June 13, 2012, 8:00 a.m. EDT ALPHARETTA, Ga., Jun 13, 2012 (BUSINESS WIRE) -- SANUWAVE Health, Inc. SNWV -3.23% , today reported the publication of peer-reviewed, preclinical osteoarthritis research that demonstrates the ability of the Company's Extracorporeal Shock Wave Technology (ESWT) to prevent the onset of osteoarthritis after a single treatment session that showed beneficial effects in as early as two weeks and continuing for at least three months. The publication, entitled "Extracorporeal Shockwave Therapy Shows Time-Dependent Chondroprotective Effects in Osteoarthritis of the Knee in Rats," by Wang, C. J. et al., appeared in the online edition of the Journal of Surgical Research as an ePublication ahead of print. The abstract of the publication can be viewed online at the Journal of Surgical Research website: http://www.journalofsurgicalresearch.com/article/S0022-4804 (12)00010-8/abstract. Osteoarthritis of the knee is considered primarily a cartilage disease, but emerging evidence suggests that changes within the subchondral bone (below the cartilage) play a corresponding role in the onset and progression of the disease. As a result, in this randomized study, six different evaluation parameters were assessed -- three for cartilage and three for subchondral bone. The tests were performed following surgical trauma to the anterior cruciate ligament (ACL) to induce osteoarthritic changes in the knee in two study groups, with one of these groups subsequently receiving ESWT treatment of the subchondral bone. A third group, used as a comparator control, included healthy animals that did not receive surgical trauma or ESWT treatment.
Summary of Key Study Findings -- The group that received ESWT treatment had comparable results to the control group of normal, healthy animals across all six assessed parameters, strongly suggesting that ESWT treatment prevented the onset of osteoarthritis. -- For evaluation parameters taken at 2, 4, 8 and 12 weeks, the group that received ESWT treatment compared with the non-ESWT group showed statistically significant improvements in the structure and overall health of cartilage, together with improvements in vascular function and new microvascular activity within bone, and new bone formation. -- The results demonstrated that the beneficial effects of ESWT occurred as early as two weeks after treatment, maximized between two and four weeks, and continued for at least twelve weeks, which was the longest time point analyzed in this study. Commenting on the study, the lead investigator, Dr. Wang, an orthopedic surgeon at Chang Gung Memorial Hospital in Kaohsiung, Taiwan and a prominent researcher in the field of shock wave treatment, said, "Our research team has previously conducted multiple studies on osteoarthritis of the knee using a SANUWAVE ESWT device which showed that a single ESWT procedure applied to the subchondral bone, prior to the onset of osteoarthritis, provides a chondroprotective effect that prevents osteoarthritic changes to the knee. We also showed that a single ESWT procedure applied after the onset of osteoarthritis delays, and can even regress, osteoarthritic changes to the knee. Those prior studies demonstrated the effects of ESWT treatment at a predetermined time point, so the purpose of this study was to investigate the effects of ESWT treatment over time, specifically between two and twelve weeks. Our results clearly show that ESWT treatment provides early and sustained benefits to both cartilage and bone that together prevent osteoarthritis in the knee." Dr. Wang concluded, "Our research is perhaps the first to use acoustic shock waves to prevent osteoarthritic changes to the knee, and the results are similar to those seen with pharmacotherapy. Based on our positive study results to date, I believe that SANUWAVE's platform of proprietary ESWT devices, known as PACE(R) technology, may offer an effective, noninvasive and low-cost treatment option in humans that carries little risk compared with other treatments." Christopher M. Cashman, President and CEO of SANUWAVE, said, "Multiple preclinical studies have shown that ESWT has a positive effect on joint diseases, including osteoarthritis. This latest study by Dr. Wang underscores the potential of our Pulsed Acoustic Cellular Expression (PACE) technology in this promising field of medicine. Osteoarthritis clinical research is a future focus area for SANUWAVE, and these early-stage studies are advancing our knowledge and bringing us closer to human trials. Our ultimate goal is to improve quality of life and mobility for a large and increasing number of people who suffer from the effects of osteoarthritis." 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(R), 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(R) device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its Ossatron, Evotron(R) and orthoPACE(R) devices in Europe. Forward-Looking Statements 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.
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