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SANUWAVE, Inc. Receives Conditional Approval from the FDA on Clinical Trial Plan for dermaPACE



5/8/2012 7:18:59 AM

ALPHARETTA, Ga.--(BUSINESS WIRE)-- SANUWAVE Health, Inc. (OTCBB: SNWV.OB - News) today reported that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE) Supplement for an additional clinical trial utilizing the Company’s dermaPACE® device in the treatment of diabetic foot ulcers. The Company estimates the clinical trial could be completed and submitted in support of a Premarket Approval (PMA) application for dermaPACE in as early as 20 months from trial initiation, assuming such data to be collected meets the agreed upon statistical and clinical plan of success.

The Company worked closely with the FDA to develop the protocol and statistical plan that were submitted in the IDE Supplement. A substantial component of this work involved using Bayesian statistical principles to define the dermaPACE treatment benefit established in the Company’s previously conducted pivotal study. Bayesian designs are supported by the FDA where there is strong prior evidence that can be incorporated into the clinical study design. By incorporating the prior positive information regarding complete wound closure after one treatment cycle to bear on the design of the additional study, substantially fewer patients should be required than would otherwise be the case while still ensuring adequate statistical power. This approach will save significant time and preserve scientific rigor.

Importantly, the study design allows for controlled interim monitoring of the data by an independent Data Monitoring Committee (DMC) to determine whether study success has been achieved. The first analysis for success is projected to occur after 90 patients (approximately 45 per arm) have completed the 12-week primary efficacy evaluation period. If study data achieves pre-defined statistical and clinical success criteria associated with wound closure favoring dermaPACE, then the clinical trial can be stopped, and the Company will submit an amendment to its current PMA for approval.

The clinical trial plan incorporates the same primary efficacy endpoint of complete wound closure at 12 weeks as was utilized in the recently completed pivotal trial. Similar to the previous trial, four (4) dermaPACE procedures will be administered during the first two weeks following subject enrollment. However, up to four (4) additional dermaPACE procedures can now be delivered bi-weekly between weeks 4 and 10 which the Company believes will increase the between-group difference in complete wound closure in favor of dermaPACE from that observed in the first clinical trial.

The Company has already identified clinical study sites and is in the process of qualifying them for participation. Patient enrollment is expected to begin once Institutional Review Board (IRB) approvals and appropriate funding to conduct the study are in place, which is forecasted to occur as early as the third quarter of this year.

Christopher M. Cashman, President and CEO of SANUWAVE, said, “As previously reported, we believe that an IDE Supplement is the most appropriate course of action to support our PMA for dermaPACE in the treatment of diabetic foot ulcers. The FDA’s conditional approval of the IDE Supplement is a highly positive development in the approval process of dermaPACE for the U.S. market. This additional clinical trial provides a scientifically robust, yet potentially more expeditious pathway to validation of dermaPACE’s safety and efficacy and subsequent FDA approval.”

“We have worked diligently and openly with the FDA to develop the statistical plan and the protocol for the IDE Supplement while, in parallel, recruiting key investigational sites to perform this next clinical trial. The FDA’s support of the study’s Bayesian framework allows us to build upon the wound closure data previously demonstrated for dermaPACE. We are moving quickly toward our ultimate goal of obtaining FDA approval for dermaPACE and commercializing the technology in the U.S. where millions of people suffer from costly and debilitating diabetic foot ulcers,” concluded Mr. Cashman.

Medical Need

According to the Centers for Disease Control and Prevention (CDC), diabetes has reached an epidemic level in the U.S., with nearly 26 million American adults having diabetes, and an estimated 79 million more having pre-diabetes. The CDC also reports that, in 2010, nearly two million Americans aged 20 years or older were first diagnosed with diabetes. If current trends continue, 1 in 3 Americans will develop diabetes at some point in their lifetime, and those with diabetes will lose, on average, 10-15 years of life expectancy. The World Health Organization (WHO) projects that by the year 2030 the prevalence of diabetes is expected to double to 366 million people worldwide.

Importantly, as published in the Journal of the American Medical Association (JAMA) in 2005, up to 25% of people with diabetes will develop a diabetic foot ulcer in their lifetime, resulting in up to 2.6 million diabetic foot ulcers annually in the U.S. alone. Research published in Diabetes Care in 2006 demonstrated that more than half of all foot ulcers will become infected, thus requiring hospitalization, and 1 in 5 will require an amputation that carries a high risk of mortality. The CDC reports that more than 60% of nontraumatic lower limb amputations occur in people with diabetes, while the International Diabetes Federation estimates that 85% of all diabetes related amputations are preceded by foot ulcers, and a lower limb is lost to diabetes every 30 seconds. Disturbingly, patients hospitalized with diabetes are 28 times more likely to have an amputation than patients without diabetes, according to the Agency for Healthcare Research and Quality (AHRQ). As reported in 2007 in the International Wound Journal, the consequences of major lower extremity amputations in diabetic patients are severe, with an estimated 5-year postoperative survival rate of less than 50%, indicating that mortality associated with diabetic lower extremity amputations exceeds that of most cancers.

The economic burden of diabetic foot ulcers and their complications is enormous. The American Diabetes Association (ADA) estimates that the average cost to heal a diabetic foot ulcer in 2010 was $8,000, while an infected ulcer cost $17,000, and a major lower extremity amputation in a diabetic patient cost $45,000. Since the ADA reports that more than 80,000 amputations are performed each year on diabetic patients in the U.S., the total costs of lower extremity amputations in diabetic patients may exceed $3.6 billion annually. The staggering economic and clinical burdens associated with diabetes and its complications, to include diabetic foot ulcers and lower extremity amputations, make diabetes one of the most pressing and challenging diseases for healthcare systems worldwide.

About dermaPACE

dermaPACE, the Company’s Pulsed Acoustic Cellular Expression (PACE®) technology for use in acute and chronic wound healing, delivers high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures. These mechanical stresses are believed to induce, at both the macro and micro levels, cellular responses crucial to the initiation of the healing cascade. Responses to the mechanical stresses have been shown in studies involving both animals and humans to include microcirculatory improvement, increased perfusion and blood vessel widening (arteriogenesis), the production of angiogenic growth factors, and enhanced new blood vessel formation (angiogenesis). dermaPACE is an Investigational Device in the United States and is limited by Federal law to investigational use only.

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.

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.

For additional information about the Company, visit www.sanuwave.com.

Contact:

SANUWAVE Health, Inc.

Barry Jenkins, 678-578-0103

CFO

or

Bernie Laurel, 678-578-0103

VP of Sales and Marketing

investorrelations@sanuwave.com


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