ALPHARETTA, Ga.--SANUWAVE Health, Inc. (OTCBB: SNWV) (www.sanuwave.com), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announced that study results from the Company’s pivotal Phase III, Investigational Device Exemption (IDE) clinical trial with dermaPACE ® to treat diabetic foot ulcers will be presented in a podium presentation at the Symposium on Advanced Wound Care (SAWC) Spring 2011 taking place April 14 -17, 2011 in Grapevine, Texas.
“Pulsed Acoustic Cellular Expression Technology in the Treatment of Diabetic Foot Ulcers: A Sham-controlled, Double-blinded, Randomized Clinical Trial”
Commenting on the upcoming presentation, Christopher M. Cashman, SANUWAVE’s President and Chief Executive Officer, said, “We are excited to share these highly positive and clinically relevant results from our dermaPACE pivotal Phase III clinical trial to a distinguished audience at SAWC, the largest annual gathering of wound care clinicians in the United States. These study results underscore the potential of dermaPACE, should the FDA approve dermaPACE through our PMA submission process, to change the clinical and economic landscape in diabetic foot ulcer healing through more efficient utilization of clinical resources, increased limb salvage, decreased overall healthcare costs and greatly improved patient quality of life.”
The presentation, entitled “Pulsed Acoustic Cellular Expression Technology in the Treatment of Diabetic Foot Ulcers: A Sham-controlled, Double-blinded, Randomized Clinical Trial,” will be delivered by Robert Galiano, M.D., a principal investigator in the study and Assistant Professor, Division of Plastic Surgery, Department of Surgery at the Northwestern University Feinberg School of Medicine, on Friday, April 15, 2011 between 4:45 – 5:45 p.m. (local time) in the Grapevine C room at the Gaylord Texan Hotel and Convention Center.
Dr. Galiano’s presentation will detail the clinical trial’s rigorous design and compelling outcomes. Top-line data were announced in December 2010 and reported that patients treated with dermaPACE were twice as likely to achieve 90% to 100% wound closure within 12 weeks of their initial dermaPACE treatment compared to patients randomized to receive Sham control, suggesting the potential of dermaPACE to be a novel, nonpharmacologic and noninvasive advanced wound healing modality.
“The scientific mechanism activated by dermaPACE technology has a direct and lasting impact on wounds by immediately increasing blood perfusion and stimulating the body’s own angiogenic and positive inflammatory wound healing responses,” noted Dr. Galiano. “This biological mechanism has a direct and lasting impact on wounds by immediately increasing blood perfusion and stimulating the body’s own angiogenic and positive inflammatory wound healing responses. The dermaPACE clinical trial results provide the necessary clinical evidence to validate the benefits of such a mechanism when combined with proper wound care.”
Study Design Relevance
Unlike many other chronic wound trials conducted in this diabetic patient population, there were two important elements incorporated in the dermaPACE study design: double-blind (patient and principal investigator) randomization, and elimination of the option to close the target ulcer surgically or by other primary means. Maintaining the double-blind in this device trial restricted the knowledge of the treatment assignment so not to influence how a patient was treated or maintained on study and evaluated. This eliminated unintended human bias and qualifies this research as level 1 evidence, allowing the results to be accepted at face value. By not allowing the clinical investigators to surgically close the target ulcer in this study, the results provide a clear and unbiased view of the granulation and epithelialization process attributable to dermaPACE alone.
Diabetes is common, disabling and deadly. In the U.S., diabetes has reached epidemic proportions. According to the American Diabetes Association, about 27 million people (9% of the total U.S. population) have diabetes, and nearly two million new cases are diagnosed in people aged 20 years or older each year. If current trends continue, 1 in 3 Americans will develop diabetes at some point in their lifetime, and those with diabetes will lose, on average, 10-15 years of life expectancy. Importantly, up to 25% of people with diabetes will develop a diabetic foot ulcer, resulting in 3 million diabetic foot ulcers annually in the U.S. alone. More than half of all foot ulcers will become infected, thus requiring hospitalization, and 1 in 5 will require an amputation that carries a high risk of mortality. According to the American Diabetes Association, by the year 2025 the prevalence of diabetes is expected to rise by 72% to 324 million people worldwide.
PACE, defined as Pulsed Acoustic Cellular Expression, delivers high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures to promote angiogenic and positive inflammatory responses, and quickly initiate the healing cascade. This results in revascularization and microcirculatory improvement, including the production of angiogenic growth factors, enhanced new blood vessel formation (angiogenesis), and the subsequent regeneration of tissue such as skin, musculoskeletal and vascular structures. PACE treatment triggers the initiation of an accelerated inflammatory response that speeds wounds into proliferation phases of healing and subsequently returns a chronic condition to an acute condition to help reinitiate the body’s own healing response.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. ( www.sanuwave.com) is an emerging regenerative medicine company focused on the development and commercialization of noninvasive, biological response-activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVE’s portfolio of products and product candidates 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 its PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE, is CE marked for treatment of the skin and subcutaneous soft tissue and recently completed its highly positive pivotal Phase III, Investigational Device Exemption (IDE) clinical trial in the U.S. for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has 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 its U.S. Class III PMA approved Ossatron ® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its Ossatron, Evotron™ and orthoPACE ® devices in Europe.
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