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 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.