LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical
device company, today announced regulatory approval from the Japanese
Ministry of Health, Labor and Welfare (MHLW) of the PHOENIX®
Minimally Invasive Spinal (MIS) Fixation System. The introduction of
PHOENIX will set the stage for Orthofix to bring more of its innovative
spine technologies to this important market in the near future.
"The Japanese approval and full market launch of the PHOENIX MIS
fixation system represents an important step towards broadening the
availability of our spine fixation products globally by entering the
second largest spine market in the world," said Ray Fujikawa, President
of Orthofix Spine Fixation. "We are committed to continuing to work
towards securing additional product approvals in order to provide
surgeons in Japan with a full range of our spine fixation solutions."
Estimates by healthcare market research firm GlobalData indicate that by
2020 the spinal fusion market will be $684 million in Japan.
The PHOENIX MIS system enables the percutaneous placement of pedicle
screws designed to provide stabilization and correction to assist fusion
in patients suffering from degenerative disc disease, spinal stenosis
and trauma conditions in the middle and lower back. Featuring a unique
implant design for percutaneous and mini open surgical approaches, the
PHOENIX MIS system permits a smaller working diameter, thereby reducing
the surgical incision.
Orthofix International N.V. is a diversified, global medical device
company focused on improving patients' lives by providing superior
reconstructive and regenerative orthopedic and spine solutions to
physicians worldwide. Headquartered in Lewisville, Texas, the Company
has four strategic business units that include BioStim, Biologics,
Extremity Fixation and Spine Fixation. Orthofix products are widely
distributed via the Company's sales representatives, distributors and
its subsidiaries. In addition, Orthofix is collaborating on research and
development activities with leading clinical organizations such as the
Musculoskeletal Transplant Foundation and the Texas Scottish Rite
Hospital for Children. For more information, 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, 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.
The forward-looking statements in this release do not constitute
guarantees or promises of future performance. Factors that could cause
or contribute to such differences may include, but are not limited to
the risks described in the "Risk Factors" section of our 2015 Annual
Report on Form 10-K, as well as in other reports that we file in the
future. Existing and prospective investors are cautioned not to place
undue reliance on these forward-looking statements, which speak only as
of the date hereof. The Company undertakes no obligation to update or
revise the information contained in this press release.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160728005129/en/
Orthofix International N.V.
Denise Landry, 214-937-2529
Source: Orthofix International N.V.
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