SANUWAVE Announces Cooperation with Ortho-Medico in Europe on a New 100 Subject Trial Treating Patients with Diabetic Foot Ulcers In-Home Care Using Dermapace
SUWANEE, GA / ACCESSWIRE / December 15, 2016 / SANUWAVE Health, Inc. (OTC QB: SNWV) is pleased to announce that the Company, in partnership with Ortho-Medico, a member of B&Co, Herzele, Belgium, is sponsoring continuing clinical investigation on diabetic foot ulcers (DFU). This trial is expected to begin in January 2017, and will be conducted by the VUB (Free University of Brussels) and UZ Brussel (University Hospital). Earlier work in 2015 at this hospital found that DFU patients, treated in-home with dermaPACE system, responded positively to the treatment. This trial will take the home-care procedures, used in a limited basis, and extend them to a randomized, controlled trial of 100 subjects. The intent of this trial is to compare the effectiveness of in-home treatment of diabetic foot ulcers (DFUs) using dermaPACE as compared to in-home treatment of DFUs using standard of care only. This trial will help to provide evidence that dermaPACE can be used outside the clinical setting and in essence increase the potential for expanded sales in Europe.
Ortho-Medico has long been SANUWAVE’s partner in the European Union. With their strength, experience, and knowledge of the orthopedics and wound care market, they are well positioned to help expand SANUWAVE’s market penetration via increased clinical presence and to continue to promote the Company’s core products, dermaPACE, and orthoPACE systems.
Commenting on today’s announcement, Kevin A. Richardson II, SANUWAVE’s Chairman of the Board, said, “We are very excited about this opportunity to investigate the use of dermaPACE in the home environment. We are equally excited that this opportunity is the first of many that SANUWAVE will partner with Ortho-Medico to help expand the clinical evidence associated with the use of dermaPACE system on diabetic foot ulcers.” Added Jo Schops, General Manager of Ortho-Medico, “Our company has long been a proponent of dermaPACE and orthoPACE and this clinical trial will help to show the strong efficacy exhibited by the use of dermaPACE on DFU’s. We are pleased to be partnering with SANUWAVE and the combined strength of our two companies will only help to expand market penetration in the European Union.”
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (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 CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. 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.
About Ortho-Medico
Ortho-Medico has been a known player in the Benelux since 1987 with its full range of orthopedic aids and specific treatments as Shockwave. Ortho-Medico’s final aim, its mission, is to keep the patient as dynamic and active as possible, therefor our innovative expansion in the field of wound care and neurology. Ortho-Medico’s success is founded on a very high-quality, complete product portfolio, very close collaboration with specialists and orthopedic technicians, very quick terms of delivery, reliable advice and an attitude which is aimed at finding solutions.
