07/11/2018 | Press release | Distributed by Public on 07/11/2018 11:27
SUWANEE, GA, July 11, 2018 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce a partnership with HyperMed in Memphis, TN to sponsor a continuing clinical investigation on Diabetic Foot Ulcers (DFUs). This investigational work is expected to begin in August 2018. An initial case series will be conducted at two sites, the primary site being the Vascular and Wound Care Center at University Hospital, Rutgers NJMS in Newark, NJ with Dr. Oscar Alvarez as the Principal Investigator, and the second site at Olive View-UCLA Medical Center with Dr. Aksone Nouvong leading the efforts. The intent of this trial is to quantify the level of increased perfusion and oxygenation during and after treatment with the dermaPACE® System.
Previous animal studies and clinical work using the dermaPACE® System has shown that treated tissue exhibits increased perfusion to the area, as measured by doppler imaging, and an increase in venule and arteriole diameters, indicating increased red blood cell velocity. This case series will utilize HyperMed's Hyperview spectral imaging device to measure oxygen saturation, oxyhemoglobin level, and deoxyhemoglobin level in superficial tissue and using TcPO2 values as a control.
As a result of Dr. Alvarez's leadership and case work, he will be able to provide SANWUAVE with valuable, measurable data to continue to expand our understanding of the dermaPACE® System's mechanism of action. Dr. Nouvong has already performed and published extensive research using the HyperView spectral imaging device. These two renowned investigators and practitioners in wound care, with their combined expertise, will expand the already extensive clinical data associated with dermaPACE®. Both researchers participated in previous dermaPACE® DFU trials.
Commenting on today's announcement, Kevin A. Richardson II, SANUWAVE's Chairman of the Board and Chief Executive Officer, said, 'We are very excited about this next opportunity to investigate the effects that the dermaPACE® System has on improving perfusion and oxygenation in treated tissue. This case series will enable us to quantify the increases and help us to better understand how dermaPACE® improves patients' quality of life, leading to future research and improvement of clinical protocols for the treatment of Diabetic Foot Ulcers and other skin conditions. We are another step closer to Healing Today, Curing Tomorrow.'
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.
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 [email protected] SANUWAVE Health, Inc. Kevin Richardson II Chairman of the Board 978-922-2447 [email protected]