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 the publication of a research study conducted by Maria Siemionow, MD, PhD, DSc, at Cleveland Clinic investigating the working mechanisms of Pulsed Acoustic Cellular [removed]PACE™) technology as it applies to the treatment of ischemic (inadequate blood supply) conditions caused by surgical trauma.
“Pulsed Acoustic Cellular Treatment Induces Expression of Proangiogenic Factors and Chemokines in Muscle Flaps”
The study was published in the online edition of The Journal of Trauma in an article entitled, “Pulsed Acoustic Cellular Treatment Induces Expression of Proangiogenic Factors and Chemokines in Muscle Flaps,” and investigates how PACE™ treatment benefits ischemic conditions at the tissue and cellular levels following surgical trauma. The study is now available online at http://www.ncbi.nlm.nih.gov/pubmed/20571448.
In the study, PACE™ treatment was applied to a thin piece of rat muscle known as a cremaster flap prior to dissection and microcirculation analysis. PACE™ treatment resulted in an immediate increase in blood vessel diameters, suggesting an increase in blood perfusion that can benefit the healing of ischemic conditions. PACE™ also increased proangiogenic expression of several protein indicators (known as growth factors) of vessel growth and regeneration, including vascular endothelial growth factor (VEGF), endothelial nitric oxide synthase (eNOS) and von Willebrand factor (vWF), and this expression correlated with new blood vessel formation. Most importantly, this expression is known to increase cellular proliferation and tissue regeneration, and ultimately influence tissue viability and healing.
Dr. Siemionow is a renowned plastic, reconstructive and microvascular surgeon who gained worldwide acclaim in December 2008 when she successfully performed the first human facial transplant in the United States. In this latest research, Dr. Siemionow and her Cleveland Clinic colleagues concluded that PACE™ treatment correlated with new blood vessel formation as confirmed by heightened CD31 expression on the vessel endothelium, and that these results may justify the use of PACE™ as a conditioning therapy when enhancement of tissue neovascularization is required after surgical trauma.
Christopher M. Cashman, President and CEO of SANUWAVE, said, “Validating the underlying science and working mechanisms of PACE™ is vital to our understanding and application of this novel regenerative technology. Dr. Siemionow has made significant contributions to our scientific research over the past four years, especially in the areas of wound care and ischemia reperfusion. This knowledge supports our clinical research efforts, which are being led by our pivotal Phase III, Investigational Device Exemption (IDE) clinical trial with dermaPACE™ for the treatment of diabetic foot ulcers, and will continue in other areas where ischemia-related side effects complicate tissue healing, such as critical limb ischemia, mixed venous-arterial ulcers, and surgical flaps and grafts.”
Cashman concluded, “The ability of PACE™ to regulate the inflammatory process and induce proangiogenic activity has been repeatedly shown to accelerate healing. This latest research by Dr. Siemionow and her colleagues at Cleveland Clinic further validates the broad applicability – and tremendous commercial potential – of PACE™ technology in chronic and acute wound care.”
Dr. Siemionow is a paid consultant for SANUWAVE as a member of the Company’s Scientific Advisory Board.
PACE™, defined as Pulsed Acoustic Cellular Expression, delivers high-energy acoustic pressure waves to produce compressive and tensile stresses on cells and tissue structures to promote a positive inflammatory response and quickly initiate the healing cascade. This results in revascularization and microcirculatory improvement, including the production of angiogenic growth factors, enhanced new blood vessel formation (angiogenesis), and the subsequent regeneration of tissue, such as skin, musculoskeletal and vascular structures. PACE™ treatment triggers the initiation of the inflammatory and proliferation phases of healing and subsequently returns a chronic condition to an acute condition to help the body’s own healing response to re-initiate.
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 patient follow-up in its pivotal Phase III, 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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