Expects To Initiate Phase II IDE Study in U.S. For Treatment of Burns in 2010
Plans to Pursue Distribution Partnerships in Europe for PACE Technology
ALPHARETTA, Ga.--SANUWAVE Health, Inc., (OTC BB: SNWV) (www.sanuwave.com), an emerging medical technology company focused on regenerative medicine, announced that a European scientific study reporting the successful treatment of severe burns using the dermaPACE ® device has been published by BURNS, the Journal of the International Society for Burn Injuries .
“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.”
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 ( www.burnsjournal.com), and 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 impulses on days 3 and 5 after their injury. 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.
The study involved fifteen 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, 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 response to positive European clinical results and the need for non-invasive advanced burn care modalities, 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.
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, “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.”
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.
Christopher M. Cashman, President and CEO of SANUWAVE said, “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™. 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.”
Mr. Cashman continued, “Our 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. 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.”
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. ( www.sanuwave.com) 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 [removed]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. SANUWAVE researches, designs, manufactures, markets and services its products worldwide and believes it 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 its U.S. Class III PMA approved Ossatron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its Ossatron® and Evotron™ devices in Europe.
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