ALPHARETTA, Ga.--SANUWAVE, Inc., ( www.sanuwave.com)an emerging leader in the development and commercialization of noninvasive, biologic response activating devices in the regenerative medicine segment, has added Southern Arizona VA in Tucson, Arizona as the newest clinical trial site for its Investigational Device Exemption (IDE) clinical trial evaluating Pulsed Acoustic Cellular [removed]“PACE™”) technology and the safety and efficacy of dermaPACE™ in healing diabetic foot ulcers. Dr. Katherine Neiderer will be the Principal Investigator for the site.
“With diabetic foot ulcers afflicting a growing number of diabetic patients, often resulting in loss of limbs, I am pleased that our center has become part of the dermaPACE clinical trial, as it offers a potential and promising solution for those patients.”
Patient enrollment for the dermaPACE trial for healing diabetic foot ulcers recently reached 75% completion. With 19 other trial sites in the U.S. and two international sites in the United Kingdom and Germany, the Southern Arizona VA site becomes the twenty-second site that is actively recruiting subjects for the dermaPACE trial. The objective of this clinical study is to compare the safety and effectiveness of the dermaPACE device to sham application, when administered in conjunction with the standard of care, in the treatment of diabetic foot ulcers. It is a randomized, double blind, placebo control, parallel assignment study design. Other notable leading wound care institutions that are actively involved in the trial include Calvary Hospital in New York, North American Center for Limb Preservation in New Haven, Connecticut, Boston Medical Center, Phoenix VA, VA Long Beach, California, Northwestern University in Chicago, The Ohio State University Medical Center in Columbus, King’s College Hospital in London, and Emory Orthopedics and Spine Center in Atlanta.
“The dermaPACE device has generated a lot of excitement in the wound care medical community, and I am very pleased to be able to participate in the final enrollment stage of this trial,” said Katherine Neiderer, DPM. “With diabetic foot ulcers afflicting a growing number of diabetic patients, often resulting in loss of limbs, I am pleased that our center has become part of the dermaPACE clinical trial, as it offers a potential and promising solution for those patients.”
Christopher M. Cashman, President and CEO of SANUWAVE said, “We are very encouraged by the support that the wound care medical community has shown our dermaPACE trial and their continued desire to join as the study nears its final enrollment stage. As our clinical trial continues, we believe that we are getting closer to being able to offer the healthcare community and the patients who suffer from an estimated 1.5 million diabetic foot ulcers in the U.S. alone, a unique solution to a demanding medical problem at a reasonable cost.”
According to the American Diabetes Association (ADA), 23.6 million people in the United States have diabetes and 57 million are pre-diabetic. The National Institutes of Health (NIH) reported that 15% of people with diabetes will acquire a non-healing ulcer in their lifetime, and chronic leg wounds (ulcers) are estimated to account for the loss of two million workdays a year at a cost of approximately $300 million in lost productivity. Diabetic foot ulcers are a recurrent condition and lead to over 82,000 amputations annually. Advanced Medical Technology Association (AdvaMed) estimates it costs roughly $60,000 for a lower limb amputation that can result from a diabetic foot ulcer, representing an annual cost of $5.0 billion. Hospitalization costs alone for a patient with a diabetic foot ulcer can cost $16,000-$20,000 annually.
About SANUWAVE, Inc.
SANUWAVE, Inc. is an emerging leader in the development and commercialization of noninvasive, biologic response activating devices in the regenerative medicine area 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 restoring the body’s normal healing processes and regeneration. SANUWAVE is applying its Pulsed Acoustic Cellular [removed]PACE™) technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Headquartered in Alpharetta, GA, SANUWAVE designs, manufactures, markets, and services its industry leading products worldwide and has already 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 our U.S. Class III PMA approved OssaTron® device and in the European community for the stimulation of bone and chronic tendonitis regeneration in the musculoskeletal environment. Its lead development product for the global wound care market, dermaPACE®, is CE marked for the treatment of acute and chronic defects of the skin and subcutaneous soft tissue. SANUWAVE is undertaking extensive research into the biological mechanisms and cellular effects of PACE, to include inflammatory response, angiogenesis promotion, and bactericidal capabilities. For more information about the dermaPACE trial, please visit www.dermapace.com.
This press release contains forward-looking statements that involve risks and uncertainties. These include statements regarding the Company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements.