Orthofix International N.V. (NASDAQ: OFIX) (the Company) announced today
that the Company has received CE Marking for its Advent™
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.
About Orthofix
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.
Forward-Looking Statements
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.