hospital in London, Emory Orthopedics and Spine Center in Atlanta, Calvary Hospital in New York, and the North American Center for Limb Preservation in New Haven, Connecticut. The principal investigators in the study represent the multidisciplinary nature of treating chronic wounds, including specialties such as vascular surgery, plastic surgery, podiatry, and endocrinology. The study patients must be followed a total of 24 weeks. The study's primary endpoint— wound closure— is defined as "successful" if the skin is re-epithelialized without drainage or dressing requirements confirmed at two consecutive study visits.

  Final study data including time to closure, total wound size reduction, long-term safety, and study subject assessments is expected to be available by the fourth quarter of this year. The Company plans to announce a summary of the top-line data immediately following validation of study results and statistical analysis. In addition, the Company is finalizing its regulatory submission plan with the Food and Drug Administration and will provide further information when the plan is established.

  Visit www.sanuwave.com for more information.