SANUWAVE Health Inc., an emerging regenerativee medicine company, today announced that positive data from its phase III clinical trial of dermaPACE® for the treatment of diabetic foot ulcers was the subject of a Continuing Medical Education (CME) accredited presentation at Desert Foot 2011: The 8th Annual High Risk Diabetic Foot Conference, honoring Federal Service Healthcare Providers, in Phoenix, Ariz.
The company’s PACE® technology delivers high-energy acoustic pressure waves to accelerate inflammatory response to speed up the body’s natural healing process.
Robert Frykberg, DPM, MPH, chairman of Desert Foot 2011, a surgeon at the Carl T. Hayden Veterans Affairs Medical Center in Phoenix, and a principal investigator in the dermaPACE clinical trial, presented the technology in an exhibition titled “A Shocking RCT: Getting Wounds to Heal.”
Dr. Frykberg’s presentation highlighted the dermaPACE pivotal phase III clinical trial results, which demonstrated statistical significance of 100% wound disclosure compared to alternative treatment, Sham-control. dermaPACE also significantly reduced the size of the target ulcer compared with Sham-control treatment, was associated with low ulcer recurrence, and was well tolerated.
“The results of this rigorously designed and executed pivotal phase III clinical trial strongly suggests dermaPACE has an effect in the stabilization, size reduction and with time complete closure of diabetic foot ulcers. Pending FDA approval, the availability and utilization of dermaPACE has the potential to positively impact the way we treat diabetic foot ulcers, and may bring us closer to our goal of improving wound outcomes through primarily cost-effective, clinically efficient pathways,” Dr. Frykberg stated in the press release.
Christopher M. Cashman, president and CEO of SANUWAVE, noted the significance of the presentation itself.
“This CME-accredited presentation to a largely federal healthcare provider audience appropriately highlights the clinical relevance of the dermaPACE study results to this clinical community. Dr. Frykberg is a leading authority in the diabetic foot ulcer field, and as a principal investigator in the dermaPACE clinical trial, he was able to speak with first-hand experience about the study results and also share his personal insights into the overall value proposition that dermaPACE may offer,” he stated.
For more information visit www.sanuwave.com
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