Healthcare Industry News: Diabetic Foot Ulcer
News Release - March 10, 2010
SANUWAVE Health's Technology Shown to Successfully Treat Nonunion Fractures of the TibiaExpects To Introduce New Commercial Product in Europe in the Second Quarter
ALPHARETTA, Ga.--(HSMN NewsFeed)--SANUWAVE Health, Inc., (OTC BB: SNWV ) (www.sanuwave.com), an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, today announced that a journal article titled Extracorporeal Shock Wave Therapy for Nonunion of the Tibia, was published in the March 2010 issue of the Journal of Orthopedic Trauma. Based on the results of the study, the authors suggest that non-invasive Extracorporeal Shock Wave Technology (ESWT) applied with SANUWAVE’s Ossatron® device with one treatment session of 4000 pulses followed by fracture immobilization resulted in an 80% rate of healing of the nonunion bone fractures (incomplete fracture healing) as assessed by both clinical and radiographic means.
The authors of the study, Elster E., Stojadinovic A., Forsberg J., Shawen S., Andersen R. and Schaden W., represent the National Naval Medical Center, Naval Medical Research Center, Walter Reed Army Medical Center and AUVA Trauma Center in Vienna, Austria. The journal article detailed a 6-year study that included 172 patients undergoing treatment for tibia nonunion utilizing SANUWAVE’s Ossatron® device. The majority of patients referred to the study for tibia nonunion were resistant or unresponsive to one or more surgical treatments. Median time to healing from last orthopaedic operation was 14 months with a mean follow-up of nearly 16 months. The average time to healing after ESWT was 4.8 months. The authors stated that although the precise mechanism of targeted physical energy to produce the desired biologic effect of bone healing is not completely understood, migration and differentiation of mesenchymal stem cells (multipoint stem cells that can differentiate into a variety of cell types), and promotion of angiogenesis are thought to contribute increased bone mass and strength.
SANUWAVE expects to introduce a new commercial device to European markets called the orthoPACE™ that is capable of treating in an equivalent energy range utilized in this study. Scheduled to be launched during the second quarter of 2010, the orthoPACE™ has a compact, portable design and allows for treatments to be performed by a single operator in both the hospital and office setting. The orthoPACE™ replaces SANUWAVE’s Ossatron®, the 800 lb. legacy device that was used in this study. The orthoPACE™ will be indicated for a wide range of orthopedic, sports medicine and trauma indications including acute and nonunion fracture treatment.
In the U.S., 6,000,000 traumatic fractures are treated each year, and the prevalence of nonunion among these fractures is between 2.5% and 10.0% depending on the fracture type.
SANUWAVE President and CEO, Christopher M. Cashman said, “This comprehensive study, which reports an 80% healing rate of nonunions of the tibia, supports the utilization of PACE™ technology in the orthopedic space beyond the well-established treatment of chronic tendinopathies. We are looking forward to our expected second quarter launch of orthoPACE™ in Europe, where our growing base of distribution partners can continue to expand the use of PACE™ technology. The orthoPACE™ can be used across multiple care settings which we expect will increase the number of patients who are treated in a convenient, non-invasive and cost-effective way.”
Mr. Cashman concluded, “In addition to the important fracture healing results of this tibia study, SANUWAVE anticipates releasing the results of its U.S. Phase IIb Investigational Device Exemption (IDE) study focused on extremity small bone nonunion or delayed healing fracture in the second quarter of this year. SANUWAVE’s strategy for orthoPACE™ in the U.S. is to focus our clinical efforts and FDA submissions on the $4.2 billion orthopedic repair market.”
About the Study
The journal article detailed a 6 year study that included 172 patients undergoing treatment for tibia nonunion (incomplete fracture healing) utilizing SANUWAVE’s Ossatron® device. A nonunion was defined as a fracture that had failed to demonstrate cortical continuity on three of four cortices despite operative or nonoperative intervention for 6 months or more or showed no radiographic changes for 3 consecutive months and was associated with inability to bear weight on the affected extremity, pain on palpitation, or motion at the fracture site 6 months post trauma. Patients received an average of 5,510 impulses at an energy flux density of 0.38 to 0.40 mJ/mm2. Eighty percent (80%) of patients had one ESWT treatment, and 20% of patients had between 2 and 4 treatments. This resulted in complete fracture healing for 80.2% of nonunions within an average of 4.8 months.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVE’s portfolio of products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body’s normal healing processes and regeneration. SANUWAVE intends to apply its Pulsed Acoustic Cellular Expression (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 for treatment of the skin and subcutaneous soft tissue and is currently involved in an FDA-approved Investigational Device Exemption trial in the U.S. for the treatment of Diabetic Foot Ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide and believes it has already demonstrated that this 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® and Evotron® devices in Europe. For more information about the dermaPACE™ Diabetic Foot Ulcer trial, please visit www.dermapace.com.
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Source: ANUWAVE Health
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