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Cleveland Clinic Foundation study demonstrates that the patented PEMF-based waveform of Orthofix's Physio-Stim(R) bone growth stimulator augments and accelerates the healing of bone traumaHUNTERSVILLE, N.C. --(Business Wire)-- Sept. 28, 2005 -- A different PEMF waveform, when tested, failed to produce the beneficial effects that were observed with Physio-Stim(R) Data published in Journal of Orthopedic Research "We now have scientific proof of what has been long-observed in clinical outcomes: our unique, PMA-approved waveform does indeed stimulate the bone-healing process." Charles Federico, Group President and CEO, Orthofix Orthofix International N.V. (Nasdaq: OFIX) announced today that a study by the Cleveland Clinic Foundation's Lerner Research Institute demonstrated that the specific PEMF (Pulsed ElectroMagnetic Field) waveform of Orthofix's patented, PMA-approved Physio-Stim(R) bone growth stimulator is "causal to the observed improvement in the healing responses of...bone, augmenting the repair of acute bone trauma in a significantly faster time period than that observed for native healing." In addition, and equally important, the Cleveland Clinic study also concluded that the beneficial effects on bone healing were not observed when a different PEMF waveform was used. The study, led by Ronald J. Midura, Ph.D., has been published in this month's issue of the Journal of Orthopedic Research, a peer-reviewed medical journal. "We believe that this is a groundbreaking study because--for the first time--a group of researchers from an esteemed medical institution has scientifically validated the causal clinical benefit of our specific and patented PEMF waveform," said Charles Federico, Group President and CEO, Orthofix. "We expect this study to further demonstrate that Orthofix is the leader in bone growth stimulator technology. "Frost & Sullivan estimates that there are about six million bone fractures per year in the U.S., and that approximately five percent of them--or 300,000 fractures--will be non-unions and not heal without intervention. Given these Cleveland Clinic data, we believe we now have strong evidence that non-union bone fractures are prime candidates for our Physio-Stim bone growth product," added Federico. "More pieces of the bone-healing puzzle will be provided later this year when another Cleveland Clinic Foundation study is published about the cellular basis of Orthofix's PEMF activation," Federico added. "And a final paper is planned to summarize the major conclusions from this fruitful research. Orthofix is committed to this research--not just because we are the leader in this technology--but because we have a corporate commitment to the advancement of basic orthopedic science." Frost & Sullivan's 2005 U.S. forecast for the 'long bone external stimulation' market is $175 million. About Orthofix International, Orthofix International N.V., a global diversified orthopedic products company, offers a broad line of minimally invasive surgical, as well as non-surgical, products for the spine, reconstruction, and trauma market sectors that address the lifelong bone-and-joint health needs of patients of all ages--helping them achieve a more active and mobile lifestyle. Orthofix's products are widely distributed around the world to orthopedic surgeons and patients--via Orthofix's sales representatives and its subsidiaries, including Breg Inc., and via partnerships with other leading orthopedic product companies, such as Medtronic Sofamor Danek and Kendall Healthcare. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Orthopedic Research and Education Foundation, the Cleveland Clinic Foundation, Innovative Spinal Technologies and National Osteoporosis Institute. For more information about Orthofix, please visit www.orthofix.com. Forward-Looking Statements This news release contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix, and are based on management's current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the integration of the businesses of Orthofix and Breg, unanticipated expenditures, changing relationships with customers, suppliers and strategic partners, risks relating to the protection of intellectual property, changes to the reimbursement policies of third parties, changes to governmental regulation of medical devices, the impact of competitive products, changes to the competitive environment, the acceptance of new products in the market, conditions of the orthopedic industry and the economy and other factors described in the most recent report on Form 10-K and other periodic reports filed by Orthofix with the Securities and Exchange Commission. |
