Orthofix Announces Japanese Approval and Market Launch of PHOENIX Minimally Invasive Spinal Fixation System

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.

About Orthofix

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.

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, 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.