SUWANEE, GA, Dec. 04, 2018 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCQB: SNWV) an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, announces the publication of the research that investigated the effects of dermaPACE® System (an Extracorporeal Shock Wave Technology (ESWT)) compared with Standard of Care in Diabetic Foot Ulcers (DFUs). The peer reviewed article, titled “Diabetic foot ulcer treatment with focused shockwave therapy: two multicentre prospective, controlled, double-blinded, randomised phase III clinical trials,” by Robert Snyder, DPM, Robert Galiano M.D., Perry Mayer MB, Oscar Alvarez PhD, Lee C. Rogers DPM, will be published in the December 2018 issue of the Journal of Wound Care.
Summary of Key Study Findings
This peer reviewed article details the results from the two Phase-III clinical trials that SANUWAVE sponsored to study the effects of the dermaPACE® System’s treatment on Diabetic Foot Ulcers in conjunction with standard of care as compared to standard of care alone. The two studies evaluated 336 patients; 172 patients treated with dermaPACE® System and 164 managed with a sham device. The demographic characteristics of patients in the two arms of both studies were balanced and statistical comparison of the two studies justified pooling datasets for analysis.
-- The dermaPACE® System showed statistically significantly more DFU healed at 20 (35.5% versus 24.4%; p=0.027) and 24 weeks (37.8% versus 26.2%; p=0.023) in the active treatment arm compared with the sham-controlled arm. At 12 weeks the active therapy arm trended to significance (22.7% versus 18.3%)
-- There were more amputations in the foot with the target (treated) DFU in the sham group (2.3% in the group treated with dermaPACE® System versus 6.4% in the Sham group). The incidence trended towards significance.
-- The relationships between complete wound closure and the characteristics of subsets of patients in the pooled dataset were observed. Notable differences were found in patient BMI, gender, and target ulcer age.
-- There were no statistical differences between the dermaPACE® cohort and the sham cohort in rates of Adverse Events during the course of the trial
-- In analyses of secondary objectives in the pooled dataset, wound area reduction was statistically significantly different in favor of active therapy from week 6 to week 24. By week 4, more subjects in the active therapy group had achieved 50% wound closure than in the control group although this did not reach statistical significance. More subjects in the active therapy group achieved 80% wound area reduction than in the control group from week 6 on, achieving significance at week 14.
A separate article is in preparation to report in greater specificity about these results, with expected publication in Spring 2019.
Kevin A. Richardson II, Chairman of the Board and CEO of SANUWAVE, said, “We are proud of the publication of this important research with our flagship dermaPACE® System. Our clinical trials investigating the use of the dermaPACE® System in the treatment of DFUs, ultimately leading to U.S. FDA clearance, are groundbreaking. We believe the dermaPACE® System is a generational medical device that will significantly and positively impact the treatment of DFUs here in the U.S. and world-wide. These two prospective, multicenter, randomized, controlled trials set the bar for comprehensive study design and control and will help support the use of dermaPACE® across multiple care settings including wound centers, clinics and hospitals.”
SANUWAVE president, Mr. Shri Parikh added, “dermaPACE® is proven to be effective and safe. Treatment of DFUs with our dermaPACE® System suggests that the therapy is influential in the management and stabilization of wounds. Due to the significance in reduced rates of amputations in the dermaPACE® System arm, savings in healthcare costs as well as improvement in the patient’s quality of life are achievable, balanced goals.” Mr. Parikh continued, “These trials are just the beginning in the evolution of the use of the dermaPACE® System in wound care. We will be active in 2019 in initiating follow-on DFU studies to support our reimbursement strategy as well as to expand the indications which can be treated using the dermaPACE® System.”
If you are interested in obtaining a copy of the article, please contact SANUWAVE via e-mail at thepulse@sanuwave.com; otherwise, please call (770)-419-7525.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB:SNWV) (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 US FDA cleared for the treatment of Diabetic Foot Ulcers. The device is also CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. 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.
Forward-Looking Statements
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