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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version on businesswire.com: https://www.businesswire.com/news/home/20240118330867/en/
Media Relations Denise Landry DeniseLandry@orthofix.com
214.937.2529 Investor Relations Louisa Smith, Gilmartin
Group IR@orthofix.com
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