ALPHARETTA, Ga.--SANUWAVE Health, Inc. (OTCBB: SNWV) today reported publication of peer-reviewed, preclinical data conducted at Heidelberg University Hospital, the largest medical center in Germany, that demonstrates the ability of the Company’s dermaPACE ® technology to improve skin flap survival after a specific type of tissue injury known as ischemia-reperfusion (IR) injury. During IR injury, a period of low blood flow (ischemia) is followed by restoration of normal blood flow (reperfusion). This sequence of events is known to cause negative tissue effects, and it is often encountered clinically in many types of microsurgical procedures, including skin flaps and replantation surgery.
“Extracorporeal Shock Wave Treatment Protects Skin Flaps Against Ischemia-Reperfusion Injury”
The publication, entitled “Extracorporeal Shock Wave Treatment Protects Skin Flaps Against Ischemia-Reperfusion Injury,” appeared in the March 2012 issue of Injury. The authors demonstrated that a single treatment of dermaPACE delivered after tissue injury significantly improved skin flap survival and blood flow. Importantly, the data also illustrated that dermaPACE treatment improved skin flap survival to an extent that replicated healthy tissue with normal blood flow, suggesting that dermaPACE treatment protects skin flaps against the negative effects of IR injuries.
Visit http://www.injuryjournal.com/article/S0020-1383(11)00566-3/abstract to view an online abstract of the publication.
Author-Reported Beneficial Effects of dermaPACE
- dermaPACE treatment improved skin flap survival by promoting angiogenesis and inhibiting tissue inflammation.
- dermaPACE treatment resulted in significantly more newly formed blood vessels.
- dermaPACE treatment significantly improved beneficial gene and protein expression.
- dermaPACE treatment protected tissue from the damaging effects of IR injury.
Summarizing the study results, lead author Matthias Reichenberger, M.D., an acclaimed plastic and aesthetic surgeon, commented, “The tissue protecting effect of dermaPACE makes this easy, quick, cost-effective and noninvasive treatment an attractive tool in all surgical procedures that aim at reducing the negative effects of IR injuries. Based on our findings, we conclude that dermaPACE may have benefits for free flaps or replantation surgery in clinical practice. dermaPACE could be easily administered on the area of interest – after the surgical procedure, without risk to the treated tissue and without the need for wound management. Moreover, this treatment may be of great benefit in more complex clinical situations involving a patient population whose vascular conditions are frequently insufficient due to diabetes or arterial occlusive disease. In acute clinical situations, dermaPACE may be used postoperatively when intraoperative microvascular perfusion failure occurs with a high risk of loss of nutritional oxygen supply and consequential damage to the free flap or replanted tissue.”
Christopher M. Cashman, President and CEO of SANUWAVE, said, “Reperfusion injuries are common clinical events, notably in plastic and reconstructive, trauma, cardiac and general surgery. This important study, combined with a large body of published preclinical and clinical data, underscores the potential of dermaPACE to protect against ischemia and IR injuries by positively influencing the multifactorial process of tissue healing, with a clinically relevant focus on inhibition of inflammation and new blood vessel growth.”
Summary of Study Data
- dermaPACE treatment resulted in significantly more newly formed blood vessels compared with both the non-treated ischemia group (p = 0.003) and healthy controls (p = 0.005).
- dermaPACE treatment significantly increased proangiogenic (supporting new blood vessel growth) gene [removed]p < 0.001) and significantly decreased expression of proinflammatory chemokines and cytokines (p < 0.001) compared with the non-treated ischemia group.
- dermaPACE treatment significantly enlarged the mean flap survival area compared with the non-treated ischemia group (p < 0.001). Of note, the mean skin flap survival area after dermaPACE treatment nearly equaled that observed in healthy controls, 70.9 ± 11.3% compared with 80.9 ± 4.2%, respectively.
- dermaPACE treatment had a significantly higher mean perfusion (blood flow) index (PI) compared with the non-treated ischemia group (p < 0.001). Of note, the mean PI values of the dermaPACE treatment group were nearly identical to the mean PI values of healthy controls, 80.8 ± 8.7% compared with 80.0 ± 4.4%, respectively, predicting a similar skin flap survival rate in these two groups.
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.
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.
For additional information about the Company, visit www.sanuwave.com.