ALPHARETTA, Ga., July 15, 2013 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCBB:SNWV) today reported that pre-clinical results using the Company's patented Pulsed Acoustic Cellular Expression (PACE®) technology, which uses focused high-energy acoustic shock waves, were presented by Dr. Maria Siemionow in an oral presentation at the 2013 World Congress of Microsurgery. The results showed that the application of dermaPACE® appears to substantially decrease the inflammation and tissue damage that typically occurs when blood flow is interrupted during microsurgical procedures.
Ischemia-reperfusion injury (IRI) occurs when the blood supply is temporarily cut-off (ischemia) and then restored (reperfusion), releasing inflammatory factors that cause damage to cells and tissues. Prolonged ischemia, which normally occurs during complex microsurgical procedures, may lead to significant postoperative complications, including muscle damage and tissue necrosis. By measuring specific markers of inflammation before and after surgically induced IRI, this preclinical study demonstrated an anti-inflammatory effect, indicating protection from long-term tissue damage.
"I am excited by the preclinical results seen with PACE therapy in ischemia-reperfusion injury," commented Maria Siemionow, MD, PhD, Director of Plastic Surgery Research and Head of Microsurgical Training at Cleveland Clinic's Department of Plastic Surgery. "If these results hold true in further investigations, such an effect should lead to quicker and more complete tissue healing in a variety of medical and surgical settings. PACE therapy could feasibly be used in everyday clinical practice as a novel and convenient therapeutic strategy for protection of tissues against ischemia-reperfusion related injury after microsurgical procedures."
Joseph Chiarelli, CEO of SANUWAVE commented, "This data suggests that, when administered before and after complicated surgeries, the PACE treatments have an effect in reducing inflammation that leads to tissue damage. Reducing inflammation via PACE treatments could provide benefit to both patients and providers. We intend to explore the use of our technology as an adjunct therapy in complex, surgical procedures."
Maria Siemionow, MD, PhD, is a world-renowned scientist and microsurgeon. She is the Director of Plastic Surgery Research and Head of Microsurgical Training at Cleveland Clinic's Department of Plastic Surgery. Dr. Siemionow specializes in microsurgery, hand surgery, peripheral nerve surgery, transplantation, and microcirculation research. Dr. Siemionow received the first IRB approval in the world for her face transplant protocol and, in 2008, led a team of surgeons in performing the first face transplant in the United States.
A copy of Dr. Siemionow's presentation can be found on SANUWAVE's website at www.sanuwave.com. The international meeting was held from July 11-14 in Chicago and was well-attended by plastic, reconstructive, and orthopedic surgeons as well as microsurgeons from all over the world.
About the PACE Technology
SANUWAVE's patented Pulsed Acoustic Cellular Expression (PACE®) therapy is a novel, non-invasive, and potentially cost-effective method to accelerate the healing of wounds and damaged tissues. PACE technology utilizes high-energy waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissues to elicit a series of biological responses. PACE acts via vascular, inflammatory, and tissue regeneration components within cells to produce wound healing proteins. These proteins initiate a cascade of activities leading to tissue repair. The mechanical stimulation of these cells, via shockwave, causes growth factor upregulation, blood vessel widening (arteriogenesis), blood vessel proliferation (angiogenesis), and a modulated inflammatory response, all leading to the subsequent regeneration of skin, musculoskeletal, and vascular tissue. PACE has also been shown to cause biofilm disruption.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE's portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body's normal healing processes and regeneration. SANUWAVE intends to apply its patented 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 throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA's Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its 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 orthoPACE® devices in Europe and Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE's shock wave technology for non-medical uses, including energy, water, food and industrial markets.
This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company's ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company's product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company's ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
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