Orthofix Announces Commercial Partnership with MRIguidance

First radiation-free spine procedures using pre-operative MRI completed with the 7D FLASH Navigation System and BoneMRI Technology

Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced it has entered into an agreement with MRIguidance to distribute its BoneMRI™ imaging software in the U.S. The Company also announced the successful completion of the world’s first eight cases utilizing BoneMRI software with 7D’s FLASH^™ Navigation System. BoneMRI creates a synthetic CT from an MRI imaging exam without the use of harmful radiation. For the first time, surgeons, their staff, and patients can now benefit from completely radiation-free preoperative imaging and spinal navigation using BoneMRI with the 7D FLASH Navigation System.

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Image of the 7D FLASH Navigation System. (Photo: Business Wire)

“I can now provide my patients a one-hundred percent radiation-free experience from their pre-op exam through the navigation imaging for their spine surgery,” said Dr. Jacob Rumley, an orthopedic surgeon with the Center for Spine and Orthopedics in Denver, CO. “The dangers of radiation exposure to patients, hospital staff and surgeons are very real. Technologies like the 7D FLASH Navigation System that enable radiation-free navigation are essential as we continue to advance patient care.”

The 7D FLASH Navigation System uses visible light to create a three-dimensional image for surgical navigation in seconds, enabling faster and more efficient spinal procedures. The only marketed image-guidance system that utilizes novel and proprietary camera-based technology, coupled with machine-vision algorithms, the 7D FLASH Navigation System eliminates many of the long-standing frustrations of legacy surgical navigation platforms. The speed, accuracy and efficiency of machine-vision technology is intended to provide significant economic value and lower radiation exposure for staff and patients during spinal fusion procedures.

“Our team is passionate about optimizing clinical workflows and reducing radiation exposure to improve patient care and physician safety,” said Dr. Beau Standish, President of Global Enabling Technologies at Orthofix. “In addition to removing the need for pre-operative radiation, this collaborative innovation also minimizes the number of pre-operative scans down to just one saving the healthcare system both time and money. This is truly revolutionary.”

“We are excited and proud to see BoneMRI software enabling and complementing the 7D FLASH Navigation System to offer a completely radiation-free pre- and intra-operative workflow for our patients and to protect the surgical team,” said Marijn van Stralen, Chief Technology Officer at MRIguidance. “This is the first time we have demonstrated the recurrent use of BoneMRI as an alternative to a CT scan. This marks the successful start to a fruitful collaboration with Orthofix to deliver radiation-free spine surgery.”

To learn more about the 7D FLASH Navigation System, please visit SeaSpine.com or 7DSurgical.com.

About Orthofix

Orthofix is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Its products are distributed in approximately 68 countries worldwide.

The Company is headquartered in Lewisville, Texas and has primary offices in Carlsbad, CA, with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics. The combined Company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Branch, MS, Maidenhead, UK, Munich, Germany, Paris, France and Sao Paulo, Brazil. To learn more, visit Orthofix.com.

About MRIguidance

MRIguidance is a Dutch medical imaging software company founded in 2016 that leverages the technological possibilities in medical imaging to benefit value-based healthcare and to deliver safety for patients and healthcare professionals. The company enables radiologists and orthopedic surgeons by providing seamlessly integrated radiation free BoneMRI in regular imaging workflows, to visualize and characterize the osseous and soft tissue structures from one imaging exam.

Since 2023 MRIguidance expanded its presence from the EU to also serve the U.S. market through offices in New York and headquarters in Utrecht, the Netherlands.

Forward-Looking Statements

This news release may include forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” “continue” or other comparable terminology. Orthofix cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Each forward-looking statement contained in this news release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of robust clinical validation; and the risks identified under the heading “Risk Factors” in Orthofix Medical Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on March 6, 2023. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Orthofix does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

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