SANUWAVE’s primary market segment is wound care and dermaPACE is our lead product candidate. We are addressing diabetic foot ulcers first and conducting pilot studies in decubitus (pressure ulcers), burns and chronic wounds.
Diabetic Foot Ulcers
Our primary interest is developing our lead product candidate, dermaPACE, for the global wound care market, with the first focus in the United States on diabetic foot ulcers. The Advanced Medical Technology Association (“AdvaMed”) estimates that the management and treatment of chronic and complex wounds costs the United States $20 billion annually. According to the American Diabetes Association (the “ADA”), 23.6 million people in the United States have diabetes, 57 million are pre-diabetic and 15% of people with diabetes will acquire a non-healing ulcer in their lifetime. AdvaMed states that over 1.5 million diabetic foot ulcers occur annually, are a recurrent condition, and lead to over 82,000 amputations each year, at a direct and indirect cost ranging from $20,000 to $60,000 per patient. AdvaMed estimates that chronic leg wounds (ulcers) account for the loss of two million workdays per year, at a cost of approximately $300 million in lost productivity. We believe that our dermaPACE system represents an opportunity to significantly decrease overall healthcare costs, while providing wound care outcomes that are significantly better than current treatments.
The dermaPACE Device
The dermaPACE device received European CE Mark approval for the treatment of acute and chronic defects of the skin and subcutaneous soft tissues e.g. post-operative wound healing defects, post-traumatic wounds, deep partial thickness burns, decubitus ulcers, diabetic ulcers, and arterial ulcers. Given that current conservative therapy or standard of care may not be effective for all patients, PACE may be a preferable, lower risk alternative. In the U.S., dermaPACE has recently completed a pivotal Phase III, Investigational Device Exemption (IDE) study for the treatment of diabetic foot ulcers.
Click here to view publications of dermaPACE clinical results.
dermaPACE is currently under review by the U.S. Food and Drug Administration (FDA) for Premarket Approval and is not available for sale or distribution in the U.S.