ALPHARETTA, Ga., April 30, 2014 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCQB:SNWV) today announced that the Company has enrolled its 90th patient in the Phase III supplemental clinical trial using dermaPACE® for treating diabetic foot ulcers (DFU's), which represents the minimum number of patients the Company must enroll for the first interim analysis.
Kevin Richardson, Chairman of the board of directors of SANUWAVE, stated, "We are very pleased to have reached this major milestone for minimum enrollment in the supplemental clinical trial of dermaPACE to treat diabetic foot ulcers. We anticipate having the feedback from the Data Monitoring Committee regarding the first 90 patients in the third quarter and look forward to updating shareholders at that time."
The goal of the trial is to demonstrate that the healing rate of dermaPACE is statistically superior to that of sham at 12 weeks post initial device application. Patients enrolled in the study receive four (4) non-invasive procedures (dermaPACE or sham) during the first two weeks. In addition, up to four (4) additional non-invasive procedures (dermaPACE or control) are delivered bi-weekly, between weeks 4 and 10. After the 12 week efficacy evaluation, patients are followed for an additional 12 weeks for safety. The study will continue to enroll new patients while 12-week efficacy data are collected on the first 90 patients.
"I would like to give credit and thanks to our Study Investigators and their dedicated staff. They have done an outstanding job in recruiting high quality patients in a relatively short timeframe," added Dr. Daniel Jorgensen, Chief Medical Officer for SANUWAVE. "Assuming positive study results, dermaPACE could transform the way diabetic foot ulcers are treated."
The first interim analysis will be performed by an independent Data Monitoring Committee (DMC) shortly after the 90th patient has completed the 12 week efficacy visit. If success criteria are met, the DMC will recommend to SANUWAVE that further enrollment can be stopped.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE's portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body's normal healing processes and regeneration. SANUWAVE applies its patented 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 throughout Europe 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, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE's shock wave technology for 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.
Source:SANUWAVE Health, Inc.