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dermaPACE Pivotal Phase III Clinical Trial Data in Diabetic Foot Ulcer Healing to Be Presented at Plastic Surgery 2011

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Published on Thursday, September 22nd 2011 at 5:09 GMT by Market Wire}  

ALPHARETTA, Ga.--([ BUSINESS WIRE ])--SANUWAVE Health, Inc. (OTCBB: SNWV), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announced that the Companya™s dermaPACE^® device will be the subject of a presentation at Plastic Surgery 2011, the American Society of Plastic Surgeonsa™ National Meeting being held September 23-27 in Denver.

"This event marks the first time that an esteemed national and international audience of plastic surgeons will be exposed to the healing power of PACE® technology to treat diabetic foot ulcers and to the commitment of SANUWAVE to support evidence-based medicine."

The presentation, titled aChanges in Wound Closure Rate Over Time in a Prospective, Randomized, Double-Blinded, Sham-Controlled, Multicenter Study of Shockwave Technology for the Treatment of Non-Healing Diabetic Foot Ulcers,a will take place as part of the Research & Technology Track I on Saturday, September 24 from 1:00 p.m. to 2:00 p.m. Mountain time. The presentation will be delivered by Lawrence Bass, M.D., Clinical Assistant Professor of Plastic Surgery, Department of Plastic Surgery, NYU School of Medicine, and the safety monitor for the recently completed pivotal Phase III, Investigational Device Exemption (IDE) clinical trial of dermaPACE for the treatment of diabetic foot ulcers.

aI am pleased that the dermaPACE clinical trial results have been accepted for presentation at the premier educational event for plastic surgeons and supporting industry in the U.S.,a stated Christopher M. Cashman, President and Chief Executive Officer of SANUWAVE. aThis event marks the first time that an esteemed national and international audience of plastic surgeons will be exposed to the healing power of PACE^® technology to treat diabetic foot ulcers and to the commitment of SANUWAVE to support evidence-based medicine.a

The Company will showcase dermaPACE and discuss the clinical trial data at Exhibit Booth #614.

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. SANUWAVEa™s portfolio of products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the bodya™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 for treatment of the skin and subcutaneous soft tissue and recently completed its highly positive pivotal Phase III, Investigational Device Exemption (IDE) clinical trial in the U.S. 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, Evotrona" and orthoPACE^® devices in Europe.

Forward-Looking Statements

This press release may contain aforward-looking statementsa 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 Companya™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 Companya™s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Companya™s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Companya™s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.