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
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.
CONTACT INFORMATION Millennium Park Capital LLC Christopher Wynne 312-724-7845 cwynne@mparkcm.com SANUWAVE Health, Inc. Kevin Richardson II Chairman of the Board 978-922-2447 investorrelations@sanuwave.com
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