Orthopaedic Tissue Regeneration Research Presented at Bone-Tec Congress by Dr. Myron Specto





SANUWAVE, Inc., an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, reported that scientific findings titled “Extracorporeal Shock Wave Stimulation of Osteoprogenitor Cells” were presented at the 2009 International Bone-Tissue-Engineering Congress (“Bone-Tec”) in Hannover, Germany, which was held October 9-11, 2009.

Dr. Myron Spector, PhD, Professor of Orthopaedic Surgery (Biomaterials) at Harvard Medical School, Director of Orthopaedic Research at Brigham and Women's Hospital and Director of Tissue Engineering at VA Boston Healthcare System, was an invited guest speaker at the Conference. The Bone–Tec Congress featured an international scientific forum to discuss progresses in modern bone tissue regeneration and extended a worldwide network to exchange findings on the latest developments.

Dr. Spector’s team employed SANUWAVE’s Pulsed Acoustic Cellular Expression (PACE™) technology in preclinical research to create autogenous sources of stem cells for bone tissue engineering. Results support the proposition that PACE™ could be employed as a non-invasive technique to cause proliferation and thickening of the cambium layer of the femur’s periosteum for the subsequent intraoperative harvesting of progenitor stem cells days later for bone or cartilage regeneration.

PACE™ stimulated a dramatic proliferation and thickening (up to 10 fold) of osteoprogenitor stem cells, precursors to bone and cartilage cells, in the cambium layer of the periosteum in the femur of the adult rats within 4 days. Neovascularization and new bone formation within the thickened periosteum were also evident after 4 days.

Dr. Spector said, “This research has shown great potential. Through more study, this technology could further advance tissue engineering autologous transplant techniques towards clinical applications such as bone reconstruction and cartilage defect repair."

Christopher M. Cashman, President and CEO of SANUWAVE said, “We are excited about the preliminary research that Dr. Spector and his team have conducted on our PACE™ technology. The procedure could have meaningful use in clinical applications, whereby a patient’s own steoprogenitor cells could be harvested and reimplanted for procedures such as bone fusion, joint reconstruction and cartilage repair. In clinical application, stimulating a large amount of a patient’s own cells for harvest and reuse elsewhere in the body may have the added benefit of reducing the need for anti-rejection drug regimens. Further studies are needed to confirm that the proliferated cambium stem cells maintain their ability to differentiate into bone and cartilage cells.”

Mr. Cashman concluded, “Dr. Spector’s research is quite exciting and supports our efforts to further develop our technology for multiple regenerative medicine uses, in addition to SANUWAVE’s IDE clinical trial that is in progress for diabetic foot ulcers.”

About SANUWAVE®, Inc.

SANUWAVE, 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 Expression (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 Investigation Device Exemption trial in the U.S. for the treatment of diabetic foot ulcers. SANUWAVE 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 it’s U.S Class III PMA approved Ossatron® device and in the stimulation of 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.