- Strong efficacy and safety results supported throughout article
- Supports acceleration of placements and insurance coverage during 2019 roll out
- Published in Journal of Wound Care: June 2019
Suwanee, Ga - (NewMediaWire) - June 13, 2019 - SANUWAVE Health, Inc. (OTCBB: SNWV), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announces the follow-on publication of the research that investigated the effects of dermaPACE® extracorporeal shock wave technology (ESWT) compared with Standard of Care in the treatment of diabetic foot ulcers. The peer reviewed article, titled “Focused shockwave therapy in diabetic foot ulcers: secondary endpoints of two multicentre randomized controlled trials” by Robert Galiano M.D, Robert Snyder, DPM, Perry Mayer MB, Oscar Alvarez PhD, Lee C. Rogers DPM has been published in the June 2019 issue of the Journal of Wound Care. This is the second peer reviewed article detailing the results of Phase III DFU trials using dermaPACE as the investigative device and is a follow-on to the first peer-reviewed article “Diabetic foot ulcer treatment with focused shockwave therapy: two multicentre, prospective, controlled, double-blinded, randomised phase III clinical trials” by the same authors.
Kevin Richardson, Chairman and CEO of Sanuwave, commented, “The publication of this second, peer-reviewed article is a clear demonstration of the safety and effectiveness of the dermaPACE System in the treatment of diabetic foot ulcers. The results in this article highlight dermaPACE’s strong performance in a real world setting. This gold standard study’s results will allow Sanuwave to continue the roll out of the product on an accelerated basis and work with insurance carriers to understand the true benefit brought by using dermaPACE to treat DFU’s. We can accelerate patient healing, save limbs, save lives, and save money for the insurance carriers, it’s a win win all around. Although, no advanced modality is a panacea for treating DFU. The dermaPACE System demonstrates the ability to close wounds faster, but in the other cases, the dermaPACE System can serve in preparing the wound bed for other advanced modalities. The initial results from our roll out are confirming what was highlighted in the article.”
Summary of Key Study Findings
This second peer reviewed article further details the results from the two Phase III clinical trials SANUWAVE sponsored to study the effects of dermaPACE System treatment on Diabetic Foot Ulcers (DFU) in conjunction with standard of care as compared to standard of care alone. The two studies evaluated 336 patients; 172 patients treated with dermaPACE 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. While the first peer reviewed article discussed the study design and results of the primary objective of comparison of wound closure rates at 12 weeks between dermaPACE and Standard of Care (SOC), this paper discusses the secondary safety and efficacy outcomes.
Highlights of the efficacy and safety outcomes are:
-- the mean wound reduction for dermaPACE subjects was statistically significant compared to the control group from the 6 week follow-up visit through the end of the study (at 6 weeks, p=0.018 and at 24 weeks p=0.049). dermaPACE closes wounds faster than standard of care.
-- beginning at week 4 and through to 24 weeks, the dermaPACE group has a higher percentage of subjects with a 50% wound reduction compared to the control (p=0.0581 and p=0.0899, respectively). dermaPACE helps clinicians achieve of point of being more manageable than standard of care.
-- The difference in the proportion of wounds achieving > 90% reduction was significantly higher in the dermaPACE group than in the control group (p=0.0064 in Study 1 at 12 weeks and p=0.014 at 14 weeks in the combined studies). dermaPACE helps the patient get extremely close to full closure better than standard of care.
-- The difference in time to wound closure between the active therapy and sham-treated groups was statistically significant in favor of the dermaPACE group (p=0.0346). Approximately 25% of dermaPACE subjects achieved wound closure by 84 days, as compared to the same number in the control group reaching closure by 116 days. dermaPACE closed wounds one full month faster than standard of care.
-- Rate of recurrence of closed ulcers was higher in the control group but not significant (7.7% or 5/65 in the dermaPACE group vs. 11.6% or 5/43 in the control group. dermaPACE provided a better wound closure than standard of care.
-- The dermaPACE treatment was well tolerated by the subjects; there was no significant change in pain from SOC with only 1.2% of the dermaPACE subjects reporting procedural or application site pain vs. 1.8% in the control group. dermaPACE is less painful than standard of care.
This study is among some of the more uniquely designed and analyzed studies in that the results from the combined studies reflect that of the Intent to Treat population. The inclusion and exclusion criteria allowed a broader range of subjects to be enrolled, including hard-to-heal subjects such as smokers. Additionally, subjects whose wounds reduced in size by up to 50% during the two-week run-in period were allowed into the study. Typical study designs allow no more than 30% wound area reduction in the run-in period. The bold design of this study allows it to provide a more true-to-life picture of how dermaPACE will perform in the treatment of DFU in a real-world setting. Clinicians appreciate the high level of real world applicability used by Sanuwave during the trial, truly a gold standard.
Shri Parikh, President of SANUWAVE Health, added, “Our clinical trials investigating the use of dermaPACE System in the treatment of DFUs, ultimately leading to U.S. FDA clearance, are groundbreaking. We believe dermaPACE System is a generational medical device that will greatly and positively impact the treatment of DFUs here in the U.S. as well as world-wide. These trials are just the beginning in the evolution of the use of the dermaPACE System in wound care. We will be active in later 2019 in initiating follow-on DFU studies to support our placement and reimbursement strategy. We will also look to expand the indications which can be treated using the dermaPACE System. Lastly, we will begin Proof of Concept trials combining dermaPACE with other treatment modalities.”
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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.
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Contact: Millennium Park Capital LLC Christopher Wynne 312-724-7845 firstname.lastname@example.org SANUWAVE Health, Inc. Kevin Richardson II CEO and Chairman of the Board 978-922-2447 email@example.com