ALPHARETTA, Ga., Oct. 8, 2013 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCBB:SNWV) today reported that it has enrolled fifty percent (50%) of the minimum required patients in the Phase III supplemental clinical trial evaluating the dermaPACE® device on patients with diabetic foot ulcers. The clinical trial is designed to enroll a minimum of 90 patients and is on-track for completion in the first quarter of 2014.
The on-going Phase III clinical trial has enrolled 45 of the 90 minimum required patients needed to evaluate the safety and efficacy of dermaPACE in treating patients with diabetic foot ulcers. The trial is designed 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 with offloading from a walking boot as required. Treatment consists of four (4) non-invasive procedures during the first two weeks, and up to four (4) additional non-invasive procedures delivered bi-weekly between weeks 4 and 10. The primary endpoint is complete wound closure at 12 weeks.
"We are pleased with the collective efforts of the trial sites and the SANUWAVE clinical team in expediting enrollment in our on-going Phase III dermaPACE clinical trial," commented Joseph Chiarelli, Chief Executive Officer of SANUWAVE. "While there are many variables that can affect the pace of enrollment in the next few months, particularly the holiday season, we and the sites will continue to use our best efforts to keep enrollment on-track for completion in the first quarter of 2014."
Dr. Daniel M. Jorgensen, Chief Medical Officer of SANUWAVE added, "This trial is an important milestone in our efforts to bring the CE Marked dermaPACE device to the U.S. market. We expect to show, through a successful trial, that the dermaPACE device can offer significant benefit over current therapies for diabetic foot ulcers, a common debilitating problem among patients with diabetes. We believe the medical community would welcome a cost effective method that promotes the natural healing process of chronic, non-healing ulcers."
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 non-invasive, 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 intends to apply 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 and 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.
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