ALPHARETTA, Ga.--SANUWAVE Health, Inc. (OTCBB:SNWV) (www.sanuwave.com), an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in regenerative medicine, today announced that an article titled “Microvascular Response to Shock Wave Application in Striated Skin Muscle” was recently published in the on-line edition of the Journal of Surgical Research . The complete article can be accessed at http://www.journalofsurgicalresearch.com. Based on the results of the study, the authors suggest that non-invasive Pulsed Acoustic Cellular [removed]PACE™) technology applied with one treatment session from SANUWAVE’s dermaPACE™ device results in a favorable and continuous microcirculatory response that occurs within one hour of treatment and lasts for at least three days. PACE™ is a proprietary form of Extracorporeal Shock Wave Technology (ESWT).
“This study demonstrates that PACE™ has a positive influence on microcirculation, while supporting earlier mechanism of action research that demonstrates that PACE™ creates a favorable wound healing environment by regulating growth factor and enzyme expression, capillary perfusion (filling the vessels with blood), cellular proliferation and cellular lifecycles.”
The study, conducted at the University Hospital in Zurich, Switzerland in conjunction with Shanghai Jiao Tong University School of Medicine in China, observed changes in microvascular response after PACE™ treatment using a literal viewing window implanted into the skin-folds of mice that allowed a very thin living tissue layer to be observed in real time.
Christopher M. Cashman, President and CEO of SANUWAVE, commented, “This study demonstrates that PACE™ has a positive influence on microcirculation, while supporting earlier mechanism of action research that demonstrates that PACE™ creates a favorable wound healing environment by regulating growth factor and enzyme expression, capillary perfusion (filling the vessels with blood), cellular proliferation and cellular lifecycles.”
In the study, PACE™ produced an immediate 20% increase in functional capillary density – which corresponds to an increase in capillary “openness” and blood perfusion – in treated tissues one hour after treatment with 1,000 impulses, reaching a maximal increase of 40% after 24 hours that lasted throughout the study’s three-day observation period (p<0.05). This effect was reproduced, although to a slightly lesser extent, after administration of 500 impulses.
Study authors, Contaldo C. et al., suggested that the rapid increase in functional capillary density is most likely caused by the recruitment of capillaries. The authors hypothesized that the bioactivating force applied to the tissues through PACE™ treatment activates the endothelium and causes significant up-regulation of numerous enzymes and growth factors, such as eNOS, a marker for nitric oxide, and von Willebrand factor, a strong marker for endothelial activation.
In addition to an increase in functional capillary density and eNOS expression, direct real time observation also revealed an increase of leukocyte (white blood cell) activity including rolling (2- to 3.5-fold increase) and adherence to the vessel lining (1.5- to 2-fold increase), clearly demonstrating a favorable, pro-inflammatory response (p<0.05). Other markers observed through immunohistochemical analysis included elevated caspase-3 and proliferating cell nuclear antibody levels, suggesting that PACE™ may support the growth of new blood vessels, including cellular proliferation and pro-apoptosis (favorable cell death vital to healing), as early as one hour after treatment (p<0.05).
Mr. Cashman continued, “This study clearly supports our previous mechanism of action research, which includes reports by Siemionow et al. from Cleveland Clinic, Davis et al. of the Naval Medical Research Center, Meirer et al. of the University of Innsbruck and others. This entire body of work demonstrates that ESWT and PACE™ activate a complex cascade of biological processes that improves microcirculation. We also know that PACE™ induces vasculogenesis and angiogenesis, ultimately leading to complete healing of acute and chronic hard and soft tissue. We believe that these biological effects make PACE™ clinically relevant and perfectly suited for widespread clinical application.”
The dermaPACE™ device is the Company’s lead product candidate for the global wound care market. It incorporates the Company’s proprietary PACE™ technology platform that delivers ESWT to treat a wide variety of chronic and acute conditions in hard and soft tissue. The dermaPACE™ is CE marked for treatment of the skin and subcutaneous soft tissue and has completed enrollment in its FDA-approved Phase III, pivotal, Investigational Device Exemption (IDE) trial in the U.S. for the treatment of diabetic foot ulcers (DFU). The dermaPACE™ U.S. DFU study is currently nearing completion of the patient follow-up phase. The Company expects to unblind data from this pivotal study in the fourth quarter, and plans to file a Pre-Market Approval (PMA) submission with the FDA by first quarter of 2011.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. ( www.sanuwave.com) is an emerging regenerative medicine company focused on the development and commercialization of non-invasive, biological response activating devices 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 has completed enrollment in its FDA-approved Phase III, pivotal, Investigational Device Exemption (IDE) trial in the U.S. for the treatment of diabetic foot ulcers (DFU). 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®, Evotron™, and recently introduced orthoPACE™, devices in Europe.
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