Healthcare Industry News: cervical spine
News Release - July 15, 2009
Orthofix International Receives CE Marking for Advent Cervical DiscWith approval for sale in Europe, Company expects limited release in select international markets in Q409
BOSTON--(HSMN NewsFeed)--Orthofix International N.V. (NASDAQ: OFIX ) (the Company) announced today that the Company has received CE Marking for its Advent(TM) Cervical Disc, allowing it to begin selling the new device in Europe.
“Receiving our CE Marking for Advent is an important step in our plans for the global commercialization of our first artificial cervical disc,” said Alan Milinazzo, President and CEO of Orthofix International. “A key element of our plans for the continued expansion of our spinal implant portfolio is the addition of motion preservation devices that are designed to help spine patients maintain some degree of natural motion post surgically.”
Orthofix expects to begin a limited market release of Advent in Europe during the fourth quarter of this year. The Company also has a U.S. Advent study underway as part of the process for obtaining FDA approval for the device. With approximately 100 patients already enrolled at 15 centers, Orthofix plans to add 10 additional sites during the fourth quarter this year and the first quarter next year, and expects to enroll a total of 450 patients in the study from all of these sites. Upon completion of this study, Orthofix anticipates submitting the results to the FDA seeking its approval for the Company to begin marketing the device in the U.S.
Constructed with Titanium endplates and a flexible elastomer core, Advent is designed to be implanted in the cervical spine using a surgical procedure that is very similar to a standard anterior cervical discectomy and fusion (ACDF) procedure, which is the current standard of care for the treatment of many degenerative or traumatic disc conditions.
The European market for artificial cervical discs was estimated to be approximately €37.5 million in 2008, and is expected to increase at a compound annual growth rate of 14% over the next several years.
Orthofix International, N.V., a global medical device company, offers a broad line of minimally invasive surgical, and 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 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. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Musculoskeletal Transplant Foundation, the Orthopedic Research and Education Foundation, Rutgers University, Texas Scottish Rite Hospital for Children and National Osteoporosis Institute. For more information about Orthofix, please visit www.orthofix.com.
This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of 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, risks relating to the expected sales of its products, including recently launched products, 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 and interpretation of 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, corporate development and market development activities, including acquisitions or divestitures, unexpected costs or operating unit performance related to recent acquisitions and other factors described in our annual report on Form 10-K and other periodic reports filed by the Company with the Securities and Exchange Commission.
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