6/6/2012 — ALPHARETTA, Ga.–(BUSINESS WIRE)– SANUWAVE Health, Inc. (OTCBB: SNWV), announced the publication of peer-reviewed, preclinical research that demonstrates the ability of the Company’s Extracorporeal Shock Wave Technology (ESWT) to stimulate proliferation of periosteal adult stem cells (cambium cells) within the body and subsequently form bone. In addition, the combination of ESWT-proliferated adult stem cells and a bioactive scaffold regenerated more bone than a bioactive scaffold alone.
The publication, titled “The Use of Extracorporeal Shock Wave-Stimulated Periosteal Cells for Orthotopic Bone Regeneration,” appeared in the online edition of Tissue Engineering, Part A as an ePublication ahead of print. The abstract of the publication can be viewed online at: http://online.liebertpub.com/doi/abs/10.1089/ten.TEA.2011.0573.
Led by Myron Spector, M.D., a professor and researcher at Harvard-MIT Division of Health Sciences and Technology, the authors stated, “This study investigated a novel approach for treatment of bone loss, which has potential for many clinical situations where bone apposition is required (e.g., vertical ridge augmentation, regrowing bone following tumor resection, and regenerating bone lost at sites of osteolysis or bone degeneration).”
“The cambium cells of the periosteum (outer membrane covering bone) currently have limited suitability for clinical applications in their native state due to their low cell number (only 2 to 5 cells thick). However, ESWT has been shown to cause a rapid increase in periosteal cambium cell numbers and subsequent periosteal osteogenesis (bone formation). The advantages of adding scaffolds as we did in this study are threefold: the scaffold contours the new bone, it helps maintain bone at the implant site, and it creates a space to allow the periosteal cells to further proliferate and fill the scaffold.”
The authors concluded, “The ESWT-stimulated samples of tibial bone outperformed the control group in all key outcome variables, and the study results therefore demonstrated the efficacy of ESWT-stimulated periosteum for bone generation. These results successfully demonstrated the efficacy of periosteum stimulated by ESWT technology for bone generation.”
In the first phase of this research, the authors successfully demonstrated that ESWT increased the thickness of the cambium layer surrounding bone and the number of cambium cells within that layer. This proliferation of adult stem cells is an important part of many tissue engineering strategies. Then, in a novel second phase, the authors combined the ESWT-proliferated adult stem cells with a porous calcium phosphate scaffold that is commonly utilized in clinical applications to stimulate bone regeneration. A comparator control group received the scaffold alone with no prior ESWT treatment. The results were statistically significant and favored the ESWT group. In fact, at two weeks post-surgery, there was a significant increase in all key outcome variables for bone growth favoring the group that received ESWT prior to being combined with a scaffold compared with the group that received only the scaffold.
Summary of Key Study Findings
>In the rabbit tibia, four days after a single treatment, ESWT resulted in a 2.7-fold increase in the number of adult stem cells within the cambium layer and a 4-fold increase in cambium layer thickness, suggesting the potential for efficient stem cell harvesting and transplantation for orthopedic applications.
>At two weeks post-surgery, there was a significant increase in all key outcome variables for bone growth favoring the group that received ESWT prior to being combined with a bioactive scaffold compared with the group that received only the scaffold, including: a 4-fold increase in bone tissue in the upper half of the scaffold underlying the periosteum (p=0.008), a 12-fold increase in bone tissue overlying the scaffold (p=0.005), and a 2-fold increase in callus (hard bony tissue) size (p=0.02).
>A highly positive finding regarding safety is that ESWT was shown not to permanently alter the adult stem cells.
>This study successfully investigated a novel approach for noninvasively addressing clinical situations in which bone regeneration is needed.
About SANUWAVE Health, Inc. SANUWAVE Health, Inc. (www.sanuwave.com) is an emerging regenerative medicine company focused on the development and commercialization of noninvasive, 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 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 and has Canadian device license approval for the treatment of the skin and subcutaneous soft tissue. 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.
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SANUWAVE Health, Inc.
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