Favorable data in a European scientific study demonstrating the effectiveness of Sanuwave's (Alpharetta, Georgia) dermaPACE technology to treat burn victims could pave the way for the company to bring the product to the U.S. for regulatory approval. The latest results were published in BURNS, the Journal of the International Society for Burn Injuries (Floresville, Texas).
"The [paper] is only helping to move us forward and get our product out there," Christopher Cashman, president/CEO of Sanuwave told Medical Device Daily. "The publication of these results allows us to have a step off point, of which we can move forward and start a Phase II IDE Study in the U.S."
The paper, titled Extracorporeal Shock Waves, a New Non-Surgical Method to Treat Severe Burns, detailed the successful use of PACE protocols with the dermaPACE device for the treatment of severe burns, including deep partial and full thickness burns. Between January and May 2009, patients with second and third degree burns received dermaPACE treatments of 500 shock impulses on days 3 and 5 after their injury.
"In some cases, the burn is so deep that the patient has lost blood support near the affected area," Cashman told MDD. "Using the Laser Doppler imaging [technology], researchers were able to see where the blood supply was limited."
The study involved 15 deep-partial and full-thickness burns initially diagnosed as deep enough to require surgical treatment according to the article's authors. However, these burn wounds healed after non-invasive PACE treatment.
The dermaPACE treatment is an extracorporeal shockwave therapy that stimulates angiogenesis, increases perfusion in ischemic tissues, decreases inflammation, enhances cell differentiation and accelerates wound healing.
The results go on to show that burns healed without complications within 15 days for 12 out of 15 patients (80%), 2 patients required grafting and 1 patient was lost to follow up. No side effects were observed.
The study concluded that the dermaPACE therapy has the potential to emerge as a new non-invasive, feasible safe and cost-effective method in deep partial/full thickness burns. The study goes on to say that the method of therapy could decrease the need of surgery and therefore the morbidity of the patient.
"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," Cashman said. "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 news of the results continues to build on the recent string of success the nearly 5-year-old company has enjoyed, despite 2009 being a trying year for some companies.
Last Fall, Sanuwave reported that it was fortunate enough to go public by becoming the subsidiary of a publicly traded company through a reverse merger agreement with a subsidiary of Rub Music Enterprises (Medical Device Daily, Oct. 1, 2009).
The company also made significant progress with its enrollment for the dermaPACE trial for healing diabetic foot ulcers. By last summer the trial had reached 75% completion with 19 other trial sites in the U.S. and two international sites in the UK and Germany (MDD, Aug. 25, 2009).
"We're doing very well," Cashman told MDD. "We're getting ready to launch two products and we're finalizing the planning for the [dermaPACE Phase II IDE Study]. Our goal is to have it start in the first half of this year."
Omar Ford, 404-262-5546;