SANUWAVE Health Inc. today announced the publication of a European scientific study covering the company’s dermaPACE burn treatment device. The report details the successful treatment of severe burns using SANUWAVE’s device in a paper titled Extracorporeal Shock Waves, a New Non-Surgical Method to Treat Severe Burns in BURNS (www.burnsjournal.com).
According to the article, the study observed 15 deep-partial and full-thickness burns initially diagnosed as deep enough to require surgical treatment. After application of the company’s PACE treatment, the burn wounds were healed, and in 80 percent of those cases re-growth of damaged tissue was achieved without surgery. Additionally, the report said the wounds had a significant increase in acute blood flow to the burn area as measured with Laser Doppler Imaging.
In many cases, severe burns cause scaring and sometimes infection; however, for the patients healed with PACE, there was neither, and only three in 15 patients reported any pain at all during the treatment.
Juan P. Barret, M.D., Ph.D., head of the Department of Plastic, Aesthetic and Reconstructive Surgery and director of the Burn Center at Vall d’Hebron University Hospital in Barcelona, Spain, one of the authors, said SANUWAVE’s device addresses challenges and needs for burn patients.
“The dermaPACE® device fulfills a need in the burn treatment community. It is a new, non-invasive device to successfully treat burns safely and cost effectively, producing excellent results and in many cases may preclude additional patient trauma due to surgery and grafting,” Dr. Barret stated in the article.
SANUWAVE said it expects to initiate a phase II, Investigational Device Exemption (IDE) study for dermaPACE in the U.S. in 2010, supported by positive outcomes in various studies and research.
“Since 2005 there has been promising research published using SANUWAVE’s technology for the treatment of burn injuries, and this new paper detailing the effectiveness of dermaPACE® for burn treatment further validates the safe and effective outcomes achievable with PACE,” Christopher M. Cashman, president and CEO of SANUWAVE stated. “This study provides evidence of the commercial potential that dermaPACE® has in the European Community where dermaPACE® is approved to treat acute and chronic wounds, including burns. We plan to pursue distribution partnerships in Europe to make PACE technology available to patients who could benefit from it.”
The company’s research of its PACE technology is suggests a wide application potential, from diabetic foot ulcers to traumatic wounds and burns.
“We look forward to initiating a phase II IDE Study in the U.S. as we aggressively pursue a multi-faceted approach to treating injuries of the skin and subcutaneous tissue, and burns are a vital part of that mission,” Cashman stated.