SANUWAVE Health, Inc. is a regenerative medicine company headquartered in Alpharetta, Georgia. The Company is focusing on the development and commercialization of noninvasive, biological response activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures. Their product and product candidate portfolio activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body’s normal healing processes and regeneration.
SANUWAVE intends to apply their PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. The Company’s lead product candidate for the worldwide wound care market is dermaPACE. This product has CE marking for the treatment of the skin and subcutaneous soft tissue. It recently completed its positive pivotal Phase III, Investigational Device Exemption (IDE) clinical trial in the United States for the treatment of diabetic foot ulcers.
The Company researches, designs, manufactures, markets and services their products globally. They believe they have demonstrated that this technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through their U.S. Class III PMA approved Ossatron® device. They also believe they have demonstrated that this technology is safe and effective in stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of their Ossatron, Evotron™ and orthoPACE® devices in Europe.
Yesterday, SANUWAVE Health, Inc. announced that their dermaPACE® is the subject of a Continuing Medical Education (CME) accredited presentation at the American Podiatric Medical Association (APMA) 2011 National Meeting being held July 26-28, 2011 in Boston. The presentation is titled “Pulsed Acoustic Cellular Expression Technology in the Treatment of Diabetic Foot Ulcers: A Sham-controlled, Double-blinded, Randomized Clinical Trial.” The presentation highlights and expands on the dermaPACE pivotal Phase III clinical trial results.
Christopher M. Cashman, President and Chief Executive Officer of SANUWAVE Health, Inc., said, “The results for dermaPACE are compelling. Diabetic foot ulcers treated with dermaPACE, in general, immediately stabilized and did not worsen. These ulcers quickly reduced in size and continued to full closure in a significantly greater proportion than ulcers in the comparative Sham-control group. Ulcers closed with dermaPACE didn’t tend to recur, and dermaPACE procedures were shown to be safe and were associated with a lower overall incidence of infection.”
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