SUWANEE, GA, Aug. 01, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to provide an update of current clinical events and news involving the company’s dermaPACE System, the only shockwave product cleared by FDA for the treatment of Diabetic Foot Ulcers (DFUs). The dermaPACE System is by far the most studied shockwave device on the market for wound indications; having more than 15 peer reviewed articles, including the two most recently published by JWC discussing the DFU Phase III trial, and over 30 abstracts and posters. This work has established a strong effectiveness and safety profile and helped us gain a solid understanding of how DFUs respond to dermaPACE treatment: increased perfusion, reduction in inflammation, accelerated wound area reduction and wound healing. SANUWAVE is continuing to strive to remain at the forefront of wound care research involving the company’s proprietary Pulsed Acoustic Cellular Expression (PACE®) technology. In addition to forward looking plans for pharma-economic studies involving the dermaPACE System, on-going case series measuring the increase in perfusion after treatment with dermaPACE is on-going at three major universities. A comprehensive evaluation of the effects on wound response to shock count and wound area is on-going in Poland. In the past few months, a number of posters have been presented at major wound care symposia and research forums.
· Dr. Windy Cole, DPM, Adjunct Professor and Director of Wound Care KSUCPM and Medical Director, UH Ahuja Wound Center presented at “The National”, the annual gathering for American Podiatric Medical Association (APMA) held in Salt Lake City, Utah in July 2019 titled: “The Use of Non-Invasive Pulsed Acoustic Cellular Expression System to Promote Angiogenesis in Chronic Wounds.” This case series discussed results to date of the objective to measure and monitor tissue oxygen saturation levels before and after a treatment regimen using the dermaPACE System on DFUs. Measurement of hemoglobin levels is via the Snapshot NIRS device from Kent Imaging. The on-going series reported wound improvement as measure by wound area reduction and increased granulation while also exhibiting an improvement in tissue oxygenation by 11%. To date, 5 patients have been treated with an additional 5 patients to be enrolled and reported on.
· Dr. Roberto Cassino, who is affiliated with the Interdepartmental Center Team of Diabetic Foot from Istituto Clinico Città Studi – Milano, Italy, presented at SAWC Spring in San Antonio, TX a poster titled: “Extracorporeal Shockwave Therapy (ESWT) in wound care: state of the art in Italy.” In this poster, Dr. Cassino presented results on the effectiveness of treatment of chronic wounds using dermaPACE System on 50 patients. Significant results included: 25% reduction in wound area after the first dermaPACE treatment, 70% of wounds healed by the end of the study period, and 90% of the wounds with surgical indication completely healed without surgery.
· The “Effect of Extracorporeal Shockwaves (ESWs) on Osteocytes In Vitro” poster, presented at Harvard Research Day Forum earlier in 2019, shows a study performed by researchers from Harvard Medical School, Brigham and Women’s Hospital, and Veteran Affairs (VA) Boston Healthcare System, and Hangzhou Dianzi University, China. The results shown that on the full range of shockwaves input energy (E1 to E6 setting for SANUWAVE’s orthoPACE System), the viability of osteocytes from cell cultures was slightly impaired when compared to control, which did not affect their viability to orchestrate the osteoblasts and osteoclast activity that are involved in new bone formation. Two (2) days after the shockwave treatment the proinflammatory Tumor Necrosis Factor Alpha (TNF-α) was significantly reduced, which indicates a favorable modulation of the inflammatory process, a key factor in wound healing. Also, shockwaves produce an increase in the angiogenesis Vessel Endothelial Growth Factor (ESGF) on day 4, which is an indication of new blood vessels formation. The intracellular Reactive Oxygen Species (ROS) had a transient increase and rapidly dropped below the normal level, which reduces the possibility of DNA, RNA, and proteins damage that can cause cell death. In conclusion, this study indicates the favorable effects of shockwaves on osteocytes.
· The “Effects of Extracorporeal Shockwaves on Bone Marrow/Synovium Activation and Articular Cartilage Repair” poster, presented at Harvard Research Day Forum earlier in 2019, shows a study performed by researchers from Harvard Medical School, Brigham and Women’s Hospital, and Veteran Affairs (VA) Boston Healthcare System, Southern Medical University and Hangzhou Dianzi University, China, and Institute of Bioengineering and Nanotechnology, Singapore. For this study 4 mm diameter cartilage defects were created in the knee joint of a goat-model. The cartilage defects were filled with Gtn-HPA hydrogel. The shockwaves were applied, using SANUWAVE’s orthoPACE System, 4 days before the defects were create and 30 minutes before animal sacrifice, which occurred at day 14. The histological analysis shown that shockwaves produce bone marrow activation and subsequently stem cells migration to the joint’s synovial fluid and towards the injured cartilage. Also, stromal and vascular proliferation resulted in neovascularization and tissue repair, which combined with stem cells migration ultimately can enhance cartilage regeneration and repair onsite. The study also shown that the Gtn-HPA hydrogel is capable of recruiting stem cells, which in combination with shockwaves might enhance cartilage repair process and become a viable treatment option for cartilage regeneration. The more active population and the increase in life-expectancy will certainly increase the cartilage problems, which according to analysts will produce a global market size of $2.195 billion in 2025, with at least 15.0% increase per year from 2018 and 2025.
Kevin Richardson, Chairman of the Board and CEO of SANUWAVE, stated, “SANUWAVE has been the leader in wound care research using shockwave technology for more than 15 years, and we plan to be the continued leader for years to come. Our groundbreaking work in developing our understanding of the dermaPACE System mechanism of action has brought us to the forefront in wound care using our PACE technology. We will not slow down in furthering our understanding of how PACE affects the body’s biological response. You will see a number of posters and abstracts and SANUWAVE sponsored symposia at upcoming medical device shows this fall and next spring. Other peer-reviewed articles will be forthcoming based upon on-going research in perfusion measurement. Additionally, we expect to begin enrollment of our follow-on study supporting our DFU indication. And of course, we fully expect to be active in 2020 in setting the clinical groundwork for expansion into new indications.”
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
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