ALPHARETTA, Ga.--SANUWAVE Health, Inc. (OTCBB: SNWV), an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, reports the European launch of the orthoPACE™ device intended for use in orthopedic, trauma and sports medicine indications following CE mark approval last month.
“Extracorporeal Shock Wave Therapy for Nonunion of the Tibia”
The orthoPACE™ incorporates the Company’s proprietary Pulsed Acoustic Cellular [removed]PACE™) technology platform that delivers extracorporeal shock wave technology (ESWT) to treat a wide variety of chronic and acute conditions in hard and soft tissue. This award-winning device platform generates high energy, electrohydraulic shock waves that activate biological signaling and angiogenic responses, including revascularization and microcirculatory improvement, helping restore the body’s normal healing processes and promote regeneration. 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 device features a new, unique applicator that is less painful for some indications and may reduce or completely eliminate anesthesia for some patients.
Orthopedic and sports medicine conditions such as nonunion fracture and tendinopathy treated with the orthoPACE™ device have a proven success rate that is equal to and often greater than that of surgery – usually with just one procedure and without the inherent risks, complications and lengthy recovery time associated with invasive surgery. Most procedures can be performed in less than 15 minutes, and patients can return home the same day. Patients can bear weight immediately and are able to return to normal activity within a few days of the procedure. PACE™ treatment is completely non-invasive so there is no risk of infection or scarring. Importantly, it preserves the opportunity for any future treatment options as it does not change the biomechanics of the underlying musculoskeletal system.
The orthoPACE™ is the successor to the Ossatron®, the Company’s legacy device that was highlighted in the March 2010 issue of the Journal of Orthopaedic Trauma , in an article entitled “Extracorporeal Shock Wave Therapy for Nonunion of the Tibia” which detailed a 6 year study that included 172 patients undergoing treatment for tibia nonunion (incomplete fracture healing). In this study, nonunion was defined as a fracture that had failed to demonstrate cortical continuity on three of four cortices despite operative or non-operative 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. 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. Patients received an average of 5,510 impulses at an energy flux density of 0.38 to 0.40 mJ/mm 2. The orthoPACE™ is capable of treating in an equivalent energy range utilized in this study, which when combined with its compact, portable design, make it an efficient, user-friendly alternative to the much larger format Ossatron®.
Christopher M. Cashman, President and CEO of SANUWAVE, said, “The orthoPACE™ device offers significant enhancements to our past successful legacy orthopedic products, including the Ossatron®. The orthoPACE™ offers the best aspects and the same solid clinical efficacy, along with new features and expanded treatment potential. The orthoPACE™ has been well received by our European distributors and clinicians, and we expect the product to continue to gain visibility and momentum in 2010.”
In the orthopedic setting, the orthoPACE™ will initially be used to treat tendinopathies and acute and nonunion fractures, including the soft tissue surrounding the fracture to accelerate healing and prevent secondary complications and their associated treatment costs. The orthoPACE™ can also be used as an adjunctive treatment to fixation, fusion and grafting procedures. Recently reported scientific findings from a study titled “Extracorporeal Shock Wave Stimulation of Osteoprogenitor Cells,” presented at the 2009 International Bone-Tissue-Engineering Congress (“Bone-Tec”), indicate that this technology can create autogenous sources of stem cells for bone tissue engineering and repair. In addition to PACE™ technology’s scientifically demonstrated increases in microcirculation and growth factor production, the ability to create progenitor cells will greatly benefit these trauma indications.
In addition to the PACE™ platform’s orthoPACE™ introduction, SANUWAVE has developed dermaPACE™, its lead product candidate for the global wound care market. The dermaPACE™ is CE marked for treatment of the skin and subcutaneous soft tissue and has completed enrollment in its FDA-approved Phase III, pivotal, Investigational Device Exemption (IDE) trial in the U.S. for the treatment of diabetic foot ulcers (DFU). The dermaPACE™ U.S. DFU study is currently in the patient follow-up phase.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. ( www.sanuwave.com) is an emerging regenerative medicine company focused on the development and commercialization of non-invasive, biological response activating devices 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 [removed]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 has completed enrollment in its FDA-approved Phase III, pivotal, Investigational Device Exemption (IDE) 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®, Evotron™, and recently introduced orthoPACE™, devices in Europe.
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