SANUWAVE Health Inc. is an emerging medical technology company channeling its efforts to develop and commercialize non-invasive, biological response activating devices in the regenerative medicine area. The Journal of Orthopedic Trauma published an article titled Extracorporeal Shock Wave Therapy for Nonunion of the Tibia in its March 2010 issue highlighting a study involving SANUWAVE’s Ossatron device.
Authors of the article suggest that non-invasive Extracorporeal Shock Wave Technology (ESWT), when applied with SANUWAVE’s Ossatron device and one treatment session of 4,000 pulses followed by fracture immobilization, results in an 80 percent healing rate for nonunion bone fractures (incomplete fracture healing). The results were asses both clinically and by radiographic means.
The article details the six-year study of 172 patients undergoing treatment for tibia nonunion, utilizing SANUWAVE’s Ossatron® device. Most of the patients were resistant or unresponsive to previous surgical treatments. The average healing time from their operations was about 14 months; the average healing time after ESWT was a significant decrease at 4.8 months.
SANUWAVE president and CEO Christopher M. Cashman acknowledged the study’s results and said the company is anticipating the impending expansion of its technology.
“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,” Cashman stated.
Despite the positive studies of Ossatron, the company is advancing its technology. SANUWAVE’s orthoPACE is capable of treating in an equivalent energy range utilized in this study, and is scheduled for launch in the second quarter of 2010. The orthoPAC will replace the Ossatron, the 800 lb. legacy device that was used in this study in a wide range of orthopedic, sports medicine and trauma indications including acute and nonunion fracture treatment.
“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,” Cashman concluded.