Suwanee, GA, April 04, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCBB: SNWV) (www.sanuwave.com): SANUWAVE® is pleased to announce initial enrollment beginning this week in two company-sponsored studies. First, SANUWAVE is sponsoring an initial case series to quantify the level of increased perfusion and oxygenation during and after treatment of Diabetic Foot Ulcers (DFU’s) with the dermaPACE® System. This study will be conducted at two sites, with the primary site located at the Vascular and Wound Care Center at University Hospital, Rutgers NJMS, Newark, NJ with Dr. Mark Grannick as the Principal Investigator and Dr. Oscar Alvarez as the Co-Principal Investigator. The second site is located at the Olive View-UCLA Medical Center with Dr. Aksone Nouvong leading the effort and enrollment beginning by the end of April.
Previous animal studies and clinical work using the dermaPACE® System have shown that treated tissue exhibits increased perfusion to the area as measured by Doppler imaging and also increased venule and arteriole diameters, indicating increased red blood cell velocity. This case series will utilize spectral imaging to measure oxygen saturation, oxyhemoglobin level, and deoxyhemoglobin level in superficial tissue and using TcPO2 values as a control. This initial case series will help us to quantify these increases and will help us to better understand how dermaPACE® works, leading to future research and improvement of clinical protocols for the treatment of Diabetic Foot Ulcers and other skin conditions.
A second, more extensive study will assess the response of DFU’s treated with an increasing number of shockwaves/pulses. In our U.S. based Phase III trial measuring the effects that treatment of DFUs in conjunction with Standard of Care as compared to Standard of Care alone, a single dosage regimen of 500 shocks/treatment was used. In this new three-arm study, to be conducted at NZOZ PROFIL Private Wound Clinic from Poznan, Poland, the researchers will observe how DFU’s respond to the dermaPACE® System treatment in conjunction with Standard of Care in three different dosage regimens that use a higher number of shockwaves when compared to the U.S. Phase III study. The Principal Investigator for this study is Professor Tomasz Banasiewicz, who is the head of Department and Clinic of General, Endocrinological and Gastroenterological Oncology, associated with Poznan University of Medical Sciences, Poland. This study will be managed by the Medigent Foundation. The total number of patients for this study is 60, with 20 patients for each arm. These three regimens will be applied to wounds in between 1.0 cm2 to 8.9 cm2 and the number of shockwaves is a calculated function of wound area (in cm squared) plus an additional 2 cm peri-wound region in all directions around the wound perimeter. The total number of treatments are ten (10) for each patient. The efficacy will be assessed in between different arms/treatment groups by comparing the target ulcer area and perimeter at the end of the clinical study, by determining the hazard ratio of complete target ulcer closure by 12 weeks and at the end of the study, by assessing reduction in pain at mid-term point of the clinical study and at the end of the clinical study, by comparing Quality of Life based on the POLISH Diabetic Foot Ulcer Scale-Short Form (POLISH DFS-SF) at the beginning of the clinical study, at mid-term point of the clinical study, and at the end of the clinical study; and by determining the rate of adverse events in between the three arms/treatment groups at the end of the clinical study.
Commenting on today’s announcement, Shri Parikh, President of SANUWAVE Health, stated, “We are excited to continue our commitment in clinical research, further supporting our dermaPACE® System launch here in the U.S. and abroad. We are dedicated to continuously improving and educating through clinical innovation. The perfusion study will further clarify how our dermaPACE® system can be optimally used within a wound clinic. Wounds cannot heal without perfusion and we believe our device is very effective, if not one of the most effective on the market, for improving wound care perfusion.” Regarding the second study, Mr. Parikh continues, “The study in Poland will explore if more shocks can accelerate or improve the speed at which a wound is healed. We know through prior experience, that the dermaPACE® System has an excellent safety profile and therefore this research will help to measure the response of DFU’s when treated with higher dosages applied to wound and peri-wound areas.”
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shockwave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating systems 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® System, is U.S. FDA cleared for the treatment of Diabetic Foot Ulcers. The system is also CE Marked throughout Europe and has 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® System, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron®, Evotron®, and orthoPACE® Systems in Europe, Asia, and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shockwave 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.
CONTACT INFORMATION Millennium Park Capital LLC Christopher Wynne 312-724-7845 firstname.lastname@example.org SANUWAVE Health, Inc. Kevin Richardson II Chairman of the Board 978-922-2447 email@example.com