Healthcare Industry News: osteoporosis
News Release - June 13, 2007
Orthofix Announces First Surgical Procedure Using Advent(TM) Cervical DiscHUNTERSVILLE, N.C.--(HSMN NewsFeed)--Orthofix International N.V. (NASDAQ: OFIX ) announced today the completion of the first surgical procedure to implant the Advent(TM) Cervical Disc, which is the first motion preservation device developed by Orthofix's spine implant subsidiary, Blackstone Medical. The successful procedure was performed at the prestigious Sao Paulo University Medical Center in Sao Paulo, Brazil by Dr. Tarcisio Eloy de Barros Filho and Dr. Alexandre Fogaca. The Vice-Dean of the Sao Paulo University Medical School and Titular Professor of the Orthopaedic Department, Dr. Barros is also the president-elect of the Brazilian Orthopaedic and Traumatology Society.
"The procedure involving the implantation of an artificial vertebral disc in a 51-year old female patient went very well," said Dr. Barros. "I found the simplicity of the surgical technique used to implant the device and the well-designed, intuitive instrumentation to be important advantages of the Advent disc."
Dr. Scott Blumenthal of the Texas Back Institute in Dallas, Texas, a member of Blackstone's medical advisory board who also attended the surgery and provided additional training, stated that, "as one of the first artificial cervical discs to incorporate a flexible elastomer core, the Advent disc has advanced biomechanical properties designed to provide patients with a natural range of motion post-surgically. Additionally, the pre-assembled design reduces the need for complex instrumentation and simplifies the surgical technique."
"This is truly a breakthrough product for the company, as it represents our entrance into the important motion preservation segment of the spine industry which is estimated to grow to several billion dollars worldwide over the next few years", said Alan Milinazzo, Orthofix's CEO. "Though motion preservation is a surgical trend that is in its infancy, we believe it will become an accepted standard of care for many patients."
Matthew Lyons, the President of Blackstone Medical, added that, "our design team received important advice and feedback from key surgeons that facilitated the development of the compliant core and the simplified surgical technique used to implant the Advent disc. And, our engineers and medical advisory board will continue to work on the development of innovative products to expand our portfolio of motion preservation devices."
Orthofix indicated that it hopes to obtain a CE mark for the Advent Cervical Disc by the fourth quarter of this year, representing approval for commercial use throughout the European Union. The company also has plans to begin clinical trials in the U.S. by early next year, and anticipates obtaining FDA approval by the end of 2011.
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, orthopedic, and sports medicine 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, hospitals and patients via Orthofix's sales representatives and its subsidiaries, including Breg, Inc. and Blackstone Medical, Inc., and via partnerships with other leading orthopedic product companies including 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, and the National osteoporosis Institute. For more information about Orthofix, please visit www.orthofix.com.
This news release contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements concerning expectations related to new products at Orthofix and its subsidiaries, 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, 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.
Source: Orthofix International
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