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 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 10th Annual Wound Healing: Science and Industry conference held December 11th through 13th in St. Thomas, U.S. Virgin Islands.
The presentation discussed preclinical work regarding the effects of Pulsed Acoustic Cellular [removed]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.
About the 10th Annual Wound Healing: Science and Industry Conference
The Wound Healing: Science and Industry conference is a three-day interdisciplinary meeting that focuses on topical issues affecting wound healing. Faculty presented on the emerging science of wound care from both academic and industry perspectives. Wound healing leaders representing many disciplines discussed and presented on state-of-the-art developments in wound healing and technology developments. SANUWAVE was a supporter of the event with an educational grant.
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. For more information about the dermaPACE™ trial, please visit www.dermapace.com.
About the dermaPACE™ Trial
Patient enrollment for the dermaPACE™ IDE trial for healing diabetic foot ulcers recently reached 75% completion. 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.
Safe Harbor Statement
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 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.