ALPHARETTA, Ga., Dec. 1, 2014 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCQB:SNWV) today announced that the Company has enrolled its 130th patient in the Phase III supplemental clinical trial using dermaPACE® for treating diabetic foot ulcers (DFU's), which represents the number of patients the Company must enroll for the second interim analysis by the independent Data Monitoring Committee (DMC). The Company has suspended further enrollment in the study until the Data Monitoring Committee provides feedback on the 130 patients.
Kevin Richardson, II, Chairman of the board of directors of SANUWAVE, stated, "We are very pleased to have reached this enrollment milestone in the supplemental clinical trial of dermaPACE to treat diabetic foot ulcers. We anticipate having the feedback from the Data Monitoring Committee regarding the 130 patients in the first quarter of 2015 and look forward to updating shareholders at that time."
The DMC will perform an analysis on the entire 130 patient population once the patients have completed the twelve week efficacy analysis period. This is expected to be completed in the first quarter of 2015. After their review of the 130 patients, the DMC may recommend: 1) stopping enrollment because the dermaPACE has met the minimum success criteria as compared to sham-control, 2) increasing enrollment to 170 patients which is the next predefined patient analysis point, or 3) stopping the trial due to poor results.
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 non-invasive procedures (dermaPACE or sham) during the first two weeks. In addition, up to four 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.
"I would like to thank our Study Investigators and their dedicated staff. They have done an outstanding job in recruiting high quality patients in our gold standard study. The dermaPACE, with its novel biologic regenerative effects, holds promise to heal diabetic foot ulcers and increase limb preservation, thus improving quality of life for these patients and their families and significantly easing the economic burden on an overwhelmed healthcare system that cares for these patients. We continue to work towards 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. Richardson.
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.
For additional information about the Company, visit www.sanuwave.com.
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