Dermapace to treat severe burns without surgery, grafts show promise, says Sanuwave

Dermapace, a new device thto treat severe burns without surgery, has been found successful in studies, according to Sanuwave Health, Inc.

The study involved fifteen deep-partial and full-thickness burns initially diagnosed as deep enough to require surgical treatment.

Patients with second and third degree burns received Dermapace treatments of 500 impulses on days 3 and 5 after their injury between January and May 2009.

Burns healed uneventfully 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.

However, these burn wounds healed after non-invasive Pace treatment, and re-epithelialization was achieved without surgery in 80% of cases.

After Pace treatment, burns had a significant increase in acute blood flow to the burn area as measured with Laser Doppler Imaging.

Significantly, patients healed with Pace did not experience scarring typical of these injuries, and none of the wounds became infected. In addition, only 3 in 15 patients reported any pain at all during the treatment, and they rated the pain level as minimal.

In view of the positive outcome from European clinical results, Sanuwave expects to initiate a Phase II, Investigational Device Exemption (IDE) study in the U.S. in 2010 using the dermapace for the treatment of burns.

“[Dermapace] device 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,” stated 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.

Approximately 27 million burn cases requiring professional treatment occur worldwide each year, according to the Wound Care Markets, 2nd Edition, Vol II. Burns: Market Report, resulting in a worldwide burn treatment market forecasted to reach $2.6 billion in 2011.

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.

The research in burn injuries with Pace technology is demonstrative of the enormous potential that Dermapace has across many different treatment applications, from diabetic foot ulcers to traumatic wounds and burns.

The paper titled, Extracorporeal Shock Waves, a New Non-Surgical Method to Treat Severe Burns, appeared as an e-publication ahead of print in Burns, and detailed the use of Pace protocols with the Dermapace device for the treatment of severe burns, including deep partial and full thickness burns.

Sanuwave Health, Inc is an emerging medical technology company focused on the development and commercialization of non-invasive, biological 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, including new vascularization and microcirculatory improvement, helping to restore the body’s normal healing processes and regeneration.

Sanuwave intends to apply its Pulsed Acoustic Cellular Expression (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 is currently involved in an FDA-approved Investigational Device Exemption trial in the U.S. for the treatment of diabetic foot ulcers.