ALPHARETTA, Ga., May 13, 2013 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCBB:SNWV) today announced that the Company held an investigator meeting in Atlanta, Georgia on May 10-11, 2013. The meeting served as the official kick-off of the supplemental Phase III clinical trial utilizing dermaPACE® for the treatment of diabetic foot ulcers. Representatives from 18 clinical sites engaged to participate in the clinical trial attended the meeting to receive training. These sites are now ready to begin screening and enrolling patients.
"The enthusiasm shown by more than 75 clinical site professionals attending the investigator meeting illustrates the medical community's interest in participating in this important study," commented Daniel Jorgensen, MD, Chief Medical Officer of SANUWAVE. "At the meeting, we discussed best practices to execute the study protocol and to maximize patient enrollment and follow-up. We also reviewed those additional measures that we have implemented versus the original trial to enhance the probability of successfully achieving the primary endpoint."
Diabetes is on the increase worldwide and diabetic foot ulcers are a growing problem among diabetics. As published by CDC and in JAMA, diabetic foot ulcers represent a $5 billion U.S. and $22 billion international market opportunity. More than half of all diabetic foot ulcers become infected, thus requiring hospitalization, and 1 in 5 require an amputation - which carries a high risk of mortality. Advanced, cost-effective treatment modalities for diabetic foot ulcers are in great need, yet in short supply.
Joseph Chiarelli, Chief Executive Officer of SANUWAVE commented, "We anticipate dermaPACE to be a cost-effective alternative that addresses this growing global issue. We share in the excitement with our clinical sites, and are on-track to screen and enroll the first patient in the second quarter of 2013."
For more information on the trial, please go to clinicaltrials.gov.
The Company will hold a conference call on Wednesday, May 15, 2013 beginning at 10:00 a.m. Eastern time to discuss the first quarter 2013 financial results, provide a business update including discussion of the investigator meeting and to answer questions.
Shareholders and other interested parties can participate in the conference call by dialing 877-407-9055 (U.S. and Canada) or 201-493-6743 (international).
A replay of the conference call will be available beginning two hours after its completion through May 22, 2013 by dialing 877-660-6853 (U.S. and Canada) or 201-612-7415 (international) and entering Conference ID 414704.
About the dermaPACE Phase III Supplemental U.S Clinical Trial
The dermaPACE Phase III supplemental clinical trial is a prospective, randomized, double-blind, multicenter study. The goal of the trial is to establish superiority in diabetic foot ulcer healing rates using the dermaPACE treatments as compared with the control group, when both are combined with standard of care dressings and, for some patients, with offloading from a walking boot.
This supplemental trial expands upon the positive treatment effect observed in the first study and incorporates many important features, including doubling the number of treatments, which we believe greatly increases the probability of success.
The dermaPACE Phase III supplemental study is designed to enroll a minimum of 90 patients at 20 U.S. sites. Patients will be randomized 1:1 to receive either dermaPACE treatment or control. Treatment consists of four non-invasive procedures (dermaPACE or control) during the first two weeks, and up to four additional non-invasive procedures (dermaPACE or control) delivered bi-weekly between weeks 4 and 10. The primary endpoint is complete wound closure at 12 weeks. Wound closure is defined as full skin re-epithelialization, without drainage or dressing requirements, confirmed at two consecutive visits. Secondary trial endpoints include time to closure, reduction in total wound surface area and volume, rates of ulcer recurrence and amputations, and other safety assessments. The clinical trial is anticipated to be completed with data available to support a Premarket Approval (PMA) application for dermaPACE as early as the end of 2014, assuming such data meet the agreed upon statistical endpoints.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially 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 regenerative medicine 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 device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. 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 and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE's shock wave technology in non-medical uses, including energy, water, food and industrial markets.
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 regulatory approval and 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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