Orthofix receives FDA approval for its new product Cervical-StimÒ,the world’s first and only ‘on-label’ bone growth stimulator for use as an adjunct to cervical (upper) spine fusion in ‘high-risk’ patients.Orthofix now is the only company that can offer surgeons and their patients a full range of FDA-approved, clinically effective, non-invasive, stimulation products for healing the cervical and lumbar spine and long-bone fractures.
“We expect this milestone to establish us as the market growth leader in the spine stimulation business in 2005.”
Charles Federico, Group President and CEO
Orthofix International, N.V. (NASDAQ: OFIX) announced today that it has received from the U.S. Food and Drug Administration (FDA) approval to market the Company’s Cervical-Stim® bone growth stimulator as an FDA Class III device. This is the first and only FDA-approved bone growth stimulator for use as an adjunct to cervical (upper) spine fusion in high-risk patients.
Orthofix is the only company that can offer surgeons and their patients a full range of FDA-approved, clinically effective, non-invasive, low-energy stimulation products for healing the cervical and lumbar spine as well as long bone non-unions.
“This new product Cervical-Stim is a very valuable complement to our existing Physio-Stim and Spinal-Stim lines of bone growth stimulators. FDA approval of Cervical-Stim means that, now, for the first time, there is an ‘on-label’ adjunct therapy that spine surgeons can prescribe for their cervical fusion patients who are at high risk of not healing properly,” said Charles W. Federico, Group President and Chief Executive Officer of Orthofix.
“Because of the expected demand for our new product, we will begin marketing and selling Cervical-Stim immediately,” added Federico. “The spine stimulation market is estimated to be about a $205 million market next year. We believe FDA approval of Cervical-Stim will provide us with the necessary product line portfolio to increase our current 38 percent share of the total spinal stimulation market. Our 2005 growth rate should exceed the current market growth rate in this area.”
The FDA approved Cervical-Stim® based on a PMA (pre-market approval) application that included the results of a prospective, randomized, multi-center clinical investigation of Cervical-Stim® led by Kevin Foley, M.D., of the University of Tennessee’s Department of Neurosurgery. The clinical trial randomized a total of 323 ‘high-risk’ patients who had undergone cervical fusion surgery for degenerative conditions. The results of this pivotal study were presented from the podium by Dr. Foley at the North American Spine Society’s 2004 Annual Meeting in Chicago, Oct. 26-30.
Cervical-Stim® generates a uniform, low-level pulsed electromagnetic field (PEMF) at the fusion site. Application of PEMF activates the body's natural repair mechanism when it is absent or not fully functional in certain patients, and consequently enhances bone growth for successful fusion outcomes. Orthofix is sponsoring independent research at the Cleveland Clinic, where scientists are conducting ‘mechanism of action’ studies to identify the influence of PEMF on bone cell proliferation. Results show that application of PEMF activates specific bone cell membrane receptors and sets off internal signaling within the bone cell—causing proliferation. Results of these studies are scheduled for publication in 2005.
To view a video of an interview with neurosurgeon Kevin Foley, MD, principal investigator for the pivotal clinical study of Cervical-Stim®, please visit www.orthofix.com.
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, Stryker Howmedica, and Kendall Healthcare. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Wake Forest University School of Medicine, 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 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 and other periodic reports filed by Orthofix with the Securities and Exchange Commission.
© 2005 HealthNewsDigest.com
