Basis for Protocol Development for the dermaPACE IDE DFU Clinical Trial
Company On Track To Complete Enrollment in IDE Trial By End Of First Quarter
ALPHARETTA, Ga.--SANUWAVE Health, Inc., (OTC BB: SNWV) (www.sanuwave.com), an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, announced that the scientific study that optimized PACE™ technology protocols for improving blood flow to ischemic skin was published in the Journal of Reconstructive Microsurgery.
“the application of 500 shockwave impulses showed the smallest mean percentage of necrosis after 7 days, making the protocol the most promising for clinical applications treating ischemic conditions.”
The paper titled, Extracorporeal Shock Wave Treatment in Ischemic Tissues: What is the Appropriate Number of Shock Wave Impulses?, appeared in the February 2010 issue of the Journal of Reconstructive Microsurgery, and details the optimized number of impulses for improving blood flow in ischemic skin indications. After utilizing a rat epigastric skin flap model to create ischemic skin conditions, several protocols with varying impulse counts were evaluated to determine their effects on preventing skin flap necrosis (cell death) due to ischemia. The study found that the most effective protocols used 500 to 2500 impulses per treatment. A link to the paper can be found at: https://www.thieme-connect.de/ejournals/toc/jrm
Florian Kamelger, M.D., of the Medical University of Innsbruck in Austria, one of the authors, said, “Partial skin flap necrosis caused by inadequate blood flow remains a significant problem in reconstructive surgery. For this reason, we investigated shock wave treatment as a means to increase blood flow to ischemic tissues. The results from this new study, and our team’s previously published studies, indicate that this technology significantly enhances epigastric skin flap survival at optimized energy and impulse settings.”
The authors found that “the application of 500 shockwave impulses showed the smallest mean percentage of necrosis after 7 days, making the protocol the most promising for clinical applications treating ischemic conditions.” For this ischemic skin study, optimization was completed using SANUWAVE’s EvoTron™ device, a precursor of the current dermaPACE™ device.
Christopher M. Cashman, President and CEO of SANUWAVE said, “The optimized treatment protocol of 500 shockwave impulses reported in the publication was used during the development of SANUWAVE’s U.S. Investigational Device Exemption (IDE) trial protocol investigating the dermaPACE™ device for the treatment of diabetic foot ulcers (DFU). This ischemic skin study reported in the Journal of Reconstructive Microsurgery indicates that the optimized protocol in the dermaPACE™ trial would be expected to protect and significantly improve blood flow to ischemic tissues in the ulcer area and minimize tissue necrosis, thereby creating a beneficial wound healing environment.”
Mr. Cashman continued, “Determining the optimal dosage is an extremely important step in developing the dermaPACE™ device for both efficacy and cost profile. It is our intent to bring to market a product with a superior efficacy and cost profile, particularly in today’s healthcare environment. I am pleased to report that we remain on track to complete enrollment in the IDE trial by the end of March 2010, and look forward to achieving that milestone and updating our shareholders and the medical community on our progress.”
Other studies published by the same group of authors using the optimized protocol reported that PACE™ treatment stimulates the expression of pro-angiogenic growth factors and has a highly positive effect on partial-thickness burns in humans. Further, the group determined that PACE™ treatment protects ischemic tissues better than topical growth factor treatment because PACE™ quickly initiates a cascade of growth factors and other cellular-level events which interact in a complex and more efficient way than a single agent does.
About the dermaPACE™ Trial
Patient enrollment for the dermaPACE™ IDE trial for healing diabetic foot ulcers is expected to complete enrollment by the end of March 2010. The trial has 22 sites, with 20 in the U.S. and two international sites in the United Kingdom and Germany. The objective of this clinical study is to compare the safety and effectiveness of the dermaPACE™ device to sham application, when administered in conjunction with the standard of care, in the treatment of diabetic foot ulcers. It is a randomized, double blind, placebo control, parallel assignment study design. Notable leading wound care institutions that are actively involved in the trial include Calvary Hospital in New York, North American Center for Limb Preservation in New Haven, Connecticut, Boston Medical Center, Phoenix VA, VA Long Beach, California, Northwestern University in Chicago, The Ohio State University Medical Center in Columbus, King’s College Hospital in London, and Emory Orthopedics and Spine Center in Atlanta. For more information about the dermaPACE™ trial, please visit www.dermapace.com.
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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