Orthofix Announces Commercial Partnership with MRIguidance
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Insights
Orthofix Medical Inc.'s agreement with MRIguidance to distribute BoneMRI™ imaging software represents a strategic move in the medical imaging sector. The successful integration of BoneMRI technology with the 7D FLASH Navigation System marks a significant advancement in spinal surgery procedures. By negating the need for ionizing radiation, this innovation addresses long-standing concerns regarding patient and staff exposure during preoperative imaging. The shift towards radiation-free imaging is likely to influence the competitive landscape, compelling peers to accelerate the development of similar technologies.
The economic implications for Orthofix and its stakeholders are multifaceted. Adoption of the BoneMRI and FLASH Navigation System could lead to cost savings by reducing the need for additional imaging studies and potential complications associated with radiation exposure. Furthermore, this technology may improve operational efficiency within the operating room, given the system's ability to rapidly generate three-dimensional images for surgical navigation. As healthcare providers increasingly prioritize patient safety and cost-effectiveness, Orthofix may experience an uptick in demand for its innovative solutions.
The introduction of Orthofix's radiation-free imaging and navigation technology could disrupt the current standard of care in spine surgery. The promise of increased safety and efficiency has the potential to drive market adoption, which may result in an expanded customer base for Orthofix. However, the company's ability to capitalize on this technological edge will depend on factors such as insurance coverage, regulatory approvals and the results of clinical studies validating the efficacy and safety of the procedures performed using the new system.
From an industry perspective, Orthofix's announcement may set a new benchmark in surgical imaging standards. This could lead to increased regulatory scrutiny on radiation use in medical imaging, possibly affecting other medical device manufacturers. The long-term impact on the stock market will hinge on the broader adoption of the technology and the potential for Orthofix to secure a larger market share in the spine surgery segment.
The BoneMRI technology's ability to create a synthetic CT from an MRI exam is a noteworthy innovation in the field of radiology. This approach could potentially reduce the cumulative radiation dose that patients receive over their lifetime, which is a critical consideration in pediatric populations and individuals requiring multiple imaging studies. The 7D FLASH Navigation System's use of visible light for three-dimensional imaging also represents a shift from traditional fluoroscopy-based navigation, which may reduce intraoperative radiation exposure for both patients and staff.
While the immediate benefits of reducing radiation exposure are clear, it will be important to monitor the long-term outcomes and accuracy of spinal procedures conducted with this new technology. Comparisons with conventional imaging modalities will be essential to validate the efficacy of BoneMRI and the FLASH Navigation System in various clinical scenarios. The radiology community will be keenly interested in peer-reviewed studies and data that demonstrate the system's performance relative to current standards.
First radiation-free spine procedures using pre-operative MRI completed with the 7D FLASH Navigation System and BoneMRI Technology
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
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
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
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.
View source 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
Source: Orthofix Medical Inc.
FAQ
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