Orthofix Receives Reimbursement from the French Government for Its Physio-Stim Bone Growth Stimulator.HUNTERSVILLE, N.C. -- Orthofix International NV (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : OFIX) today announced that it has received reimbursement approval from France's Ministry of Health for Orthofix's Physio-Stim(R) bone growth stimulator. To prepare Physio-Stim for reimbursement in France, Orthofix first had to make certain it had an excellent technical and medical assessment file, with strong clinical data supporting the effectiveness and safety of Physio-Stim. The Company also had to make a strong case for the economic justification of Physio-Stim. "While bone growth stimulation Bone Growth Stimulation Definition Bone growth stimulation is the technique of promoting bone growth in difficult to heal fractures by applying a low electrical current or ultrasound to the fracture. products are well-established in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , stimulation is a relatively new technology in Europe--thus offering an attractive level of potential growth, due in part to increasing procedure volumes, but also due to the significant competitive advantages of our stimulation product family," said Charles Federico, Group President and Chief Executive Officer of Orthofix. "We expect that we can grow our second-place(1) market share in France now that Physio-Stim will be reimbursed by the French government. In addition, we will continue to be aggressive in seeking reimbursement for our stimulation products in other European countries. Orthofix has the broadest line of clinically proven and FDA-cleared stimulation products, and we believe this presents us with significant competitive advantages--not only in Europe, but in the U.S. as well." "We are very proud to be the first PEMF PEMF pulse electromagnetic field. See magnetic field therapy. treatment reimbursed in France for pseudoarthosis and delayed union delayed union Orthopedics A delay in the healing of the ends of a fracture ," added Francoise Havez, General Manager of Orthofix, S.A. "The recommendation of the CEPP CEPP Chemical Emergency Preparedness Program (EPA) CEPP Chartered Estate Planning Practitioner CEPP Chemical Emergency Preparedness Plan CEPP Community Emergency Preparedness Programme (Singapore) (Commission d'Evaluation des Produits et Prestations) placed Physio-Stim ahead of a second surgery or ultrasound treatment. Physio-Stim enables quantifiable public healthcare cost-savings and will allow patients to come back to work earlier. Our great reputation among surgeons has presumably pre·sum·a·ble adj. That can be presumed or taken for granted; reasonable as a supposition: presumable causes of the disaster. always been a competitive advantage. Reimbursement is an additional benefit." According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. Medtech Insight, a division of Windhover wind·hov·er n. Chiefly British A kestrel. Information, in 2004 there were approximately 1,838 procedures in France that used bone growth stimulation products post-operatively, representing approximately $4.2 million in sales. Sales in France are expected to increase to $4.5 million in the year 2008. (1) About Physio-Stim(R) Physio-Stim is indicated for the treatment of an established nonunion nonunion /non·union/ (non-un´yun) failure of the ends of a fractured bone to unite. non·un·ion n. The failure of a fractured bone to heal normally. acquired secondary to trauma. A nonunion is considered to be established when the fracture site shows no visible progressive signs of healing. Physio-Stim is a single-piece, self-contained, battery-powered, non-invasive, low energy, pulsed electromagnetic device. It contains an integrated microprocessor-based control unit that generates programmed current pulses for the treatment transducer transducer, device that accepts an input of energy in one form and produces an output of energy in some other form, with a known, fixed relationship between the input and output. . The Transducer, in turn, delivers a uniform low-amplitude pulsed electromagnetic field electromagnetic field Property of space caused by the motion of an electric charge. A stationary charge produces an electric field in the surrounding space. If the charge is moving, a magnetic field is also produced. A changing magnetic field also produces an electric field. (PEMF) to the fracture site. The device is powered by a single 9-volt disposable battery. The integrated Transducer/Control unit design eliminates all cords, connections and cables for the patient to manage. The device is lightweight and allows great freedom of movement during treatment sessions. Phsyio-Stim is intended for daily application of three hours per day for 90 to 180 days of usage. (1) Source: Medtech Insight, a division of Windhover Information, "European Markets for Orthopedic Implants and Trauma Products", October 2004. About Orthofix International, N.V. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 relationship 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and other periodic reports filed by Orthofix with the Securities and Exchange Commission. |
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