ALPHARETTA, Ga., Jan. 29, 2014 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCBB:SNWV) today reported that it has enrolled over seventy-five percent (75%) 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; which is on track to occur in the first quarter of 2014.
PRIMARY ENDPOINT SUCCESS – A MATTER OF NUMBERS
The primary endpoint is complete wound closure at 12 weeks. Only a 12 percentage point difference is required between the active and sham arms for success in the dermaPACE clinical trial using the Bayesian Statistical Method. The range of results can be broad - an example would be 12 patients achieving complete wound closure in the active arm while tolerating 6 closures in the sham arm, or, a 25% complete closure rate in the active arm and 13% in the sham arm.
FOUR ADDITIONAL TREATMENTS INCREASES PROBABILITY OF SUCCESS
Treatment consists of up to eight applications - 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 original dermaPACE trial used only the first four (4) non-invasive treatments. Research subsequent to the start of the original trial demonstrated that additional treatments every two weeks maintained the rejuvenative effect of focused shock wave therapy. This important difference increases the probability of achieving the primary endpoint.
MAINTAINING THE BENEFICIAL IMPACT OF FOCUSED SHOCK WAVES
"We believe that these four additional treatments – which maintain the treatment's benefits for a longer time period - together with the use of the Bayesian Statistical Method increases substantially our probability of successfully meeting the primary endpoint," commented Joseph Chiarelli, Chief Executive Officer of SANUWAVE.
RATE OF ENROLLMENT REMAINS HIGH
"We are pleased with the collective efforts of the trial sites, our CRO, and the SANUWAVE clinical team in maintaining the rate of enrollment in our on-going Phase III supplemental dermaPACE clinical trial," added Mr. Chiarelli. "We are exceptionally gratified that sites continued to screen during the holiday season and that the rate of screening and enrollment increased substantially during January."
Dr. Daniel M. Jorgensen, Chief Medical Officer of SANUWAVE added, "We believe that the continued high rate of screening and enrollment demonstrates the satisfaction of investigators with our trial's design and management, and the safety of the CE Marked dermaPACE device. We expect to show, through a successful trial, that the dermaPACE device can offer significant benefits for patients with diabetic foot ulcers and believe that the medical community would welcome a safe, convenient, and cost effective method that promotes the natural healing process."
This supplement to the original dermaPACE trial incorporates input from the FDA and experts in the field of wound care, some of whom are principal investigators (PIs). Enrollment began in mid-June 2013, and has continued at a brisk pace. For more information about the trial, please visit www.clinicaltrials.gov.
"I am encouraged by the possibilities offered for patients by this simple yet innovative technology in treating chronic diabetic foot ulcers," commented Dr. Robert Snyder, President, Association for the Advancement of Wound Care. Dr. Snyder is Professor and Director of Clinical Research at the Paul & Margaret Brand Research Center at Barry University, which is located in Florida and is one of the Company's clinical trial sites. "Diabetic foot ulcers are a common debilitating problem among patients with diabetes. I would welcome into our armentarium of treatments a novel, cost effective method that promotes the natural healing process of patients who have chronic, non-healing ulcers."
FUNDING EFFORTS CONTINUE
As previously indicated, the Company continues to raise funds to support the current dermaPACE Pivotal Trial and provide for its working capital needs. SANUWAVE expects to close on a bridge loan within the near future and complete additional transactions to provide sufficient funds through release of top line data of the dermaPACE trial.
SANUWAVE expects to report its fourth quarter and full year 2013 earnings and results in March 2014.
About the dermaPACE Device
The dermaPACE device emits focused, high-energy, acoustic shock waves that restore the body's normal healing processes. Research indicates the technology initiates the reactivation of the body's natural healing cascade, including increased perfusion and blood vessel widening (arteriogenesis), the production of growth factors, formation of new blood vessels (angiogenesis), and the subsequent regeneration of skin tissue, musculoskeletal, and vascular structures. The dermaPACE device is currently being utilized outside the U.S. for the treatment of skin and soft tissue conditions including ulcers, pressure sores, scar reduction, and wound healing. Advanced wound care using the dermaPACE represents a $5 billion U.S. and $22 billion international market opportunity.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company with approximately 170 devices in use throughout the world. The Company is 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 leads to regeneration of tissue. In the United States, SANUWAVE intends to apply its patented Pulsed Acoustic Cellular Expression (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 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.
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Source:SANUWAVE Health, Inc.