Cellular and subcellular effects of PACE technology presented

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 cellular and subcellular effects of PACE™ technology were described during a lecture presented this past weekend. Joanna Cwykiel, MSc of Cleveland Clinic conducted the oral presentation titled, Pulsed Acoustic Cellular Expression, at the 10^th Annual Wound Healing: Science and Industry conference held December 11^th through 13^th in St. Thomas, U.S. Virgin Islands.

The presentation discussed preclinical work regarding the effects of Pulsed Acoustic Cellular Expression (PACE™) technology on microcirculation. Using microscopic techniques in a muscle flap model, the research assessed the effect of PACE™ treatment on microcirculatory hemodynamics, neovascularization and interactions between specialized white blood cells of the immune system (leukocytes) and cells lining the interior surface of blood vessels (endothelial cells).

The study found that a PACE™ treatment of 500 impulses was superior to a treatment of 200 impulses for the same tissue area. 500 impulses resulted in immediate activation of leukocytes while 200 had no effect. The increased leukocyte activity after 500 impulses contributed to cellular interactions within the blood vessels and expression of proangiogenic growth factors, VEGF and vWF. These growth factors are precursors of new blood vessel formation that is necessary to promote wound healing. Pronounced growth factor activity was seen within 24 hours of PACE™ treatment, supporting earlier findings that PACE™ technology quickly initiates a cascade of cellular-level events to improve microcirculation and promote neovascularization.

Ms. Cwykiel’s presentation also included a summary of internationally published data that suggests additional promising benefits of acoustic pressure waves applied in the shockwave spectrum. Wang et al. demonstrated wound healing in a diabetic rat model through increased perfusion and regeneration, while Davis et al. found suppression of inflammatory immune responses. Both studies support PACE™ technology for accelerated wound healing. A pre-operative PACE™ treatment study by Reichenberger et al. reported results of enhanced skin flap survival when administering PACE™ treatment prior to surgical procedures, lending credibility to the use of PACE™ technology to improve outcomes for skin flap patients through proactive tissue preconditioning. These recent laboratory studies show PACE™ treatment is compatible with wound healing by increasing microcirculation, decreasing inflammation, and stimulating cell growth and proliferation.

Christopher M. Cashman, President and Chief Executive Officer of SANUWAVE said, “We are excited about the full breadth of research conducted at Cleveland Clinic. Their work has greatly advanced our scientific understanding of PACE™ technology and confirms our belief that PACE™ technology has a wide range of clinical applications. Their most recent microcirculatory effect findings validate the protocol that we have found to be effective in European clinical studies. We expect the dermaPACE™ IDE trial for the treatment of diabetic foot ulcers, for which we are on track to complete enrollment by the first quarter of 2010, to be equally successful.”

Joanna Cwykiel, MSc is a molecular biologist and research fellow at Cleveland Clinic in the Plastic Surgery Research Department headed by Maria Siemionow, M.D., Ph.D. She has presented at many conferences, including the American Association of Plastic Surgeons, Plastic Surgery Research Council, and the Diabetic Foot Convention.